0A4F4F9BD490A749D5437F821CF06DF1

Food, Drug, and Cosmetic Act

https://www.govinfo.gov/content/pkg/USCODE-2011-title21/html/USCODE-2011-title21-chap9.htm

http://leaux.net/URLS/ConvertAPI Text Files/2C9188C7A7DA002D82DD7C9C2DE98A65.en.txt

Examining the file media/Synopses/2C9188C7A7DA002D82DD7C9C2DE98A65.html:

This file was generated: 2020-07-14 04:38:49

Indicators in focus are typically shown highlighted in yellow; Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; "Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; Trigger Words/Phrases are shown highlighted in gray.

Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)


Applicable Type / Vulnerability / Indicator Overlay for this Input

Vulnerability TypeVulnerabilityIndicator# Matches
PoliticalCriminal Convictionsfelony15
PoliticalIllegal Activityillegal8
PoliticalIllegal Activityunlawful8
Politicalcriminalcriminal46
Politicalpolitical affiliationparty184
Politicalpolitical affiliationpolitical56
Politicalstateless personsnation2
Politicalvulnerablevulnerable3
Politicalvulnerablevulnerability1
HealthCognitive Impairmentimpaired1
HealthCognitive Impairmentimpairment7
HealthDrug Dependencedependence11
HealthDrug Dependencedependency1
HealthDrug Usagedrug3342
HealthDrug Usageinfluence3
HealthDrug Usagesubstance160
HealthDrug Usageusage4
HealthMentally Disableddisability3
HealthMotherhood/Familyfamily31
HealthPhysically Disabledillness49
HealthPhysically Disabledphysically8
HealthPregnantpregnant3
Healthalcoholismalcoholic1
Healthpatients in emergency situationsemergencies5
Healthpatients in emergency situationsemergency situation2
SocialAccess to Social Goodsnecessities1
SocialAccess to Social Goodsaccess111
SocialAccess to informationaccess to information1
SocialAccess to informationfreedom of information5
SocialAgeage49
SocialChildchild3
SocialChildchildren57
SocialElderlyelderly5
SocialEthnicityethnic6
SocialFetus/Neonateneonates5
SocialIncarceratedprison1
SocialIncarceratedrestricted33
SocialInfantinfant82
SocialLinguistic Proficiencylanguage30
SocialLiteracyliteracy1
SocialMarital Statussingle80
SocialPolice Officerofficer137
SocialProperty Ownershiphome2
SocialProperty Ownershipproperty10
SocialRacial Minorityminority3
SocialRacial Minorityracial6
SocialReligionfaith14
SocialReligionbelief8
SocialReligionconviction40
SocialReligionreligious1
SocialSoldierarmed forces3
SocialSoldiermilitary4
SocialThreat of Stigmathreat27
SocialTrade Union Membershipunion3
SocialVictim of Abuseabuse9
SocialWomenwomen19
SocialYouth/Minorsminor84
SocialYouth/Minorsyouth8
Socialeducationeducation137
Socialeducationeducational6
Socialemployeesemployees152
Socialorphanorphan25
Socialparentsparent10
Socialparentsparents2
Socialphilosophical differences/differences of opinionopinion27
EconomicEconomic/Povertypoor1
General/OtherDependentdependent3
General/OtherIncapacitatedincapacity3
General/OtherNatural Hazardshazard46
General/OtherOther Countryforeign country10
General/OtherPublic Emergencyemergency52
General/OtherRelationship to Authorityauthority241

Political / Criminal Convictions

Searching for indicator felony:

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p.001994: act or causing it to be done acted in good faith and had no reason to believe that the drug
p.001994: was a counterfeit drug.
p.001994: (d) Exceptions involving misbranded food
p.001994: No person shall be subject to the penalties of subsection (a)(1) of this section for a
p.001994: violation of section 331 of this title involving misbranded food if the violation exists solely
p.001994: because the food is misbranded under section 343(a)(2) of this title because of its
p.001994: advertising.
p.001994: (e) Prohibited distribution of human growth hormone
p.001994: (1) Except as provided in paragraph (2), whoever knowingly distributes, or possesses
p.001994: with intent to distribute, human growth hormone for any use in humans other than the
p.001994: treatment of a disease or other recognized medical condition, where such use has been
p.001994: authorized by the Secretary of Health and Human Services under section 355 of this title
p.001994: and pursuant to the order of a physician, is guilty of an offense punishable by not more than
p.001994: 5 years in prison, such fines as are authorized by title 18, or both.
p.001994: (2) Whoever commits any offense set forth in paragraph (1) and such offense involves an
p.001994: individual under 18 years of age is punishable by not more than 10 years imprisonment,
p.001994: such fines as are authorized by title 18, or both.
p.001994: (3) Any conviction for a violation of paragraphs (1) and (2) of this subsection shall be
p.001994: considered a felony violation of the Controlled Substances Act [21 U.S.C. 801 et seq.] for
p.001994: the purposes of forfeiture under section 413 of such Act [21 U.S.C. 853].
p.001994: (4) As used in this subsection the term “human growth hormone” means somatrem,
p.001994: somatropin, or an analogue of either of them.
p.001994: (5) The Drug Enforcement Administration is authorized to investigate offenses punishable
p.001994: by this subsection.
p.001994: (f) Violations related to devices
p.001994: (1)(A) Except as provided in subparagraph (B), any person who violates a requirement of
p.001994: this chapter which relates to devices shall be liable to the United States for a civil penalty in
p.001994: an amount not to exceed $15,000 for each such violation, and not to exceed $1,000,000 for
p.001994: all such violations adjudicated in a single proceeding. For purposes of the preceding
p.001994: sentence, a person accredited under paragraph (2) of section 374(g) of this title who is
p.001994: substantially not in compliance with the standards of accreditation under such section, or
p.001994: who poses a threat to public health or fails to act in a manner that is consistent with the
p.001994: purposes of such section, shall be considered to have violated a requirement of this chapter
p.001994: that relates to devices.
p.001994: (B) Subparagraph (A) shall not apply—
p.001994: (i) to any person who violates the requirements of section 360i(a) or 360j(f) of this title
p.001994: unless such violation constitutes (I) a significant or knowing departure from such
p.001994: requirements, or (II) a risk to public health,
...

p.001994: Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this
p.001994: title.
p.001994:
p.001994:
p.001994: §335. Hearing before report of criminal violation
p.001994: Before any violation of this chapter is reported by the Secretary to any United States
p.001994: attorney for institution of a criminal proceeding, the person against whom such proceeding
p.001994: is contemplated shall be given appropriate notice and an opportunity to present his views,
p.001994: either orally or in writing, with regard to such contemplated proceeding.
p.001994: (June 25, 1938, ch. 675, §305, 52 Stat. 1045.)
p.001994: TRANSFER OF FUNCTIONS
p.001994: For transfer of functions of Federal Security Administrator to Secretary of Health, Education,
p.001994: and Welfare [now Health and Human Services], and of Food and Drug Administration in the
p.001994: Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this
p.001994: title.
p.001994:
p.001994:
p.001994: §335a. Debarment, temporary denial of approval, and suspension
p.001994: (a) Mandatory debarment; certain drug applications
p.001994: (1) Corporations, partnerships, and associations
p.001994: If the Secretary finds that a person other than an individual has been convicted, after
p.001994: May 13, 1992, of a felony under Federal law for conduct relating to the development or
p.001994: approval, including the process for development or approval, of any abbreviated drug
p.001994: application, the Secretary shall debar such person from submitting, or assisting in the
p.001994: submission of, any such application.
p.001994: (2) Individuals
p.001994: If the Secretary finds that an individual has been convicted of a felony under Federal
p.001994: law for conduct—
p.001994: (A) relating to the development or approval, including the process for development or
p.001994: approval, of any drug product, or
p.001994: (B) otherwise relating to the regulation of any drug product under this chapter,
p.001994:
p.001994: the Secretary shall debar such individual from providing services in any capacity to a
p.001994: person that has an approved or pending drug product application.
p.001994: (b) Permissive debarment; certain drug applications; food imports
p.001994: (1) In general
p.001994: The Secretary, on the Secretary's own initiative or in response to a petition, may, in
p.001994: accordance with paragraph (2), debar—
p.001994: (A) a person other than an individual from submitting or assisting in the submission of
p.001994: any abbreviated drug application,
p.001994: (B) an individual from providing services in any capacity to a person that has an
p.001994: approved or pending drug product application, or
p.001994: (C) a person from importing an article of food or offering such an article for import
p.001994: into the United States.
p.001994: (2) Persons subject to permissive debarment; certain drug applications
p.001994: The following persons are subject to debarment under subparagraph (A) or (B) of
p.001994: paragraph (1):
p.001994: (A) Corporations, partnerships, and associations
p.001994: Any person other than an individual that the Secretary finds has been convicted—
p.001994: (i) for conduct that—
p.001994: (I) relates to the development or approval, including the process for the
p.001994: development or approval, of any abbreviated drug application; and
p.001994: (II) is a felony under Federal law (if the person was convicted before May 13,
p.001994: 1992), a misdemeanor under Federal law, or a felony under State law, or
p.001994:
p.001994: (ii) of a conspiracy to commit, or aiding or abetting, a criminal offense described in
p.001994: clause (i) or a felony described in subsection (a)(1) of this section,
p.001994:
p.001994: if the Secretary finds that the type of conduct which served as the basis for such
p.001994: conviction undermines the process for the regulation of drugs.
p.001994: (B) Individuals
p.001994: (i) Any individual whom the Secretary finds has been convicted of—
p.001994: (I) a misdemeanor under Federal law or a felony under State law for conduct
p.001994: relating to the development or approval, including the process for development or
p.001994: approval, of any drug product or otherwise relating to the regulation of drug products
p.001994: under this chapter, or
p.001994: (II) a conspiracy to commit, or aiding or abetting, such criminal offense or a felony
p.001994: described in subsection (a)(2) of this section,
p.001994:
p.001994: if the Secretary finds that the type of conduct which served as the basis for such
p.001994: conviction undermines the process for the regulation of drugs.
p.001994: (ii) Any individual whom the Secretary finds has been convicted of—
p.001994: (I) a felony which is not described in subsection (a)(2) of this section or clause (i)
p.001994: of this subparagraph and which involves bribery, payment of illegal gratuities, fraud,
p.001994: perjury, false statement, racketeering, blackmail, extortion, falsification or destruction
p.001994: of records, or interference with, obstruction of an investigation into, or prosecution of,
p.001994: any criminal offense, or
p.001994: (II) a conspiracy to commit, or aiding or abetting, such felony,
p.001994:
p.001994: if the Secretary finds, on the basis of the conviction of such individual and other
p.001994: information, that such individual has demonstrated a pattern of conduct sufficient to find that
p.001994: there is reason to believe that such individual may violate requirements under this chapter
p.001994: relating to drug products.
p.001994: (iii) Any individual whom the Secretary finds materially participated in acts that were
p.001994: the basis for a conviction for an offense described in subsection (a) of this section or in
p.001994: clause (i) or (ii) for which a conviction was obtained, if the Secretary finds, on the basis
p.001994: of such participation and other information, that such individual has demonstrated a
p.001994: pattern of conduct sufficient to find that there is reason to believe that such individual
p.001994: may violate requirements under this chapter relating to drug products.
p.001994: (iv) Any high managerial agent whom the Secretary finds—
p.001994: (I) worked for, or worked as a consultant for, the same person as another
p.001994: individual during the period in which such other individual took actions for which a
p.001994: felony conviction was obtained and which resulted in the debarment under
p.001994: subsection (a)(2) of this section, or clause (i), of such other individual,
p.001994: (II) had actual knowledge of the actions described in subclause (I) of such other
p.001994: individual, or took action to avoid such actual knowledge, or failed to take action for
p.001994: the purpose of avoiding such actual knowledge,
p.001994: (III) knew that the actions described in subclause (I) were violative of law, and
p.001994: (IV) did not report such actions, or did not cause such actions to be reported, to an
p.001994: officer, employee, or agent of the Department or to an appropriate law enforcement
p.001994: officer, or failed to take other appropriate action that would have ensured that the
p.001994: process for the regulation of drugs was not undermined, within a reasonable time
p.001994: after such agent first knew of such actions,
p.001994:
p.001994: if the Secretary finds that the type of conduct which served as the basis for such other
p.001994: individual's conviction undermines the process for the regulation of drugs.
p.001994: (3) Persons subject to permissive debarment; food importation
p.001994: A person is subject to debarment under paragraph (1)(C) if—
p.001994: (A) the person has been convicted of a felony for conduct relating to the importation
p.001994: into the United States of any food; or
p.001994: (B) the person has engaged in a pattern of importing or offering for import
p.001994: adulterated food that presents a threat of serious adverse health consequences or
p.001994: death to humans or animals.
p.001994: (4) Stay of certain orders
p.001994: An order of the Secretary under clause (iii) or (iv) of paragraph (2)(B) shall not take
p.001994: effect until 30 days after the order has been issued.
p.001994: (c) Debarment period and considerations
p.001994: (1) Effect of debarment
p.001994: The Secretary—
p.001994: (A) shall not accept or review (other than in connection with an audit under this
p.001994: section) any abbreviated drug application submitted by or with the assistance of a
p.001994: person debarred under subsection (a)(1) or (b)(2)(A) of this section during the period
p.001994: such person is debarred,
p.001994: (B) shall, during the period of a debarment under subsection (a)(2) or (b)(2)(B) of this
p.001994: section, debar an individual from providing services in any capacity to a person that has
p.001994: an approved or pending drug product application and shall not accept or review (other
p.001994: than in connection with an audit under this section) an abbreviated drug application
p.001994: from such individual, and
p.001994: (C) shall, if the Secretary makes the finding described in paragraph (6) or (7) of
p.001994: section 335b(a) of this title, assess a civil penalty in accordance with section 335b of
p.001994: this title.
p.001994: (2) Debarment periods
p.001994: (A) In general
...

p.001994: subsection (a)(2) of this section or clause (i), (ii), (iii), or (iv) of subsection (b)(2)(B) or
p.001994: subsection (b)(3) of this section is reversed, the Secretary shall withdraw the order of
p.001994: debarment.
p.001994: (ii) Application
p.001994: Upon application submitted under paragraph (1), the Secretary shall terminate the
p.001994: debarment of an individual who has been debarred under subsection (b)(2)(B) or
p.001994: subsection (b)(3) of this section if such termination serves the interests of justice and
p.001994: adequately protects the integrity of the drug approval process or the food importation
p.001994: process, as the case may be.
p.001994: (4) Special termination
p.001994: (A) Application
p.001994: Any person that is debarred under subsection (a)(1) of this section (other than a
p.001994: person permanently debarred under subsection (c)(2)(A)(i) of this section) or any
p.001994: individual who is debarred under subsection (a)(2) of this section may apply to the
p.001994: Secretary for special termination of debarment under this subsection. Any information
p.001994: submitted to the Secretary under this subparagraph does not constitute an amendment
p.001994: or supplement to pending or approved abbreviated drug applications.
p.001994: (B) Corporations
p.001994: Upon an application submitted under subparagraph (A), the Secretary may take the
p.001994: action described in subparagraph (D) if the Secretary, after an informal hearing, finds
p.001994: that—
p.001994: (i) the person making the application under subparagraph (A) has demonstrated
p.001994: that the felony conviction which was the basis for such person's debarment involved
p.001994: the commission of an offense which was not authorized, requested, commanded,
p.001994: performed, or recklessly tolerated by the board of directors or by a high managerial
p.001994: agent acting on behalf of the person within the scope of the board's or agent's office
p.001994: or employment,
p.001994: (ii) all individuals who were involved in the commission of the offense or who knew
p.001994: or should have known of the offense have been removed from employment involving
p.001994: the development or approval of any drug subject to sections 1 355 of this title,
p.001994: (iii) the person fully cooperated with all investigations and promptly disclosed all
p.001994: wrongdoing to the appropriate authorities, and
p.001994: (iv) the person acted to mitigate any impact on the public of any offense involved,
p.001994: including the recall, or the discontinuation of the distribution, of any drug with respect
p.001994: to which the Secretary requested a recall or discontinuation of distribution due to
p.001994: concerns about the safety or efficacy of the drug.
p.001994: (C) Individuals
p.001994: Upon an application submitted under subparagraph (A), the Secretary may take the
p.001994: action described in subparagraph (D) if the Secretary, after an informal hearing, finds
p.001994: that such individual has provided substantial assistance in the investigations or
p.001994: prosecutions of offenses which are described in subsection (a) or (b) of this section or
p.001994: which relate to any matter under the jurisdiction of the Food and Drug Administration.
...

p.001994: or State court, regardless of whether there is an appeal pending,
p.001994: (B) when a plea of guilty or nolo contendere by the person has been accepted by a
p.001994: Federal or State court, or
p.001994: (C) when the person has entered into participation in a first offender, deferred
p.001994: adjudication, or other similar arrangement or program where judgment of conviction
p.001994: has been withheld.
p.001994: (2) Effective dates
p.001994: Subsection (a) of this section, subparagraph (A) of subsection (b)(2) of this section,
p.001994: clauses (i) and (ii) of subsection (b)(2)(B) of this section, and subsection (b)(3)(A) of this
p.001994: section shall not apply to a conviction which occurred more than 5 years before the
p.001994: initiation of an agency action proposed to be taken under subsection (a) or (b) of this
p.001994: section. Clauses (iii) and (iv) of subsection (b)(2)(B) of this section, subsection (b)(3)(B)
p.001994: of this section, and subsections (f) and (g) of this section shall not apply to an act or
p.001994: action which occurred more than 5 years before the initiation of an agency action
p.001994: proposed to be taken under subsection (b), (f), or (g) of this section. Clause (iv) of
p.001994: subsection (b)(2)(B) of this section shall not apply to an action which occurred before
p.001994: June 1, 1992. Subsection (k) of this section shall not apply to applications submitted to
p.001994: the Secretary before June 1, 1992.
p.001994: (m) Devices; mandatory debarment regarding third-party inspections and reviews
p.001994: (1) In general
p.001994: If the Secretary finds that a person has been convicted of a felony under section
p.001994: 331(gg) of this title, the Secretary shall debar such person from being accredited under
p.001994: section 360m(b) or 374(g)(2) of this title and from carrying out activities under an
p.001994: agreement described in section 383(b) of this title.
p.001994: (2) Debarment period
p.001994: The Secretary shall debar a person under paragraph (1) for the following periods:
p.001994: (A) The period of debarment of a person (other than an individual) shall not be less
p.001994: than 1 year or more than 10 years, but if an act leading to a subsequent debarment
p.001994: under such paragraph occurs within 10 years after such person has been debarred
p.001994: under such paragraph, the period of debarment shall be permanent.
p.001994: (B) The debarment of an individual shall be permanent.
p.001994: (3) Termination of debarment; judicial review; other matters
p.001994: Subsections (c)(3), (d), (e), (i), (j), and (l)(1) of this section apply with respect to a
p.001994: person (other than an individual) or an individual who is debarred under paragraph (1) to
p.001994: the same extent and in the same manner as such subsections apply with respect to a
p.001994: person who is debarred under subsection (a)(1) of this section, or an individual who is
p.001994: debarred under subsection (a)(2) of this section, respectively.
p.001994: (June 25, 1938, ch. 675, §306, as added Pub. L. 102–282, §2, May 13, 1992, 106 Stat. 150;
p.001994: amended Pub. L. 105–115, title I, §125(b)(2)(C), Nov. 21, 1997, 111 Stat. 2325; Pub. L.
p.001994: 107–188, title III, §304(a)–(c), June 12, 2002, 116 Stat. 665, 666; Pub. L. 107–250, title II,
p.001994: §203, Oct. 26, 2002, 116 Stat. 1610.)
p.001994: PRIOR PROVISIONS
p.001994: A prior section 306 of act June 25, 1938, was renumbered section 309 and is classified to
p.001994: section 336 of this title.
p.001994: AMENDMENTS
...

p.000398: the operation of this subsection as he finds necessary for the proper administration of the
p.000398: provisions of this chapter.
p.000398: (c) Records of other departments and agencies
p.000398: For purposes of enforcement of this chapter, records of any department or independent
p.000398: establishment in the executive branch of the Government shall be open to inspection by any
p.000398: official of the Department duly authorized by the Secretary to make such inspection.
p.000398: (d) Information on patents for drugs
p.000398: The Secretary is authorized and directed, upon request from the Under Secretary of
p.000398: Commerce for Intellectual Property and Director of the United States Patent and Trademark
p.000398: Office, to furnish full and complete information with respect to such questions relating to
p.000398: drugs as the Director may submit concerning any patent application. The Secretary is
p.000398: further authorized, upon receipt of any such request, to conduct or cause to be conducted,
p.000398: such research as may be required.
p.000398: (e) Powers of enforcement personnel
p.000398: Any officer or employee of the Department designated by the Secretary to conduct
p.000398: examinations, investigations, or inspections under this chapter relating to counterfeit drugs
p.000398: may, when so authorized by the Secretary—
p.000398: (1) carry firearms;
p.000398: (2) execute and serve search warrants and arrest warrants;
p.000398: (3) execute seizure by process issued pursuant to libel under section 334 of this title;
p.000398: (4) make arrests without warrant for offenses under this chapter with respect to such
p.000398: drugs if the offense is committed in his presence or, in the case of a felony, if he has
p.000398: probable cause to believe that the person so arrested has committed, or is committing,
p.000398: such offense; and
p.000398: (5) make, prior to the institution of libel proceedings under section 334(a)(2) of this title,
p.000398: seizures of drugs or containers or of equipment, punches, dies, plates, stones, labeling,
p.000398: or other things, if they are, or he has reasonable grounds to believe that they are, subject
p.000398: to seizure and condemnation under such section 334(a)(2). In the event of seizure
p.000398: pursuant to this paragraph (5), libel proceedings under section 334(a)(2) of this title shall
p.000398: be instituted promptly and the property seized be placed under the jurisdiction of the
p.000398: court.
p.000398: (June 25, 1938, ch. 675, §702, 52 Stat. 1056; Pub. L. 87–781, title III, §§307(b), 308, Oct.
p.000398: 10, 1962, 76 Stat. 796; Pub. L. 89–74, §8(a), July 15, 1965, 79 Stat. 234; Pub. L. 91–513,
p.000398: title II, §701(f), Oct. 27, 1970, 84 Stat. 1282; Pub. L. 102–300, §6(b)(2), June 16, 1992, 106
p.000398: Stat. 240; Pub. L. 103–80, §3(dd)(2), Aug. 13, 1993, 107 Stat. 779; Pub. L. 106–113, div. B,
p.000398: §1000(a)(9) [title IV, §4732(b)(12)], Nov. 29, 1999, 113 Stat. 1536, 1501A–584; Pub. L.
p.000398: 107–188, title III, §314, June 12, 2002, 116 Stat. 674; Pub. L. 111–31, div. A, title I, §103(g),
p.000398: June 22, 2009, 123 Stat. 1837.)
p.000398: AMENDMENTS
p.000398: 2009—Subsec. (a)(1). Pub. L. 111–31 designated existing provisions as subpar. (A) and added
p.000398: subpar. (B).
p.000398: 2002—Subsec. (a). Pub. L. 107–188 inserted “(1)” before “The Secretary is authorized to
p.000398: conduct”, added par. (2), inserted “(3)” before “In the case of food packed”, and substituted “(4)
p.000398: For the purposes of this subsection,” for “For the purposes of this subsection”.
...

Political / Illegal Activity

Searching for indicator illegal:

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p.001994: 1988—Par. (t). Pub. L. 100–293 added par. (t).
p.001994: 1986—Par. (s). Pub. L. 99–570 amended par. (s) generally. Prior to amendment, par. (s) read
p.001994: as follows: “The failure to provide the notice required by section 350a(b) or 350a(c), the failure to
p.001994: make the reports required by section 350a(d)(1)(B), or the failure to meet the requirements
p.001994: prescribed under section 350a(d)(2).”
p.001994: 1980—Par. (e). Pub. L. 96–359, §5(b), inserted reference to section 350a of this title in two
p.001994: places.
p.001994: Par. (j). Pub. L. 96–359, §5(c), inserted reference to section 350a of this title.
p.001994: Par. (s). Pub. L. 96–359, §5(a), added par. (s).
p.001994: 1976—Par. (e). Pub. L. 94–295, §3(b)(2), inserted references to sections 360e(f) and 360i of
p.001994: this title.
p.001994: Par. (j). Pub. L. 94–295, §3(b)(3), inserted references to sections 360, 360c, 360d, 360e, 360f,
p.001994: 360h, 360i, 360j, and 379 of this title.
p.001994: Par. (l). Pub. L. 94–295, §3(b)(4), substituted “drug or device” for “drug” wherever appearing,
p.001994: and inserted references to sections 360e and 360j(g) of this title.
p.001994: Par. (p). Pub. L. 94–295, §4(b)(1), substituted “section 360(j) or 360(k) of this title,” for “section
p.001994: 360(j) of this title,”.
p.001994: Par. (q). Pub. L. 94–295, §3(b)(1), added par. (q).
p.001994: Par. (r). Pub. L. 94–295, §7(b), added par. (r).
p.001994: 1972—Par. (p). Pub. L. 92–387 added failure to provide information required by section 360(j)
p.001994: of this title, and failure to provide notice required by section 360(j)(2) of this title as prohibited acts.
p.001994: 1970—Par. (q). Pub. L. 91–513 struck out par. (q) which set out penalties for illegal
p.001994: manufacture, sale, disposition, possession and other traffic in stimulant and depressant drugs.
p.001994: See section 801 et seq. of this title.
p.001994: 1968—Par. (e). Pub. L. 90–399, §103(1), struck out “or” before “357(d) or (g)” and inserted “, or
p.001994: 360b(j), (l), or (m)” after “357(d) or (g)”. Amendment striking out “or” was executed as described,
p.001994: notwithstanding directory language that “or” before “357,” be stricken out, to reflect the probable
p.001994: intent of Congress.
p.001994: Par. (j). Pub. L. 90–399, §103(2), inserted reference to section 360b of this title.
p.001994: Par. (q). Pub. L. 90–639 divided cl. (3), which referred simply to possession in violation of
p.001994: section 360a(c) of this title, into subcls. (A) and (B) which refer, respectively, to possession in
p.001994: violation of section 360a(c)(1) of this title and possession in violation of section 360a(c)(2) of this
p.001994: title.
p.001994: 1965—Par. (i). Pub. L. 89–74, §9(c), designated existing provisions as subpar. (1) and added
p.001994: subpars. (2) and (3).
p.001994: Par. (q). Pub. L. 89–74, §5, added par. (q).
p.001994: 1962—Par. (e). Pub. L. 87–781, §§103(c), 106(c), prohibited the failure to establish or maintain
p.001994: any record, or make any report, required under sections 355(i) or (j) and 507(d) or (g) of this title,
p.001994: or the refusal to permit access to, or verification or copying of, any such required record.
p.001994: Par. (l). Pub. L. 87–781, §104(e)(1), inserted “approval of” before “an application”, and
p.001994: substituted “in effect” for “effective”.
p.001994: Par. (o). Pub. L. 87–781, §114(a), added par. (o).
p.001994: Par. (p). Pub. L. 87–781, §304, added par. (p).
...

p.001994: 2009 Amendment note set out under section 301 of this title and Tables for classifications] and,
p.001994: for purposes of mitigating a civil penalty to be applied for a violation by a retailer of any
p.001994: restriction promulgated under section 906(d) [21 U.S.C. 387f(d)], shall consider the amount of
p.001994: any penalties paid by the retailer to a State for the same violation.”
p.001994: CONSTRUCTION OF 2011 AMENDMENT
p.001994: Nothing in amendment by Pub. L. 111–353 to be construed to alter jurisdiction and authorities
p.001994: established under certain other Acts or in a manner inconsistent with international agreements to
p.001994: which the United States is a party, see sections 2251 and 2252 of this title.
p.001994: ENFORCEMENT
p.001994: Pub. L. 99–660, title I, §103, Nov. 14, 1986, 100 Stat. 3751, provided that: “For the fines
p.001994: authorized to be imposed under section 303 of the Federal Food, Drug, and Cosmetic Act [21
p.001994: U.S.C. 333], see section 3623 of title 18, United States Code, for the period ending October 31,
p.001994: 1986 [probably should be October 31, 1987], and sections 3559 and 3571 of such title for the
p.001994: period beginning November 1, 1986 [probably should be November 1, 1987].”
p.001994:
p.001994: 1 So in original. Words “of this section” probably should not appear.
p.001994:
p.001994: 2 See References in Text note below.
p.001994:
p.001994:
p.001994:
p.001994: §333a. Repealed. Pub. L. 101–647, title XIX, §1905, Nov. 29, 1990, 104
p.001994: Stat. 4853
p.001994: Section, Pub. L. 100–690, title II, §2401, Nov. 18, 1988, 102 Stat. 4230, related to forfeiture and
p.001994: illegal trafficking in steroids or human growth hormones.
p.001994:
p.001994:
p.001994: §334. Seizure
p.001994: (a) Grounds and jurisdiction
p.001994: (1) Any article of food, drug, or cosmetic that is adulterated or misbranded when
p.001994: introduced into or while in interstate commerce or while held for sale (whether or not the
p.001994: first sale) after shipment in interstate commerce, or which may not, under the provisions of
p.001994: section 331(ll), 344, or 355 of this title, be introduced into interstate commerce, shall be
p.001994: liable to be proceeded against while in interstate commerce, or at any time thereafter, on
p.001994: libel of information and condemned in any district court of the United States or United
p.001994: States court of a Territory within the jurisdiction of which the article is found. No libel for
p.001994: condemnation shall be instituted under this chapter, for any alleged misbranding if there is
p.001994: pending in any court a libel for condemnation proceeding under this chapter based upon the
p.001994: same alleged misbranding, and not more than one such proceeding shall be instituted if no
p.001994: such proceeding is so pending, except that such limitations shall not apply (A) when such
p.001994: misbranding has been the basis of a prior judgment in favor of the United States, in a
p.001994: criminal, injunction, or libel for condemnation proceeding under this chapter, or (B) when the
p.001994: Secretary has probable cause to believe from facts found, without hearing, by him or any
p.001994: officer or employee of the Department that the misbranded article is dangerous to health, or
p.001994: that the labeling of the misbranded article is fraudulent, or would be in a material respect
...

p.001994: clause (i) or a felony described in subsection (a)(1) of this section,
p.001994:
p.001994: if the Secretary finds that the type of conduct which served as the basis for such
p.001994: conviction undermines the process for the regulation of drugs.
p.001994: (B) Individuals
p.001994: (i) Any individual whom the Secretary finds has been convicted of—
p.001994: (I) a misdemeanor under Federal law or a felony under State law for conduct
p.001994: relating to the development or approval, including the process for development or
p.001994: approval, of any drug product or otherwise relating to the regulation of drug products
p.001994: under this chapter, or
p.001994: (II) a conspiracy to commit, or aiding or abetting, such criminal offense or a felony
p.001994: described in subsection (a)(2) of this section,
p.001994:
p.001994: if the Secretary finds that the type of conduct which served as the basis for such
p.001994: conviction undermines the process for the regulation of drugs.
p.001994: (ii) Any individual whom the Secretary finds has been convicted of—
p.001994: (I) a felony which is not described in subsection (a)(2) of this section or clause (i)
p.001994: of this subparagraph and which involves bribery, payment of illegal gratuities, fraud,
p.001994: perjury, false statement, racketeering, blackmail, extortion, falsification or destruction
p.001994: of records, or interference with, obstruction of an investigation into, or prosecution of,
p.001994: any criminal offense, or
p.001994: (II) a conspiracy to commit, or aiding or abetting, such felony,
p.001994:
p.001994: if the Secretary finds, on the basis of the conviction of such individual and other
p.001994: information, that such individual has demonstrated a pattern of conduct sufficient to find that
p.001994: there is reason to believe that such individual may violate requirements under this chapter
p.001994: relating to drug products.
p.001994: (iii) Any individual whom the Secretary finds materially participated in acts that were
p.001994: the basis for a conviction for an offense described in subsection (a) of this section or in
p.001994: clause (i) or (ii) for which a conviction was obtained, if the Secretary finds, on the basis
p.001994: of such participation and other information, that such individual has demonstrated a
p.001994: pattern of conduct sufficient to find that there is reason to believe that such individual
p.001994: may violate requirements under this chapter relating to drug products.
p.001994: (iv) Any high managerial agent whom the Secretary finds—
p.001994: (I) worked for, or worked as a consultant for, the same person as another
p.001994: individual during the period in which such other individual took actions for which a
...

p.001994: (i) in the case of a person other than an individual—
p.001994: (I) terminating the debarment immediately, or
p.001994: (II) limiting the period of debarment to less than one year, and
p.001994:
p.001994: (ii) in the case of an individual, limiting the period of debarment to less than
p.001994: permanent but to no less than 1 year,
p.001994:
p.001994: whichever best serves the interest of justice and protects the integrity of the drug
p.001994: approval process.
p.001994: (e) Publication and list of debarred persons
p.001994: The Secretary shall publish in the Federal Register the name of any person debarred
p.001994: under subsection (a) or (b) of this section, the effective date of the debarment, and the
p.001994: period of the debarment. The Secretary shall also maintain and make available to the public
p.001994: a list, updated no less often than quarterly, of such persons, of the effective dates and
p.001994: minimum periods of such debarments, and of the termination of debarments.
p.001994: (f) Temporary denial of approval
p.001994: (1) In general
p.001994: The Secretary, on the Secretary's own initiative or in response to a petition, may, in
p.001994: accordance with paragraph (3), refuse by order, for the period prescribed by paragraph
p.001994: (2), to approve any abbreviated drug application submitted by any person—
p.001994: (A) if such person is under an active Federal criminal investigation in connection with
p.001994: an action described in subparagraph (B),
p.001994: (B) if the Secretary finds that such person—
p.001994: (i) has bribed or attempted to bribe, has paid or attempted to pay an illegal gratuity,
p.001994: or has induced or attempted to induce another person to bribe or pay an illegal
p.001994: gratuity to any officer, employee, or agent of the Department of Health and Human
p.001994: Services or to any other Federal, State, or local official in connection with any
p.001994: abbreviated drug application, or has conspired to commit, or aided or abetted, such
p.001994: actions, or
p.001994: (ii) has knowingly made or caused to be made a pattern or practice of false
p.001994: statements or misrepresentations with respect to material facts relating to any
p.001994: abbreviated drug application, or the production of any drug subject to an abbreviated
p.001994: drug application, to any officer, employee, or agent of the Department of Health and
p.001994: Human Services, or has conspired to commit, or aided or abetted, such actions, and
p.001994:
p.001994: (C) if a significant question has been raised regarding—
p.001994: (i) the integrity of the approval process with respect to such abbreviated drug
p.001994: application, or
p.001994: (ii) the reliability of data in or concerning such person's abbreviated drug
p.001994: application.
p.001994:
p.001994: Such an order may be modified or terminated at any time.
p.001994: (2) Applicable period
p.001994: (A) In general
p.001994: Except as provided in subparagraph (B), a denial of approval of an application of a
p.001994: person under paragraph (1) shall be in effect for a period determined by the Secretary
p.001994: but not to exceed 18 months beginning on the date the Secretary finds that the
...

p.001994: any action or civil penalty under an amendment made by this Act.”
p.001994: CONGRESSIONAL FINDINGS
p.001994: Section 1(c) of Pub. L. 102–282 provided that: “The Congress finds that—
p.001994: “(1) there is substantial evidence that significant corruption occurred in the Food and Drug
p.001994: Administration's process of approving drugs under abbreviated drug applications,
p.001994: “(2) there is a need to establish procedures designed to restore and to ensure the integrity
p.001994: of the abbreviated drug application approval process and to protect the public health, and
p.001994: “(3) there is a need to establish procedures to bar individuals who have been convicted of
p.001994: crimes pertaining to the regulation of drug products from working for companies that
p.001994: manufacture or distribute such products.”
p.001994:
p.001994: 1 So in original. Probably should be “section”.
p.001994:
p.001994:
p.001994:
p.001994: §335b. Civil penalties
p.001994: (a) In general
p.001994: Any person that the Secretary finds—
p.001994: (1) knowingly made or caused to be made, to any officer, employee, or agent of the
p.001994: Department of Health and Human Services, a false statement or misrepresentation of a
p.001994: material fact in connection with an abbreviated drug application,
p.001994: (2) bribed or attempted to bribe or paid or attempted to pay an illegal gratuity to any
p.001994: officer, employee, or agent of the Department of Health and Human Services in
p.001994: connection with an abbreviated drug application,
p.001994: (3) destroyed, altered, removed, or secreted, or procured the destruction, alteration,
p.001994: removal, or secretion of, any material document or other material evidence which was the
p.001994: property of or in the possession of the Department of Health and Human Services for the
p.001994: purpose of interfering with that Department's discharge of its responsibilities in connection
p.001994: with an abbreviated drug application,
p.001994: (4) knowingly failed to disclose, to an officer or employee of the Department of Health
p.001994: and Human Services, a material fact which such person had an obligation to disclose
p.001994: relating to any drug subject to an abbreviated drug application,
p.001994: (5) knowingly obstructed an investigation of the Department of Health and Human
p.001994: Services into any drug subject to an abbreviated drug application,
p.001994: (6) is a person that has an approved or pending drug product application and has
p.001994: knowingly—
p.001994: (A) employed or retained as a consultant or contractor, or
p.001994: (B) otherwise used in any capacity the services of,
p.001994:
...

p.001994: penalty under this section an amount not to exceed—
p.001994: (1) $250,000, or
p.001994: (2) one-half of the penalty so imposed and collected,
p.001994:
p.001994: whichever is less. The decision of the Secretary on such award shall not be reviewable.
p.001994: (June 25, 1938, ch. 675, §307, as added Pub. L. 102–282, §3, May 13, 1992, 106 Stat. 159;
p.001994: amended Pub. L. 103–80, §3(g), Aug. 13, 1993, 107 Stat. 776.)
p.001994: PRIOR PROVISIONS
p.001994: A prior section 307 of act June 25, 1938, was renumbered section 310 and is classified to
p.001994: section 337 of this title.
p.001994: AMENDMENTS
p.001994: 1993—Subsec. (b)(3)(A). Pub. L. 103–80 made technical amendment to reference to May 13,
p.001994: 1992, to reflect correction of corresponding provision of original act.
p.001994: CONSTRUCTION
p.001994: This section not to preclude any other civil, criminal, or administrative remedy provided under
p.001994: Federal or State law, including any private right of action against any person for the same action
p.001994: subject to any action or civil penalty under an amendment made by Pub. L. 102–282, see section
p.001994: 7 of Pub. L. 102–282, set out as a note under section 335a of this title.
p.001994: §335c. Authority to withdraw approval of abbreviated drug applications
p.001994: (a) In general
p.001994: The Secretary—
p.001994: (1) shall withdraw approval of an abbreviated drug application if the Secretary finds that
p.001994: the approval was obtained, expedited, or otherwise facilitated through bribery, payment of
p.001994: an illegal gratuity, or fraud or material false statement, and
p.001994: (2) may withdraw approval of an abbreviated drug application if the Secretary finds that
p.001994: the applicant has repeatedly demonstrated a lack of ability to produce the drug for which
p.001994: the application was submitted in accordance with the formulations or manufacturing
p.001994: practice set forth in the abbreviated drug application and has introduced, or attempted to
p.001994: introduce, such adulterated or misbranded drug into commerce.
p.001994: (b) Procedure
p.001994: The Secretary may not take any action under subsection (a) of this section with respect
p.001994: to any person unless the Secretary has issued an order for such action made on the record
p.001994: after opportunity for an agency hearing on disputed issues of material fact. In the course of
p.001994: any investigation or hearing under this subsection, the Secretary may administer oaths and
p.001994: affirmations, examine witnesses, receive evidence, and issue subpoenas requiring the
p.001994: attendance and testimony of witnesses and the production of evidence that relates to the
p.001994: matter under investigation.
p.001994: (c) Applicability
p.001994: Subsection (a) of this section shall apply with respect to offenses or acts regardless of
p.001994: when such offenses or acts occurred.
p.001994: (d) Judicial review
p.001994: Any person that is the subject of an adverse decision under subsection (a) of this section
p.001994: may obtain a review of such decision by the United States Court of Appeals for the District
p.001994: of Columbia or for the circuit in which the person resides, by filing in such court (within 60
...

p.000398: regulations under this section.
p.000398: (5) Recordkeeping by retailers
p.000398: The Secretary shall not require any retailer to maintain records relating to individual
p.000398: purchasers of tobacco products for personal consumption.
p.000398: (c) Records inspection
p.000398: If the Secretary has a reasonable belief that a tobacco product is part of an illicit trade or
p.000398: smuggling or is a counterfeit product, each person who manufactures, processes,
p.000398: transports, distributes, receives, holds, packages, exports, or imports tobacco products
p.000398: shall, at the request of an officer or employee duly designated by the Secretary, permit such
p.000398: officer or employee, at reasonable times and within reasonable limits and in a reasonable
p.000398: manner, upon the presentation of appropriate credentials and a written notice to such
p.000398: person, to have access to and copy all records (including financial records) relating to such
p.000398: article that are needed to assist the Secretary in investigating potential illicit trade,
p.000398: smuggling, or counterfeiting of tobacco products. The Secretary shall not authorize an
p.000398: officer or employee of the government of any of the several States to exercise authority
p.000398: under the preceding sentence on Indian country without the express written consent of the
p.000398: Indian tribe involved.
p.000398: (d) Knowledge of illegal transaction
p.000398: (1) Notification
p.000398: If the manufacturer or distributor of a tobacco product has knowledge which reasonably
p.000398: supports the conclusion that a tobacco product manufactured or distributed by such
p.000398: manufacturer or distributor that has left the control of such person may be or has been—
p.000398: (A) imported, exported, distributed, or offered for sale in interstate commerce by a
p.000398: person without paying duties or taxes required by law; or
p.000398: (B) imported, exported, distributed, or diverted for possible illicit marketing,
p.000398:
p.000398: the manufacturer or distributor shall promptly notify the Attorney General and the
p.000398: Secretary of the Treasury of such knowledge.
p.000398: (2) Knowledge defined
p.000398: For purposes of this subsection, the term “knowledge” as applied to a manufacturer or
p.000398: distributor means—
p.000398: (A) the actual knowledge that the manufacturer or distributor had; or
p.000398: (B) the knowledge which a reasonable person would have had under like
p.000398: circumstances or which would have been obtained upon the exercise of due care.
p.000398: (e) Consultation
p.000398: In carrying out this section, the Secretary shall consult with the Attorney General of the
p.000398: United States and the Secretary of the Treasury, as appropriate.
p.000398: (June 25, 1938, ch. 675, §920, as added Pub. L. 111–31, div. A, title III, §301, June 22,
p.000398: 2009, 123 Stat. 1850.)
p.000398: REFERENCES IN TEXT
p.000398: Section 201 of the Family Smoking Prevention and Tobacco Control Act, referred to in subsec.
p.000398: (a)(1), is section 201 of div. A of Pub. L. 111–31.
p.000398:
p.000398: 1 So in original. Probably should be “the Family”.
p.000398:
p.000398:
p.000398:
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p.001994: of title 42.
p.001994: (ee) The term “Commissioner” means the Commissioner of Food and Drugs.
p.001994: (ff) The term “dietary supplement”—
p.001994: (1) means a product (other than tobacco) intended to supplement the diet that bears or
p.001994: contains one or more of the following dietary ingredients:
p.001994: (A) a vitamin;
p.001994: (B) a mineral;
p.001994: (C) an herb or other botanical;
p.001994: (D) an amino acid;
p.001994: (E) a dietary substance for use by man to supplement the diet by increasing the total
p.001994: dietary intake; or
p.001994: (F) a concentrate, metabolite, constituent, extract, or combination of any ingredient
p.001994: described in clause (A), (B), (C), (D), or (E);
p.001994:
p.001994: (2) means a product that—
p.001994: (A)(i) is intended for ingestion in a form described in section 350(c)(1)(B)(i) of this
p.001994: title; or
p.001994: (ii) complies with section 350(c)(1)(B)(ii) of this title;
p.001994: (B) is not represented for use as a conventional food or as a sole item of a meal or
p.001994: the diet; and
p.001994: (C) is labeled as a dietary supplement; and
p.001994:
p.001994: (3) does—
p.001994: (A) include an article that is approved as a new drug under section 355 of this title or
p.001994: licensed as a biologic under section 262 of title 42 and was, prior to such approval,
p.001994: certification, or license, marketed as a dietary supplement or as a food unless the
p.001994: Secretary has issued a regulation, after notice and comment, finding that the article,
p.001994: when used as or in a dietary supplement under the conditions of use and dosages set
p.001994: forth in the labeling for such dietary supplement, is unlawful under section 342(f) of this
p.001994: title; and
p.001994: (B) not include—
p.001994: (i) an article that is approved as a new drug under section 355 of this title, certified
p.001994: as an antibiotic under section 357 of this title, or licensed as a biologic under section
p.001994: 262 of title 42, or
p.001994: (ii) an article authorized for investigation as a new drug, antibiotic, or biological for
p.001994: which substantial clinical investigations have been instituted and for which the
p.001994: existence of such investigations has been made public,
p.001994:
p.001994: which was not before such approval, certification, licensing, or authorization marketed as
p.001994: a dietary supplement or as a food unless the Secretary, in the Secretary's discretion, has
p.001994: issued a regulation, after notice and comment, finding that the article would be lawful
p.001994: under this chapter.2
p.001994: Except for purposes of paragraph (g) and section 350f of this title, a dietary supplement
p.001994: shall be deemed to be a food within the meaning of this chapter.
p.001994: (gg) The term “processed food” means any food other than a raw agricultural commodity
p.001994: and includes any raw agricultural commodity that has been subject to processing, such as
p.001994: canning, cooking, freezing, dehydration, or milling.
p.001994: (hh) The term “Administrator” means the Administrator of the United States
p.001994: Environmental Protection Agency.
p.001994: (ii) The term “compounded positron emission tomography drug”—
p.001994: (1) means a drug that—
p.001994: (A) exhibits spontaneous disintegration of unstable nuclei by the emission of
...

p.001994: Health and Human Services, under applicable statutes and regulations.”
p.001994: TRANSFER OF FUNCTIONS
p.001994: For transfer of functions of Federal Security Administrator to Secretary of Health, Education,
p.001994: and Welfare [now Health and Human Services], and of Food and Drug Administration in the
p.001994: Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this
p.001994: title.
p.001994:
p.001994: 1 See References in Text note below.
p.001994:
p.001994: 2 So in original.
p.001994:
p.001994:
p.001994:
p.001994: §332. Injunction proceedings
p.001994: (a) Jurisdiction of courts
p.001994: The district courts of the United States and the United States courts of the Territories
p.001994: shall have jurisdiction, for cause shown 1 to restrain violations of section 331 of this title,
p.001994: except paragraphs (h), (i), and (j).
p.001994: (b) Violation of injunction
p.001994: In case of violation of an injunction or restraining order issued under this section, which
p.001994: also constitutes a violation of this chapter, trial shall be by the court, or, upon demand of the
p.001994: accused, by a jury.
p.001994: (June 25, 1938, ch. 675, §302, 52 Stat. 1043; Pub. L. 87–781, title I, §103(d), title II,
p.001994: §201(c), Oct. 10, 1962, 76 Stat. 784, 793; Pub. L. 103–80, §3(d), Aug. 13, 1993, 107 Stat.
p.001994: 775.)
p.001994: AMENDMENTS
p.001994: 1993—Subsec. (a). Pub. L. 103–80, §3(d)(1), struck out “, and subject to the provisions of
p.001994: section 17 (relating to notice to opposite party) of the Act entitled ‘An Act to supplement existing
p.001994: laws against unlawful restraints and monopolies, and for other purposes’, approved October 15,
p.001994: 1914, as amended (U.S.C., 1934 ed., title 28, sec. 381),” after “for cause shown”.
p.001994: Subsec. (b). Pub. L. 103–80, §3(d)(2), struck out at end “Such trial shall be conducted in
p.001994: accordance with the practice and procedure applicable in the case of proceedings subject to the
p.001994: provisions of section 22 of such Act of October 15, 1914, as amended (U.S.C., 1934 ed., title 28,
p.001994: sec. 387).”
p.001994: 1962—Subsec. (a). Pub. L. 87–781, §103(d), struck out “(e),” after “paragraphs”.
p.001994: Pub. L. 87–781, §201(c), struck out “(f),” after “paragraphs”.
p.001994: EFFECTIVE DATE OF 1962 AMENDMENT
p.001994: Amendment by section 103(c) of Pub. L. 87–781 effective on first day of seventh calendar
p.001994: month following October 1962, see section 107 of Pub. L. 87–781, set out as a note under section
p.001994: 321 of this title.
p.001994: Section 203 of title II of Pub. L. 87–781 provided that: “The amendments made by this title
p.001994: [amending this section and section 374 of this title and enacting provisions set out as notes under
p.001994: sections 321 and 374 of this title] shall take effect on the date of enactment of this Act [Oct. 10,
p.001994: 1962].”
p.001994:
p.001994: 1 So in original. Probably should be followed by a comma.
p.001994:
p.001994:
p.001994:
p.001994: §333. Penalties
p.001994: (a) Violation of section 331 of this title; second violation; intent to defraud or mislead
p.001994: (1) Any person who violates a provision of section 331 of this title shall be imprisoned for
p.001994: not more than one year or fined not more than $1,000, or both.
p.001994: (2) Notwithstanding the provisions of paragraph (1) of this section,1 if any person commits
...

p.001994: pursuant to the order of a physician shall be imprisoned for not more than three years or fined
p.001994: under title 18, or both.
p.001994: “(2) Any person who distributes or possesses with the intent to distribute to an individual under
p.001994: 18 years of age, any anabolic steroid for any use in humans other than the treatment of disease
p.001994: pursuant to the order of a physician shall be imprisoned for not more than six years or fined under
p.001994: title 18, or both.”
p.001994: Subsec. (f). Pub. L. 101–629 added subsec. (f).
p.001994: 1988—Subsecs. (a), (b). Pub. L. 100–293 designated existing subsecs. (a) and (b) as pars. (1)
p.001994: and (2) of subsec. (a), substituted “paragraph (1)” for “subsection (a)” in par. (2), and added
p.001994: subsec. (b).
p.001994: Subsec. (e). Pub. L. 100–690 added subsec. (e).
p.001994: 1976—Subsec. (d). Pub. L. 94–278 added subsec. (d).
p.001994: 1970—Subsec. (a). Pub. L. 91–513 struck out reference to subsec. (b) and transferred to
p.001994: subsec. (b) provisions covering second offenses and offenses committed with intent to defraud or
p.001994: mislead.
p.001994: Subsec. (b). Pub. L. 91–513 inserted provisions covering second offenses and offenses
p.001994: committed with intent to defraud or mislead formerly set out in subsec. (a) and struck out
p.001994: provisions covering violations involving depressant and stimulant drugs. See section 801 et seq.
p.001994: of this title.
p.001994: 1968—Subsecs. (a), (b). Pub. L. 90–639 made a general revision in the penalties prescribed for
p.001994: offenses involving depressant or stimulant drugs, set a fine of not to exceed $10,000 or
p.001994: imprisonment of not more than 5 years for offenses involving the unlawful manufacturing of, sale,
p.001994: or disposal of, or possession with intent to sell, a depressant or stimulant drug or involving
p.001994: counterfeit depressant or stimulant drugs, stiffened the penalties for unlawful sales or other
p.001994: disposals by persons over 18 to persons under 21, and set new penalties for possession of a
p.001994: depressant or stimulant drug for purposes other than sale or other disposal.
p.001994: 1965—Subsec. (a). Pub. L. 89–74, §7(a), inserted proviso limiting the penalties for depressant
p.001994: or stimulant drug violations to two years imprisonment or $5,000 fine or both for first offense and
p.001994: to two years imprisonment or $15,000 fine or both for subsequent offenses.
p.001994: Subsec. (b). Pub. L. 89–74, §7(b), inserted parenthetical exception provision.
p.001994: Subsec. (c)(5). Pub. L. 89–74, §9(d), added cl. (5).
p.001994: 1960—Subsec. (c)(3). Pub. L. 86–618 substituted “a color additive” for “a coal-tar color”, “the
p.001994: color additive” for “the coal-tar color” and “such color additive was” for “such color was”.
p.001994: 1951—Subsec. (c)(4). Act Oct. 26, 1951, added cl. (4).
p.001994: EFFECTIVE DATE OF 2009 AMENDMENT
p.001994: Pub. L. 111–31, div. A, title I, §103(q)(3), (4), June 22, 2009, 123 Stat. 1840, provided that:
p.001994: “(3) GENERAL EFFECTIVE DATE.—The amendments made by paragraphs (2) [amending this
p.001994: section], (3) [amending this section], and (4) [no par. (4) has been enacted] of subsection (c) shall
p.001994: take effect upon the issuance of guidance described in paragraph (1) of this subsection [set out as
p.001994: a Guidance note below].
p.001994: “(4) SPECIAL EFFECTIVE DATE.—The amendment made by subsection (c)(1) [amending this section]
p.001994: shall take effect on the date of enactment of this Act [June 22, 2009].”
p.001994: EFFECTIVE DATE OF 2007 AMENDMENT
p.001994: Amendment by sections 901(d)(4) and 902(b) of Pub. L. 110–85 effective 180 days after Sept.
...

p.001994: (l) Harmonization with action under other laws
p.001994: (1) Coordination with FIFRA
p.001994: To the extent practicable and consistent with the review deadlines in subsection (q) of
p.001994: this section, in issuing a final rule under this subsection that suspends or revokes a
p.001994: tolerance or exemption for a pesticide chemical residue in or on food, the Administrator
p.001994: shall coordinate such action with any related necessary action under the Federal
p.001994: Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 136 et seq.].
p.001994: (2) Revocation of tolerance or exemption following cancellation of associated
p.001994: registrations
p.001994: If the Administrator, acting under the Federal Insecticide, Fungicide, and Rodenticide
p.001994: Act, cancels the registration of each pesticide that contains a particular pesticide
p.001994: chemical and that is labeled for use on a particular food, or requires that the registration
p.001994: of each such pesticide be modified to prohibit its use in connection with the production,
p.001994: storage, or transportation of such food, due in whole or in part to dietary risks to humans
p.001994: posed by residues of that pesticide chemical on that food, the Administrator shall revoke
p.001994: any tolerance or exemption that allows the presence of the pesticide chemical, or any
p.001994: pesticide chemical residue that results from its use, in or on that food. Subsection (e) of
p.001994: this section shall apply to actions taken under this paragraph. A revocation under this
p.001994: paragraph shall become effective not later than 180 days after—
p.001994: (A) the date by which each such cancellation of a registration has become effective;
p.001994: or
p.001994: (B) the date on which the use of the canceled pesticide becomes unlawful under the
p.001994: terms of the cancellation, whichever is later.
p.001994: (3) Suspension of tolerance or exemption following suspension of associated
p.001994: registrations
p.001994: (A) Suspension
p.001994: If the Administrator, acting under the Federal Insecticide, Fungicide, and Rodenticide
p.001994: Act, suspends the use of each registered pesticide that contains a particular pesticide
p.001994: chemical and that is labeled for use on a particular food, due in whole or in part to
p.001994: dietary risks to humans posed by residues of that pesticide chemical on that food, the
p.001994: Administrator shall suspend any tolerance or exemption that allows the presence of the
p.001994: pesticide chemical, or any pesticide chemical residue that results from its use, in or on
p.001994: that food. Subsection (e) of this section shall apply to actions taken under this
p.001994: paragraph. A suspension under this paragraph shall become effective not later than 60
p.001994: days after the date by which each such suspension of use has become effective.
p.001994: (B) Effect of suspension
p.001994: The suspension of a tolerance or exemption under subparagraph (A) shall be
p.001994: effective as long as the use of each associated registration of a pesticide is suspended
p.001994: under the Federal Insecticide, Fungicide, and Rodenticide Act. While a suspension of a
p.001994: tolerance or exemption is effective the tolerance or exemption shall not be considered
p.001994: to be in effect. If the suspension of use of the pesticide under that Act is terminated,
p.001994: leaving the registration of the pesticide for such use in effect under that Act, the
p.001994: Administrator shall rescind any associated suspension of tolerance or exemption.
p.001994: (4) Tolerances for unavoidable residues
p.001994: In connection with action taken under paragraph (2) or (3), or with respect to pesticides
...

p.001962: and amended Pub. L. 101–629, §19(a)(1)(B), (2)(E), (3), (4), Nov. 28, 1990, 104 Stat. 4529,
p.001962: 4530; Pub. L. 103–80, §4(a)(2), Aug. 13, 1993, 107 Stat. 779.)
p.001962: CODIFICATION
p.001962: Section was classified to section 263i of Title 42, The Public Health and Welfare, prior to
p.001962: renumbering by Pub. L. 101–629.
p.001962: AMENDMENTS
p.001962: 1993—Pub. L. 103–80 amended directory language of Pub. L. 101–629, §19(a)(4), which
p.001962: renumbered section 263i of Title 42, The Public Health and Welfare, as this section.
p.001962: 1990—Subsec. (a). Pub. L. 101–629, §19(a)(1)(B), (2)(E), substituted “section 360kk(h)” for
p.001962: “section 263f(h)”, “this part” for “this subpart”, and “section 360ll(a)(2) or 360ll(e)” for “section
p.001962: 263g(a)(2) or 263g(e)”.
p.001962: Subsecs. (b) to (e). Pub. L. 101–629, §19(a)(1)(B), substituted “this part” for “this subpart”
p.001962: wherever appearing.
p.001962: Subsec. (f). Pub. L. 101–629, §19(a)(1)(B), (2)(E)(ii), substituted “this part” for “this subpart”,
p.001962: “section 360ll” for “section 263g” in three places, and “section 360ll(a)” for “section 263g(a)”.
p.001962: NONINTERFERENCE WITH OTHER FEDERAL AGENCIES
p.001962: Enactment of this section not to be construed to supersede or limit the functions under any
p.001962: other provision of law of any officer or agency of the United States, see section 4 of Pub. L. 90–
p.001962: 602, set out as a note under section 360hh of this title.
p.001962:
p.001962:
p.001962: §360oo. Prohibited acts
p.001962: (a) It shall be unlawful
p.001962: (1) for any manufacturer to introduce, or to deliver for introduction, into commerce, or
p.001962: to import into the United States, any electronic product which does not comply with an
p.001962: applicable standard prescribed pursuant to section 360kk of this title;
p.001962: (2) for any person to fail to furnish any notification or other material or information
p.001962: required by section 360ll or 360nn of this title; or to fail to comply with the requirements of
p.001962: section 360ll(f) of this title;
p.001962: (3) for any person to fail or to refuse to establish or maintain records required by this
p.001962: part or to permit access by the Secretary or any of his duly authorized representatives to,
p.001962: or the copying of, such records, or to permit entry or inspection, as required by or
p.001962: pursuant to section 360nn of this title;
p.001962: (4) for any person to fail or to refuse to make any report required pursuant to section
p.001962: 360nn(b) of this title or to furnish or preserve any information required pursuant to section
p.001962: 360nn(f) of this title; or
p.001962: (5) for any person (A) to fail to issue a certification as required by section 360kk(h) of
p.001962: this title, or (B) to issue such a certification when such certification is not based upon a
p.001962: test or testing program meeting the requirements of section 360kk(h) of this title or when
p.001962: the issuer, in the exercise of due care, would have reason to know that such certification
p.001962: is false or misleading in a material respect.
p.001962:
p.001962: (b) The Secretary may exempt any electronic product, or class thereof, from all or part of
p.001962: subsection (a) of this section, upon such conditions as he may find necessary to protect the
...

p.001962: Subsec. (a)(4). Pub. L. 101–629, §19(a)(2)(F)(iii), substituted “section 360nn(b)” for “section
p.001962: 263i(b)” and “section 360nn(f)” for “section 263i(f)”.
p.001962: Subsec. (a)(5). Pub. L. 101–629, §19(a)(2)(F)(i), substituted “section 360kk(h)” for “section
p.001962: 263f(h)” in two places.
p.001962: NONINTERFERENCE WITH OTHER FEDERAL AGENCIES
p.001962: Enactment of this section not to be construed to supersede or limit the functions under any
p.001962: other provision of law of any officer or agency of the United States, see section 4 of Pub. L. 90–
p.001962: 602, set out as a note under section 360hh of this title.
p.001962:
p.001962:
p.001962: §360pp. Enforcement
p.001962: (a) Jurisdiction of courts
p.001962: The district courts of the United States shall have jurisdiction, for cause shown, to restrain
p.001962: violations of section 360oo of this title and to restrain dealers and distributors of electronic
p.001962: products from selling or otherwise disposing of electronic products which do not conform to
p.001962: an applicable standard prescribed pursuant to section 360kk of this title except when such
p.001962: products are disposed of by returning them to the distributor or manufacturer from whom
p.001962: they were obtained. The district courts of the United States shall also have jurisdiction in
p.001962: accordance with section 1355 of title 28 to enforce the provisions of subsection (b) of this
p.001962: section.
p.001962: (b) Penalties
p.001962: (1) Any person who violates section 360oo of this title shall be subject to a civil penalty of
p.001962: not more than $1,000. For purposes of this subsection, any such violation shall with respect
p.001962: to each electronic product involved, or with respect to each act or omission made unlawful
p.001962: by section 360oo of this title, constitute a separate violation, except that the maximum civil
p.001962: penalty imposed on any person under this subsection for any related series of violations
p.001962: shall not exceed $300,000.
p.001962: (2) Any such civil penalty may on application be remitted or mitigated by the Secretary. In
p.001962: determining the amount of such penalty, or whether it should be remitted or mitigated and in
p.001962: what amount, the appropriateness of such penalty to the size of the business of the person
p.001962: charged and the gravity of the violation shall be considered. The amount of such penalty,
p.001962: when finally determined, may be deducted from any sums owing by the United States to the
p.001962: person charged.
p.001962: (c) Venue; process
p.001962: Actions under subsections (a) and (b) of this section may be brought in the district court
p.001962: of the United States for the district wherein any act or omission or transaction constituting
p.001962: the violation occurred, or in such court for the district where the defendant is found or
p.001962: transacts business, and process in such cases may be served in any other district of which
p.001962: the defendant is an inhabitant or wherever the defendant may be found.
p.001962: (d) Warnings
p.001962: Nothing in this part shall be construed as requiring the Secretary to report for the
p.001962: institution of proceedings minor violations of this part whenever he believes that the public
p.001962: interest will be adequately served by a suitable written notice or warning.
p.001962: (e) Compliance with regulations
p.001962: Except as provided in the first sentence of section 360ss of this title, compliance with this
p.001962: part or any regulations issued thereunder shall not relieve any person from liability at
p.001962: common law or under statutory law.
...

p.000398: and Welfare [now Health and Human Services], and of Food and Drug Administration in the
p.000398: Department of Agriculture to Federal Security Agency, see note set out under section 41 of this
p.000398: title.
p.000398:
p.000398:
p.000398: §372a. Transferred
p.000398: CODIFICATION
p.000398: Section, act June 25, 1938, ch. 675, §702A, formerly June 30, 1906, ch. 3915, §10A, as added
p.000398: June 22, 1934, ch. 712, 48 Stat. 1204, and amended, which related to examination of sea food,
p.000398: was renumbered section 706 of act June 25, 1938, by Pub. L. 102–571, title I, §106(3), Oct. 29,
p.000398: 1992, 106 Stat. 4498, and transferred to section 376 of this title.
p.000398:
p.000398:
p.000398: §373. Records
p.000398: (a) In general
p.000398: For the purpose of enforcing the provisions of this chapter, carriers engaged in interstate
p.000398: commerce, and persons receiving food, drugs, devices, tobacco products, or cosmetics in
p.000398: interstate commerce or holding such articles so received, shall, upon the request of an
p.000398: officer or employee duly designated by the Secretary, permit such officer or employee, at
p.000398: reasonable times, to have access to and to copy all records showing the movement in
p.000398: interstate commerce of any food, drug, device, tobacco product, or cosmetic, or the holding
p.000398: thereof during or after such movement, and the quantity, shipper, and consignee thereof;
p.000398: and it shall be unlawful for any such carrier or person to fail to permit such access to and
p.000398: copying of any such record so requested when such request is accompanied by a
p.000398: statement in writing specifying the nature or kind of food, drug, device, tobacco product, or
p.000398: cosmetic to which such request relates, except that evidence obtained under this section, or
p.000398: any evidence which is directly or indirectly derived from such evidence, shall not be used in
p.000398: a criminal prosecution of the person from whom obtained, and except that carriers shall not
p.000398: be subject to the other provisions of this chapter by reason of their receipt, carriage,
p.000398: holding, or delivery of food, drugs, devices, tobacco products, or cosmetics in the usual
p.000398: course of business as carriers, except as provided in subsection (b) of this section.
p.000398: (b) Food transportation records
p.000398: A shipper, carrier by motor vehicle or rail vehicle, receiver, or other person subject to
p.000398: section 350e of this title shall, on request of an officer or employee designated by the
p.000398: Secretary, permit the officer or employee, at reasonable times, to have access to and to
p.000398: copy all records that the Secretary requires to be kept under section 350e(c)(1)(E) of this
p.000398: title.
p.000398: (June 25, 1938, ch. 675, §703, 52 Stat. 1057; Pub. L. 91–452, title II, §230, Oct. 15, 1970,
p.000398: 84 Stat. 930; Pub. L. 103–80, §3(z), Aug. 13, 1993, 107 Stat. 778; Pub. L. 109–59, title VII,
...

Political / criminal

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p.001994: 21 U.S.C.
p.001994: United States Code, 2011 Edition
p.001994: Title 21 - FOOD AND DRUGS
p.001994: CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
p.001994: From the U.S. Government Publishing Office, www.gpo.gov
p.001994:
p.001994:
p.001994:
p.001994:
p.001994: CHAPTER 9—FEDERAL FOOD, DRUG, AND COSMETIC ACT
p.001994: SUBCHAPTER I—SHORT TITLE
p.001994: Sec.
p.001994: 301. Short title.
p.001994:
p.001994:
p.001994: SUBCHAPTER II—DEFINITIONS
p.001994: 321. Definitions; generally.
p.001994: 321a. “Butter” defined.
p.001994: 321b. “Package” defined.
p.001994: 321c. Nonfat dry milk; “milk” defined.
p.001994: 321d. Market names for catfish and ginseng.
p.001994:
p.001994:
p.001994: SUBCHAPTER III—PROHIBITED ACTS AND PENALTIES
p.001994: 331. Prohibited acts.
p.001994: 332. Injunction proceedings.
p.001994: 333. Penalties.
p.001994: 333a. Repealed.
p.001994: 334. Seizure.
p.001994: 335. Hearing before report of criminal violation.
p.001994: 335a. Debarment, temporary denial of approval, and suspension.
p.001994: 335b. Civil penalties.
p.001994: 335c. Authority to withdraw approval of abbreviated drug applications.
p.001994: 336. Report of minor violations.
p.001994: 337. Proceedings in name of United States; provision as to subpoenas.
p.001994:
p.001994:
p.001994: SUBCHAPTER IV—FOOD
p.001994: 341. Definitions and standards for food.
p.001994: 342. Adulterated food.
p.001994: 343. Misbranded food.
p.001994: 343–1. National uniform nutrition labeling.
p.001994: 343–2. Dietary supplement labeling exemptions.
p.001994: 343–3. Disclosure.
p.001994: 343a. Repealed.
p.001994: 344. Emergency permit control.
p.001994: 345. Regulations making exemptions.
p.001994: 346. Tolerances for poisonous or deleterious substances in food; regulations.
p.001994: 346a. Tolerances and exemptions for pesticide chemical residues.
p.001994: 346b. Authorization of appropriations.
p.001994: 347. Intrastate sales of colored oleomargarine.
p.001994: 347a. Congressional declaration of policy regarding oleomargarine sales.
p.001994: 347b. Contravention of State laws.
p.001994: 348. Food additives.
p.001994: 349. Bottled drinking water standards; publication in Federal Register.
p.001994: 350. Vitamins and minerals.
p.001994: 350a. Infant formulas.
p.001994: 350b. New dietary ingredients.
p.001994: 350c. Maintenance and inspection of records.
p.001994: 350d. Registration of food facilities.
...

p.001994: 360c to 360k, 379, and 379a of this title and section 3512 of Title 42, The Public Health and
p.001994: Welfare, and amending sections 321, 331, 334, 351, 352, 358, 360, 374, 379e, and 381 of this title
p.001994: and section 55 of Title 15, Commerce and Trade] may be cited as the ‘Medical Device
p.001994: Amendments of 1976’.”
p.001994: SHORT TITLE OF 1972 AMENDMENT
p.001994: Pub. L. 92–387, §1, Aug. 16, 1972, 86 Stat. 559, provided that: “This Act [amending sections
p.001994: 331, 335, and 360 of this title and enacting provisions set out as notes under section 360 of this
p.001994: title] may be cited as the ‘Drug Listing Act of 1972’.”
p.001994: SHORT TITLE OF 1968 AMENDMENTS
p.001994: Pub. L. 90–602, §1, Oct. 18, 1968, 82 Stat. 1173, provided that: “This Act [enacting provisions
p.001994: now comprising part C (§§360hh–360ss) of subchapter III of this chapter and provisions set out as
p.001994: notes under section 360hh of this title] may be cited as the ‘Radiation Control for Health and
p.001994: Safety Act of 1968’.”
p.001994: Pub. L. 90–399, §1, July 13, 1968, 82 Stat. 342, provided: “That this Act [enacting section 360b
p.001994: of this title, amending sections 321, 331, 342, 351, 352, 357, 381, and 392 of this title, and
p.001994: enacting provisions set out as a note under section 360b of this title] may be cited as the ‘Animal
p.001994: Drug Amendments of 1968’.”
p.001994: SHORT TITLE OF 1965 AMENDMENT
p.001994: Pub. L. 89–74, §1, July 15, 1965, 79 Stat. 226, provided: “That this Act [amending sections 321,
p.001994: 331, 333, 334, 360, and 372 of this title and section 1114 of Title 18, Crimes and Criminal
p.001994: Procedure, and enacting provisions set out as notes under sections 321 and 352 of this title] may
p.001994: be cited as the ‘Drug Abuse Control Amendments of 1965’.”
p.001994: SHORT TITLE OF 1962 AMENDMENT
p.001994: Pub. L. 87–781, §1, Oct. 10, 1962, 76 Stat. 780, provided in part that such Act [enacting
p.001994: sections 358 to 360 of this title, amending sections 321, 331, 332, 348, 351 to 353, 355, 357, 372,
p.001994: 374, 379e, and 381 of this title, and enacting provisions set out as notes under sections 321, 331,
p.001994: 332, 352, 355, 358, 360, and 374 of this title] may be cited as the ‘Drug Amendments of 1962’.”
p.001994: SHORT TITLE OF 1960 AMENDMENT
p.001994: Pub. L. 86–618, §1, July 12, 1960, 74 Stat. 397, provided: “That this Act [amending sections
p.001994: 321, 331, 333, 342, 346, 351, 352, 361, 362, 371, and 379e of this title, repealing sections 354
p.001994: and 364 of this title, and enacting notes set out under this section] may be cited as the ‘Color
p.001994: Additive Amendments of 1960’.”
p.001994: SHORT TITLE OF 1958 AMENDMENT
p.001994: Pub. L. 85–929, §1, Sept. 6, 1958, 72 Stat. 1784, provided: “That this Act [amending sections
p.001994: 321, 331, 342, 346, 348 of this title and section 210 of Title 42, The Public Health and Welfare,
p.001994: and enacting provisions set out as notes under sections 321, 342, and 451 of this title] may be
p.001994: cited as the ‘Food Additives Amendment of 1958’.”
p.001994: SEVERABILITY
p.001994: Pub. L. 110–85, title XI, §1105, Sept. 27, 2007, 121 Stat. 975, provided that: “If any provision of
p.001994: this Act [see Short Title of 2007 Amendment note above], an amendment made [by] this Act, or
...

p.001994: when intended solely for use under conditions prescribed, recommended, or suggested in labeling
p.001994: with respect to such drug on that day, see section 108(a), (b)(3) of Pub. L. 90–399, as amended,
p.001994: set out as an Effective Date and Transitional Provisions note under section 360b of this title.
p.001994: EFFECTIVE DATE OF 1965 AMENDMENT
p.001994: Section 11 of Pub. L. 89–74 provided that: “The foregoing provisions of this Act [see Short Title
p.001994: of 1965 Amendment note set out under section 301 of this title] shall take effect on the first day of
p.001994: the seventh calendar month [Feb. 1, 1966] following the month in which this Act is enacted [July
p.001994: 15, 1965]; except that (1) the Secretary shall permit persons, owning or operating any
p.001994: establishment engaged in manufacturing, preparing, propagating, compounding, processing,
p.001994: wholesaling, jobbing, or distributing any depressant or stimulant drug, as referred to in the
p.001994: amendments made by section 4 of this Act to section 510 of the Federal Food, Drug, and
p.001994: Cosmetic Act [section 360 of this title], to register their name, places of business, and
p.001994: establishments, and other information prescribed by such amendments, with the Secretary prior to
p.001994: such effective date, and (2) sections 201(v) and 511(g) of the Federal Food, Drug, and Cosmetic
p.001994: Act, as added by this act [par. (v) of this section and par. (g) of section 360a of this title], and the
p.001994: provisions of sections 8 [amending section 372 of this title and section 1114 of Title 18, Crimes
p.001994: and Criminal Procedure] and 10 [set out as a note under this section] shall take effect upon the
p.001994: date of enactment of this Act [July 15, 1965].”
p.001994: EFFECTIVE DATE OF 1962 AMENDMENT
p.001994: Section 107 of Pub. L. 87–781 provided that:
p.001994: “(a) Except as otherwise provided in this section, the amendments made by the foregoing
p.001994: sections of this part A [amending this section and sections 331, 332, 348, 351 to 353, 355, 357,
p.001994: 379e of this title, and enacting provisions set out as a note under section 355 of this title] shall
p.001994: take effect on the date of enactment of this Act [Oct. 10, 1962].
p.001994: “(b) The amendments made by sections 101, 103, 105, and 106 of this part A [amending
p.001994: sections 331, 332, 351, 352, 355, and 357 of this title] shall, with respect to any drug, take effect
p.001994: on the first day of the seventh calendar month following the month in which this Act is enacted
p.001994: [Oct. 1962].
p.001994: “(c)(1) As used in this subsection, the term ‘enactment date’ means the date of enactment of
p.001994: this Act; and the term ‘basic Act’ means the Federal Food, Drug, and Cosmetic Act [this chapter].
p.001994: “(2) An application filed pursuant to section 505(b) of the basic Act [section 355(b) of this title]
p.001994: which was ‘effective’ within the meaning of that Act on the day immediately preceding the
p.001994: enactment date shall be deemed as of the enactment date, to be an application ‘approved’ by the
p.001994: Secretary within the meaning of the basic Act as amended by this Act.
p.001994: “(3) In the case of any drug with respect to which an application filed under section 505(b) of the
...

p.001994: sentence of such section 505(e) [section 355(e) of this title], withdrawing or suspending the
p.001994: approval of such application.
p.001994: “(4) In the case of any drug which, on the day immediately preceding the enactment date, (A)
p.001994: was commercially used or sold in the United States, (B) was not a new drug as defined by section
p.001994: 201(p) of the basic Act as then in force [par. (p) of this section], and (C) was not covered by an
p.001994: effective application under section 505 of that Act [section 355 of this title], the amendments to
p.001994: section 201(p) [par. (p) of this section] made by this Act shall not apply to such drug when
p.001994: intended solely for use under conditions prescribed, recommended, or suggested in labeling with
p.001994: respect to such drug on that day.”
p.001994: EFFECTIVE DATE OF 1960 AMENDMENT
p.001994: Amendment by Pub. L. 86–618 effective July 12, 1960, subject to provisions of section 203 of
p.001994: Pub. L. 86–618, see section 202 of Pub. L. 86–618, set out as a note under section 379e of this
p.001994: title.
p.001994: EFFECTIVE DATE OF 1958 AMENDMENT
p.001994: Amendment by Pub. L. 85–929 effective Sept. 6, 1958, see section 6(a) of Pub. L. 85–929, set
p.001994: out as a note under section 342 of this title.
p.001994: EFFECTIVE DATE OF 1954 AMENDMENT
p.001994: For effective date of amendment by act July 22, 1954, see section 5 of that act, set out as a
p.001994: note under section 342 of this title.
p.001994: CONSTRUCTION OF AMENDMENTS BY PUB. L. 102–282
p.001994: Amendment by Pub. L. 102–282 not to preclude any other civil, criminal, or administrative
p.001994: remedy provided under Federal or State law, including any private right of action against any
p.001994: person for the same action subject to any action or civil penalty under an amendment made by
p.001994: Pub. L. 102–282, see section 7 of Pub. L. 102–282, set out as a note under section 335a of this
p.001994: title.
p.001994: CONSTRUCTION OF AMENDMENTS BY PUB. L. 101–535
p.001994: Amendments by Pub. L. 101–535 not to be construed to alter authority of Secretary of Health
p.001994: and Human Services and Secretary of Agriculture under the Federal Food, Drug, and Cosmetic
p.001994: Act (21 U.S.C. 301 et seq.), the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry
p.001994: Products Inspection Act (21 U.S.C. 451 et seq.), and the Egg Products Inspection Act (21 U.S.C.
p.001994: 1031 et seq.), see section 9 of Pub. L. 101–535, set out as a note under section 343 of this title.
p.001994: SAVINGS PROVISION
p.001994: Section 702 of Pub. L. 91–513, as amended by Pub. L. 93–481, §2, Oct. 26, 1974, 88 Stat.
p.001994: 1455, provided that:
p.001994: “(a) Prosecutions for any violation of law occurring prior to the effective date [see Effective Date
p.001994: of 1970 Amendment note above] of section 701 [repealing section 360a of this title, and amending
p.001994: sections 321, 331, 333, 334, 360, 372, and 381 of this title, sections 1114 and 1952 of Title 18,
p.001994: Crimes and Criminal Procedure, and section 242 of Title 42, The Public Health and Welfare] shall
p.001994: not be affected by the repeals or amendments made by such section, or abated by reason
p.001994: thereof.
p.001994: “(b) Civil seizures or forfeitures and injunctive proceedings commenced prior to the effective
p.001994: date of section 701 shall not be affected by the repeals or amendments made by such section, or
p.001994: abated by reason thereof.
p.001994: “(c) All administrative proceedings pending before the Bureau of Narcotics and Dangerous
p.001994: Drugs [now the Drug Enforcement Administration] on the date of enactment of this Act [Oct. 27,
p.001994: 1970] shall be continued and brought to final determination in accord with laws and regulations in
p.001994: effect prior to such date of enactment. Where a drug is finally determined under such proceedings
p.001994: to be a depressant or stimulant drug, as defined in section 201(v) of the Federal Food, Drug, and
p.001994: Cosmetic Act [par. (v) of this section], such drug shall automatically be controlled under this title
p.001994: [subchapter I of chapter 13 of this title] by the Attorney General without further proceedings and
p.001994: listed in the appropriate schedule after he has obtained the recommendation of the Secretary. Any
p.001994: drug with respect to which such a final determination has been made prior to the date of
p.001994: enactment of this Act which is not listed in section 202 [section 812 of this title] within schedules I
...

p.001994: interstate commerce; that the use of such drugs, when not under the supervision of a licensed
p.001994: practitioner, often endangers safety on the highways (without distinction of interstate and
p.001994: intrastate traffic thereon) and otherwise has become a threat to the public health and safety,
p.001994: making additional regulation of such drugs necessary regardless of the intrastate or interstate
p.001994: origin of such drugs; that in order to make regulation and protection of interstate commerce in
p.001994: such drugs effective, regulation of intrastate commerce is also necessary because, among other
p.001994: things, such drugs, when held for illicit sale, often do not bear labeling showing their place of
p.001994: origin and because in the form in which they are so held or in which they are consumed a
p.001994: determination of their place of origin is often extremely difficult or impossible; and that regulation
p.001994: of interstate commerce without the regulation of intrastate commerce in such drugs, as provided
p.001994: in this Act [see Short Title of 1965 Amendment note set out under section 301 of this title], would
p.001994: discriminate against and adversely affect interstate commerce in such drugs.”
p.001994: EFFECT OF DRUG ABUSE CONTROL AMENDMENTS OF 1965 ON STATE LAWS
p.001994: Section 10 of Pub. L. 89–74 provided that:
p.001994: “(a) Nothing in this Act [enacting section 360a of this title, amending sections 321, 331, 333,
p.001994: 334, 360, and 372 of this title and section 1114 of Title 18, Crimes and Criminal Procedure, and
p.001994: enacting provisions set out as notes under sections 321, 352, and 360a of this title] shall be
p.001994: construed as authorizing the manufacture, compounding, processing, possession, sale, delivery,
p.001994: or other disposal of any drug in any State in contravention of the laws of such State.
p.001994: “(b) No provision of this Act nor any amendment made by it shall be construed as indicating an
p.001994: intent on the part of the Congress to occupy the field in which such provision or amendment
p.001994: operates to the exclusion of any State law on the same subject matter, unless there is a direct and
p.001994: positive conflict between such provision or amendment and such State law so that the two cannot
p.001994: be reconciled or consistently stand together.
p.001994: “(c) No amendment made by this Act shall be construed to prevent the enforcement in the
p.001994: courts of any State of any statute of such State prescribing any criminal penalty for any act made
p.001994: criminal by any such amendment.”
p.001994: EFFECT OF DRUG AMENDMENTS OF 1962 ON STATE LAWS
p.001994: Section 202 of Pub. L. 87–781 provided that: “Nothing in the amendments made by this Act
p.001994: [enacting sections 358 to 360, amending sections 321, 331, 332, 348, 351 to 353, 355, 357, 372,
p.001994: 374, 379e, and 381 of this title, and enacting provisions set out as notes under sections 321, 331,
p.001994: 332, 352, 355, 360, and 374 of this title] to the Federal Food, Drug, and Cosmetic Act [this
p.001994: chapter] shall be construed as invalidating any provision of State law which would be valid in the
p.001994: absence of such amendments unless there is a direct and positive conflict between such
p.001994: amendments and such provision of State law.”
p.001994: DEFINITIONS
p.001994: Section 2 of Pub. L. 105–115 provided that: “In this Act [see Short Title of 1997 Amendment
p.001994: note set out under section 301 of this title], the terms ‘drug’, ‘device’, ‘food’, and ‘dietary
p.001994: supplement’ have the meaning given such terms in section 201 of the Federal Food, Drug, and
p.001994: Cosmetic Act (21 U.S.C. 321).”
p.001994:
p.001994: 1 So in original. Probably should be paragraph “(v)”.
p.001994:
p.001994: 2 So in original. Provision probably should be set flush with subpar. (B).
p.001994:
p.001994:
p.001994:
p.001994: §321a. “Butter” defined
p.001994: For the purposes of the Food and Drug Act of June 30, 1906 (Thirty-fourth Statutes at
p.001994: Large, page 768) “butter” shall be understood to mean the food product usually known as
...

p.001994: Nothing in amendments by sections 103(e), 105(c), 106(d), 204(j)(1), 211(b), (c), and 301(b) of
p.001994: Pub. L. 111–353 to be construed to apply to certain alcohol-related facilities, see section 2206 of
p.001994: this title.
p.001994: Nothing in amendments by Pub. L. 111–353 to be construed to alter jurisdiction and authorities
p.001994: established under certain other Acts or in a manner inconsistent with international agreements to
p.001994: which the United States is a party, see sections 2251 and 2252 of this title.
p.001994: CONSTRUCTION OF 2009 AMENDMENTS
p.001994: Pub. L. 111–31, div. A, title I, §103(p), June 22, 2009, 123 Stat. 1838, provided that: “Nothing in
p.001994: this section [amending this section and sections 333, 334, 355, 360m, 372 to 374, 375, 379a, 381,
p.001994: 393, 399, and 679 of this title and enacting provisions set out as notes under sections 333 and
p.001994: 387c of this title] is intended or shall be construed to expand, contract, or otherwise modify or
p.001994: amend the existing limitations on State government authority over tribal restricted fee or trust
p.001994: lands.”
p.001994: CONSTRUCTION OF 2002 AMENDMENTS
p.001994: Pub. L. 107–188, title III, §315, June 12, 2002, 116 Stat. 675, provided that: “Nothing in this title
p.001994: [enacting sections 350c, 350d, 398, 399, and 679c of this title, sections 3353, 3354, 8319, and
p.001994: 8320 of Title 7, Agriculture, and section 247b–20 of Title 42, The Public Health and Welfare,
p.001994: amending this section, sections 334, 335a, 342, 343, 360, 372, 374, and 381 of this title, and
p.001994: section 43 of Title 18, Crimes and Criminal Procedure, and enacting provisions set out as notes
p.001994: under this section and sections 341, 350c, 350d, and 381 of this title], or an amendment made by
p.001994: this title, shall be construed to alter the jurisdiction between the Secretaries of Agriculture and of
p.001994: Health and Human Services, under applicable statutes and regulations.”
p.001994: TRANSFER OF FUNCTIONS
p.001994: For transfer of functions of Federal Security Administrator to Secretary of Health, Education,
p.001994: and Welfare [now Health and Human Services], and of Food and Drug Administration in the
p.001994: Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this
p.001994: title.
p.001994:
p.001994: 1 See References in Text note below.
p.001994:
p.001994: 2 So in original.
p.001994:
p.001994:
p.001994:
p.001994: §332. Injunction proceedings
p.001994: (a) Jurisdiction of courts
p.001994: The district courts of the United States and the United States courts of the Territories
p.001994: shall have jurisdiction, for cause shown 1 to restrain violations of section 331 of this title,
p.001994: except paragraphs (h), (i), and (j).
p.001994: (b) Violation of injunction
p.001994: In case of violation of an injunction or restraining order issued under this section, which
p.001994: also constitutes a violation of this chapter, trial shall be by the court, or, upon demand of the
p.001994: accused, by a jury.
p.001994: (June 25, 1938, ch. 675, §302, 52 Stat. 1043; Pub. L. 87–781, title I, §103(d), title II,
p.001994: §201(c), Oct. 10, 1962, 76 Stat. 784, 793; Pub. L. 103–80, §3(d), Aug. 13, 1993, 107 Stat.
p.001994: 775.)
p.001994: AMENDMENTS
...

p.001994: this title because of a violation of section 353(c)(1) of this title or violated any State law
p.001994: prohibiting the sale, purchase, or trade of a drug sample subject to section 353(b) of this
p.001994: title or the offer to sell, purchase, or trade such a drug sample shall, upon conviction of the
p.001994: representative for such violation, be subject to the following civil penalties:
p.001994: (A) A civil penalty of not more than $50,000 for each of the first two such violations
p.001994: resulting in a conviction of any representative of the manufacturer or distributor in any 10-
p.001994: year period.
p.001994: (B) A civil penalty of not more than $1,000,000 for each violation resulting in a
p.001994: conviction of any representative after the second conviction in any 10-year period.
p.001994:
p.001994: For the purposes of this paragraph, multiple convictions of one or more persons arising
p.001994: out of the same event or transaction, or a related series of events or transactions, shall be
p.001994: considered as one violation.
p.001994: (3) Any manufacturer or distributor who violates section 331(t) of this title because of a
p.001994: failure to make a report required by section 353(d)(3)(E) of this title shall be subject to a civil
p.001994: penalty of not more than $100,000.
p.001994: (4)(A) If a manufacturer or distributor or any representative of such manufacturer or
p.001994: distributor provides information leading to the institution of a criminal proceeding against,
p.001994: and conviction of, any representative of that manufacturer or distributor for a violation of
p.001994: section 331(t) of this title because of a sale, purchase, or trade or offer to purchase, sell, or
p.001994: trade a drug sample in violation of section 353(c)(1) of this title or for a violation of State law
p.001994: prohibiting the sale, purchase, or trade or offer to sell, purchase, or trade a drug sample,
p.001994: the conviction of such representative shall not be considered as a violation for purposes of
p.001994: paragraph (2).
p.001994: (B) If, in an action brought under paragraph (2) against a manufacturer or distributor
p.001994: relating to the conviction of a representative of such manufacturer or distributor for the sale,
p.001994: purchase, or trade of a drug or the offer to sell, purchase, or trade a drug, it is shown, by
p.001994: clear and convincing evidence—
p.001994: (i) that the manufacturer or distributor conducted, before the institution of a criminal
p.001994: proceeding against such representative for the violation which resulted in such conviction,
p.001994: an investigation of events or transactions which would have led to the reporting of
p.001994: information leading to the institution of a criminal proceeding against, and conviction of,
p.001994: such representative for such purchase, sale, or trade or offer to purchase, sell, or trade,
p.001994: or
p.001994: (ii) that, except in the case of the conviction of a representative employed in a
p.001994: supervisory function, despite diligent implementation by the manufacturer or distributor of
p.001994: an independent audit and security system designed to detect such a violation, the
p.001994: manufacturer or distributor could not reasonably have been expected to have detected
p.001994: such violation,
p.001994:
p.001994: the conviction of such representative shall not be considered as a conviction for purposes
p.001994: of paragraph (2).
p.001994: (5) If a person provides information leading to the institution of a criminal proceeding
p.001994: against, and conviction of, a person for a violation of section 331(t) of this title because of
p.001994: the sale, purchase, or trade of a drug sample or the offer to sell, purchase, or trade a drug
p.001994: sample in violation of section 353(c)(1) of this title, such person shall be entitled to one-half
p.001994: of the criminal fine imposed and collected for such violation but not more than $125,000.
p.001994: (6) Notwithstanding subsection (a) of this section, any person who is a manufacturer or
p.001994: importer of a prescription drug under section 384(b) of this title and knowingly fails to
p.001994: comply with a requirement of section 384(e) of this title that is applicable to such
p.001994: manufacturer or importer, respectively, shall be imprisoned for not more than 10 years or
p.001994: fined not more than $250,000, or both.
p.001994: (c) Exceptions in certain cases of good faith, etc.
p.001994: No person shall be subject to the penalties of subsection (a)(1) of this section, (1) for
p.001994: having received in interstate commerce any article and delivered it or proffered delivery of it,
p.001994: if such delivery or proffer was made in good faith, unless he refuses to furnish on request of
p.001994: an officer or employee duly designated by the Secretary the name and address of the
p.001994: person from whom he purchased or received such article and copies of all documents, if
p.001994: any there be, pertaining to the delivery of the article to him; or (2) for having violated
p.001994: section 331(a) or (d) of this title, if he establishes a guaranty or undertaking signed by, and
p.001994: containing the name and address of, the person residing in the United States from whom he
p.001994: received in good faith the article, to the effect, in case of an alleged violation of section
p.001994: 331(a) of this title, that such article is not adulterated or misbranded, within the meaning of
...

p.001994: purposes of such section, shall be considered to have violated a requirement of this chapter
p.001994: that relates to devices.
p.001994: (B) Subparagraph (A) shall not apply—
p.001994: (i) to any person who violates the requirements of section 360i(a) or 360j(f) of this title
p.001994: unless such violation constitutes (I) a significant or knowing departure from such
p.001994: requirements, or (II) a risk to public health,
p.001994: (ii) to any person who commits minor violations of section 360i(e) or 360i(g) of this title
p.001994: (only with respect to correction reports) if such person demonstrates substantial
p.001994: compliance with such section, or
p.001994: (iii) to violations of section 351(a)(2)(A) of this title which involve one or more devices
p.001994: which are not defective.
p.001994:
p.001994: (2)(A) Any person who introduces into interstate commerce or delivers for introduction
p.001994: into interstate commerce an article of food that is adulterated within the meaning of section
p.001994: 342(a)(2)(B) of this title or any person who does not comply with a recall order under
p.001994: section 350l of this title shall be subject to a civil money penalty of not more than $50,000 in
p.001994: the case of an individual and $250,000 in the case of any other person for such introduction
p.001994: or delivery, not to exceed $500,000 for all such violations adjudicated in a single
p.001994: proceeding.
p.001994: (B) This paragraph shall not apply to any person who grew the article of food that is
p.001994: adulterated. If the Secretary assesses a civil penalty against any person under this
p.001994: paragraph, the Secretary may not use the criminal authorities under this section to sanction
p.001994: such person for the introduction or delivery for introduction into interstate commerce of the
p.001994: article of food that is adulterated. If the Secretary assesses a civil penalty against any
p.001994: person under this paragraph, the Secretary may not use the seizure authorities of section
p.001994: 334 of this title or the injunction authorities of section 332 of this title with respect to the
p.001994: article of food that is adulterated.
p.001994: (C) In a hearing to assess a civil penalty under this paragraph, the presiding officer shall
p.001994: have the same authority with regard to compelling testimony or production of documents as
p.001994: a presiding officer has under section 346a(g)(2)(B) of this title. The third sentence of
p.001994: paragraph (5)(A) shall not apply to any investigation under this paragraph.
p.001994: (3)(A) Any person who violates section 331(jj) of this title shall be subject to a civil
p.001994: monetary penalty of not more than $10,000 for all violations adjudicated in a single
p.001994: proceeding.
p.001994: (B) If a violation of section 331(jj) of this title is not corrected within the 30-day period
p.001994: following notification under section 282(j)(5)(C)(ii) 2 of title 42, the person shall, in addition to
p.001994: any penalty under subparagraph (A), be subject to a civil monetary penalty of not more than
p.001994: $10,000 for each day of the violation after such period until the violation is corrected.
p.001994: (4)(A) Any responsible person (as such term is used in section 355–1 of this title) that
...

p.001994: 1990 Amendment note below.
p.001994: 1993—Subsecs. (e) to (g). Pub. L. 103–80, which directed the amendment of this section by
p.001994: redesignating the second subsec. (e) and subsec. (f) as subsecs. (f) and (g), respectively, could
p.001994: only be executed by designating subsec. (f) as (g) because this section did not contain a second
p.001994: subsec. (e) subsequent to amendment of Pub. L. 101–647 by Pub. L. 103–322. See 1990 and
p.001994: 1994 amendment notes for subsec. (e) under this section.
p.001994: 1992—Subsec. (b)(1). Pub. L. 102–353, §3(a), amended par. (1) generally. Prior to amendment,
p.001994: par. (1) read as follows: “Notwithstanding subsection (a) of this section, any person who violates
p.001994: section 331(t) of this title because of an importation of a drug in violation of section 381(d)(1) of
p.001994: this title, because of a sale, purchase, or trade of a drug or drug sample or the offer to sell,
p.001994: purchase, or trade a drug or drug sample in violation of section 353(c) of this title, because of the
p.001994: sale, purchase, or trade of a coupon, the offer to sell, purchase, or trade such a coupon, or the
p.001994: counterfeiting of such a coupon in violation of section 353(c)(2) of this title, or the distribution of
p.001994: drugs in violation of section 353(e)(2)(A) of this title shall be imprisoned for not more than 10 years
p.001994: or fined not more than $250,000, or both.”
p.001994: Subsec. (b)(4)(A). Pub. L. 102–353, §3(b)(1), substituted “the institution of a criminal proceeding
p.001994: against, and conviction of,” for “the arrest and conviction of”.
p.001994: Subsec. (b)(4)(B)(i). Pub. L. 102–353, §3(b)(1), (2), substituted “before the institution of a
p.001994: criminal proceeding against” for “before the arrest of” and “the institution of a criminal proceeding
p.001994: against, and conviction of,” for “the arrest and conviction of”.
p.001994: Subsec. (b)(5). Pub. L. 102–353, §3(b)(3), substituted “the institution of a criminal proceeding
p.001994: against, and conviction of,” for “the arrest and conviction of”.
p.001994: Subsec. (c). Pub. L. 102–353, §3(b)(4), substituted “subsection (a)(1) of this section” for
p.001994: “subsection (a) of this section”.
p.001994: Subsec. (d). Pub. L. 102–353, §3(b)(4), (5), substituted “subsection (a)(1) of this section” for
p.001994: “subsection (a) of this section” and struck out “, and no person shall be subject to the penalties of
p.001994: subsection (b) of this section for such a violation unless the violation is committed with the intent
p.001994: to defraud or mislead” after “advertising”.
p.001994: 1990—Subsec. (e). Pub. L. 101–647, as amended by Pub. L. 103–322, amended subsec. (e)
p.001994: generally. Prior to amendment, subsec. (e) read as follows:
p.001994: “(e)(1) Except as provided in paragraph (2), any person who distributes or possesses with the
p.001994: intent to distribute any anabolic steroid for any use in humans other than the treatment of disease
p.001994: pursuant to the order of a physician shall be imprisoned for not more than three years or fined
p.001994: under title 18, or both.
p.001994: “(2) Any person who distributes or possesses with the intent to distribute to an individual under
p.001994: 18 years of age, any anabolic steroid for any use in humans other than the treatment of disease
p.001994: pursuant to the order of a physician shall be imprisoned for not more than six years or fined under
p.001994: title 18, or both.”
p.001994: Subsec. (f). Pub. L. 101–629 added subsec. (f).
p.001994: 1988—Subsecs. (a), (b). Pub. L. 100–293 designated existing subsecs. (a) and (b) as pars. (1)
p.001994: and (2) of subsec. (a), substituted “paragraph (1)” for “subsection (a)” in par. (2), and added
...

p.001994:
p.001994: 1 So in original. Words “of this section” probably should not appear.
p.001994:
p.001994: 2 See References in Text note below.
p.001994:
p.001994:
p.001994:
p.001994: §333a. Repealed. Pub. L. 101–647, title XIX, §1905, Nov. 29, 1990, 104
p.001994: Stat. 4853
p.001994: Section, Pub. L. 100–690, title II, §2401, Nov. 18, 1988, 102 Stat. 4230, related to forfeiture and
p.001994: illegal trafficking in steroids or human growth hormones.
p.001994:
p.001994:
p.001994: §334. Seizure
p.001994: (a) Grounds and jurisdiction
p.001994: (1) Any article of food, drug, or cosmetic that is adulterated or misbranded when
p.001994: introduced into or while in interstate commerce or while held for sale (whether or not the
p.001994: first sale) after shipment in interstate commerce, or which may not, under the provisions of
p.001994: section 331(ll), 344, or 355 of this title, be introduced into interstate commerce, shall be
p.001994: liable to be proceeded against while in interstate commerce, or at any time thereafter, on
p.001994: libel of information and condemned in any district court of the United States or United
p.001994: States court of a Territory within the jurisdiction of which the article is found. No libel for
p.001994: condemnation shall be instituted under this chapter, for any alleged misbranding if there is
p.001994: pending in any court a libel for condemnation proceeding under this chapter based upon the
p.001994: same alleged misbranding, and not more than one such proceeding shall be instituted if no
p.001994: such proceeding is so pending, except that such limitations shall not apply (A) when such
p.001994: misbranding has been the basis of a prior judgment in favor of the United States, in a
p.001994: criminal, injunction, or libel for condemnation proceeding under this chapter, or (B) when the
p.001994: Secretary has probable cause to believe from facts found, without hearing, by him or any
p.001994: officer or employee of the Department that the misbranded article is dangerous to health, or
p.001994: that the labeling of the misbranded article is fraudulent, or would be in a material respect
p.001994: misleading to the injury or damage of the purchaser or consumer. In any case where the
p.001994: number of libel for condemnation proceedings is limited as above provided the proceeding
p.001994: pending or instituted shall, on application of the claimant, seasonably made, be removed for
p.001994: trial to any district agreed upon by stipulation between the parties, or, in case of failure to so
p.001994: stipulate within a reasonable time, the claimant may apply to the court of the district in
p.001994: which the seizure has been made, and such court (after giving the United States attorney
p.001994: for such district reasonable notice and opportunity to be heard) shall by order, unless good
p.001994: cause to the contrary is shown, specify a district of reasonable proximity to the claimant's
p.001994: principal place of business, to which the case shall be removed for trial.
p.001994: (2) The following shall be liable to be proceeded against at any time on libel of
p.001994: information and condemned in any district court of the United States or United States court
p.001994: of a Territory within the jurisdiction of which they are found: (A) Any drug that is a counterfeit
p.001994: drug, (B) Any container of a counterfeit drug, (C) Any punch, die, plate, stone, labeling,
...

p.001994: implement the amendment made by this section [amending this section].”
p.001994: SAVINGS PROVISION
p.001994: Amendment by Pub. L. 91–513 not to affect or abate any prosecutions for any violation of law or
p.001994: any civil seizures or forfeitures and injunctive proceedings commenced prior to the effective date
p.001994: of such amendment, and all administrative proceedings pending before the Bureau of Narcotics
p.001994: and Dangerous Drugs [now the Drug Enforcement Administration] on Oct. 27, 1970, to be
p.001994: continued and brought to final determination in accord with laws and regulations in effect prior to
p.001994: Oct. 27, 1970, see section 702 of Pub. L. 91–513, set out as a note under section 321 of this title.
p.001994: CONSTRUCTION OF 2011 AMENDMENT
p.001994: Nothing in amendment by Pub. L. 111–353 to be construed to alter jurisdiction and authorities
p.001994: established under certain other Acts or in a manner inconsistent with international agreements to
p.001994: which the United States is a party, see sections 2251 and 2252 of this title.
p.001994: TRANSFER OF FUNCTIONS
p.001994: For transfer of functions of Federal Security Administrator to Secretary of Health, Education,
p.001994: and Welfare [now Health and Human Services], and of Food and Drug Administration in the
p.001994: Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this
p.001994: title.
p.001994:
p.001994:
p.001994: §335. Hearing before report of criminal violation
p.001994: Before any violation of this chapter is reported by the Secretary to any United States
p.001994: attorney for institution of a criminal proceeding, the person against whom such proceeding
p.001994: is contemplated shall be given appropriate notice and an opportunity to present his views,
p.001994: either orally or in writing, with regard to such contemplated proceeding.
p.001994: (June 25, 1938, ch. 675, §305, 52 Stat. 1045.)
p.001994: TRANSFER OF FUNCTIONS
p.001994: For transfer of functions of Federal Security Administrator to Secretary of Health, Education,
p.001994: and Welfare [now Health and Human Services], and of Food and Drug Administration in the
p.001994: Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this
p.001994: title.
p.001994:
p.001994:
p.001994: §335a. Debarment, temporary denial of approval, and suspension
p.001994: (a) Mandatory debarment; certain drug applications
p.001994: (1) Corporations, partnerships, and associations
p.001994: If the Secretary finds that a person other than an individual has been convicted, after
p.001994: May 13, 1992, of a felony under Federal law for conduct relating to the development or
p.001994: approval, including the process for development or approval, of any abbreviated drug
p.001994: application, the Secretary shall debar such person from submitting, or assisting in the
p.001994: submission of, any such application.
p.001994: (2) Individuals
p.001994: If the Secretary finds that an individual has been convicted of a felony under Federal
p.001994: law for conduct—
...

p.001994: (1) In general
p.001994: The Secretary, on the Secretary's own initiative or in response to a petition, may, in
p.001994: accordance with paragraph (2), debar—
p.001994: (A) a person other than an individual from submitting or assisting in the submission of
p.001994: any abbreviated drug application,
p.001994: (B) an individual from providing services in any capacity to a person that has an
p.001994: approved or pending drug product application, or
p.001994: (C) a person from importing an article of food or offering such an article for import
p.001994: into the United States.
p.001994: (2) Persons subject to permissive debarment; certain drug applications
p.001994: The following persons are subject to debarment under subparagraph (A) or (B) of
p.001994: paragraph (1):
p.001994: (A) Corporations, partnerships, and associations
p.001994: Any person other than an individual that the Secretary finds has been convicted—
p.001994: (i) for conduct that—
p.001994: (I) relates to the development or approval, including the process for the
p.001994: development or approval, of any abbreviated drug application; and
p.001994: (II) is a felony under Federal law (if the person was convicted before May 13,
p.001994: 1992), a misdemeanor under Federal law, or a felony under State law, or
p.001994:
p.001994: (ii) of a conspiracy to commit, or aiding or abetting, a criminal offense described in
p.001994: clause (i) or a felony described in subsection (a)(1) of this section,
p.001994:
p.001994: if the Secretary finds that the type of conduct which served as the basis for such
p.001994: conviction undermines the process for the regulation of drugs.
p.001994: (B) Individuals
p.001994: (i) Any individual whom the Secretary finds has been convicted of—
p.001994: (I) a misdemeanor under Federal law or a felony under State law for conduct
p.001994: relating to the development or approval, including the process for development or
p.001994: approval, of any drug product or otherwise relating to the regulation of drug products
p.001994: under this chapter, or
p.001994: (II) a conspiracy to commit, or aiding or abetting, such criminal offense or a felony
p.001994: described in subsection (a)(2) of this section,
p.001994:
p.001994: if the Secretary finds that the type of conduct which served as the basis for such
p.001994: conviction undermines the process for the regulation of drugs.
p.001994: (ii) Any individual whom the Secretary finds has been convicted of—
p.001994: (I) a felony which is not described in subsection (a)(2) of this section or clause (i)
p.001994: of this subparagraph and which involves bribery, payment of illegal gratuities, fraud,
p.001994: perjury, false statement, racketeering, blackmail, extortion, falsification or destruction
p.001994: of records, or interference with, obstruction of an investigation into, or prosecution of,
p.001994: any criminal offense, or
p.001994: (II) a conspiracy to commit, or aiding or abetting, such felony,
p.001994:
p.001994: if the Secretary finds, on the basis of the conviction of such individual and other
p.001994: information, that such individual has demonstrated a pattern of conduct sufficient to find that
p.001994: there is reason to believe that such individual may violate requirements under this chapter
p.001994: relating to drug products.
p.001994: (iii) Any individual whom the Secretary finds materially participated in acts that were
p.001994: the basis for a conviction for an offense described in subsection (a) of this section or in
p.001994: clause (i) or (ii) for which a conviction was obtained, if the Secretary finds, on the basis
p.001994: of such participation and other information, that such individual has demonstrated a
p.001994: pattern of conduct sufficient to find that there is reason to believe that such individual
p.001994: may violate requirements under this chapter relating to drug products.
p.001994: (iv) Any high managerial agent whom the Secretary finds—
p.001994: (I) worked for, or worked as a consultant for, the same person as another
p.001994: individual during the period in which such other individual took actions for which a
p.001994: felony conviction was obtained and which resulted in the debarment under
p.001994: subsection (a)(2) of this section, or clause (i), of such other individual,
...

p.001994: which relate to any matter under the jurisdiction of the Food and Drug Administration.
p.001994: (D) Secretarial action
p.001994: The action referred to in subparagraphs (B) and (C) is—
p.001994: (i) in the case of a person other than an individual—
p.001994: (I) terminating the debarment immediately, or
p.001994: (II) limiting the period of debarment to less than one year, and
p.001994:
p.001994: (ii) in the case of an individual, limiting the period of debarment to less than
p.001994: permanent but to no less than 1 year,
p.001994:
p.001994: whichever best serves the interest of justice and protects the integrity of the drug
p.001994: approval process.
p.001994: (e) Publication and list of debarred persons
p.001994: The Secretary shall publish in the Federal Register the name of any person debarred
p.001994: under subsection (a) or (b) of this section, the effective date of the debarment, and the
p.001994: period of the debarment. The Secretary shall also maintain and make available to the public
p.001994: a list, updated no less often than quarterly, of such persons, of the effective dates and
p.001994: minimum periods of such debarments, and of the termination of debarments.
p.001994: (f) Temporary denial of approval
p.001994: (1) In general
p.001994: The Secretary, on the Secretary's own initiative or in response to a petition, may, in
p.001994: accordance with paragraph (3), refuse by order, for the period prescribed by paragraph
p.001994: (2), to approve any abbreviated drug application submitted by any person—
p.001994: (A) if such person is under an active Federal criminal investigation in connection with
p.001994: an action described in subparagraph (B),
p.001994: (B) if the Secretary finds that such person—
p.001994: (i) has bribed or attempted to bribe, has paid or attempted to pay an illegal gratuity,
p.001994: or has induced or attempted to induce another person to bribe or pay an illegal
p.001994: gratuity to any officer, employee, or agent of the Department of Health and Human
p.001994: Services or to any other Federal, State, or local official in connection with any
p.001994: abbreviated drug application, or has conspired to commit, or aided or abetted, such
p.001994: actions, or
p.001994: (ii) has knowingly made or caused to be made a pattern or practice of false
p.001994: statements or misrepresentations with respect to material facts relating to any
p.001994: abbreviated drug application, or the production of any drug subject to an abbreviated
p.001994: drug application, to any officer, employee, or agent of the Department of Health and
p.001994: Human Services, or has conspired to commit, or aided or abetted, such actions, and
p.001994:
p.001994: (C) if a significant question has been raised regarding—
p.001994: (i) the integrity of the approval process with respect to such abbreviated drug
p.001994: application, or
p.001994: (ii) the reliability of data in or concerning such person's abbreviated drug
p.001994: application.
p.001994:
p.001994: Such an order may be modified or terminated at any time.
p.001994: (2) Applicable period
p.001994: (A) In general
p.001994: Except as provided in subparagraph (B), a denial of approval of an application of a
p.001994: person under paragraph (1) shall be in effect for a period determined by the Secretary
p.001994: but not to exceed 18 months beginning on the date the Secretary finds that the
p.001994: conditions described in subparagraphs (A), (B), and (C) of paragraph (1) exist. The
p.001994: Secretary shall terminate such denial—
p.001994: (i) if the investigation with respect to which the finding was made does not result in
p.001994: a criminal charge against such person, if criminal charges have been brought and the
p.001994: charges have been dismissed, or if a judgment of acquittal has been entered, or
p.001994: (ii) if the Secretary determines that such finding was in error.
p.001994: (B) Extension
p.001994: If, at the end of the period described in subparagraph (A), the Secretary determines
p.001994: that a person has been criminally charged for an action described in subparagraph (B)
p.001994: of paragraph (1), the Secretary may extend the period of denial of approval of an
p.001994: application for a period not to exceed 18 months. The Secretary shall terminate such
p.001994: extension if the charges have been dismissed, if a judgment of acquittal has been
p.001994: entered, or if the Secretary determines that the finding described in subparagraph (A)
p.001994: was in error.
p.001994: (3) Informal hearing
p.001994: Within 10 days of the date an order is issued under paragraph (1), the Secretary shall
p.001994: provide such person with an opportunity for an informal hearing, to be held within such 10
p.001994: days, on the decision of the Secretary to refuse approval of an abbreviated drug
p.001994: application. Within 60 days of the date on which such hearing is held, the Secretary shall
p.001994: notify the person given such hearing whether the Secretary's refusal of approval will be
p.001994: continued, terminated, or otherwise modified. Such notification shall be final agency
p.001994: action.
p.001994: (g) Suspension authority
p.001994: (1) In general
p.001994: If—
p.001994: (A) the Secretary finds—
p.001994: (i) that a person has engaged in conduct described in subparagraph (B) of
p.001994: subsection (f)(1) of this section in connection with 2 or more drugs under abbreviated
p.001994: drug applications, or
p.001994: (ii) that a person has engaged in flagrant and repeated, material violations of good
p.001994: manufacturing practice or good laboratory practice in connection with the
p.001994: development, manufacturing, or distribution of one or more drugs approved under an
p.001994: abbreviated drug application during a 2-year period, and—
p.001994: (I) such violations may undermine the safety and efficacy of such drugs, and
p.001994: (II) the causes of such violations have not been corrected within a reasonable
p.001994: period of time following notice of such violations by the Secretary, and
p.001994:
p.001994: (B) such person is under an active investigation by a Federal authority in connection
p.001994: with a civil or criminal action involving conduct described in subparagraph (A),
p.001994:
p.001994: the Secretary shall issue an order suspending the distribution of all drugs the
p.001994: development or approval of which was related to such conduct described in
p.001994: subparagraph (A) or suspending the distribution of all drugs approved under abbreviated
p.001994: drug applications of such person if the Secretary finds that such conduct may have
p.001994: affected the development or approval of a significant number of drugs which the
p.001994: Secretary is unable to identify. The Secretary shall exclude a drug from such order if the
p.001994: Secretary determines that such conduct was not likely to have influenced the safety or
p.001994: efficacy of such drug.
p.001994: (2) Public health waiver
p.001994: The Secretary shall, on the Secretary's own initiative or in response to a petition, waive
p.001994: the suspension under paragraph (1) (involving an action described in paragraph (1)(A)(i))
p.001994: with respect to any drug if the Secretary finds that such waiver is necessary to protect the
p.001994: public health because sufficient quantities of the drug would not otherwise be available.
p.001994: The Secretary shall act on any petition seeking action under this paragraph within 180
p.001994: days of the date the petition is submitted to the Secretary.
p.001994: (h) Termination of suspension
p.001994: The Secretary shall withdraw an order of suspension of the distribution of a drug under
...

p.001994: following the date the person is notified of the Secretary's decision) a petition requesting
p.001994: that the decision be modified or set aside.
p.001994: (2) Exception
p.001994: Any person that is the subject of an adverse decision under clause (iii) or (iv) of
p.001994: subsection (b)(2)(B) of this section may obtain a review of such decision by the United
p.001994: States District Court for the District of Columbia or a district court of the United States for
p.001994: the district in which the person resides, by filing in such court (within 30 days following the
p.001994: date the person is notified of the Secretary's decision) a complaint requesting that the
p.001994: decision be modified or set aside. In such an action, the court shall determine the matter
p.001994: de novo.
p.001994: (k) Certification
p.001994: Any application for approval of a drug product shall include—
p.001994: (1) a certification that the applicant did not and will not use in any capacity the services
p.001994: of any person debarred under subsection (a) or (b) of this section, in connection with such
p.001994: application, and
p.001994: (2) if such application is an abbreviated drug application, a list of all convictions,
p.001994: described in subsections (a) and (b) of this section which occurred within the previous 5
p.001994: years, of the applicant and affiliated persons responsible for the development or
p.001994: submission of such application.
p.001994: (l) Applicability
p.001994: (1) Conviction
p.001994: For purposes of this section, a person is considered to have been convicted of a
p.001994: criminal offense—
p.001994: (A) when a judgment of conviction has been entered against the person by a Federal
p.001994: or State court, regardless of whether there is an appeal pending,
p.001994: (B) when a plea of guilty or nolo contendere by the person has been accepted by a
p.001994: Federal or State court, or
p.001994: (C) when the person has entered into participation in a first offender, deferred
p.001994: adjudication, or other similar arrangement or program where judgment of conviction
p.001994: has been withheld.
p.001994: (2) Effective dates
p.001994: Subsection (a) of this section, subparagraph (A) of subsection (b)(2) of this section,
p.001994: clauses (i) and (ii) of subsection (b)(2)(B) of this section, and subsection (b)(3)(A) of this
p.001994: section shall not apply to a conviction which occurred more than 5 years before the
p.001994: initiation of an agency action proposed to be taken under subsection (a) or (b) of this
p.001994: section. Clauses (iii) and (iv) of subsection (b)(2)(B) of this section, subsection (b)(3)(B)
p.001994: of this section, and subsections (f) and (g) of this section shall not apply to an act or
p.001994: action which occurred more than 5 years before the initiation of an agency action
p.001994: proposed to be taken under subsection (b), (f), or (g) of this section. Clause (iv) of
p.001994: subsection (b)(2)(B) of this section shall not apply to an action which occurred before
p.001994: June 1, 1992. Subsection (k) of this section shall not apply to applications submitted to
p.001994: the Secretary before June 1, 1992.
p.001994: (m) Devices; mandatory debarment regarding third-party inspections and reviews
p.001994: (1) In general
...

p.001994: introductory provisions.
p.001994: Subsec. (b)(3), (4). Pub. L. 107–188, §304(a)(2)(B), (C), added par. (3) and redesignated former
p.001994: par. (3) as (4).
p.001994: Subsec. (c)(2)(A)(iii). Pub. L. 107–188, §304(b)(3), substituted “paragraph (2) or (3) of
p.001994: subsection (b)” for “subsection (b)(2)”.
p.001994: Subsec. (d)(3)(A)(i). Pub. L. 107–188, §304(b)(4)(A), substituted “subsection (a)(1) of this
p.001994: section or paragraph (2)(A) or (3) of subsection (b)” for “subsection (a)(1) or (b)(2)(A)”.
p.001994: Subsec. (d)(3)(A)(ii)(II). Pub. L. 107–188, §304(b)(4)(B), inserted “in applicable cases,” before
p.001994: “sufficient audits”.
p.001994: Subsec. (d)(3)(B)(i). Pub. L. 107–188, §304(b)(4)(C), inserted “or subsection (b)(3)” after
p.001994: “subsection (b)(2)(B)”.
p.001994: Subsec. (d)(3)(B)(ii). Pub. L. 107–188, §304(b)(4)(C), (D), inserted “or subsection (b)(3)” after
p.001994: “subsection (b)(2)(B)” and “or the food importation process, as the case may be” before period.
p.001994: Subsec. (l)(2). Pub. L. 107–188, §304(c), in first sentence struck out “and” after “subsection (b)
p.001994: (2) of this section,” and inserted “, and subsection (b)(3)(A) of this section” after “subsection (b)(2)
p.001994: (B) of this section” and in second sentence inserted “, subsection (b)(3)(B) of this section,” after
p.001994: “subsection (b)(2)(B) of this section”.
p.001994: Subsec. (m). Pub. L. 107–250 added subsec. (m).
p.001994: 1997—Subsec. (d)(4)(B)(ii). Pub. L. 105–115 struck out “or 357” after “355”.
p.001994: CONSTRUCTION
p.001994: Section 7 of Pub. L. 102–282 provided that: “No amendment made by this Act [enacting this
p.001994: section and sections 335b and 335c of this title and amending sections 321, 336, 337, and 355 of
p.001994: this title] shall preclude any other civil, criminal, or administrative remedy provided under Federal
p.001994: or State law, including any private right of action against any person for the same action subject to
p.001994: any action or civil penalty under an amendment made by this Act.”
p.001994: CONGRESSIONAL FINDINGS
p.001994: Section 1(c) of Pub. L. 102–282 provided that: “The Congress finds that—
p.001994: “(1) there is substantial evidence that significant corruption occurred in the Food and Drug
p.001994: Administration's process of approving drugs under abbreviated drug applications,
p.001994: “(2) there is a need to establish procedures designed to restore and to ensure the integrity
p.001994: of the abbreviated drug application approval process and to protect the public health, and
p.001994: “(3) there is a need to establish procedures to bar individuals who have been convicted of
p.001994: crimes pertaining to the regulation of drug products from working for companies that
p.001994: manufacture or distribute such products.”
p.001994:
p.001994: 1 So in original. Probably should be “section”.
p.001994:
p.001994:
p.001994:
p.001994: §335b. Civil penalties
p.001994: (a) In general
p.001994: Any person that the Secretary finds—
p.001994: (1) knowingly made or caused to be made, to any officer, employee, or agent of the
p.001994: Department of Health and Human Services, a false statement or misrepresentation of a
p.001994: material fact in connection with an abbreviated drug application,
...

p.001994:
p.001994: a person who was debarred under section 335a of this title, or
p.001994: (7) is an individual debarred under section 335a of this title and, during the period of
p.001994: debarment, provided services in any capacity to a person that had an approved or
p.001994: pending drug product application,
p.001994:
p.001994: shall be liable to the United States for a civil penalty for each such violation in an amount
p.001994: not to exceed $250,000 in the case of an individual and $1,000,000 in the case of any other
p.001994: person.
p.001994: (b) Procedure
p.001994: (1) In general
p.001994: (A) Action by the Secretary
p.001994: A civil penalty under subsection (a) of this section shall be assessed by the Secretary
p.001994: on a person by an order made on the record after an opportunity for an agency hearing
p.001994: on disputed issues of material fact and the amount of the penalty. In the course of any
p.001994: investigation or hearing under this subparagraph, the Secretary may administer oaths
p.001994: and affirmations, examine witnesses, receive evidence, and issue subpoenas requiring
p.001994: the attendance and testimony of witnesses and the production of evidence that relates
p.001994: to the matter under investigation.
p.001994: (B) Action by the Attorney General
p.001994: In lieu of a proceeding under subparagraph (A), the Attorney General may, upon
p.001994: request of the Secretary, institute a civil action to recover a civil money penalty in the
p.001994: amount and for any of the acts set forth in subsection (a) of this section. Such an action
p.001994: may be instituted separately from or in connection with any other claim, civil or criminal,
p.001994: initiated by the Attorney General under this chapter.
p.001994: (2) Amount
p.001994: In determining the amount of a civil penalty under paragraph (1), the Secretary or the
p.001994: court shall take into account the nature, circumstances, extent, and gravity of the act
p.001994: subject to penalty, the person's ability to pay, the effect on the person's ability to continue
p.001994: to do business, any history of prior, similar acts, and such other matters as justice may
p.001994: require.
p.001994: (3) Limitation on actions
p.001994: No action may be initiated under this section—
p.001994: (A) with respect to any act described in subsection (a) of this section that occurred
p.001994: before May 13, 1992, or
p.001994: (B) more than 6 years after the date when facts material to the act are known or
p.001994: reasonably should have been known by the Secretary but in no event more than 10
p.001994: years after the date the act took place.
p.001994: (c) Judicial review
p.001994: Any person that is the subject of an adverse decision under subsection (b)(1)(A) of this
p.001994: section may obtain a review of such decision by the United States Court of Appeals for the
p.001994: District of Columbia or for the circuit in which the person resides, by filing in such court
p.001994: (within 60 days following the date the person is notified of the Secretary's decision) a
p.001994: petition requesting that the decision be modified or set aside.
p.001994: (d) Recovery of penalties
p.001994: The Attorney General may recover any civil penalty (plus interest at the currently
p.001994: prevailing rates from the date the penalty became final) assessed under subsection (b)(1)
p.001994: (A) of this section in an action brought in the name of the United States. The amount of
p.001994: such penalty may be deducted, when the penalty has become final, from any sums then or
p.001994: later owing by the United States to the person against whom the penalty has been
p.001994: assessed. In an action brought under this subsection, the validity, amount, and
p.001994: appropriateness of the penalty shall not be subject to judicial review.
p.001994: (e) Informants
p.001994: The Secretary may award to any individual (other than an officer or employee of the
p.001994: Federal Government or a person who materially participated in any conduct described in
p.001994: subsection (a) of this section) who provides information leading to the imposition of a civil
p.001994: penalty under this section an amount not to exceed—
p.001994: (1) $250,000, or
p.001994: (2) one-half of the penalty so imposed and collected,
p.001994:
p.001994: whichever is less. The decision of the Secretary on such award shall not be reviewable.
p.001994: (June 25, 1938, ch. 675, §307, as added Pub. L. 102–282, §3, May 13, 1992, 106 Stat. 159;
p.001994: amended Pub. L. 103–80, §3(g), Aug. 13, 1993, 107 Stat. 776.)
p.001994: PRIOR PROVISIONS
p.001994: A prior section 307 of act June 25, 1938, was renumbered section 310 and is classified to
p.001994: section 337 of this title.
p.001994: AMENDMENTS
p.001994: 1993—Subsec. (b)(3)(A). Pub. L. 103–80 made technical amendment to reference to May 13,
p.001994: 1992, to reflect correction of corresponding provision of original act.
p.001994: CONSTRUCTION
p.001994: This section not to preclude any other civil, criminal, or administrative remedy provided under
p.001994: Federal or State law, including any private right of action against any person for the same action
p.001994: subject to any action or civil penalty under an amendment made by Pub. L. 102–282, see section
p.001994: 7 of Pub. L. 102–282, set out as a note under section 335a of this title.
p.001994: §335c. Authority to withdraw approval of abbreviated drug applications
p.001994: (a) In general
p.001994: The Secretary—
p.001994: (1) shall withdraw approval of an abbreviated drug application if the Secretary finds that
p.001994: the approval was obtained, expedited, or otherwise facilitated through bribery, payment of
p.001994: an illegal gratuity, or fraud or material false statement, and
p.001994: (2) may withdraw approval of an abbreviated drug application if the Secretary finds that
p.001994: the applicant has repeatedly demonstrated a lack of ability to produce the drug for which
p.001994: the application was submitted in accordance with the formulations or manufacturing
p.001994: practice set forth in the abbreviated drug application and has introduced, or attempted to
p.001994: introduce, such adulterated or misbranded drug into commerce.
p.001994: (b) Procedure
p.001994: The Secretary may not take any action under subsection (a) of this section with respect
p.001994: to any person unless the Secretary has issued an order for such action made on the record
p.001994: after opportunity for an agency hearing on disputed issues of material fact. In the course of
p.001994: any investigation or hearing under this subsection, the Secretary may administer oaths and
p.001994: affirmations, examine witnesses, receive evidence, and issue subpoenas requiring the
p.001994: attendance and testimony of witnesses and the production of evidence that relates to the
p.001994: matter under investigation.
p.001994: (c) Applicability
p.001994: Subsection (a) of this section shall apply with respect to offenses or acts regardless of
p.001994: when such offenses or acts occurred.
p.001994: (d) Judicial review
p.001994: Any person that is the subject of an adverse decision under subsection (a) of this section
p.001994: may obtain a review of such decision by the United States Court of Appeals for the District
p.001994: of Columbia or for the circuit in which the person resides, by filing in such court (within 60
p.001994: days following the date the person is notified of the Secretary's decision) a petition
p.001994: requesting that the decision be modified or set aside.
p.001994: (June 25, 1938, ch. 675, §308, as added Pub. L. 102–282, §4, May 13, 1992, 106 Stat.
p.001994: 160.)
p.001994: CONSTRUCTION
p.001994: This section not to preclude any other civil, criminal, or administrative remedy provided under
p.001994: Federal or State law, including any private right of action against any person for the same action
p.001994: subject to any action or civil penalty under an amendment made by Pub. L. 102–282, see section
p.001994: 7 of Pub. L. 102–282, set out as a note under section 335a of this title.
p.001994:
p.001994:
p.001994: §336. Report of minor violations
p.001994: Nothing in this chapter shall be construed as requiring the Secretary to report for
p.001994: prosecution, or for the institution of libel or injunction proceedings, minor violations of this
p.001994: chapter whenever he believes that the public interest will be adequately served by a
p.001994: suitable written notice or warning.
p.001994: (June 25, 1938, ch. 675, §309, formerly §306, 52 Stat. 1045; renumbered §309, Pub. L.
p.001994: 102–282, §2, May 13, 1992, 106 Stat. 150.)
p.001994: TRANSFER OF FUNCTIONS
p.001994: For transfer of functions of Federal Security Administrator to Secretary of Health, Education,
p.001994: and Welfare [now Health and Human Services], and of Food and Drug Administration in the
p.001994: Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this
p.001994: title.
p.001994:
p.001994:
p.001994: §337. Proceedings in name of United States; provision as to subpoenas
p.001994: (a) Except as provided in subsection (b) of this section, all such proceedings for the
p.001994: enforcement, or to restrain violations, of this chapter shall be by and in the name of the
p.001994: United States. Subpoenas for witnesses who are required to attend a court of the United
...

p.000001: time prior to dispensing the label of the drug fails to bear, at a minimum, the symbol “Rx
p.000001: only”.
p.000001: (B) A drug to which paragraph (1) does not apply shall be deemed to be misbranded if at
p.000001: any time prior to dispensing the label of the drug bears the symbol described in
p.000001: subparagraph (A).
p.000001: (5) Nothing in this subsection shall be construed to relieve any person from any
p.000001: requirement prescribed by or under authority of law with respect to drugs now included or
p.000001: which may hereafter be included within the classifications stated in sections 4721, 6001,
p.000001: and 6151 of title 26, or to marihuana as defined in section 4761 of title 26.
p.000001: (c) Sales restrictions
p.000001: (1) No person may sell, purchase, or trade or offer to sell, purchase, or trade any drug
p.000001: sample. For purposes of this paragraph and subsection (d) of this section, the term “drug
p.000001: sample” means a unit of a drug, subject to subsection (b) of this section, which is not
p.000001: intended to be sold and is intended to promote the sale of the drug. Nothing in this
p.000001: paragraph shall subject an officer or executive of a drug manufacturer or distributor to
p.000001: criminal liability solely because of a sale, purchase, trade, or offer to sell, purchase, or trade
p.000001: in violation of this paragraph by other employees of the manufacturer or distributor.
p.000001: (2) No person may sell, purchase, or trade, offer to sell, purchase, or trade, or counterfeit
p.000001: any coupon. For purposes of this paragraph, the term “coupon” means a form which may be
p.000001: redeemed, at no cost or at a reduced cost, for a drug which is prescribed in accordance with
p.000001: subsection (b) of this section.
p.000001: (3)(A) No person may sell, purchase, or trade, or offer to sell, purchase, or trade, any
p.000001: drug
p.000001: (i) which is subject to subsection (b) of this section, and
p.000001: (ii)(I) which was purchased by a public or private hospital or other health care entity, or
p.000001: (II) which was donated or supplied at a reduced price to a charitable organization
p.000001: described in section 501(c)(3) of title 26.
p.000001:
p.000001: (B) Subparagraph (A) does not apply to—
p.000001: (i) the purchase or other acquisition by a hospital or other health care entity which is a
p.000001: member of a group purchasing organization of a drug for its own use from the group
p.000001: purchasing organization or from other hospitals or health care entities which are
p.000001: members of such organization,
p.000001: (ii) the sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug by
p.000001: an organization described in subparagraph (A)(ii)(II) to a nonprofit affiliate of the
...

p.000001: Food, Drug, and Cosmetic Act, the Secretary shall consider the application under the applicable
p.000001: requirements of such section. The Secretary of Health and Human Services may not approve
p.000001: such an abbreviated new drug application which is filed for a drug which is described in sections
p.000001: 505(c)(3)(D) and 505(j)(4)(D) of the Federal Food, Drug, and Cosmetic Act, except in accordance
p.000001: with such section.”
p.000001: EFFECTIVE DATE OF 1972 AMENDMENT
p.000001: Amendment by Pub. L. 92–387 effective on first day of sixth month beginning after Aug. 16,
p.000001: 1972, see section 5 of Pub. L. 92–387, set out as a note under section 360 of this title.
p.000001: EFFECTIVE DATE OF 1962 AMENDMENT
p.000001: Amendment by Pub. L. 87–781 effective on first day of seventh calendar month following
p.000001: October 1962, see section 107 of Pub. L. 87–781, set out as a note under section 321 of this title.
p.000001: CONSTRUCTION OF AMENDMENT BY PUB. L. 110–85
p.000001: Pub. L. 110–85, title IX, §905(b), Sept. 27, 2007, 121 Stat. 949, provided that: “Nothing in this
p.000001: section [amending this section] or the amendment made by this section shall be construed to
p.000001: prohibit the lawful disclosure or use of data or information by an entity other than as described in
p.000001: paragraph (4)(B) or (4)(G) of section 505(k) of the Federal Food, Drug, and Cosmetic Act [21
p.000001: U.S.C. 355(k)], as added by subsection (a).”
p.000001: CONSTRUCTION OF AMENDMENTS BY PUB. L. 102–282
p.000001: Amendment by Pub. L. 102–282 not to preclude any other civil, criminal, or administrative
p.000001: remedy provided under Federal or State law, including any private right of action against any
p.000001: person for the same action subject to any action or civil penalty under an amendment made by
p.000001: Pub. L. 102–282, see section 7 of Pub. L. 102–282, set out as a note under section 335a of this
p.000001: title.
p.000001: TRANSFER OF FUNCTIONS
p.000001: For transfer of functions of Federal Security Administrator to Secretary of Health, Education,
p.000001: and Welfare [now Health and Human Services], and of Food and Drug Administration in the
p.000001: Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this
p.000001: title.
p.000001: EFFECT OF AMENDMENTS BY PUB. L. 110–85 ON VETERINARY MEDICINE
p.000001: Pub. L. 110–85, title IX, §907, Sept. 27, 2007, 121 Stat. 950, provided that: “This subtitle
p.000001: [subtitle A (§§901–909) of title IX of Pub. L. 110–85, enacting sections 353b and 355–1 of this
p.000001: title, amending this section and sections 331, 333, and 352 of this title and section 262 of Title 42,
p.000001: The Public Health and Welfare, and enacting provisions set out as notes under this section and
p.000001: sections 331, 352, and 355a of this title], and the amendments made by this subtitle, shall have no
p.000001: effect on the use of drugs approved under section 505 of the Federal Food, Drug, and Cosmetic
p.000001: Act [21 U.S.C. 355] by, or on the lawful written or oral order of, a licensed veterinarian within the
p.000001: context of a veterinarian-client-patient relationship, as provided for under section 512(a)(5) of such
...

p.000001: Not later than 30 months after September 27, 2007, the Secretary shall develop a
p.000001: standardized numerical identifier (which, to the extent practicable, shall be harmonized
p.000001: with international consensus standards for such an identifier) to be applied to a
p.000001: prescription drug at the point of manufacturing and repackaging (in which case the
p.000001: numerical identifier shall be linked to the numerical identifier applied at the point of
p.000001: manufacturing) at the package or pallet level, sufficient to facilitate the identification,
p.000001: validation, authentication, and tracking and tracing of the prescription drug.
p.000001: (3) Promising technologies
p.000001: The standards developed under this subsection shall address promising technologies,
p.000001: which may include—
p.000001: (A) radio frequency identification technology;
p.000001: (B) nanotechnology;
p.000001: (C) encryption technologies; and
p.000001: (D) other track-and-trace or authentication technologies.
p.000001: (4) Interagency collaboration
p.000001: In carrying out this subsection, the Secretary shall consult with Federal health and
p.000001: security agencies, including—
p.000001: (A) the Department of Justice;
p.000001: (B) the Department of Homeland Security;
p.000001: (C) the Department of Commerce; and
p.000001: (D) other appropriate Federal and State agencies.
p.000001: (c) Inspection and enforcement
p.000001: (1) In general
p.000001: The Secretary shall expand and enhance the resources and facilities of agency
p.000001: components of the Food and Drug Administration involved with regulatory and criminal
p.000001: enforcement of this chapter to secure the drug supply chain against counterfeit, diverted,
p.000001: subpotent, substandard, adulterated, misbranded, or expired drugs including biological
p.000001: products and active pharmaceutical ingredients from domestic and foreign sources.
p.000001: (2) Activities
p.000001: The Secretary shall undertake enhanced and joint enforcement activities with other
p.000001: Federal and State agencies, and establish regional capacities for the validation of
p.000001: prescription drugs and the inspection of the prescription drug supply chain.
p.000001: (d) Definition
p.000001: In this section, the term “prescription drug” means a drug subject to section 353(b)(1) of
p.000001: this title.
p.000001: (June 25, 1938, ch. 675, §505D, as added Pub. L. 110–85, title IX, §913, Sept. 27, 2007,
p.000001: 121 Stat. 952.)
p.000001:
p.000001:
p.000001: §356. Fast track products
p.000001: (a) Designation of drug as fast track product
p.000001: (1) In general
p.000001: The Secretary shall, at the request of the sponsor of a new drug, facilitate the
p.000001: development and expedite the review of such drug if it is intended for the treatment of a
p.000001: serious or life-threatening condition and it demonstrates the potential to address unmet
p.000001: medical needs for such a condition. (In this section, such a drug is referred to as a “fast
p.000001: track product”.)
p.000001: (2) Request for designation
...

p.001962: thereof) to be taken before the Secretary, and to be adduced upon the hearing, in such
p.001962: manner and upon such terms and conditions as to the court may seem proper. The
p.001962: Secretary may modify his findings, or make new findings, by reason of the additional
p.001962: evidence so taken, and he shall file such modified or new findings, and his
p.001962: recommendations, if any, for the modification or setting aside of his original regulation, with
p.001962: the return of such additional evidence.
p.001962: (3) Upon the filing of the petition referred to in paragraph (1) of this subsection, the court
p.001962: shall have jurisdiction to review the regulation in accordance with chapter 7 of title 5 and to
p.001962: grant appropriate relief as provided in such chapter.
p.001962: (4) The judgment of the court affirming or setting aside, in whole or in part, any such
p.001962: regulation of the Secretary shall be final, subject to review by the Supreme Court of the
p.001962: United States upon certiorari or certification as provided in section 1254 of title 28.
p.001962: (5) Any action instituted under this subsection shall survive, notwithstanding any change
p.001962: in the person occupying the office of Secretary or any vacancy in such office.
p.001962: (6) The remedies provided for in this subsection shall be in addition to and not in
p.001962: substitution for any other remedies provided by law.
p.001962: (e) Availability of record
p.001962: A certified copy of the transcript of the record and administrative proceedings under this
p.001962: section shall be furnished by the Secretary to any interested party at his request, and
p.001962: payment of the costs thereof, and shall be admissible in any criminal, exclusion of imports,
p.001962: or other proceeding arising under or in respect of this part irrespective of whether
p.001962: proceedings with respect to the regulation have previously been initiated or become final
p.001962: under this section.
p.001962: (f) Technical Electronic Product Radiation Safety Standards Committee
p.001962: (1)(A) The Secretary shall establish a Technical Electronic Product Radiation Safety
p.001962: Standards Committee (hereafter in this part referred to as the “Committee”) which he shall
p.001962: consult before prescribing any standard under this section. The Committee shall be
p.001962: appointed by the Secretary, after consultation with public and private agencies concerned
p.001962: with the technical aspect of electronic product radiation safety, and shall be composed of
p.001962: fifteen members each of whom shall be technically qualified by training and experience in
p.001962: one or more fields of science or engineering applicable to electronic product radiation
p.001962: safety, as follows:
p.001962: (i) Five members shall be selected from governmental agencies, including State and
p.001962: Federal Governments;
p.001962: (ii) Five members shall be selected from the affected industries after consultation with
p.001962: industry representatives; and
p.001962: (iii) Five members shall be selected from the general public, of which at least one shall
p.001962: be a representative of organized labor.
p.001962:
p.001962: (B) The Committee may propose electronic product radiation safety standards to the
p.001962: Secretary for his consideration. All proceedings of the Committee shall be recorded and the
p.001962: record of each such proceeding shall be available for public inspection.
p.001962: (2) Payments to members of the Committee who are not officers or employees of the
...

p.001962: granted by the Secretary under section 360ll(a)(2) or 360ll(e) of this title.
p.001962: (b) Record keeping
p.001962: Every manufacturer of electronic products shall establish and maintain such records
p.001962: (including testing records), make such reports, and provide such information, as the
p.001962: Secretary may reasonably require to enable him to determine whether such manufacturer
p.001962: has acted or is acting in compliance with this part and standards prescribed pursuant to this
p.001962: part and shall, upon request of an officer or employee duly designated by the Secretary,
p.001962: permit such officer or employee to inspect appropriate books, papers, records, and
p.001962: documents relevant to determining whether such manufacturer has acted or is acting in
p.001962: compliance with standards prescribed pursuant to this part.
p.001962: (c) Disclosure of technical data
p.001962: Every manufacturer of electronic products shall provide to the Secretary such
p.001962: performance data and other technical data related to safety as may be required to carry out
p.001962: the purposes of this part. The Secretary is authorized to require the manufacturer to give
p.001962: such notification of such performance and technical data at the time of original purchase to
p.001962: the ultimate purchaser of the electronic product, as he determines necessary to carry out
p.001962: the purposes of this part after consulting with the affected industry.
p.001962: (d) Public nature of reports
p.001962: Accident and investigation reports made under this part by any officer, employee, or agent
p.001962: of the Secretary shall be available for use in any civil, criminal, or other judicial proceeding
p.001962: arising out of such accident. Any such officer, employee, or agent may be required to testify
p.001962: in such proceedings as to the facts developed in such investigations. Any such report shall
p.001962: be made available to the public in a manner which need not identify individuals. All reports
p.001962: on research projects, demonstration projects, and other related activities shall be public
p.001962: information.
p.001962: (e) Trade secrets
p.001962: The Secretary or his representative shall not disclose any information reported to or
p.001962: otherwise obtained by him, pursuant to subsection (a) or (b) of this section, which concerns
p.001962: any information which contains or relates to a trade secret or other matter referred to in
p.001962: section 1905 of title 18, except that such information may be disclosed to other officers or
p.001962: employees of the Department and of other agencies concerned with carrying out this part or
p.001962: when relevant in any proceeding under this part. Nothing in this section shall authorize the
p.001962: withholding of information by the Secretary, or by any officers or employees under his
p.001962: control, from the duly authorized committees of the Congress.
p.001962: (f) Information required to identify and locate first purchasers of electronic products
p.001962: The Secretary may by regulation (1) require dealers and distributors of electronic
p.001962: products, to which there are applicable standards prescribed under this part and the retail
p.001962: prices of which is not less than $50, to furnish manufacturers of such products such
p.001962: information as may be necessary to identify and locate, for purposes of section 360ll of this
...

p.000398: additional evidence so taken, and he shall file such modified or new findings, and his
p.000398: recommendation, if any, for the modification or setting aside of his original order, with the
p.000398: return of such additional evidence.
p.000398: (3) Upon the filing of the petition referred to in paragraph (1) of this subsection, the court
p.000398: shall have jurisdiction to affirm the order, or to set it aside in whole or in part, temporarily or
p.000398: permanently. If the order of the Secretary refuses to issue, amend, or repeal a regulation
p.000398: and such order is not in accordance with law the court shall by its judgment order the
p.000398: Secretary to take action, with respect to such regulation, in accordance with law. The
p.000398: findings of the Secretary as to the facts, if supported by substantial evidence, shall be
p.000398: conclusive.
p.000398: (4) The judgment of the court affirming or setting aside, in whole or in part, any such
p.000398: order of the Secretary shall be final, subject to review by the Supreme Court of the United
p.000398: States upon certiorari or certification as provided in section 1254 of title 28.
p.000398: (5) Any action instituted under this subsection shall survive notwithstanding any change in
p.000398: the person occupying the office of Secretary or any vacancy in such office.
p.000398: (6) The remedies provided for in this subsection shall be in addition to and not in
p.000398: substitution for any other remedies provided by law.
p.000398: (g) Copies of records of hearings
p.000398: A certified copy of the transcript of the record and proceedings under subsection (e) of
p.000398: this section shall be furnished by the Secretary to any interested party at his request, and
p.000398: payment of the costs thereof, and shall be admissible in any criminal, libel for
p.000398: condemnation, exclusion of imports, or other proceeding arising under or in respect to this
p.000398: chapter, irrespective of whether proceedings with respect to the order have previously been
p.000398: instituted or become final under subsection (f) of this section.
p.000398: (h) Guidance documents
p.000398: (1)(A) The Secretary shall develop guidance documents with public participation and
p.000398: ensure that information identifying the existence of such documents and the documents
p.000398: themselves are made available to the public both in written form and, as feasible, through
p.000398: electronic means. Such documents shall not create or confer any rights for or on any
p.000398: person, although they present the views of the Secretary on matters under the jurisdiction
p.000398: of the Food and Drug Administration.
p.000398: (B) Although guidance documents shall not be binding on the Secretary, the Secretary
p.000398: shall ensure that employees of the Food and Drug Administration do not deviate from such
p.000398: guidances without appropriate justification and supervisory concurrence. The Secretary
p.000398: shall provide training to employees in how to develop and use guidance documents and
p.000398: shall monitor the development and issuance of such documents.
p.000398: (C) For guidance documents that set forth initial interpretations of a statute or regulation,
p.000398: changes in interpretation or policy that are of more than a minor nature, complex scientific
p.000398: issues, or highly controversial issues, the Secretary shall ensure public participation prior to
...

p.000398: was renumbered section 706 of act June 25, 1938, by Pub. L. 102–571, title I, §106(3), Oct. 29,
p.000398: 1992, 106 Stat. 4498, and transferred to section 376 of this title.
p.000398:
p.000398:
p.000398: §373. Records
p.000398: (a) In general
p.000398: For the purpose of enforcing the provisions of this chapter, carriers engaged in interstate
p.000398: commerce, and persons receiving food, drugs, devices, tobacco products, or cosmetics in
p.000398: interstate commerce or holding such articles so received, shall, upon the request of an
p.000398: officer or employee duly designated by the Secretary, permit such officer or employee, at
p.000398: reasonable times, to have access to and to copy all records showing the movement in
p.000398: interstate commerce of any food, drug, device, tobacco product, or cosmetic, or the holding
p.000398: thereof during or after such movement, and the quantity, shipper, and consignee thereof;
p.000398: and it shall be unlawful for any such carrier or person to fail to permit such access to and
p.000398: copying of any such record so requested when such request is accompanied by a
p.000398: statement in writing specifying the nature or kind of food, drug, device, tobacco product, or
p.000398: cosmetic to which such request relates, except that evidence obtained under this section, or
p.000398: any evidence which is directly or indirectly derived from such evidence, shall not be used in
p.000398: a criminal prosecution of the person from whom obtained, and except that carriers shall not
p.000398: be subject to the other provisions of this chapter by reason of their receipt, carriage,
p.000398: holding, or delivery of food, drugs, devices, tobacco products, or cosmetics in the usual
p.000398: course of business as carriers, except as provided in subsection (b) of this section.
p.000398: (b) Food transportation records
p.000398: A shipper, carrier by motor vehicle or rail vehicle, receiver, or other person subject to
p.000398: section 350e of this title shall, on request of an officer or employee designated by the
p.000398: Secretary, permit the officer or employee, at reasonable times, to have access to and to
p.000398: copy all records that the Secretary requires to be kept under section 350e(c)(1)(E) of this
p.000398: title.
p.000398: (June 25, 1938, ch. 675, §703, 52 Stat. 1057; Pub. L. 91–452, title II, §230, Oct. 15, 1970,
p.000398: 84 Stat. 930; Pub. L. 103–80, §3(z), Aug. 13, 1993, 107 Stat. 778; Pub. L. 109–59, title VII,
p.000398: §7202(c), Aug. 10, 2005, 119 Stat. 1913; Pub. L. 111–31, div. A, title I, §103(h), June 22,
p.000398: 2009, 123 Stat. 1837.)
p.000398: AMENDMENTS
p.000398: 2009—Subsec. (a). Pub. L. 111–31 inserted “tobacco product,” after “device,” in two places and
p.000398: “tobacco products,” after “devices,” in two places.
p.000398: 2005—Pub. L. 109–59 struck out “of interstate shipment” after “Records” in section catchline,
p.000398: designated existing provisions as subsec. (a), inserted subsec. heading, substituted “carriers,
p.000398: except as provided in subsection (b) of this section” for “carriers” before period at end, and added
p.000398: subsec. (b).
p.000398: 1993—Pub. L. 103–80 substituted “, except that” for “: Provided, That” and “, and except that”
p.000398: for “: Provided further, That”.
p.000398: 1970—Pub. L. 91–452 inserted “, or any evidence which is directly or indirectly derived from
p.000398: such evidence,” after “under this section”.
p.000398: EFFECTIVE DATE OF 2005 AMENDMENT
p.000398: Amendment by Pub. L. 109–59 effective Oct. 1, 2005, see section 7204 of Pub. L. 109–59, set
p.000398: out as a note under section 331 of this title.
p.000398: EFFECTIVE DATE OF 1970 AMENDMENT
p.000398: Amendment by Pub. L. 91–452 effective on sixtieth day following Oct. 15, 1970, and not to
p.000398: affect any immunity to which any individual is entitled under this section by reason of any
p.000398: testimony given before sixtieth day following Oct. 15, 1970, see section 260 of Pub. L. 91–452,
p.000398: set out as an Effective Date; Savings Provision note under section 6001 of Title 18, Crimes and
p.000398: Criminal Procedure.
p.000398: TRANSFER OF FUNCTIONS
p.000398: For transfer of functions of Federal Security Administrator to Secretary of Health, Education,
p.000398: and Welfare [now Health and Human Services], and of Food and Drug Administration in the
p.000398: Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this
p.000398: title.
p.000398:
p.000398:
p.000398: §374. Inspection
p.000398: (a) Right of agents to enter; scope of inspection; notice; promptness; exclusions
p.000398: (1) For purposes of enforcement of this chapter, officers or employees duly designated by
p.000398: the Secretary, upon presenting appropriate credentials and a written notice to the owner,
p.000398: operator, or agent in charge, are authorized (A) to enter, at reasonable times, any factory,
p.000398: warehouse, or establishment in which food, drugs, devices, tobacco products, or cosmetics
p.000398: are manufactured, processed, packed, or held, for introduction into interstate commerce or
p.000398: after such introduction, or to enter any vehicle being used to transport or hold such food,
p.000398: drugs, devices, tobacco products, or cosmetics in interstate commerce; and (B) to inspect,
p.000398: at reasonable times and within reasonable limits and in a reasonable manner, such factory,
p.000398: warehouse, establishment, or vehicle and all pertinent equipment, finished and unfinished
p.000398: materials, containers, and labeling therein. In the case of any person (excluding farms and
p.000398: restaurants) who manufactures, processes, packs, transports, distributes, holds, or imports
...

p.000398: [15 U.S.C. 45, 53, or 57b] with respect to such advertising or the Attorney General has
p.000398: commenced (or intends to commence) a civil action under section 5 [15 U.S.C. 45] with
p.000398: respect to such advertising,
p.000398: (C) it has issued and served (or intends to issue and serve) a complaint under section
p.000398: 5(b) of such Act [15 U.S.C. 45(b)] respecting such advertising, or
p.000398: (D) pursuant to section 16(b) of such Act [15 U.S.C. 56(b)] it has made a certification to
p.000398: the Attorney General respecting such advertising,
p.000398:
p.000398: the Secretary may not, except as provided by paragraph (2), initiate the action described
p.000398: in the Secretary's notice to the Federal Trade Commission.
p.000398: (2) If, before the expiration of the 60-day period beginning on the date the Secretary
p.000398: receives a notice described in paragraph (1) from the Federal Trade Commission in
p.000398: response to a notice of the Secretary under subsection (a) of this section—
p.000398: (A) the Commission or the Attorney General does not commence a civil action
p.000398: described in subparagraph (B) of paragraph (1) of this subsection respecting the
p.000398: advertising described in the Secretary's notice,
p.000398: (B) the Commission does not issue and serve a complaint described in subparagraph
p.000398: (C) of such paragraph respecting such advertising, or
p.000398: (C) the Commission does not (as described in subparagraph (D) of such paragraph)
p.000398: make a certification to the Attorney General respecting such advertising, or, if the
p.000398: Commission does make such a certification to the Attorney General respecting such
p.000398: advertising, the Attorney General, before the expiration of such period, does not cause
p.000398: appropriate criminal proceedings to be brought against such advertising,
p.000398: the Secretary may, after the expiration of such period, initiate the action described in the
p.000398: notice to the Commission pursuant to subsection (a) of this section. The Commission shall
p.000398: promptly notify the Secretary of the commencement by the Commission of such a civil
p.000398: action, the issuance and service by it of such a complaint, or the causing by the Attorney
p.000398: General of criminal proceedings to be brought against such advertising.
p.000398: (c) Secretary's determination of imminent hazard to health as suspending
p.000398: applicability of provisions
p.000398: The requirements of subsections (a) and (b) of this section do not apply with respect to
p.000398: action under subchapter III of this chapter with respect to any food or food advertising if the
p.000398: Secretary determines that such action is required to eliminate an imminent hazard to health.
p.000398: (d) Coordination of action by Secretary with Federal Trade Commission
p.000398: For the purpose of avoiding unnecessary duplication, the Secretary shall coordinate any
p.000398: action taken under subchapter III of this chapter because of advertising which the Secretary
p.000398: determines causes a food to be misbranded with any action of the Federal Trade
p.000398: Commission under the Federal Trade Commission Act [15 U.S.C. 41 et seq.] with respect
p.000398: to such advertising.
p.000398: (June 25, 1938, ch. 675, §707, as added Pub. L. 94–278, title V, §502(b), Apr. 22, 1976, 90
p.000398: Stat. 412.)
p.000398: REFERENCES IN TEXT
p.000398: The Federal Trade Commission Act, referred to in subsecs. (b) and (d), is act Sept. 26, 1914,
p.000398: ch. 311, 38 Stat. 717, as amended, which is classified generally to subchapter I (§41 et seq.) of
p.000398: chapter 2 of Title 15, Commerce and Trade. For complete classification of this Act to the Code,
p.000398: see section 58 of Title 15 and Tables.
p.000398:
p.000398:
p.000398: §379. Confidential information
p.000398: The Secretary may provide any information which is exempt from disclosure pursuant to
p.000398: subsection (a) of section 552 of title 5 by reason of subsection (b)(4) of such section to a
...

p.000398: play a crucial role in the decision of these minors to begin using tobacco products. Less
p.000398: restrictive and less comprehensive approaches have not [been] and will not be effective in
p.000398: reducing the problems addressed by such regulations. The reasonable restrictions on the
p.000398: advertising and promotion of tobacco products contained in such regulations will lead to a
p.000398: significant decrease in the number of minors using and becoming addicted to those products.
p.000398: “(32) The regulations described in paragraph (30) impose no more extensive restrictions on
p.000398: communication by tobacco manufacturers and sellers than are necessary to reduce the number
p.000398: of children and adolescents who use cigarettes and smokeless tobacco and to prevent the life-
p.000398: threatening health consequences associated with tobacco use. Such regulations are narrowly
p.000398: tailored to restrict those advertising and promotional practices which are most likely to be seen
p.000398: or heard by youth and most likely to entice them into tobacco use, while affording tobacco
p.000398: manufacturers and sellers ample opportunity to convey information about their products to adult
p.000398: consumers.
p.000398: “(33) Tobacco dependence is a chronic disease, one that typically requires repeated
p.000398: interventions to achieve long-term or permanent abstinence.
p.000398: “(34) Because the only known safe alternative to smoking is cessation, interventions should
p.000398: target all smokers to help them quit completely.
p.000398: “(35) Tobacco products have been used to facilitate and finance criminal activities both
p.000398: domestically and internationally. Illicit trade of tobacco products has been linked to organized
p.000398: crime and terrorist groups.
p.000398: “(36) It is essential that the Food and Drug Administration review products sold or
p.000398: distributed for use to reduce risks or exposures associated with tobacco products and that it be
p.000398: empowered to review any advertising and labeling for such products. It is also essential that
p.000398: manufacturers, prior to marketing such products, be required to demonstrate that such products
p.000398: will meet a series of rigorous criteria, and will benefit the health of the population as a whole,
p.000398: taking into account both users of tobacco products and persons who do not currently use
p.000398: tobacco products.
p.000398: “(37) Unless tobacco products that purport to reduce the risks to the public of tobacco use
p.000398: actually reduce such risks, those products can cause substantial harm to the public health to
p.000398: the extent that the individuals, who would otherwise not consume tobacco products or would
p.000398: consume such products less, use tobacco products purporting to reduce risk. Those who use
p.000398: products sold or distributed as modified risk products that do not in fact reduce risk, rather than
p.000398: quitting or reducing their use of tobacco products, have a substantially increased likelihood of
p.000398: suffering disability and premature death. The costs to society of the widespread use of products
...

p.000398: governed by the same legal burdens of proof specified in paragraph (2)(C).
p.000398: (B) Relief
p.000398: The court shall have jurisdiction to grant all relief necessary to make the employee
p.000398: whole, including injunctive relief and compensatory damages, including—
p.000398: (i) reinstatement with the same seniority status that the employee would have had,
p.000398: but for the discharge or discrimination;
p.000398: (ii) the amount of back pay, with interest; and
p.000398: (iii) compensation for any special damages sustained as a result of the discharge
p.000398: or discrimination, including litigation costs, expert witness fees, and reasonable
p.000398: attorney's fees.
p.000398: (5) Review
p.000398: (A) In general
p.000398: Unless the complainant brings an action under paragraph (4), any person adversely
p.000398: affected or aggrieved by a final order issued under paragraph (3) may obtain review of
p.000398: the order in the United States Court of Appeals for the circuit in which the violation,
p.000398: with respect to which the order was issued, allegedly occurred or the circuit in which
p.000398: the complainant resided on the date of such violation. The petition for review must be
p.000398: filed not later than 60 days after the date of the issuance of the final order of the
p.000398: Secretary. Review shall conform to chapter 7 of title 5. The commencement of
p.000398: proceedings under this subparagraph shall not, unless ordered by the court, operate as
p.000398: a stay of the order.
p.000398: (B) No judicial review
p.000398: An order of the Secretary with respect to which review could have been obtained
p.000398: under subparagraph (A) shall not be subject to judicial review in any criminal or other
p.000398: civil proceeding.
p.000398: (6) Failure to comply with order
p.000398: Whenever any person has failed to comply with an order issued under paragraph (3),
p.000398: the Secretary may file a civil action in the United States district court for the district in
p.000398: which the violation was found to occur, or in the United States district court for the District
p.000398: of Columbia, to enforce such order. In actions brought under this paragraph, the district
p.000398: courts shall have jurisdiction to grant all appropriate relief including, but not limited to,
p.000398: injunctive relief and compensatory damages.
p.000398: (7) Civil action to require compliance
p.000398: (A) In general
p.000398: A person on whose behalf an order was issued under paragraph (3) may commence
p.000398: a civil action against the person to whom such order was issued to require compliance
p.000398: with such order. The appropriate United States district court shall have jurisdiction,
p.000398: without regard to the amount in controversy or the citizenship of the parties, to enforce
p.000398: such order.
p.000398: (B) Award
p.000398: The court, in issuing any final order under this paragraph, may award costs of
p.000398: litigation (including reasonable attorneys’ and expert witness fees) to any party
p.000398: whenever the court determines such award is appropriate.
p.000398: (c) Effect of section
p.000398: (1) Other laws
p.000398: Nothing in this section preempts or diminishes any other safeguards against
p.000398: discrimination, demotion, discharge, suspension, threats, harassment, reprimand,
p.000398: retaliation, or any other manner of discrimination provided by Federal or State law.
p.000398: (2) Rights of employees
...

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p.001994: PART D—INFORMATION AND EDUCATION
p.001994: 379k. Information system.
p.001994: 379l. Education.
p.001994:
p.001994: PART E—ENVIRONMENTAL IMPACT REVIEW
p.001994: 379o. Environmental impact.
p.001994:
p.001994: PART F—NATIONAL UNIFORMITY FOR NONPRESCRIPTION DRUGS AND PREEMPTION FOR LABELING OR
p.001994: PACKAGING OF COSMETICS
p.001994: 379r. National uniformity for nonprescription drugs.
p.001994: 379s. Preemption for labeling or packaging of cosmetics.
p.001994:
p.001994: PART G—SAFETY REPORTS
p.001994: 379v. Safety report disclaimers.
p.001994:
p.001994: PART H—SERIOUS ADVERSE EVENT REPORTS
p.001994: 379aa. Serious adverse event reporting for nonprescription drugs.
p.001994: 379aa–1. Serious adverse event reporting for dietary supplements.
p.001994:
p.001994: PART I—REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG ADMINISTRATION
p.001994: 379dd. Establishment and functions of the Foundation.
p.001994: 379dd–1. Location of Foundation.
p.001994: 379dd–2. Activities of the Food and Drug Administration.
p.001994:
p.001994:
p.001994: SUBCHAPTER VIII—IMPORTS AND EXPORTS
p.001994: 381. Imports and exports.
p.001994: 382. Exports of certain unapproved products.
p.001994: 383. Office of International Relations.
p.001994: 384. Importation of prescription drugs.
p.001994: 384a. Foreign supplier verification program.
p.001994: 384b. Voluntary qualified importer program.
p.001994: 384c. Inspection of foreign food facilities.
p.001994: 384d. Accreditation of third-party auditors.
p.001994:
p.001994:
p.001994: SUBCHAPTER IX—TOBACCO PRODUCTS
p.001994: 387. Definitions.
p.001994: 387a. FDA authority over tobacco products.
p.001994: 387a–1. Final rule.
p.001994: 387b. Adulterated tobacco products.
p.001994: 387c. Misbranded tobacco products.
p.001994: 387d. Submission of health information to the Secretary.
p.001994: 387e. Annual registration.
p.001994: 387f. General provisions respecting control of tobacco products.
p.001994: 387f–1. Enforcement action plan for advertising and promotion restrictions.
p.001994: 387g. Tobacco product standards.
p.001994: 387h. Notification and other remedies.
p.001994: 387i. Records and reports on tobacco products.
p.001994: 387j. Application for review of certain tobacco products.
p.001994: 387k. Modified risk tobacco products.
p.001994: 387l. Judicial review.
p.001994: 387m. Equal treatment of retail outlets.
p.001994: 387n. Jurisdiction of and coordination with the Federal Trade Commission.
p.001994: 387o. Regulation requirement.
p.001994: 387p. Preservation of State and local authority.
p.001994: 387q. Tobacco Products Scientific Advisory Committee.
p.001994: 387r. Drug products used to treat tobacco dependence.
p.001994: 387s. User fees.
p.001994: 387t. Labeling, recordkeeping, records inspection.
p.001994: 387u. Studies of progress and effectiveness.
p.001994:
p.001994:
p.001994: SUBCHAPTER X—MISCELLANEOUS
p.001994: 391. Separability clause.
p.001994: 392. Exemption of meats and meat food products.
...

p.001994:
p.001994: Provided that any drug intended for minor use or use in a minor species that is not the
p.001994: subject of a final regulation published by the Secretary through notice and comment
p.001994: rulemaking finding that the criteria of paragraphs (1) and (2) have not been met (or that the
p.001994: exception to the criterion in paragraph (1) has been met) is a new animal drug.
p.001994: (w) The term “animal feed”, as used in paragraph (w) 1 of this section, in section 360b of
p.001994: this title, and in provisions of this chapter referring to such paragraph or section, means an
p.001994: article which is intended for use for food for animals other than man and which is intended
p.001994: for use as a substantial source of nutrients in the diet of the animal, and is not limited to a
p.001994: mixture intended to be the sole ration of the animal.
p.001994: (x) The term “informal hearing” means a hearing which is not subject to section 554, 556,
p.001994: or 557 of title 5 and which provides for the following:
p.001994: (1) The presiding officer in the hearing shall be designated by the Secretary from
p.001994: officers and employees of the Department who have not participated in any action of the
p.001994: Secretary which is the subject of the hearing and who are not directly responsible to an
p.001994: officer or employee of the Department who has participated in any such action.
p.001994: (2) Each party to the hearing shall have the right at all times to be advised and
p.001994: accompanied by an attorney.
p.001994: (3) Before the hearing, each party to the hearing shall be given reasonable notice of
p.001994: the matters to be considered at the hearing, including a comprehensive statement of the
p.001994: basis for the action taken or proposed by the Secretary which is the subject of the
p.001994: hearing and a general summary of the information which will be presented by the
p.001994: Secretary at the hearing in support of such action.
p.001994: (4) At the hearing the parties to the hearing shall have the right to hear a full and
p.001994: complete statement of the action of the Secretary which is the subject of the hearing
p.001994: together with the information and reasons supporting such action, to conduct reasonable
p.001994: questioning, and to present any oral or written information relevant to such action.
p.001994: (5) The presiding officer in such hearing shall prepare a written report of the hearing to
p.001994: which shall be attached all written material presented at the hearing. The participants in
p.001994: the hearing shall be given the opportunity to review and correct or supplement the
p.001994: presiding officer's report of the hearing.
p.001994: (6) The Secretary may require the hearing to be transcribed. A party to the hearing
p.001994: shall have the right to have the hearing transcribed at his expense. Any transcription of a
p.001994: hearing shall be included in the presiding officer's report of the hearing.
p.001994:
p.001994: (y) The term “saccharin” includes calcium saccharin, sodium saccharin, and ammonium
p.001994: saccharin.
p.001994: (z) The term “infant formula” means a food which purports to be or is represented for
p.001994: special dietary use solely as a food for infants by reason of its simulation of human milk or
p.001994: its suitability as a complete or partial substitute for human milk.
p.001994: (aa) The term “abbreviated drug application” means an application submitted under
p.001994: section 355(j) of this title for the approval of a drug that relies on the approved application of
p.001994: another drug with the same active ingredient to establish safety and efficacy, and—
p.001994: (1) in the case of section 335a of this title, includes a supplement to such an application
p.001994: for a different or additional use of the drug but does not include a supplement to such an
p.001994: application for other than a different or additional use of the drug, and
p.001994: (2) in the case of sections 335b and 335c of this title, includes any supplement to such
p.001994: an application.
p.001994:
p.001994: (bb) The term “knowingly” or “knew” means that a person, with respect to information—
p.001994: (1) has actual knowledge of the information, or
...

p.001994: out as a note under section 342 of this title.
p.001994: EFFECTIVE DATE OF 1950 AMENDMENT
p.001994: Amendment by act Mar. 16, 1950, effective July 1, 1950, see section 7 of that act, set out as an
p.001994: Effective Date note under section 347 of this title.
p.001994: REGULATIONS
p.001994: Secretary of Health and Human Services to promulgate regulations to implement amendments
p.001994: made by section 401 of Pub. L. 105–115 not later than 1 year after Nov. 21, 1997, see section
p.001994: 401(c) of Pub. L. 105–115, set out as a note under section 360aaa of this title.
p.001994: SAVINGS PROVISION
p.001994: Amendment by Pub. L. 91–513 not to affect or abate any prosecutions for violation of law or any
p.001994: civil seizures or forfeitures and injunctive proceedings commenced prior to the effective date of
p.001994: such amendment, and all administrative proceedings pending before the Bureau of Narcotics and
p.001994: Dangerous Drugs [now the Drug Enforcement Administration] on Oct. 27, 1970, to be continued
p.001994: and brought to final determination in accord with laws and regulations in effect prior to Oct. 27,
p.001994: 1970, see section 702 of Pub. L. 91–513, set out as a note under section 321 of this title.
p.001994: CONSTRUCTION OF 2011 AMENDMENT
p.001994: Nothing in amendments by sections 103(e), 105(c), 106(d), 204(j)(1), 211(b), (c), and 301(b) of
p.001994: Pub. L. 111–353 to be construed to apply to certain alcohol-related facilities, see section 2206 of
p.001994: this title.
p.001994: Nothing in amendments by Pub. L. 111–353 to be construed to alter jurisdiction and authorities
p.001994: established under certain other Acts or in a manner inconsistent with international agreements to
p.001994: which the United States is a party, see sections 2251 and 2252 of this title.
p.001994: CONSTRUCTION OF 2009 AMENDMENTS
p.001994: Pub. L. 111–31, div. A, title I, §103(p), June 22, 2009, 123 Stat. 1838, provided that: “Nothing in
p.001994: this section [amending this section and sections 333, 334, 355, 360m, 372 to 374, 375, 379a, 381,
p.001994: 393, 399, and 679 of this title and enacting provisions set out as notes under sections 333 and
p.001994: 387c of this title] is intended or shall be construed to expand, contract, or otherwise modify or
p.001994: amend the existing limitations on State government authority over tribal restricted fee or trust
p.001994: lands.”
p.001994: CONSTRUCTION OF 2002 AMENDMENTS
p.001994: Pub. L. 107–188, title III, §315, June 12, 2002, 116 Stat. 675, provided that: “Nothing in this title
p.001994: [enacting sections 350c, 350d, 398, 399, and 679c of this title, sections 3353, 3354, 8319, and
p.001994: 8320 of Title 7, Agriculture, and section 247b–20 of Title 42, The Public Health and Welfare,
p.001994: amending this section, sections 334, 335a, 342, 343, 360, 372, 374, and 381 of this title, and
p.001994: section 43 of Title 18, Crimes and Criminal Procedure, and enacting provisions set out as notes
p.001994: under this section and sections 341, 350c, 350d, and 381 of this title], or an amendment made by
p.001994: this title, shall be construed to alter the jurisdiction between the Secretaries of Agriculture and of
p.001994: Health and Human Services, under applicable statutes and regulations.”
p.001994: TRANSFER OF FUNCTIONS
p.001994: For transfer of functions of Federal Security Administrator to Secretary of Health, Education,
p.001994: and Welfare [now Health and Human Services], and of Food and Drug Administration in the
p.001994: Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this
p.001994: title.
p.001994:
p.001994: 1 See References in Text note below.
p.001994:
p.001994: 2 So in original.
p.001994:
p.001994:
p.001994:
p.001994: §332. Injunction proceedings
p.001994: (a) Jurisdiction of courts
p.001994: The district courts of the United States and the United States courts of the Territories
p.001994: shall have jurisdiction, for cause shown 1 to restrain violations of section 331 of this title,
p.001994: except paragraphs (h), (i), and (j).
p.001994: (b) Violation of injunction
p.001994: In case of violation of an injunction or restraining order issued under this section, which
p.001994: also constitutes a violation of this chapter, trial shall be by the court, or, upon demand of the
p.001994: accused, by a jury.
p.001994: (June 25, 1938, ch. 675, §302, 52 Stat. 1043; Pub. L. 87–781, title I, §103(d), title II,
p.001994: §201(c), Oct. 10, 1962, 76 Stat. 784, 793; Pub. L. 103–80, §3(d), Aug. 13, 1993, 107 Stat.
p.001994: 775.)
p.001994: AMENDMENTS
p.001994: 1993—Subsec. (a). Pub. L. 103–80, §3(d)(1), struck out “, and subject to the provisions of
p.001994: section 17 (relating to notice to opposite party) of the Act entitled ‘An Act to supplement existing
p.001994: laws against unlawful restraints and monopolies, and for other purposes’, approved October 15,
p.001994: 1914, as amended (U.S.C., 1934 ed., title 28, sec. 381),” after “for cause shown”.
p.001994: Subsec. (b). Pub. L. 103–80, §3(d)(2), struck out at end “Such trial shall be conducted in
p.001994: accordance with the practice and procedure applicable in the case of proceedings subject to the
p.001994: provisions of section 22 of such Act of October 15, 1914, as amended (U.S.C., 1934 ed., title 28,
p.001994: sec. 387).”
p.001994: 1962—Subsec. (a). Pub. L. 87–781, §103(d), struck out “(e),” after “paragraphs”.
p.001994: Pub. L. 87–781, §201(c), struck out “(f),” after “paragraphs”.
p.001994: EFFECTIVE DATE OF 1962 AMENDMENT
p.001994: Amendment by section 103(c) of Pub. L. 87–781 effective on first day of seventh calendar
p.001994: month following October 1962, see section 107 of Pub. L. 87–781, set out as a note under section
p.001994: 321 of this title.
p.001994: Section 203 of title II of Pub. L. 87–781 provided that: “The amendments made by this title
p.001994: [amending this section and section 374 of this title and enacting provisions set out as notes under
p.001994: sections 321 and 374 of this title] shall take effect on the date of enactment of this Act [Oct. 10,
p.001994: 1962].”
p.001994:
p.001994: 1 So in original. Probably should be followed by a comma.
p.001994:
p.001994:
p.001994:
p.001994: §333. Penalties
p.001994: (a) Violation of section 331 of this title; second violation; intent to defraud or mislead
p.001994: (1) Any person who violates a provision of section 331 of this title shall be imprisoned for
p.001994: not more than one year or fined not more than $1,000, or both.
...

p.001994: any 30-day period, and not to exceed $10,000,000 for all such violations adjudicated
p.001994: in a single proceeding.
p.001994:
p.001994: (ii) Any person who violates a requirement of section 387k(g)(2)(C)(ii) or 387k(i)(1) of
p.001994: this title, shall be subject to a civil monetary penalty of—
p.001994: (I) not to exceed $250,000 per violation, and not to exceed $1,000,000 for all such
p.001994: violations adjudicated in a single proceeding; or
p.001994: (II) in the case of a violation that continues after the Secretary provides written
p.001994: notice to such person, $250,000 for the first 30-day period (or any portion thereof)
p.001994: that the person continues to be in violation, and such amount shall double for every
p.001994: 30-day period thereafter that the violation continues, not to exceed $1,000,000 for
p.001994: any 30-day period, and not to exceed $10,000,000 for all such violations adjudicated
p.001994: in a single proceeding.
p.001994:
p.001994: (iii) In determining the amount of a civil penalty under clause (i)(II) or (ii)(II), the
p.001994: Secretary shall take into consideration whether the person is making efforts toward
p.001994: correcting the violation of the requirements of the section for which such person is
p.001994: subject to such civil penalty.
p.001994: (g) Violations regarding direct-to-consumer advertising
p.001994: (1) With respect to a person who is a holder of an approved application under section 355
p.001994: of this title for a drug subject to section 353(b) of this title or under section 262 of title 42,
p.001994: any such person who disseminates or causes another party to disseminate a direct-to-
p.001994: consumer advertisement that is false or misleading shall be liable to the United States for a
p.001994: civil penalty in an amount not to exceed $250,000 for the first such violation in any 3-year
p.001994: period, and not to exceed $500,000 for each subsequent violation in any 3-year period. No
p.001994: other civil monetary penalties in this chapter (including the civil penalty in subsection (f)(4))
p.001994: shall apply to a violation regarding direct-to-consumer advertising. For purposes of this
p.001994: paragraph: (A) Repeated dissemination of the same or similar advertisement prior to the
p.001994: receipt of the written notice referred to in paragraph (2) for such advertisements shall be
p.001994: considered one violation. (B) On and after the date of the receipt of such a notice, all
p.001994: violations under this paragraph occurring in a single day shall be considered one violation.
p.001994: With respect to advertisements that appear in magazines or other publications that are
p.001994: published less frequently than daily, each issue date (whether weekly or monthly) shall be
p.001994: treated as a single day for the purpose of calculating the number of violations under this
p.001994: paragraph.
p.001994: (2) A civil penalty under paragraph (1) shall be assessed by the Secretary by an order
p.001994: made on the record after providing written notice to the person to be assessed a civil
p.001994: penalty and an opportunity for a hearing in accordance with this paragraph and section 554
p.001994: of title 5. If upon receipt of the written notice, the person to be assessed a civil penalty
p.001994: objects and requests a hearing, then in the course of any investigation related to such
p.001994: hearing, the Secretary may issue subpoenas requiring the attendance and testimony of
p.001994: witnesses and the production of evidence that relates to the matter under investigation,
p.001994: including information pertaining to the factors described in paragraph (3).
p.001994: (3) The Secretary, in determining the amount of the civil penalty under paragraph (1),
p.001994: shall take into account the nature, circumstances, extent, and gravity of the violation or
p.001994: violations, including the following factors:
p.001994: (A) Whether the person submitted the advertisement or a similar advertisement for
p.001994: review under section 379h–1 of this title.
p.001994: (B) Whether the person submitted the advertisement for review if required under
p.001994: section 353b of this title.
p.001994: (C) Whether, after submission of the advertisement as described in subparagraph (A)
p.001994: or (B), the person disseminated or caused another party to disseminate the
p.001994: advertisement before the end of the 45-day comment period.
p.001994: (D) Whether the person incorporated any comments made by the Secretary with regard
p.001994: to the advertisement into the advertisement prior to its dissemination.
p.001994: (E) Whether the person ceased distribution of the advertisement upon receipt of the
p.001994: written notice referred to in paragraph (2) for such advertisement.
p.001994: (F) Whether the person had the advertisement reviewed by qualified medical,
p.001994: regulatory, and legal reviewers prior to its dissemination.
p.001994: (G) Whether the violations were material.
p.001994: (H) Whether the person who created the advertisement or caused the advertisement to
p.001994: be created acted in good faith.
p.001994: (I) Whether the person who created the advertisement or caused the advertisement to
p.001994: be created has been assessed a civil penalty under this provision within the previous 1-
p.001994: year period.
p.001994: (J) The scope and extent of any voluntary, subsequent remedial action by the person.
p.001994: (K) Such other matters, as justice may require.
p.001994:
p.001994: (4)(A) Subject to subparagraph (B), no person shall be required to pay a civil penalty
p.001994: under paragraph (1) if the person submitted the advertisement to the Secretary and
p.001994: disseminated or caused another party to disseminate such advertisement after
p.001994: incorporating each comment received from the Secretary.
p.001994: (B) The Secretary may retract or modify any prior comments the Secretary has provided
p.001994: to an advertisement submitted to the Secretary based on new information or changed
p.001994: circumstances, so long as the Secretary provides written notice to the person of the new
p.001994: views of the Secretary on the advertisement and provides a reasonable time for
p.001994: modification or correction of the advertisement prior to seeking any civil penalty under
p.001994: paragraph (1).
p.001994: (5) The Secretary may compromise, modify, or remit, with or without conditions, any civil
p.001994: penalty which may be assessed under paragraph (1). The amount of such penalty, when
p.001994: finally determined, or the amount charged upon in compromise, may be deducted from any
p.001994: sums owed by the United States to the person charged.
p.001994: (6) Any person who requested, in accordance with paragraph (2), a hearing with respect
p.001994: to the assessment of a civil penalty and who is aggrieved by an order assessing a civil
p.001994: penalty, may file a petition for de novo judicial review of such order with the United States
p.001994: Court of Appeals for the District of Columbia Circuit or for any other circuit in which such
p.001994: person resides or transacts business. Such a petition may only be filed within the 60-day
p.001994: period beginning on the date the order making such assessments was issued.
p.001994: (7) If any person fails to pay an assessment of a civil penalty under paragraph (1)—
p.001994: (A) after the order making the assessment becomes final, and if such person does not
p.001994: file a petition for judicial review of the order in accordance with paragraph (6), or
p.001994: (B) after a court in an action brought under paragraph (6) has entered a final judgment
...

p.001994: amount of the civil penalty shall not exceed—
p.001994: “(I) in the case of the first violation, $250;
p.001994: “(II) in the case of a second violation within a 12-month period, $500;
p.001994: “(III) in the case of a third violation within a 24-month period, $1,000;
p.001994: “(IV) in the case of a fourth violation within a 24-month period, $2,000;
p.001994: “(V) in the case of a fifth violation within a 36-month period, $5,000; and
p.001994: “(VI) in the case of a sixth or subsequent violation within a 48-month period,
p.001994: $10,000 as determined by the Secretary on a case-by-case basis.
p.001994: “(B) TRAINING PROGRAM.—For purposes of subparagraph (A), the term ‘approved training
p.001994: program’ means a training program that complies with standards developed by the Food and
p.001994: Drug Administration for such programs.
p.001994: “(C) CONSIDERATION OF STATE PENALTIES.—The Secretary shall coordinate with the States in
p.001994: enforcing the provisions of this Act [probably means div. A of Pub. L. 111–31, see Short Title of
p.001994: 2009 Amendment note set out under section 301 of this title and Tables for classifications] and,
p.001994: for purposes of mitigating a civil penalty to be applied for a violation by a retailer of any
p.001994: restriction promulgated under section 906(d) [21 U.S.C. 387f(d)], shall consider the amount of
p.001994: any penalties paid by the retailer to a State for the same violation.”
p.001994: CONSTRUCTION OF 2011 AMENDMENT
p.001994: Nothing in amendment by Pub. L. 111–353 to be construed to alter jurisdiction and authorities
p.001994: established under certain other Acts or in a manner inconsistent with international agreements to
p.001994: which the United States is a party, see sections 2251 and 2252 of this title.
p.001994: ENFORCEMENT
p.001994: Pub. L. 99–660, title I, §103, Nov. 14, 1986, 100 Stat. 3751, provided that: “For the fines
p.001994: authorized to be imposed under section 303 of the Federal Food, Drug, and Cosmetic Act [21
p.001994: U.S.C. 333], see section 3623 of title 18, United States Code, for the period ending October 31,
p.001994: 1986 [probably should be October 31, 1987], and sections 3559 and 3571 of such title for the
p.001994: period beginning November 1, 1986 [probably should be November 1, 1987].”
p.001994:
p.001994: 1 So in original. Words “of this section” probably should not appear.
p.001994:
p.001994: 2 See References in Text note below.
p.001994:
p.001994:
p.001994:
p.001994: §333a. Repealed. Pub. L. 101–647, title XIX, §1905, Nov. 29, 1990, 104
p.001994: Stat. 4853
p.001994: Section, Pub. L. 100–690, title II, §2401, Nov. 18, 1988, 102 Stat. 4230, related to forfeiture and
p.001994: illegal trafficking in steroids or human growth hormones.
p.001994:
p.001994:
p.001994: §334. Seizure
p.001994: (a) Grounds and jurisdiction
p.001994: (1) Any article of food, drug, or cosmetic that is adulterated or misbranded when
p.001994: introduced into or while in interstate commerce or while held for sale (whether or not the
p.001994: first sale) after shipment in interstate commerce, or which may not, under the provisions of
p.001994: section 331(ll), 344, or 355 of this title, be introduced into interstate commerce, shall be
p.001994: liable to be proceeded against while in interstate commerce, or at any time thereafter, on
p.001994: libel of information and condemned in any district court of the United States or United
...

p.001994: container, or other thing used or designed for use in making a counterfeit drug or drugs, (D)
p.001994: Any adulterated or misbranded device, and (E) Any adulterated or misbranded tobacco
p.001994: product.
p.001994: (3)(A) Except as provided in subparagraph (B), no libel for condemnation may be
p.001994: instituted under paragraph (1) or (2) against any food which—
p.001994: (i) is misbranded under section 343(a)(2) of this title because of its advertising, and
p.001994: (ii) is being held for sale to the ultimate consumer in an establishment other than an
p.001994: establishment owned or operated by a manufacturer, packer, or distributor of the food.
p.001994:
p.001994: (B) A libel for condemnation may be instituted under paragraph (1) or (2) against a food
p.001994: described in subparagraph (A) if—
p.001994: (i)(I) the food's advertising which resulted in the food being misbranded under section
p.001994: 343(a)(2) of this title was disseminated in the establishment in which the food is being
p.001994: held for sale to the ultimate consumer,
p.001994: (II) such advertising was disseminated by, or under the direction of, the owner or
p.001994: operator of such establishment, or
p.001994: (III) all or part of the cost of such advertising was paid by such owner or operator; and
p.001994: (ii) the owner or operator of such establishment used such advertising in the
p.001994: establishment to promote the sale of the food.
p.001994: (b) Procedure; multiplicity of pending proceedings
p.001994: The article, equipment, or other thing proceeded against shall be liable to seizure by
p.001994: process pursuant to the libel, and the procedure in cases under this section shall conform,
p.001994: as nearly as may be, to the procedure in admiralty; except that on demand of either party
p.001994: any issue of fact joined in any such case shall be tried by jury. When libel for condemnation
p.001994: proceedings under this section, involving the same claimant and the same issues of
p.001994: adulteration or misbranding, are pending in two or more jurisdictions, such pending
p.001994: proceedings, upon application of the claimant seasonably made to the court of one such
p.001994: jurisdiction, shall be consolidated for trial by order of such court, and tried in (1) any district
p.001994: selected by the claimant where one of such proceedings is pending; or (2) a district agreed
p.001994: upon by stipulation between the parties. If no order for consolidation is so made within a
p.001994: reasonable time, the claimant may apply to the court of one such jurisdiction and such court
p.001994: (after giving the United States attorney for such district reasonable notice and opportunity to
p.001994: be heard) shall by order, unless good cause to the contrary is shown, specify a district of
p.001994: reasonable proximity to the claimant's principal place of business, in which all such pending
p.001994: proceedings shall be consolidated for trial and tried. Such order of consolidation shall not
p.001994: apply so as to require the removal of any case the date for trial of which has been fixed. The
p.001994: court granting such order shall give prompt notification thereof to the other courts having
p.001994: jurisdiction of the cases covered thereby.
p.001994: (c) Availability of samples of seized goods prior to trial
p.001994: The court at any time after seizure up to a reasonable time before trial shall by order
p.001994: allow any party to a condemnation proceeding, his attorney or agent, to obtain a
p.001994: representative sample of the article seized and a true copy of the analysis, if any, on which
p.001994: the proceeding is based and the identifying marks or numbers, if any, of the packages from
p.001994: which the samples analyzed were obtained.
p.001994: (d) Disposition of goods after decree of condemnation; claims for remission or
p.001994: mitigation of forfeitures
p.001994: (1) Any food, drug, device, tobacco product, or cosmetic condemned under this section
p.001994: shall, after entry of the decree, be disposed of by destruction or sale as the court may, in
p.001994: accordance with the provisions of this section, direct and the proceeds thereof, if sold, less
p.001994: the legal costs and charges, shall be paid into the Treasury of the United States; but such
p.001994: article shall not be sold under such decree contrary to the provisions of this chapter or the
p.001994: laws of the jurisdiction in which sold. After entry of the decree and upon the payment of the
p.001994: costs of such proceedings and the execution of a good and sufficient bond conditioned that
p.001994: such article shall not be sold or disposed of contrary to the provisions of this chapter or the
p.001994: laws of any State or Territory in which sold, the court may by order direct that such article
p.001994: be delivered to the owner thereof to be destroyed or brought into compliance with the
p.001994: provisions of this chapter, under the supervision of an officer or employee duly designated
p.001994: by the Secretary, and the expenses of such supervision shall be paid by the person
p.001994: obtaining release of the article under bond. If the article was imported into the United States
...

p.001994: committed after Oct. 24, 1968, see section 6 of Pub. L. 90–639, set out as an Effective Date of
p.001994: 1968 Amendments; Transitional Provisions note under section 321 of this title.
p.001994: EFFECTIVE DATE OF 1965 AMENDMENT
p.001994: Amendment by Pub. L. 89–74 effective Feb. 1, 1966, see section 11 of Pub. L. 89–74, set out
p.001994: as a note under section 321 of this title.
p.001994: REGULATIONS
p.001994: Pub. L. 111–353, title II, §207(b), Jan. 4, 2011, 124 Stat. 3944, provided that: “Not later than
p.001994: 120 days after the date of enactment of this Act [Jan. 4, 2011], the Secretary shall issue an
p.001994: interim final rule amending subpart K of part 1 of title 21, Code of Federal Regulations, to
p.001994: implement the amendment made by this section [amending this section].”
p.001994: SAVINGS PROVISION
p.001994: Amendment by Pub. L. 91–513 not to affect or abate any prosecutions for any violation of law or
p.001994: any civil seizures or forfeitures and injunctive proceedings commenced prior to the effective date
p.001994: of such amendment, and all administrative proceedings pending before the Bureau of Narcotics
p.001994: and Dangerous Drugs [now the Drug Enforcement Administration] on Oct. 27, 1970, to be
p.001994: continued and brought to final determination in accord with laws and regulations in effect prior to
p.001994: Oct. 27, 1970, see section 702 of Pub. L. 91–513, set out as a note under section 321 of this title.
p.001994: CONSTRUCTION OF 2011 AMENDMENT
p.001994: Nothing in amendment by Pub. L. 111–353 to be construed to alter jurisdiction and authorities
p.001994: established under certain other Acts or in a manner inconsistent with international agreements to
p.001994: which the United States is a party, see sections 2251 and 2252 of this title.
p.001994: TRANSFER OF FUNCTIONS
p.001994: For transfer of functions of Federal Security Administrator to Secretary of Health, Education,
p.001994: and Welfare [now Health and Human Services], and of Food and Drug Administration in the
p.001994: Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this
p.001994: title.
p.001994:
p.001994:
p.001994: §335. Hearing before report of criminal violation
p.001994: Before any violation of this chapter is reported by the Secretary to any United States
p.001994: attorney for institution of a criminal proceeding, the person against whom such proceeding
p.001994: is contemplated shall be given appropriate notice and an opportunity to present his views,
p.001994: either orally or in writing, with regard to such contemplated proceeding.
p.001994: (June 25, 1938, ch. 675, §305, 52 Stat. 1045.)
p.001994: TRANSFER OF FUNCTIONS
p.001994: For transfer of functions of Federal Security Administrator to Secretary of Health, Education,
p.001994: and Welfare [now Health and Human Services], and of Food and Drug Administration in the
p.001994: Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this
p.001994: title.
p.001994:
p.001994:
p.001994: §335a. Debarment, temporary denial of approval, and suspension
...

p.001994: criminal offense—
p.001994: (A) when a judgment of conviction has been entered against the person by a Federal
p.001994: or State court, regardless of whether there is an appeal pending,
p.001994: (B) when a plea of guilty or nolo contendere by the person has been accepted by a
p.001994: Federal or State court, or
p.001994: (C) when the person has entered into participation in a first offender, deferred
p.001994: adjudication, or other similar arrangement or program where judgment of conviction
p.001994: has been withheld.
p.001994: (2) Effective dates
p.001994: Subsection (a) of this section, subparagraph (A) of subsection (b)(2) of this section,
p.001994: clauses (i) and (ii) of subsection (b)(2)(B) of this section, and subsection (b)(3)(A) of this
p.001994: section shall not apply to a conviction which occurred more than 5 years before the
p.001994: initiation of an agency action proposed to be taken under subsection (a) or (b) of this
p.001994: section. Clauses (iii) and (iv) of subsection (b)(2)(B) of this section, subsection (b)(3)(B)
p.001994: of this section, and subsections (f) and (g) of this section shall not apply to an act or
p.001994: action which occurred more than 5 years before the initiation of an agency action
p.001994: proposed to be taken under subsection (b), (f), or (g) of this section. Clause (iv) of
p.001994: subsection (b)(2)(B) of this section shall not apply to an action which occurred before
p.001994: June 1, 1992. Subsection (k) of this section shall not apply to applications submitted to
p.001994: the Secretary before June 1, 1992.
p.001994: (m) Devices; mandatory debarment regarding third-party inspections and reviews
p.001994: (1) In general
p.001994: If the Secretary finds that a person has been convicted of a felony under section
p.001994: 331(gg) of this title, the Secretary shall debar such person from being accredited under
p.001994: section 360m(b) or 374(g)(2) of this title and from carrying out activities under an
p.001994: agreement described in section 383(b) of this title.
p.001994: (2) Debarment period
p.001994: The Secretary shall debar a person under paragraph (1) for the following periods:
p.001994: (A) The period of debarment of a person (other than an individual) shall not be less
p.001994: than 1 year or more than 10 years, but if an act leading to a subsequent debarment
p.001994: under such paragraph occurs within 10 years after such person has been debarred
p.001994: under such paragraph, the period of debarment shall be permanent.
p.001994: (B) The debarment of an individual shall be permanent.
p.001994: (3) Termination of debarment; judicial review; other matters
p.001994: Subsections (c)(3), (d), (e), (i), (j), and (l)(1) of this section apply with respect to a
p.001994: person (other than an individual) or an individual who is debarred under paragraph (1) to
p.001994: the same extent and in the same manner as such subsections apply with respect to a
p.001994: person who is debarred under subsection (a)(1) of this section, or an individual who is
p.001994: debarred under subsection (a)(2) of this section, respectively.
p.001994: (June 25, 1938, ch. 675, §306, as added Pub. L. 102–282, §2, May 13, 1992, 106 Stat. 150;
p.001994: amended Pub. L. 105–115, title I, §125(b)(2)(C), Nov. 21, 1997, 111 Stat. 2325; Pub. L.
p.001994: 107–188, title III, §304(a)–(c), June 12, 2002, 116 Stat. 665, 666; Pub. L. 107–250, title II,
p.001994: §203, Oct. 26, 2002, 116 Stat. 1610.)
p.001994: PRIOR PROVISIONS
...

p.001994: “(A) the findings, conclusions, and recommendations of the Commission, including a
p.001994: description of how each recommendation would improve food safety;
p.001994: “(B) a summary of any other material used by the Commission in the preparation of the
p.001994: report under this paragraph; and
p.001994: “(C) if requested by 1 or more members of the Commission, a statement of the minority
p.001994: views of the Commission.
p.001994: “(c) POWERS OF THE COMMISSION.—
p.001994: “(1) HEARINGS.—The Commission may, for the purpose of carrying out this section, hold
p.001994: such hearings, meet and act at such times and places, take such testimony, and receive such
p.001994: evidence as the Commission considers advisable.
p.001994: “(2) INFORMATION FROM FEDERAL AGENCIES.—
p.001994: “(A) IN GENERAL.—The Commission may secure directly, from any Federal agency, such
p.001994: information as the Commission considers necessary to carry out this section.
p.001994: “(B) PROVISION OF INFORMATION.—
p.001994: “(i) IN GENERAL.—Subject to subparagraph (C), on the request of the Commission,
p.001994: the head of a Federal agency described in subparagraph (A) may furnish information
p.001994: requested by the Commission to the Commission.
p.001994: “(ii) ADMINISTRATION.—The furnishing of information by a Federal agency to the
p.001994: Commission shall not be considered a waiver of any exemption available to the agency
p.001994: under section 552 of title 5, United States Code.
p.001994: “(C) INFORMATION TO BE KEPT CONFIDENTIAL.—
p.001994: “(i) IN GENERAL.—For purposes of section 1905 of title 18, United States Code—
p.001994: “(I) the Commission shall be considered an agency of the Federal Government; and
p.001994: “(II) any individual employed by an individual, entity, or organization that is a party to a contract
p.001994: with the Commission under this section shall be considered an employee of the
p.001994: Commission.
p.001994: “(ii) PROHIBITION ON DISCLOSURE.—Information obtained by the Commission, other
p.001994: than information that is available to the public, shall not be disclosed to any person in any
p.001994: manner except to an employee of the Commission as described in clause (i), for the
p.001994: purpose of receiving, reviewing, or processing the information.
p.001994: “(d) COMMISSION PERSONNEL MATTERS.—
p.001994: “(1) MEMBERS.—
p.001994: “(A) COMPENSATION.—A member of the Commission shall serve without compensation
p.001994: for the services of the member on the Commission.
p.001994: “(B) TRAVEL EXPENSES.—A member of the Commission shall be allowed travel expenses,
p.001994: including per diem in lieu of subsistence, at rates authorized for an employee of an agency
p.001994: under subchapter I of chapter 57 of title 5, United States Code, while away from the home or
p.001994: regular place of business of the member in the performance of the duties of the Commission.
p.001994: “(2) STAFF.—
p.001994: “(A) IN GENERAL.—The Chairperson of the Commission may, without regard to the civil
p.001994: service laws (including regulations), appoint and terminate the appointment of an executive
p.001994: director and such other additional personnel as are necessary to enable the Commission to
p.001994: perform the duties of the Commission.
p.001994: “(B) CONFIRMATION OF EXECUTIVE DIRECTOR.—The employment of an executive director
p.001994: shall be subject to confirmation by the Commission.
p.001994: “(C) COMPENSATION.—
p.001994: “(i) IN GENERAL.—Except as provided in clause (ii), the Chairperson of the
p.001994: Commission may fix the compensation of the executive director and other personnel
...

p.001994: and ensure that Federal agencies annually develop coordinated food safety budgets for
p.001994: submission to the OMB that sustain and strengthen existing capacities, eliminate duplication, and
p.001994: ensure the most effective use of resources for improving food safety. The Council shall also
p.001994: ensure that Federal agencies annually develop a unified budget for submission to the OMB for the
p.001994: President's Food Safety Initiative and such other food safety issues as the Council determines
p.001994: appropriate.
p.001994: (c) The Council shall ensure that the Joint Institute for Food Safety Research (JIFSR), in
p.001994: consultation with the National Science and Technology Council, establishes mechanisms to guide
p.001994: Federal research efforts toward the highest priority food safety needs. The JIFSR shall report to
p.001994: the Council on a regular basis on its efforts: (i) to develop a strategic plan for conducting food
p.001994: safety research activities consistent with the President's Food Safety Initiative and such other food
p.001994: safety activities as the JIFSR determines appropriate; and (ii) to coordinate efficiently, within the
p.001994: executive branch and with the private sector and academia, all Federal food safety research.
p.001994: SEC. 4. Cooperation. All actions taken by the Council shall, as appropriate, promote
p.001994: partnerships and cooperation with States, tribes, and other public and private sector efforts
p.001994: wherever possible to improve the safety of the food supply.
p.001994: SEC. 5. General Provisions. This order is intended only to improve the internal management of
p.001994: the executive branch and is not intended to, nor does it, create any right or benefit, substantive or
p.001994: procedural, enforceable at law by a party against the United States, its agencies, its officers or any
p.001994: person. Nothing in this order shall affect or alter the statutory responsibilities of any Federal
p.001994: agency charged with food safety responsibilities.
p.001994:
p.001994:
p.001994: §342. Adulterated food
p.001994: A food shall be deemed to be adulterated—
p.001994: (a) Poisonous, insanitary, etc., ingredients
p.001994: (1) If it bears or contains any poisonous or deleterious substance which may render it
p.001994: injurious to health; but in case the substance is not an added substance such food shall not
p.001994: be considered adulterated under this clause if the quantity of such substance in such food
p.001994: does not ordinarily render it injurious to health.1 (2)(A) if it bears or contains any added
p.001994: poisonous or added deleterious substance (other than a substance that is a pesticide
p.001994: chemical residue in or on a raw agricultural commodity or processed food, a food additive, a
p.001994: color additive, or a new animal drug) that is unsafe within the meaning of section 346 of this
p.001994: title; or (B) if it bears or contains a pesticide chemical residue that is unsafe within the
p.001994: meaning of section 346a(a) of this title; or (C) if it is or if it bears or contains (i) any food
p.001994: additive that is unsafe within the meaning of section 348 of this title; or (ii) a new animal
...

p.001994: (g) Effective date, objections, hearings, and administrative review
p.001994: (1) Effective date
p.001994: A regulation or order issued under subsection (d)(4), (e)(1), or (f)(2) of this section shall
p.001994: take effect upon publication unless the regulation or order specifies otherwise. The
p.001994: Administrator may stay the effectiveness of the regulation or order if, after issuance of
p.001994: such regulation or order, objections are filed with respect to such regulation or order
p.001994: pursuant to paragraph (2).
p.001994: (2) Further proceedings
p.001994: (A) Objections
p.001994: Within 60 days after a regulation or order is issued under subsection (d)(4), (e)(1)(A),
p.001994: (e)(1)(B), (f)(2), (n)(3), or (n)(5)(C) of this section, any person may file objections
p.001994: thereto with the Administrator, specifying with particularity the provisions of the
p.001994: regulation or order deemed objectionable and stating reasonable grounds therefor. If
p.001994: the regulation or order was issued in response to a petition under subsection (d)(1) of
p.001994: this section, a copy of each objection filed by a person other than the petitioner shall be
p.001994: served by the Administrator on the petitioner.
p.001994: (B) Hearing
p.001994: An objection may include a request for a public evidentiary hearing upon the
p.001994: objection. The Administrator shall, upon the initiative of the Administrator or upon the
p.001994: request of an interested person and after due notice, hold a public evidentiary hearing if
p.001994: and to the extent the Administrator determines that such a public hearing is necessary
p.001994: to receive factual evidence relevant to material issues of fact raised by the objections.
p.001994: The presiding officer in such a hearing may authorize a party to obtain discovery from
p.001994: other persons and may upon a showing of good cause made by a party issue a
p.001994: subpoena to compel testimony or production of documents from any person. The
p.001994: presiding officer shall be governed by the Federal Rules of Civil Procedure in making
p.001994: any order for the protection of the witness or the content of documents produced and
p.001994: shall order the payment of reasonable fees and expenses as a condition to requiring
p.001994: testimony of the witness. On contest, such a subpoena may be enforced by a Federal
p.001994: district court.
p.001994: (C) Final decision
p.001994: As soon as practicable after receiving the arguments of the parties, the Administrator
p.001994: shall issue an order stating the action taken upon each such objection and setting forth
p.001994: any revision to the regulation or prior order that the Administrator has found to be
p.001994: warranted. If a hearing was held under subparagraph (B), such order and any revision
p.001994: to the regulation or prior order shall, with respect to questions of fact at issue in the
p.001994: hearing, be based only on substantial evidence of record at such hearing, and shall set
p.001994: forth in detail the findings of facts and the conclusions of law or policy upon which the
p.001994: order or regulation is based.
p.001994: (h) Judicial review
p.001994: (1) Petition
p.001994: In a case of actual controversy as to the validity of any regulation issued under
p.001994: subsection (e)(1)(C) of this section, or any order issued under subsection (f)(1)(C) or (g)
p.001994: (2)(C) of this section, or any regulation that is the subject of such an order, any person
p.001994: who will be adversely affected by such order or regulation may obtain judicial review by
p.001994: filing in the United States Court of Appeals for the circuit wherein that person resides or
p.001994: has its principal place of business, or in the United States Court of Appeals for the District
p.001994: of Columbia Circuit, within 60 days after publication of such order or regulation, a petition
p.001994: praying that the order or regulation be set aside in whole or in part.
p.001994: (2) Record and jurisdiction
p.001994: A copy of the petition under paragraph (1) shall be forthwith transmitted by the clerk of
p.001994: the court to the Administrator, or any officer designated by the Administrator for that
p.001994: purpose, and thereupon the Administrator shall file in the court the record of the
p.001994: proceedings on which the Administrator based the order or regulation, as provided in
p.001994: section 2112 of title 28. Upon the filing of such a petition, the court shall have exclusive
p.001994: jurisdiction to affirm or set aside the order or regulation complained of in whole or in part.
p.001994: As to orders issued following a public evidentiary hearing, the findings of the
p.001994: Administrator with respect to questions of fact shall be sustained only if supported by
p.001994: substantial evidence when considered on the record as a whole.
p.001994: (3) Additional evidence
p.001994: If a party applies to the court for leave to adduce additional evidence and shows to the
p.001994: satisfaction of the court that the additional evidence is material and that there were
p.001994: reasonable grounds for the failure to adduce the evidence in the proceeding before the
p.001994: Administrator, the court may order that the additional evidence (and evidence in rebuttal
p.001994: thereof) shall be taken before the Administrator in the manner and upon the terms and
p.001994: conditions the court deems proper. The Administrator may modify prior findings as to the
p.001994: facts by reason of the additional evidence so taken and may modify the order or
p.001994: regulation accordingly. The Administrator shall file with the court any such modified
p.001994: finding, order, or regulation.
p.001994: (4) Final judgment; Supreme Court review
p.001994: The judgment of the court affirming or setting aside, in whole or in part, any regulation
p.001994: or any order and any regulation which is the subject of such an order shall be final,
p.001994: subject to review by the Supreme Court of the United States as provided in section 1254
p.001994: of title 28. The commencement of proceedings under this subsection shall not, unless
p.001994: specifically ordered by the court to the contrary, operate as a stay of a regulation or
p.001994: order.
p.001994: (5) Application
p.001994: Any issue as to which review is or was obtainable under this subsection shall not be
p.001994: the subject of judicial review under any other provision of law.
p.001994: (i) Confidentiality and use of data
p.001994: (1) General rule
p.001994: Data and information that are or have been submitted to the Administrator under this
p.001994: section or section 348 of this title in support of a tolerance or an exemption from a
p.001994: tolerance shall be entitled to confidential treatment for reasons of business confidentiality
...

p.001994: subject of a notification submitted under paragraph (1), and does not include a similar or
p.001994: identical substance manufactured or prepared by a person other than the manufacturer
p.001994: identified in the notification.
p.001994: (3)(A) The process in this subsection shall be utilized for authorizing the marketing of a
p.001994: food contact substance except where the Secretary determines that submission and review
p.001994: of a petition under subsection (b) of this section is necessary to provide adequate
p.001994: assurance of safety, or where the Secretary and any manufacturer or supplier agree that
p.001994: such manufacturer or supplier may submit a petition under subsection (b) of this section.
p.001994: (B) The Secretary is authorized to promulgate regulations to identify the circumstances in
p.001994: which a petition shall be filed under subsection (b) of this section, and shall consider criteria
p.001994: such as the probable consumption of such food contact substance and potential toxicity of
p.001994: the food contact substance in determining the circumstances in which a petition shall be
p.001994: filed under subsection (b) of this section.
p.001994: (4) The Secretary shall keep confidential any information provided in a notification under
p.001994: paragraph (1) for 120 days after receipt by the Secretary of the notification. After the
p.001994: expiration of such 120 days, the information shall be available to any interested party
p.001994: except for any matter in the notification that is a trade secret or confidential commercial
p.001994: information.
p.001994: (5)(A)(i) Except as provided in clause (ii), the notification program established under this
p.001994: subsection shall not operate in any fiscal year unless—
p.001994: (I) an appropriation equal to or exceeding the applicable amount under clause (iv) is
p.001994: made for such fiscal year for carrying out such program in such fiscal year; and
p.001994: (II) the Secretary certifies that the amount appropriated for such fiscal year for the
p.001994: Center for Food Safety and Applied Nutrition of the Food and Drug Administration
p.001994: (exclusive of the appropriation referred to in subclause (I)) equals or exceeds the amount
p.001994: appropriated for the Center for fiscal year 1997, excluding any amount appropriated for
p.001994: new programs.
p.001994:
p.001994: (ii) The Secretary shall, not later than April 1, 1999, begin accepting and reviewing
p.001994: notifications submitted under the notification program established under this subsection if—
p.001994: (I) an appropriation equal to or exceeding the applicable amount under clause (iii) is
p.001994: made for the last six months of fiscal year 1999 for carrying out such program during
p.001994: such period; and
p.001994: (II) the Secretary certifies that the amount appropriated for such period for the Center
p.001994: for Food Safety and Applied Nutrition of the Food and Drug Administration (exclusive of
p.001994: the appropriation referred to in subclause (I)) equals or exceeds an amount equivalent to
p.001994: one-half the amount appropriated for the Center for fiscal year 1997, excluding any
p.001994: amount appropriated for new programs.
p.001994:
...

p.001994: (d) “New dietary ingredient” defined
p.001994: For purposes of this section, the term “new dietary ingredient” means a dietary ingredient
p.001994: that was not marketed in the United States before October 15, 1994 and does not include
p.001994: any dietary ingredient which was marketed in the United States before October 15, 1994.
p.001994: (June 25, 1938, ch. 675, §413, as added Pub. L. 103–417, §8, Oct. 25, 1994, 108 Stat.
p.001994: 4331; amended Pub. L. 111–353, title I, §113(a), Jan. 4, 2011, 124 Stat. 3920.)
p.001994: AMENDMENTS
p.001994: 2011—Subsecs. (c), (d). Pub. L. 111–353 added subsec. (c) and redesignated former subsec.
p.001994: (c) as (d).
p.001994: GUIDANCE
p.001994: Pub. L. 111–353, title I, §113(b), Jan. 4, 2011, 124 Stat. 3921, provided that: “Not later than 180
p.001994: days after the date of enactment of this Act [Jan. 4, 2011], the Secretary shall publish guidance
p.001994: that clarifies when a dietary supplement ingredient is a new dietary ingredient, when the
p.001994: manufacturer or distributor of a dietary ingredient or dietary supplement should provide the
p.001994: Secretary with information as described in section 413(a)(2) of the Federal Food, Drug, and
p.001994: Cosmetic Act [21 U.S.C. 350b(a)(2)], the evidence needed to document the safety of new dietary
p.001994: ingredients, and appropriate methods for establishing the identify [sic] of a new dietary ingredient.”
p.001994: CONSTRUCTION OF 2011 AMENDMENT
p.001994: Nothing in amendment by Pub. L. 111–353 to be construed to apply to certain alcohol-related
p.001994: facilities, to alter jurisdiction and authorities established under certain other Acts, or in a manner
p.001994: inconsistent with international agreements to which the United States is a party, see sections
p.001994: 2206, 2251, and 2252 of this title.
p.001994:
p.001994:
p.001994: §350c. Maintenance and inspection of records
p.001994: (a) Records inspection
p.001994: (1) Adulterated food
p.001994: If the Secretary has a reasonable belief that an article of food, and any other article of
p.001994: food that the Secretary reasonably believes is likely to be affected in a similar manner, is
p.001994: adulterated and presents a threat of serious adverse health consequences or death to
p.001994: humans or animals, each person (excluding farms and restaurants) who manufactures,
p.001994: processes, packs, distributes, receives, holds, or imports such article shall, at the request
p.001994: of an officer or employee duly designated by the Secretary, permit such officer or
p.001994: employee, upon presentation of appropriate credentials and a written notice to such
p.001994: person, at reasonable times and within reasonable limits and in a reasonable manner, to
p.001994: have access to and copy all records relating to such article, and to any other article of
p.001994: food that the Secretary reasonably believes is likely to be affected in a similar manner,
p.001994: that are needed to assist the Secretary in determining whether the food is adulterated
p.001994: and presents a threat of serious adverse health consequences or death to humans or
p.001994: animals.
p.001994: (2) Use of or exposure to food of concern
p.001994: If the Secretary believes that there is a reasonable probability that the use of or
...

p.001994: that an article of food, and any other article of food that the Secretary reasonably believes is likely
p.001994: to be affected in a similar manner, is” for “If the Secretary has a reasonable belief that an article of
p.001994: food is”, inserted “, and to any other article of food that the Secretary reasonably believes is likely
p.001994: to be affected in a similar manner,” after “relating to such article”, struck out at end “The
p.001994: requirement under the preceding sentence applies to all records relating to the manufacture,
p.001994: processing, packing, distribution, receipt, holding, or importation of such article maintained by or
p.001994: on behalf of such person in any format (including paper and electronic formats) and at any
p.001994: location.”, and added pars. (2) and (3).
p.001994: EXPEDITED RULEMAKING
p.001994: Pub. L. 107–188, title III, §306(d), June 12, 2002, 116 Stat. 670, provided that: “Not later than
p.001994: 18 months after the date of the enactment of this Act [June 12, 2002], the Secretary shall
p.001994: promulgate proposed and final regulations establishing recordkeeping requirements under
p.001994: subsection 414(b) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 350c(b)] (as added by
p.001994: subsection (a)).”
p.001994: CONSTRUCTION OF 2011 AMENDMENT
p.001994: Nothing in amendment by Pub. L. 111–353 to be construed to apply to certain alcohol-related
p.001994: facilities, to alter jurisdiction and authorities established under certain other Acts, or in a manner
p.001994: inconsistent with international agreements to which the United States is a party, see sections
p.001994: 2206, 2251, and 2252 of this title.
p.001994:
p.001994:
p.001994: §350d. Registration of food facilities
p.001994: (a) Registration
p.001994: (1) In general
p.001994: The Secretary shall by regulation require that any facility engaged in manufacturing,
p.001994: processing, packing, or holding food for consumption in the United States be registered
p.001994: with the Secretary. To be registered—
p.001994: (A) for a domestic facility, the owner, operator, or agent in charge of the facility shall
p.001994: submit a registration to the Secretary; and
p.001994: (B) for a foreign facility, the owner, operator, or agent in charge of the facility shall
p.001994: submit a registration to the Secretary and shall include with the registration the name of
p.001994: the United States agent for the facility.
p.001994: (2) Registration
p.001994: An entity (referred to in this section as the “registrant”) shall submit a registration under
p.001994: paragraph (1) to the Secretary containing information necessary to notify the Secretary of
p.001994: the name and address of each facility at which, and all trade names under which, the
p.001994: registrant conducts business, the e-mail address for the contact person of the facility or,
p.001994: in the case of a foreign facility, the United States agent for the facility, and, when
p.001994: determined necessary by the Secretary through guidance, the general food category (as
p.001994: identified under section 170.3 of title 21, Code of Federal Regulations, or any other food
p.001994: categories as determined appropriate by the Secretary, including by guidance) of any
p.001994: food manufactured, processed, packed, or held at such facility. The registration shall
p.001994: contain an assurance that the Secretary will be permitted to inspect such facility at the
p.001994: times and in the manner permitted by this chapter. The registrant shall notify the
...

p.001994: “(B) activities that constitute on-farm manufacturing or processing of food that is not
p.001994: consumed on that farm or on another farm under common ownership for purposes of such
p.001994: section 415; and
p.001994: “(C) the requirements under sections 418 and 421 of the Federal Food, Drug, and Cosmetic
p.001994: Act [21 U.S.C. 350g, 350j], as added by this Act, from which the Secretary may issue
p.001994: exemptions or modifications of the requirements for certain types of facilities.”
p.001994: Pub. L. 107–188, title III, §305(e), June 12, 2002, 116 Stat. 669, provided that: “Not later than
p.001994: 18 months after the date of the enactment of this Act [June 12, 2002], the Secretary of Health and
p.001994: Human Services shall promulgate proposed and final regulations for the requirement of
p.001994: registration under section 415 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 350d] (as
p.001994: added by subsection (a) of this section). Such requirement of registration takes effect—
p.001994: “(1) upon the effective date of such final regulations; or
p.001994: “(2) upon the expiration of such 18-month period if the final regulations have not been
p.001994: made effective as of the expiration of such period, subject to compliance with the final
p.001994: regulations when the final regulations are made effective.”
p.001994: CONSTRUCTION OF 2011 AMENDMENT
p.001994: Nothing in amendments by Pub. L. 111–353 to be construed to alter jurisdiction and authorities
p.001994: established under certain other Acts or in a manner inconsistent with international agreements to
p.001994: which the United States is a party, see sections 2251 and 2252 of this title.
p.001994: SMALL ENTITY COMPLIANCE POLICY GUIDE
p.001994: Pub. L. 111–353, title I, §102(b)(2), Jan. 4, 2011, 124 Stat. 3888, provided that: “Not later than
p.001994: 180 days after the issuance of the regulations promulgated under section 415(b)(5) of the Federal
p.001994: Food, Drug, and Cosmetic Act [21 U.S.C. 350d(b)(5)] (as added by this section), the Secretary
p.001994: shall issue a small entity compliance policy guide setting forth in plain language the requirements
p.001994: of such regulations to assist small entities in complying with registration requirements and other
p.001994: activities required under such section.”
p.001994: ELECTRONIC FILING
p.001994: Pub. L. 107–188, title III, §305(d), June 12, 2002, 116 Stat. 668, provided that: “For the purpose
p.001994: of reducing paperwork and reporting burdens, the Secretary of Health and Human Services may
p.001994: provide for, and encourage the use of, electronic methods of submitting to the Secretary
p.001994: registrations required pursuant to this section [enacting this section, amending sections 331 and
p.001994: 381 of this title, and enacting provisions set out as a note under this section]. In providing for the
p.001994: electronic submission of such registrations, the Secretary shall ensure adequate authentication
p.001994: protocols are used to enable identification of the registrant and validation of the data as
p.001994: appropriate.”
p.001994:
p.001994:
p.001994: §350e. Sanitary transportation practices
p.001994: (a) Definitions
p.001994: In this section:
p.001994: (1) Bulk vehicle
p.001994: The term “bulk vehicle” includes a tank truck, hopper truck, rail tank car, hopper car,
p.001994: cargo tank, portable tank, freight container, or hopper bin, and any other vehicle in which
...

p.001994: (B) the requirement of the State or political subdivision as applied or enforced is an
p.001994: obstacle to accomplishing and carrying out this section or a regulation prescribed under
p.001994: this section.
p.001994: (2) Applicability
p.001994: This subsection applies to transportation that occurs on or after the effective date of the
p.001994: regulations promulgated under subsection (b) of this section.
p.001994: (f) Assistance of other agencies
p.001994: The Secretary of Transportation, the Secretary of Agriculture, the Administrator of the
p.001994: Environmental Protection Agency, and the heads of other Federal agencies, as appropriate,
p.001994: shall provide assistance on request, to the extent resources are available, to the Secretary
p.001994: for the purposes of carrying out this section.
p.001994: (June 25, 1938, ch. 675, §416, as added Pub. L. 109–59, title VII, §7202(b), Aug. 10, 2005,
p.001994: 119 Stat. 1911.)
p.001994: EFFECTIVE DATE
p.001994: Section effective Oct. 1, 2005, see section 7204 of Pub. L. 109–59, set out as an Effective Date
p.001994: of 2005 Amendment note under section 331 of this title.
p.001994: REGULATIONS
p.001994: Pub. L. 111–353, title I, §111(a), Jan. 4, 2011, 124 Stat. 3916, provided that: “Not later than 18
p.001994: months after the date of enactment of this Act [Jan. 4, 2011], the Secretary shall promulgate
p.001994: regulations described in section 416(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
p.001994: 350e(b)).”
p.001994:
p.001994:
p.001994: §350f. Reportable food registry
p.001994: (a) Definitions
p.001994: In this section:
p.001994: (1) Responsible party
p.001994: The term “responsible party”, with respect to an article of food, means a person that
p.001994: submits the registration under section 350d(a) of this title for a food facility that is required
p.001994: to register under section 350d(a) of this title, at which such article of food is
p.001994: manufactured, processed, packed, or held.
p.001994: (2) Reportable food
p.001994: The term “reportable food” means an article of food (other than infant formula) for
p.001994: which there is a reasonable probability that the use of, or exposure to, such article of food
p.001994: will cause serious adverse health consequences or death to humans or animals.
p.001994: (b) Establishment
p.001994: (1) In general
p.001994: Not later than 1 year after September 27, 2007, the Secretary shall establish within the
p.001994: Food and Drug Administration a Reportable Food Registry to which instances of
p.001994: reportable food may be submitted by the Food and Drug Administration after receipt of
p.001994: reports under subsection (d), via an electronic portal, from—
p.001994: (A) Federal, State, and local public health officials; or
p.001994: (B) responsible parties.
p.001994: (2) Review by Secretary
p.001994: The Secretary shall promptly review and assess the information submitted under
p.001994: paragraph (1) for the purposes of identifying reportable food, submitting entries to the
p.001994: Reportable Food Registry, acting under subsection (c), and exercising other existing food
p.001994: safety authorities under this chapter to protect the public health.
p.001994: (c) Issuance of an alert by the Secretary
p.001994: (1) In general
p.001994: The Secretary shall issue, or cause to be issued, an alert or a notification with respect
p.001994: to a reportable food using information from the Reportable Food Registry as the
p.001994: Secretary deems necessary to protect the public health.
p.001994: (2) Effect
p.001994: Paragraph (1) shall not affect the authority of the Secretary to issue an alert or a
p.001994: notification under any other provision of this chapter.
p.001994: (d) Reporting and notification
p.001994: (1) In general
p.001994: Except as provided in paragraph (2), as soon as practicable, but in no case later than
p.001994: 24 hours after a responsible party determines that an article of food is a reportable food,
p.001994: the responsible party shall—
p.001994: (A) submit a report to the Food and Drug Administration through the electronic portal
p.001994: established under subsection (b) that includes the data elements described in
p.001994: subsection (e) (except the elements described in paragraphs (8), (9), and (10) of such
p.001994: subsection); and
p.001994: (B) investigate the cause of the adulteration if the adulteration of the article of food
p.001994: may have originated with the responsible party.
p.001994: (2) No report required
p.001994: A responsible party is not required to submit a report under paragraph (1) if—
p.001994: (A) the adulteration originated with the responsible party;
p.001994: (B) the responsible party detected the adulteration prior to any transfer to another
p.001994: person of such article of food; and
p.001994: (C) the responsible party
p.001994: (i) corrected such adulteration; or
p.001994: (ii) destroyed or caused the destruction of such article of food.
p.001994: (3) Reports by public health officials
p.001994: A Federal, State, or local public health official may submit a report about a reportable
p.001994: food to the Food and Drug Administration through the electronic portal established under
p.001994: subsection (b) that includes the data elements described in subsection (e) that the official
p.001994: is able to provide.
p.001994: (4) Report number
p.001994: The Secretary shall ensure that, upon submission of a report under paragraph (1) or
p.001994: (3), a unique number is issued through the electronic portal established under subsection
p.001994: (b) to the person submitting such report, by which the Secretary is able to link reports
p.001994: about the reportable food submitted and amended under this subsection and identify the
p.001994: supply chain for such reportable food.
p.001994: (5) Review
p.001994: The Secretary shall promptly review a report submitted under paragraph (1) or (3).
p.001994: (6) Response to report submitted by a responsible party
p.001994: After consultation with the responsible party that submitted a report under paragraph
p.001994: (1), the Secretary may require such responsible party to perform, as soon as practicable,
p.001994: but in no case later than a time specified by the Secretary, 1 or more of the following:
p.001994: (A) Amend the report submitted by the responsible party under paragraph (1) to
p.001994: include the data element described in subsection (e)(9).
p.001994: (B) Provide a notification—
p.001994: (i) to the immediate previous source of the article of food, if the Secretary deems
p.001994: necessary;
p.001994: (ii) to the immediate subsequent recipient of the article of food, if the Secretary
p.001994: deems necessary; and
p.001994: (iii) that includes—
p.001994: (I) the data elements described in subsection (e) that the Secretary deems
p.001994: necessary;
p.001994: (II) the actions described under paragraph (7) that the recipient of the
p.001994: notification shall perform, as required by the Secretary; and
p.001994: (III) any other information that the Secretary may require.
p.001994: (7) Subsequent reports and notifications
p.001994: Except as provided in paragraph (8), the Secretary may require a responsible party to
p.001994: perform, as soon as practicable, but in no case later than a time specified by the
p.001994: Secretary, after the responsible party receives a notification under subparagraph (C) or
p.001994: paragraph (6)(B), 1 or more of the following:
p.001994: (A) Submit a report to the Food and Drug Administration through the electronic portal
p.001994: established under subsection (b) that includes those data elements described in
p.001994: subsection (e) and other information that the Secretary deems necessary.
p.001994: (B) Investigate the cause of the adulteration if the adulteration of the article of food
p.001994: may have originated with the responsible party.
p.001994: (C) Provide a notification—
p.001994: (i) to the immediate previous source of the article of food, if the Secretary deems
p.001994: necessary;
p.001994: (ii) to the immediate subsequent recipient of the article of food, if the Secretary
p.001994: deems necessary; and
p.001994: (iii) that includes—
p.001994: (I) the data elements described in subsection (e) that the Secretary deems
p.001994: necessary;
p.001994: (II) the actions described under this paragraph that the recipient of the
p.001994: notification shall perform, as required by the Secretary; and
p.001994: (III) any other information that the Secretary may require.
p.001994: (8) Amended report
p.001994: If a responsible party receives a notification under paragraph (6)(B) or paragraph (7)(C)
p.001994: with respect to an article of food after the responsible party has submitted a report to the
p.001994: Food and Drug Administration under paragraph (1) with respect to such article of food—
p.001994: (A) the responsible party is not required to submit an additional report or make a
p.001994: notification under paragraph (7); and
p.001994: (B) the responsible party shall amend the report submitted by the responsible party
p.001994: under paragraph (1) to include the data elements described in paragraph (9), and, with
p.001994: respect to both such notification and such report, paragraph (11) of subsection (e).
p.001994: (e) Data elements
p.001994: The data elements described in this subsection are the following:
p.001994: (1) The registration numbers of the responsible party under section 350d(a)(3) 1 of this
p.001994: title.
p.001994: (2) The date on which an article of food was determined to be a reportable food.
p.001994: (3) A description of the article of food including the quantity or amount.
p.001994: (4) The extent and nature of the adulteration.
p.001994: (5) If the adulteration of the article of food may have originated with the responsible
p.001994: party, the results of the investigation required under paragraph (1)(B) or (7)(B) of
p.001994: subsection (d), as applicable and when known.
p.001994: (6) The disposition of the article of food, when known.
p.001994: (7) Product information typically found on packaging including product codes, use-by
p.001994: dates, and names of manufacturers, packers, or distributors sufficient to identify the
p.001994: article of food.
p.001994: (8) Contact information for the responsible party.
p.001994: (9) The contact information for parties directly linked in the supply chain and notified
p.001994: under paragraph (6)(B) or (7)(C) of subsection (d), as applicable.
p.001994: (10) The information required by the Secretary to be included in a notification provided
p.001994: by the responsible party involved under paragraph (6)(B) or (7)(C) of subsection (d) or
p.001994: required in a report under subsection (d)(7)(A).
p.001994: (11) The unique number described in subsection (d)(4).
p.001994: (f) Critical information
p.001994: Except with respect to fruits and vegetables that are raw agricultural commodities, not
p.001994: more than 18 months after January 4, 2011, the Secretary may require a responsible party
p.001994: to submit to the Secretary consumer-oriented information regarding a reportable food, which
p.001994: shall include—
p.001994: (1) a description of the article of food as provided in subsection (e)(3);
p.001994: (2) as provided in subsection (e)(7), affected product identification codes, such as
p.001994: UPC, SKU, or lot or batch numbers sufficient for the consumer to identify the article of
p.001994: food;
p.001994: (3) contact information for the responsible party as provided in subsection (e)(8); and
p.001994: (4) any other information the Secretary determines is necessary to enable a consumer
p.001994: to accurately identify whether such consumer is in possession of the reportable food.
p.001994: (g) Grocery store notification
p.001994: (1) Action by Secretary
p.001994: The Secretary shall—
p.001994: (A) prepare the critical information described under subsection (f) for a reportable
p.001994: food as a standardized one-page summary;
p.001994: (B) publish such one-page summary on the Internet website of the Food and Drug
p.001994: Administration in a format that can be easily printed by a grocery store for purposes of
p.001994: consumer notification.
p.001994: (2) Action by grocery store
p.001994: A notification described under paragraph (1)(B) shall include the date and time such
p.001994: summary was posted on the Internet website of the Food and Drug Administration.
p.001994: (h) Consumer notification
p.001994: (1) In general
p.001994: If a grocery store sold a reportable food that is the subject of the posting and such
p.001994: establishment is part of 2 chain of establishments with 15 or more physical locations, then
p.001994: such establishment shall, not later than 24 hours after a one page summary described in
p.001994: subsection (g) is published, prominently display such summary or the information from
p.001994: such summary via at least one of the methods identified under paragraph (2) and
p.001994: maintain the display for 14 days.
p.001994: (2) List of conspicuous locations
p.001994: Not more than 1 year after January 4, 2011, the Secretary shall develop and publish a
p.001994: list of acceptable conspicuous locations and manners, from which grocery stores shall
p.001994: select at least one, for providing the notification required in paragraph (1). Such list shall
p.001994: include—
p.001994: (A) posting the notification at or near the register;
p.001994: (B) providing the location of the reportable food;
p.001994: (C) providing targeted recall information given to customers upon purchase of a food;
p.001994: and
p.001994: (D) other such prominent and conspicuous locations and manners utilized by grocery
p.001994: stores as of January 4, 2011, to provide notice of such recalls to consumers as
p.001994: considered appropriate by the Secretary.
p.001994: (i) Coordination of Federal, State, and local efforts
p.001994: (1) Department of Agriculture
p.001994: In implementing this section, the Secretary shall—
p.001994: (A) share information and coordinate regulatory efforts with the Department of
p.001994: Agriculture; and
p.001994: (B) if the Secretary receives a report submitted about a food within the jurisdiction of
p.001994: the Department of Agriculture, promptly provide such report to the Department of
p.001994: Agriculture.
p.001994: (2) States and localities
p.001994: In implementing this section, the Secretary shall work with the State and local public
p.001994: health officials to share information and coordinate regulatory efforts, in order to—
p.001994: (A) help to ensure coverage of the safety of the food supply chain, including those
p.001994: food establishments regulated by the States and localities that are not required to
p.001994: register under section 350d of this title; and
p.001994: (B) reduce duplicative regulatory efforts.
p.001994: (j) Maintenance and inspection of records
p.001994: The responsible party shall maintain records related to each report received, notification
p.001994: made, and report submitted to the Food and Drug Administration under this section for 2
p.001994: years. A responsible party shall, at the request of the Secretary, permit inspection of such
p.001994: records as provided for section 3 350c of this title.
p.001994: (k) Request for information
p.001994: Except as provided by section 350d(a)(4) 1 of this title, section 552 of title 5 shall apply to
p.001994: any request for information regarding a record in the Reportable Food Registry.
p.001994: (l) Safety report
p.001994: A report or notification under subsection (d) shall be considered to be a safety report
p.001994: under section 379v of this title and may be accompanied by a statement, which shall be part
p.001994: of any report released for public disclosure, that denies that the report or the notification
p.001994: constitutes an admission that the product involved caused or contributed to a death, serious
p.001994: injury, or serious illness.
p.001994: (m) Admission
p.001994: A report or notification under this section shall not be considered an admission that the
p.001994: article of food involved is adulterated or caused or contributed to a death, serious injury, or
p.001994: serious illness.
p.001994: (n) Homeland Security notification
p.001994: If, after receiving a report under subsection (d), the Secretary believes such food may
p.001994: have been deliberately adulterated, the Secretary shall immediately notify the Secretary of
p.001994: Homeland Security. The Secretary shall make relevant information from the Reportable
p.001994: Food Registry available to the Secretary of Homeland Security.
p.001994: (June 25, 1938, ch. 675, §417, as added Pub. L. 110–85, title X, §1005(b), Sept. 27, 2007,
p.001994: 121 Stat. 965; amended Pub. L. 111–353, title II, §211(a), Jan. 4, 2011, 124 Stat. 3951.)
p.001994: REFERENCES IN TEXT
p.001994: Section 350d(a)(3), (4) of this title, referred to in subsecs. (e)(1) and (k), was redesignated
p.001994: section 350d(a)(4), (5), respectively, of this title by Pub. L. 111–353, title I, §102(a)(2), Jan. 4,
p.001994: 2011, 124 Stat. 3887.
p.001994: AMENDMENTS
p.001994: 2011—Subsecs. (f) to (n). Pub. L. 111–353 added subsecs. (f) to (h) and redesignated former
p.001994: subsecs. (f) to (k) as (i) to (n), respectively.
p.001994: EFFECTIVE DATE
p.001994: Pub. L. 110–85, title X, §1005(e), Sept. 27, 2007, 121 Stat. 969, provided that: “The
p.001994: requirements of section 417(d) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 350f(d)],
p.001994: as added by subsection (a) [probably should be (b)], shall become effective 1 year after the date
p.001994: of the enactment of this Act [Sept. 27, 2007].”
p.001994: CONSTRUCTION OF 2011 AMENDMENT
p.001994: Nothing in amendment by Pub. L. 111–353 to be construed to apply to certain alcohol-related
p.001994: facilities, to alter jurisdiction and authorities established under certain other Acts, or in a manner
p.001994: inconsistent with international agreements to which the United States is a party, see sections
p.001994: 2206, 2251, and 2252 of this title.
p.001994: FINDINGS
p.001994: Pub. L. 110–85, title X, §1005(a), Sept. 27, 2007, 121 Stat. 964, provided that: “Congress
p.001994: makes the following findings:
p.001994: “(1) In 1994, Congress passed the Dietary Supplement Health and Education Act of 1994
p.001994: (Public Law 103–417) [see Short Title of 1994 Amendments note set out under section 301 of
p.001994: this title] to provide the Food and Drug Administration the legal framework which is intended to
p.001994: ensure that dietary supplements are safe and properly labeled foods.
p.001994: “(2) In 2006, Congress passed the Dietary Supplement and Nonprescription Drug
p.001994: Consumer Protection Act (Public Law 109–462) [see Short Title of 2006 Amendment note set
p.001994: out under section 301 of this title] to establish a mandatory reporting system of serious adverse
p.001994: events for nonprescription drugs and dietary supplements sold and consumed in the United
p.001994: States.
p.001994: “(3) The adverse event reporting system created under the Dietary Supplement and
p.001994: Nonprescription Drug Consumer Protection Act is intended to serve as an early warning system
p.001994: for potential public health issues associated with the use of these products.
p.001994: “(4) A reliable mechanism to track patterns of adulteration in food would support efforts by
...

p.001994: (1) In general
p.001994: Not later than 18 months after January 4, 2011, the Secretary shall promulgate
p.001994: regulations—
p.001994: (A) to establish science-based minimum standards for conducting a hazard analysis,
p.001994: documenting hazards, implementing preventive controls, and documenting the
p.001994: implementation of the preventive controls under this section; and
p.001994: (B) to define, for purposes of this section, the terms “small business” and “very small
p.001994: business”, taking into consideration the study described in subsection (l)(5).
p.001994: (2) Coordination
p.001994: In promulgating the regulations under paragraph (1)(A), with regard to hazards that
p.001994: may be intentionally introduced, including by acts of terrorism, the Secretary shall
p.001994: coordinate with the Secretary of Homeland Security, as appropriate.
p.001994: (3) Content
p.001994: The regulations promulgated under paragraph (1)(A) shall—
p.001994: (A) provide sufficient flexibility to be practicable for all sizes and types of facilities,
p.001994: including small businesses such as a small food processing facility co-located on a
p.001994: farm;
p.001994: (B) comply with chapter 35 of title 44 (commonly known as the “Paperwork Reduction
p.001994: Act”), with special attention to minimizing the burden (as defined in section 3502(2) of
p.001994: such title) on the facility, and collection of information (as defined in section 3502(3) of
p.001994: such title), associated with such regulations;
p.001994: (C) acknowledge differences in risk and minimize, as appropriate, the number of
p.001994: separate standards that apply to separate foods; and
p.001994: (D) not require a facility to hire a consultant or other third party to identify, implement,
p.001994: certify, or audit preventative controls, except in the case of negotiated enforcement
p.001994: resolutions that may require such a consultant or third party.
p.001994: (4) Rule of construction
p.001994: Nothing in this subsection shall be construed to provide the Secretary with the authority
p.001994: to prescribe specific technologies, practices, or critical controls for an individual facility.
p.001994: (5) Review
p.001994: In promulgating the regulations under paragraph (1)(A), the Secretary shall review
p.001994: regulatory hazard analysis and preventive control programs in existence on January 4,
p.001994: 2011, including the Grade “A” Pasteurized Milk Ordinance to ensure that such regulations
p.001994: are consistent, to the extent practicable, with applicable domestic and internationally-
p.001994: recognized standards in existence on such date.
p.001994: (o) Definitions
p.001994: For purposes of this section:
p.001994: (1) Critical control point
p.001994: The term “critical control point” means a point, step, or procedure in a food process at
p.001994: which control can be applied and is essential to prevent or eliminate a food safety hazard
p.001994: or reduce such hazard to an acceptable level.
p.001994: (2) Facility
p.001994: The term “facility” means a domestic facility or a foreign facility that is required to
p.001994: register under section 350d of this title.
p.001994: (3) Preventive controls
p.001994: The term “preventive controls” means those risk-based, reasonably appropriate
p.001994: procedures, practices, and processes that a person knowledgeable about the safe
p.001994: manufacturing, processing, packing, or holding of food would employ to significantly
...

p.001994: environment.
p.001994: (D) A food allergen control program.
p.001994: (E) A recall plan.
p.001994: (F) Current Good Manufacturing Practices (cGMPs) under part 110 of title 21, Code
p.001994: of Federal Regulations (or any successor regulations).
p.001994: (G) Supplier verification activities that relate to the safety of food.
p.001994: (June 25, 1938, ch. 675, §418, as added Pub. L. 111–353, title I, §103(a), Jan. 4, 2011, 124
p.001994: Stat. 3889.)
p.001994: EFFECTIVE DATE
p.001994: Pub. L. 111–353, title I, §103(i), Jan. 4, 2011, 124 Stat. 3898, provided that:
p.001994: “(1) GENERAL RULE.—The amendments made by this section [enacting this section and amending
p.001994: section 331 of this title] shall take effect 18 months after the date of enactment of this Act [Jan. 4,
p.001994: 2011].
p.001994: “(2) FLEXIBILITY FOR SMALL BUSINESSES.—Notwithstanding paragraph (1)—
p.001994: “(A) the amendments made by this section shall apply to a small business (as defined in the
p.001994: regulations promulgated under section 418(n) of the Federal Food, Drug, and Cosmetic Act [21
p.001994: U.S.C. 350g(n)] (as added by this section)) beginning on the date that is 6 months after the
p.001994: effective date of such regulations; and
p.001994: “(B) the amendments made by this section shall apply to a very small business (as defined
p.001994: in such regulations) beginning on the date that is 18 months after the effective date of such
p.001994: regulations.”
p.001994: CONSTRUCTION
p.001994: Nothing in this section to be construed to apply to certain alcohol-related facilities, to alter
p.001994: jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with
p.001994: international agreements to which the United States is a party, see sections 2206, 2251, and 2252
p.001994: of this title.
p.001994: GUIDANCE DOCUMENT
p.001994: Pub. L. 111–353, title I, §103(b), Jan. 4, 2011, 124 Stat. 3896, provided that: “The Secretary
p.001994: shall issue a guidance document related to the regulations promulgated under subsection (b)(1)
p.001994: [probably means 21 U.S.C. 350g(n)(1)] with respect to the hazard analysis and preventive
p.001994: controls under section 418 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 350g] (as
p.001994: added by subsection (a)).”
p.001994: SMALL ENTITY COMPLIANCE POLICY GUIDE
p.001994: Pub. L. 111–353, title I, §103(d), Jan. 4, 2011, 124 Stat. 3898, provided that: “Not later than 180
p.001994: days after the issuance of the regulations promulgated under subsection (n) of section 418 of the
p.001994: Federal Food, Drug, and Cosmetic Act [21 U.S.C. 350g(n)] (as added by subsection (a)), the
p.001994: Secretary shall issue a small entity compliance policy guide setting forth in plain language the
p.001994: requirements of such section 418 and this section [enacting this section, amending section 331 of
p.001994: this title, and enacting provisions set out as notes under this section and sections 342 and 350d of
p.001994: this title] to assist small entities in complying with the hazard analysis and other activities required
p.001994: under such section 418 and this section.”
p.001994: NO EFFECT ON HACCP AUTHORITIES
p.001994: Pub. L. 111–353, title I, §103(f), Jan. 4, 2011, 124 Stat. 3898, provided that: “Nothing in the
p.001994: amendments made by this section [enacting this section and amending section 331 of this title]
...

p.001994: (c) Criteria
p.001994: (1) In general
p.001994: The regulations adopted under subsection (b) shall—
p.001994: (A) set forth those procedures, processes, and practices that the Secretary
p.001994: determines to minimize the risk of serious adverse health consequences or death,
p.001994: including procedures, processes, and practices that the Secretary determines to be
p.001994: reasonably necessary to prevent the introduction of known or reasonably foreseeable
p.001994: biological, chemical, and physical hazards, including hazards that occur naturally, may
p.001994: be unintentionally introduced, or may be intentionally introduced, including by acts of
p.001994: terrorism, into fruits and vegetables, including specific mixes or categories of fruits and
p.001994: vegetables, that are raw agricultural commodities and to provide reasonable
p.001994: assurances that the produce is not adulterated under section 342 of this title;
p.001994: (B) provide sufficient flexibility to be practicable for all sizes and types of businesses,
p.001994: including small businesses such as a small food processing facility co-located on a
p.001994: farm;
p.001994: (C) comply with chapter 35 of title 44 (commonly known as the “Paperwork
p.001994: Reduction Act”), with special attention to minimizing the burden (as defined in section
p.001994: 3502(2) of such title) on the business, and collection of information (as defined in
p.001994: section 3502(3) of such title), associated with such regulations;
p.001994: (D) acknowledge differences in risk and minimize, as appropriate, the number of
p.001994: separate standards that apply to separate foods; and
p.001994: (E) not require a business to hire a consultant or other third party to identify,
p.001994: implement, certify, compliance 1 with these procedures, processes, and practices,
p.001994: except in the case of negotiated enforcement resolutions that may require such a
p.001994: consultant or third party; and
p.001994: (F) permit States and foreign countries from which food is imported into the United
p.001994: States to request from the Secretary variances from the requirements of the
p.001994: regulations, subject to paragraph (2), where the State or foreign country determines
p.001994: that the variance is necessary in light of local growing conditions and that the
p.001994: procedures, processes, and practices to be followed under the variance are reasonably
p.001994: likely to ensure that the produce is not adulterated under section 342 of this title and to
p.001994: provide the same level of public health protection as the requirements of the
p.001994: regulations adopted under subsection (b).
p.001994: (2) Variances
p.001994: (A) Requests for variances
p.001994: A State or foreign country from which food is imported into the United States may in
p.001994: writing request a variance from the Secretary. Such request shall describe the variance
p.001994: requested and present information demonstrating that the variance does not increase
p.001994: the likelihood that the food for which the variance is requested will be adulterated under
p.001994: section 342 of this title, and that the variance provides the same level of public health
p.001994: protection as the requirements of the regulations adopted under subsection (b). The
p.001994: Secretary shall review such requests in a reasonable timeframe.
p.001994: (B) Approval of variances
p.001994: The Secretary may approve a variance in whole or in part, as appropriate, and may
p.001994: specify the scope of applicability of a variance to other similarly situated persons.
p.001994: (C) Denial of variances
...

p.001994: This section shall not apply to activities of a facility that are subject to section 350g of this
p.001994: title.
p.001994: (June 25, 1938, ch. 675, §419, as added Pub. L. 111–353, title I, §105(a), Jan. 4, 2011, 124
p.001994: Stat. 3899.)
p.001994: REFERENCES IN TEXT
p.001994: The Organic Foods Production Act of 1990, referred to in subsec. (a)(1)(A), (3)(E), is title XXI of
p.001994: Pub. L. 101–624, Nov. 28, 1990, 104 Stat. 3935, which is classified generally to chapter 94
p.001994: (§6501 et seq.) of Title 7, Agriculture. For complete classification of this Act to the Code, see
p.001994: Short Title note set out under section 6501 of Title 7 and Tables.
p.001994: The FDA Food Safety Modernization Act, referred to in subsec. (a)(3)(E), is Pub. L. 111–353,
p.001994: Jan. 4, 2011, 124 Stat. 3885, which enacted chapter 27 (§2201 et seq.) and sections 350g to
p.001994: 350l–1, 379j–31, 384a to 384d, 399c, and 399d of this title, section 7625 of Title 7, Agriculture,
p.001994: and section 280g–16 of Title 42, The Public Health and Welfare, amended sections 331, 333, 334,
p.001994: 350b to 350d, 350f, 374, 381, 393, and 399 of this title and section 247b–20 of Title 42, and
p.001994: enacted provisions set out as notes under sections 331, 334, 342, 350b, 350d, 350e, 350g to
p.001994: 350j, 350l, and 381 of this title. For complete classification of this Act to the Code, see Short Title
p.001994: note set out under section 2201 of this title and Tables.
p.001994: CONSTRUCTION
p.001994: Nothing in this section to be construed to apply to certain alcohol-related facilities, to alter
p.001994: jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with
p.001994: international agreements to which the United States is a party, see sections 2206, 2251, and 2252
p.001994: of this title.
p.001994: SMALL ENTITY COMPLIANCE POLICY GUIDE
p.001994: Pub. L. 111–353, title I, §105(b), Jan. 4, 2011, 124 Stat. 3904, provided that: “Not later than 180
p.001994: days after the issuance of regulations under section 419 of the Federal Food, Drug, and Cosmetic
p.001994: Act [21 U.S.C. 350h] (as added by subsection (a)), the Secretary of Health and Human Services
p.001994: shall issue a small entity compliance policy guide setting forth in plain language the requirements
p.001994: of such section 419 and to assist small entities in complying with standards for safe production
p.001994: and harvesting and other activities required under such section.”
p.001994: NO EFFECT ON HACCP AUTHORITIES
p.001994: Pub. L. 111–353, title I, §105(d), Jan. 4, 2011, 124 Stat. 3905, provided that: “Nothing in the
p.001994: amendments made by this section [enacting this section and amending section 331 of this title]
p.001994: limits the authority of the Secretary [of Health and Human Services] under the Federal Food,
p.001994: Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or the Public Health Service Act (42 U.S.C. 201 et
p.001994: seq.) to revise, issue, or enforce product and category-specific regulations, such as the Seafood
p.001994: Hazard Analysis Critical Controls Points Program, the Juice Hazard Analysis Critical Control
p.001994: [Points] Program, and the Thermally Processed Low-Acid Foods Packaged in Hermetically
p.001994: Sealed Containers standards.”
p.001994:
...

p.001994: of food; and
p.001994: (2) specify appropriate science-based mitigation strategies or measures to prepare and
p.001994: protect the food supply chain at specific vulnerable points, as appropriate.
p.001994: (c) Applicability
p.001994: Regulations promulgated under subsection (b) shall apply only to food for which there is a
p.001994: high risk of intentional contamination, as determined by the Secretary, in consultation with
p.001994: the Secretary of Homeland Security, under subsection (a), that could cause serious adverse
p.001994: health consequences or death to humans or animals and shall include those foods—
p.001994: (1) for which the Secretary has identified clear vulnerabilities (including short shelf-life
p.001994: or susceptibility to intentional contamination at critical control points); and
p.001994: (2) in bulk or batch form, prior to being packaged for the final consumer.
p.001994: (d) Exception
p.001994: This section shall not apply to farms, except for those that produce milk.
p.001994: (e) Definition
p.001994: For purposes of this section, the term “farm” has the meaning given that term in section
p.001994: 1.227 of title 21, Code of Federal Regulations (or any successor regulation).
p.001994: (June 25, 1938, ch. 675, §420, as added Pub. L. 111–353, title I, §106(a), Jan. 4, 2011, 124
p.001994: Stat. 3905.)
p.001994: CONSTRUCTION
p.001994: Nothing in this section to be construed to apply to certain alcohol-related facilities, to alter
p.001994: jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with
p.001994: international agreements to which the United States is a party, see sections 2206, 2251, and 2252
p.001994: of this title.
p.001994: GUIDANCE DOCUMENTS
p.001994: Pub. L. 111–353, title I, §106(b), Jan. 4, 2011, 124 Stat. 3906, provided that:
p.001994: “(1) IN GENERAL.—Not later than 1 year after the date of enactment of this Act [Jan. 4, 2011], the
p.001994: Secretary of Health and Human Services, in consultation with the Secretary of Homeland Security
p.001994: and the Secretary of Agriculture, shall issue guidance documents related to protection against the
p.001994: intentional adulteration of food, including mitigation strategies or measures to guard against such
p.001994: adulteration as required under section 420 of the Federal Food, Drug, and Cosmetic Act [21
p.001994: U.S.C. 450i], as added by subsection (a).
p.001994: “(2) CONTENT.—The guidance documents issued under paragraph (1) shall—
p.001994: “(A) include a model assessment for a person to use under subsection (b)(1) of section 420
p.001994: of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a);
p.001994: “(B) include examples of mitigation strategies or measures described in subsection (b)(2) of
p.001994: such section; and
p.001994: “(C) specify situations in which the examples of mitigation strategies or measures described
p.001994: in subsection (b)(2) of such section are appropriate.
p.001994: “(3) LIMITED DISTRIBUTION .—In the interest of national security, the Secretary of Health and Human
p.001994: Services, in consultation with the Secretary of Homeland Security, may determine the time,
p.001994: manner, and form in which the guidance documents issued under paragraph (1) are made public,
p.001994: including by releasing such documents to targeted audiences.”
p.001994: PERIODIC REVIEW
...

p.001994: (2) The known safety risks of the countries or regions of origin and countries through
p.001994: which such article of food is transported.
p.001994: (3) The compliance history of the importer, including with regard to food recalls,
p.001994: outbreaks of foodborne illness, and violations of food safety standards.
p.001994: (4) The rigor and effectiveness of the activities conducted by the importer of such
p.001994: article of food to satisfy the requirements of the foreign supplier verification program
p.001994: under section 384a of this title.
p.001994: (5) Whether the food importer participates in the voluntary qualified importer program
p.001994: under section 384b of this title.
p.001994: (6) Whether the food meets the criteria for priority under section 381(h)(1) of this title.
p.001994: (7) Whether the food or the facility that manufactured, processed, packed, or held such
p.001994: food received a certification as described in section 381(q) or 384b of this title.
p.001994: (8) Any other criteria deemed necessary and appropriate by the Secretary for purposes
p.001994: of allocating inspection resources.
p.001994: (c) Interagency agreements with respect to seafood
p.001994: (1) In general
p.001994: The Secretary of Health and Human Services, the Secretary of Commerce, the
p.001994: Secretary of Homeland Security, the Chairman of the Federal Trade Commission, and
p.001994: the heads of other appropriate agencies may enter into such agreements as may be
p.001994: necessary or appropriate to improve seafood safety.
p.001994: (2) Scope of agreements
p.001994: The agreements under paragraph (1) may include—
p.001994: (A) cooperative arrangements for examining and testing seafood imports that
p.001994: leverage the resources, capabilities, and authorities of each party to the agreement;
p.001994: (B) coordination of inspections of foreign facilities to increase the percentage of
p.001994: imported seafood and seafood facilities inspected;
p.001994: (C) standardization of data on seafood names, inspection records, and laboratory
p.001994: testing to improve interagency coordination;
p.001994: (D) coordination to detect and investigate violations under applicable Federal law;
p.001994: (E) a process, including the use or modification of existing processes, by which
p.001994: officers and employees of the National Oceanic and Atmospheric Administration may
p.001994: be duly designated by the Secretary to carry out seafood examinations and
p.001994: investigations under section 381 of this title or section 203 of the Food Allergen
p.001994: Labeling and Consumer Protection Act of 2004;
p.001994: (F) the sharing of information concerning observed non-compliance with United
p.001994: States food requirements domestically and in foreign nations and new regulatory
p.001994: decisions and policies that may affect the safety of food imported into the United
p.001994: States;
p.001994: (G) conducting joint training on subjects that affect and strengthen seafood
p.001994: inspection effectiveness by Federal authorities; and
p.001994: (H) outreach on Federal efforts to enhance seafood safety and compliance with
p.001994: Federal food safety requirements.
p.001994: (d) Coordination
p.001994: The Secretary shall improve coordination and cooperation with the Secretary of
p.001994: Agriculture and the Secretary of Homeland Security to target food inspection resources.
p.001994: (e) Facility
p.001994: For purposes of this section, the term “facility” means a domestic facility or a foreign
p.001994: facility that is required to register under section 350d of this title.
p.001994: (June 25, 1938, ch. 675, §421, as added Pub. L. 111–353, title II, §201(a), Jan. 4, 2011,
p.001994: 124 Stat. 3923.)
p.001994: REFERENCES IN TEXT
p.001994: Section 203 of the Food Allergen Labeling and Consumer Protection Act of 2004, referred to in
p.001994: subsec. (c)(2)(E), is section 203 of Pub. L. 108–282, Aug. 2, 2004, 118 Stat. 906, which amended
p.001994: sections 321, 343, and 343–1 of this title and enacted provisions set out as notes under sections
p.001994: 321 and 343 of this title.
p.001994: CONSTRUCTION
p.001994: Nothing in this section to be construed to apply to certain alcohol-related facilities, to alter
p.001994: jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with
p.001994: international agreements to which the United States is a party, see sections 2206, 2251, and 2252
p.001994: of this title.
p.001994: ADVISORY COMMITTEE CONSULTATION
p.001994: Pub. L. 111–353, title II, §201(c), Jan. 4, 2011, 124 Stat. 3926, provided that: “In allocating
p.001994: inspection resources as described in section 421 of the Federal Food, Drug, and Cosmetic Act [21
p.001994: U.S.C. 450j] (as added by subsection (a)), the Secretary may, as appropriate, consult with any
p.001994: relevant advisory committee within the Department of Health and Human Services.”
p.001994:
p.001994:
p.001994: §350k. Laboratory accreditation for analyses of foods
p.001994: (a) Recognition of laboratory accreditation
p.001994: (1) In general
p.001994: Not later than 2 years after January 4, 2011, the Secretary shall—
p.001994: (A) establish a program for the testing of food by accredited laboratories;
p.001994: (B) establish a publicly available registry of accreditation bodies recognized by the
p.001994: Secretary and laboratories accredited by a recognized accreditation body, including the
p.001994: name of, contact information for, and other information deemed appropriate by the
p.001994: Secretary about such bodies and laboratories; and
p.001994: (C) require, as a condition of recognition or accreditation, as appropriate, that
p.001994: recognized accreditation bodies and accredited laboratories report to the Secretary any
p.001994: changes that would affect the recognition of such accreditation body or the
p.001994: accreditation of such laboratory.
p.001994: (2) Program requirements
p.001994: The program established under paragraph (1)(A) shall provide for the recognition of
p.001994: laboratory accreditation bodies that meet criteria established by the Secretary for
p.001994: accreditation of laboratories, including independent private laboratories and laboratories
...

p.001994: (3) Exception
p.001994: The Secretary may waive requirements under this subsection if—
p.001994: (A) a new methodology or methodologies have been developed and validated but a
p.001994: laboratory has not yet been accredited to perform such methodology or methodologies;
p.001994: and
p.001994: (B) the use of such methodology or methodologies are necessary to prevent, control,
p.001994: or mitigate a food emergency or foodborne illness outbreak.
p.001994: (c) Review by Secretary
p.001994: If food sampling and testing performed by a laboratory run and operated by a State or
p.001994: locality that is accredited by a recognized accreditation body on the registry established by
p.001994: the Secretary under subsection (a) result in a State recalling a food, the Secretary shall
p.001994: review the sampling and testing results for the purpose of determining the need for a
p.001994: national recall or other compliance and enforcement activities.
p.001994: (d) No limit on Secretarial authority
p.001994: Nothing in this section shall be construed to limit the ability of the Secretary to review and
p.001994: act upon information from food testing, including determining the sufficiency of such
p.001994: information and testing.
p.001994: (June 25, 1938, ch. 675, §422, as added Pub. L. 111–353, title II, §202(a), Jan. 4, 2011,
p.001994: 124 Stat. 3926.)
p.001994: CONSTRUCTION
p.001994: Nothing in this section to be construed to apply to certain alcohol-related facilities, to alter
p.001994: jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with
p.001994: international agreements to which the United States is a party, see sections 2206, 2251, and 2252
p.001994: of this title.
p.001994:
p.001994: 1 So in original. Probably should be “subsection”.
p.001994:
p.001994:
p.001994:
p.001994: §350l. Mandatory recall authority
p.001994: (a) Voluntary procedures
p.001994: If the Secretary determines, based on information gathered through the reportable food
p.001994: registry under section 350f of this title or through any other means, that there is a
p.001994: reasonable probability that an article of food (other than infant formula) is adulterated under
p.001994: section 342 of this title or misbranded under section 343(w) of this title and the use of or
p.001994: exposure to such article will cause serious adverse health consequences or death to
p.001994: humans or animals, the Secretary shall provide the responsible party (as defined in section
p.001994: 350f of this title) with an opportunity to cease distribution and recall such article.
p.001994: (b) Prehearing order to cease distribution and give notice
p.001994: (1) In general
p.001994: If the responsible party refuses to or does not voluntarily cease distribution or recall
p.001994: such article within the time and in the manner prescribed by the Secretary (if so
p.001994: prescribed), the Secretary may, by order require, as the Secretary deems necessary,
p.001994: such person to—
p.001994: (A) immediately cease distribution of such article; and
p.001994: (B) as applicable, immediately notify all persons—
p.001994: (i) manufacturing, processing, packing, transporting, distributing, receiving, holding,
p.001994: or importing and selling such article; and
p.001994: (ii) to which such article has been distributed, transported, or sold, to immediately
p.001994: cease distribution of such article.1
p.001994: (2) Required additional information
p.001994: (A) In general
p.001994: If an article of food covered by a recall order issued under paragraph (1)(B) has been
p.001994: distributed to a warehouse-based third party logistics provider without providing such
p.001994: provider sufficient information to know or reasonably determine the precise identity of
p.001994: the article of food covered by a recall order that is in its possession, the notice provided
p.001994: by the responsible party subject to the order issued under paragraph (1)(B) shall
p.001994: include such information as is necessary for the warehouse-based third party logistics
p.001994: provider to identify the food.
p.001994: (B) Rules of construction
p.001994: Nothing in this paragraph shall be construed—
p.001994: (i) to exempt a warehouse-based third party logistics provider from the
p.001994: requirements of this chapter, including the requirements in this section and section
p.001994: 350c of this title; or
p.001994: (ii) to exempt a warehouse-based third party logistics provider from being the
p.001994: subject of a mandatory recall order.
p.001994: (3) Determination to limit areas affected
p.001994: If the Secretary requires a responsible party to cease distribution under paragraph (1)
p.001994: (A) of an article of food identified in subsection (a), the Secretary may limit the size of the
p.001994: geographic area and the markets affected by such cessation if such limitation would not
p.001994: compromise the public health.
p.001994: (c) Hearing on order
p.001994: The Secretary shall provide the responsible party subject to an order under subsection
p.001994: (b) with an opportunity for an informal hearing, to be held as soon as possible, but not later
p.001994: than 2 days after the issuance of the order, on the actions required by the order and on why
p.001994: the article that is the subject of the order should not be recalled.
p.001994: (d) Post-hearing recall order and modification of order
p.001994: (1) Amendment of order
p.001994: If, after providing opportunity for an informal hearing under subsection (c), the
p.001994: Secretary determines that removal of the article from commerce is necessary, the
p.001994: Secretary shall, as appropriate—
p.001994: (A) amend the order to require recall of such article or other appropriate action;
p.001994: (B) specify a timetable in which the recall shall occur;
p.001994: (C) require periodic reports to the Secretary describing the progress of the recall; and
p.001994: (D) provide notice to consumers to whom such article was, or may have been,
p.001994: distributed.
p.001994: (2) Vacating of order
p.001994: If, after such hearing, the Secretary determines that adequate grounds do not exist to
p.001994: continue the actions required by the order, or that such actions should be modified, the
p.001994: Secretary shall vacate the order or modify the order.
p.001994: (e) Rule regarding alcoholic beverages
p.001994: The Secretary shall not initiate a mandatory recall or take any other action under this
p.001994: section with respect to any alcohol beverage until the Secretary has provided the Alcohol
p.001994: and Tobacco Tax and Trade Bureau with a reasonable opportunity to cease distribution and
p.001994: recall such article under the Alcohol and Tobacco Tax and Trade Bureau authority.
p.001994: (f) Cooperation and consultation
...

p.001994: have responsibilities related to the recall of a food or a foodborne illness outbreak
p.001994: associated with a food that is subject to the recall, including notification of the
p.001994: Secretary of Agriculture and the Secretary of Education in the event such recalled food
p.001994: is a commodity intended for use in a child nutrition program (as identified in section
p.001994: 1769f(b) of title 42); and
p.001994: (E) conclude operations at such time as the Secretary determines appropriate.
p.001994: (3) Multiple recalls
p.001994: The Secretary may establish multiple or concurrent incident command operations or
p.001994: similar operations in the event of multiple recalls or foodborne illness outbreaks
p.001994: necessitating such action by the Department of Health and Human Services.
p.001994: (June 25, 1938, ch. 675, §423, as added Pub. L. 111–353, title II, §206(a), Jan. 4, 2011,
p.001994: 124 Stat. 3939.)
p.001994: REFERENCES IN TEXT
p.001994: The Public Health Service Act, referred to in subsec. (i), is act July 1, 1944, ch. 373, 58 Stat.
p.001994: 682, which is classified generally to chapter 6A (§201 et seq.) of Title 42, The Public Health and
p.001994: Welfare. For complete classification of this Act to the Code, see Short Title note set out under
p.001994: section 201 of Title 42 and Tables.
p.001994: CONSTRUCTION
p.001994: Nothing in this section to be construed to alter jurisdiction and authorities established under
p.001994: certain other Acts or in a manner inconsistent with international agreements to which the United
p.001994: States is a party, see sections 2251 and 2252 of this title.
p.001994: SEARCH ENGINE
p.001994: Pub. L. 111–353, title II, §206(b), Jan. 4, 2011, 124 Stat. 3942, provided that: “Not later than 90
p.001994: days after the date of enactment of this Act [Jan. 4, 2011], the Secretary shall modify the Internet
p.001994: Web site of the Food and Drug Administration to include a search engine that—
p.001994: “(1) is consumer-friendly, as determined by the Secretary; and
p.001994: “(2) provides a means by which an individual may locate relevant information regarding
p.001994: each article of food subject to a recall under section 423 of the Federal Food, Drug, and
p.001994: Cosmetic Act [21 U.S.C. 350l] and the status of such recall (such as whether a recall is ongoing
p.001994: or has been completed).”
p.001994:
p.000001: 1
p.000001: So in original. The words “to immediately cease distribution of such article.”
p.000001: probably should follow cl. (ii).
p.000001:
p.000001: 2 So in original. Probably should be “paragraph (1).”
p.000001:
p.000001:
p.000001:
p.000001: §350l–1. Annual report to Congress
p.000001: (1) In general
p.000001: Not later than 2 years after January 4, 2011, and annually thereafter, the Secretary of
p.000001: Health and Human Services (referred to in this section as the “Secretary”) shall submit a
p.000001: report to the Committee on Health, Education, Labor, and Pensions of the Senate and the
p.000001: Committee on Energy and Commerce of the House of Representatives on the use of recall
p.000001: authority under section 350l of this title (as added by subsection (a))1 and any public health
...

p.000001: described in paragraph (1), an opportunity to cease distribution and recall under
p.000001: subsection (a) of section 350l of this title, or a mandatory recall order under subsection
p.000001: (b) of such section;
p.000001: (B) the number of responsible parties, as defined in section 350f of this title, formally
p.000001: given the opportunity to cease distribution of an article of food and recall such article, as
p.000001: described in section 350l(a) of such title;
p.000001: (C) the number of responsible parties described in subparagraph (B) who did not cease
p.000001: distribution of or recall an article of food after given the opportunity to cease distribution
p.000001: or recall under section 350l(a) of this title;
p.000001: (D) the number of recall orders issued under section 350l(b) of this title; and
p.000001: (E) a description of any instances in which there was no testing that confirmed
p.000001: adulteration of an article of food that was the subject of a recall under section 350l(b) of
p.000001: this title or a public health advisory described in paragraph (1).
p.000001: (Pub. L. 111–353, title II, §206(f), Jan. 4, 2011, 124 Stat. 3943.)
p.000001: REFERENCES IN TEXT
p.000001: Subsection (a), referred to in par. (1), means subsec. (a) of section 206 of Pub. L. 111–353.
p.000001: CODIFICATION
p.000001: Section was enacted as part of the FDA Food Safety Modernization Act, and not as part of the
p.000001: Federal Food, Drug, and Cosmetic Act which comprises this chapter.
p.000001: CONSTRUCTION
p.000001: Nothing in this section to be construed to alter jurisdiction and authorities established under
p.000001: certain other Acts or in a manner inconsistent with international agreements to which the United
p.000001: States is a party, see sections 2251 and 2252 of this title.
p.000001:
p.000001: 1 See References in Text note below.
p.000001:
p.000001:
p.000001:
p.000001: SUBCHAPTER V—DRUGS AND DEVICES
p.000001:
p.000001:
p.000001: PART A—DRUGS AND DEVICES
p.000001:
p.000001:
p.000001: §351. Adulterated drugs and devices
p.000001: A drug or device shall be deemed to be adulterated—
p.000001: (a) Poisonous, insanitary, etc., ingredients; adequate controls in manufacture
p.000001: (1) If it consists in whole or in part of any filthy, putrid, or decomposed substance; or (2)
p.000001: (A) if it has been prepared, packed, or held under insanitary conditions whereby it may have
p.000001: been contaminated with filth, or whereby it may have been rendered injurious to health; or
p.000001: (B) if it is a drug and the methods used in, or the facilities or controls used for, its
p.000001: manufacture, processing, packing, or holding do not conform to or are not operated or
p.000001: administered in conformity with current good manufacturing practice to assure that such
p.000001: drug meets the requirements of this chapter as to safety and has the identity and strength,
p.000001: and meets the quality and purity characteristics, which it purports or is represented to
p.000001: possess; or (C) if it is a compounded positron emission tomography drug and the methods
p.000001: used in, or the facilities and controls used for, its compounding, processing, packing, or
p.000001: holding do not conform to or are not operated or administered in conformity with the
p.000001: positron emission tomography compounding standards and the official monographs of the
...

p.000001: under this subsection, the Secretary shall publish it.
p.000001: (3) The approval of an application filed under subsection (b) of this section which contains
p.000001: a certification required by paragraph (2) of such subsection shall be made effective on the
p.000001: last applicable date determined by applying the following to each certification made under
p.000001: subsection (b)(2)(A) of this section:
p.000001: (A) If the applicant only made a certification described in clause (i) or (ii) of subsection
p.000001: (b)(2)(A) of this section or in both such clauses, the approval may be made effective
p.000001: immediately.
p.000001: (B) If the applicant made a certification described in clause (iii) of subsection (b)(2)(A)
p.000001: of this section, the approval may be made effective on the date certified under clause (iii).
p.000001: (C) If the applicant made a certification described in clause (iv) of subsection (b)(2)(A)
p.000001: of this section, the approval shall be made effective immediately unless, before the
p.000001: expiration of 45 days after the date on which the notice described in subsection (b)(3) of
p.000001: this section is received, an action is brought for infringement of the patent that is the
p.000001: subject of the certification and for which information was submitted to the Secretary under
p.000001: paragraph (2) or subsection (b)(1) of this section before the date on which the application
p.000001: (excluding an amendment or supplement to the application) was submitted. If such an
p.000001: action is brought before the expiration of such days, the approval may be made effective
p.000001: upon the expiration of the thirty-month period beginning on the date of the receipt of the
p.000001: notice provided under subsection (b)(3) of this section or such shorter or longer period as
p.000001: the court may order because either party to the action failed to reasonably cooperate in
p.000001: expediting the action, except that—
p.000001: (i) if before the expiration of such period the district court decides that the patent is
p.000001: invalid or not infringed (including any substantive determination that there is no cause
p.000001: of action for patent infringement or invalidity), the approval shall be made effective on—
p.000001: (I) the date on which the court enters judgment reflecting the decision; or
p.000001: (II) the date of a settlement order or consent decree signed and entered by the
p.000001: court stating that the patent that is the subject of the certification is invalid or not
p.000001: infringed;
p.000001:
p.000001: (ii) if before the expiration of such period the district court decides that the patent has
p.000001: been infringed—
p.000001: (I) if the judgment of the district court is appealed, the approval shall be made
p.000001: effective on—
p.000001: (aa) the date on which the court of appeals decides that the patent is invalid or
p.000001: not infringed (including any substantive determination that there is no cause of
p.000001: action for patent infringement or invalidity); or
p.000001: (bb) the date of a settlement order or consent decree signed and entered by the
p.000001: court of appeals stating that the patent that is the subject of the certification is
p.000001: invalid or not infringed; or
p.000001:
p.000001: (II) if the judgment of the district court is not appealed or is affirmed, the approval
p.000001: shall be made effective on the date specified by the district court in a court order
p.000001: under section 271(e)(4)(A) of title 35;
p.000001:
p.000001: (iii) if before the expiration of such period the court grants a preliminary injunction
...

p.000001: the applicant, the Secretary shall approve or disapprove the application.
p.000001: (B) The approval of an application submitted under paragraph (2) shall be made effective
p.000001: on the last applicable date determined by applying the following to each certification made
p.000001: under paragraph (2)(A)(vii):
p.000001: (i) If the applicant only made a certification described in subclause (I) or (II) of
p.000001: paragraph (2)(A)(vii) or in both such subclauses, the approval may be made effective
p.000001: immediately.
p.000001: (ii) If the applicant made a certification described in subclause (III) of paragraph (2)(A)
p.000001: (vii), the approval may be made effective on the date certified under subclause (III).
p.000001: (iii) If the applicant made a certification described in subclause (IV) of paragraph (2)(A)
p.000001: (vii), the approval shall be made effective immediately unless, before the expiration of 45
p.000001: days after the date on which the notice described in paragraph (2)(B) is received, an
p.000001: action is brought for infringement of the patent that is the subject of the certification and
p.000001: for which information was submitted to the Secretary under subsection (b)(1) or (c)(2) of
p.000001: this section before the date on which the application (excluding an amendment or
p.000001: supplement to the application), which the Secretary later determines to be substantially
p.000001: complete, was submitted. If such an action is brought before the expiration of such days,
p.000001: the approval shall be made effective upon the expiration of the thirty-month period
p.000001: beginning on the date of the receipt of the notice provided under paragraph (2)(B)(i) or
p.000001: such shorter or longer period as the court may order because either party to the action
p.000001: failed to reasonably cooperate in expediting the action, except that—
p.000001: (I) if before the expiration of such period the district court decides that the patent is
p.000001: invalid or not infringed (including any substantive determination that there is no cause
p.000001: of action for patent infringement or invalidity), the approval shall be made effective on—
p.000001: (aa) the date on which the court enters judgment reflecting the decision; or
p.000001: (bb) the date of a settlement order or consent decree signed and entered by the
p.000001: court stating that the patent that is the subject of the certification is invalid or not
p.000001: infringed;
p.000001:
p.000001: (II) if before the expiration of such period the district court decides that the patent
p.000001: has been infringed—
p.000001: (aa) if the judgment of the district court is appealed, the approval shall be made
p.000001: effective on—
p.000001: (AA) the date on which the court of appeals decides that the patent is invalid or
p.000001: not infringed (including any substantive determination that there is no cause of
p.000001: action for patent infringement or invalidity); or
p.000001: (BB) the date of a settlement order or consent decree signed and entered by the
p.000001: court of appeals stating that the patent that is the subject of the certification is
p.000001: invalid or not infringed; or
p.000001:
p.000001: (bb) if the judgment of the district court is not appealed or is affirmed, the approval
p.000001: shall be made effective on the date specified by the district court in a court order
p.000001: under section 271(e)(4)(A) of title 35;
p.000001:
p.000001: (III) if before the expiration of such period the court grants a preliminary injunction
...

p.000001: submitted with the primary purpose of delaying the approval of an application and the
p.000001: petition does not on its face raise valid scientific or regulatory issues, the Secretary
p.000001: may deny the petition at any point based on such determination. The Secretary may
p.000001: issue guidance to describe the factors that will be used to determine under this
p.000001: subparagraph whether a petition is submitted with the primary purpose of delaying the
p.000001: approval of an application.
p.000001: (F) Final agency action
p.000001: The Secretary shall take final agency action on a petition not later than 180 days
p.000001: after the date on which the petition is submitted. The Secretary shall not extend such
p.000001: period for any reason, including—
p.000001: (i) any determination made under subparagraph (A);
p.000001: (ii) the submission of comments relating to the petition or supplemental information
p.000001: supplied by the petitioner; or
p.000001: (iii) the consent of the petitioner.
p.000001: (G) Extension of 30-month period
p.000001: If the filing of an application resulted in first-applicant status under subsection (j)(5)
p.000001: (D)(i)(IV) and approval of the application was delayed because of a petition, the 30-
p.000001: month period under such subsection is deemed to be extended by a period of time
p.000001: equal to the period beginning on the date on which the Secretary received the petition
p.000001: and ending on the date of final agency action on the petition (inclusive of such
p.000001: beginning and ending dates), without regard to whether the Secretary grants, in whole
p.000001: or in part, or denies, in whole or in part, the petition.
p.000001: (H) Certification
p.000001: The Secretary shall not consider a petition for review unless the party submitting
p.000001: such petition does so in written form and the subject document is signed and contains
p.000001: the following certification: “I certify that, to my best knowledge and belief: (a) this
p.000001: petition includes all information and views upon which the petition relies; (b) this petition
p.000001: includes representative data and/or information known to the petitioner which are
p.000001: unfavorable to the petition; and (c) I have taken reasonable steps to ensure that any
p.000001: representative data and/or information which are unfavorable to the petition were
p.000001: disclosed to me. I further certify that the information upon which I have based the
p.000001: action requested herein first became known to the party on whose behalf this petition is
p.000001: submitted on or about the following date: ____________________. If I received or
p.000001: expect to receive payments, including cash and other forms of consideration, to file this
p.000001: information or its contents, I received or expect to receive those payments from the
p.000001: following persons or organizations: __________________________. I verify under
p.000001: penalty of perjury that the foregoing is true and correct as of the date of the submission
p.000001: of this petition.”, with the date on which such information first became known to such
p.000001: party and the names of such persons or organizations inserted in the first and second
p.000001: blank space, respectively.
p.000001: (I) Verification
p.000001: The Secretary shall not accept for review any supplemental information or comments
p.000001: on a petition unless the party submitting such information or comments does so in
p.000001: written form and the subject document is signed and contains the following verification:
p.000001: “I certify that, to my best knowledge and belief: (a) I have not intentionally delayed
p.000001: submission of this document or its contents; and (b) the information upon which I have
p.000001: based the action requested herein first became known to me on or about
p.000001: ____________________. If I received or expect to receive payments, including cash
p.000001: and other forms of consideration, to file this information or its contents, I received or
p.000001: expect to receive those payments from the following persons or organizations:
p.000001: __________. I verify under penalty of perjury that the foregoing is true and correct as of
p.000001: the date of the submission of this petition.”, with the date on which such information first
p.000001: became known to the party and the names of such persons or organizations inserted in
p.000001: the first and second blank space, respectively.
p.000001: (2) Exhaustion of administrative remedies
p.000001: (A) Final agency action within 180 days
p.000001: The Secretary shall be considered to have taken final agency action on a petition if—
p.000001: (i) during the 180-day period referred to in paragraph (1)(F), the Secretary makes
p.000001: a final decision within the meaning of section 10.45(d) of title 21, Code of Federal
p.000001: Regulations (or any successor regulation); or
p.000001: (ii) such period expires without the Secretary having made such a final decision.
p.000001: (B) Dismissal of certain civil actions
p.000001: If a civil action is filed against the Secretary with respect to any issue raised in the
p.000001: petition before the Secretary has taken final agency action on the petition within the
p.000001: meaning of subparagraph (A), the court shall dismiss without prejudice the action for
p.000001: failure to exhaust administrative remedies.
p.000001: (C) Administrative record
p.000001: For purposes of judicial review related to the approval of an application for which a
p.000001: petition under paragraph (1) was submitted, the administrative record regarding any
p.000001: issue raised by the petition shall include—
p.000001: (i) the petition filed under paragraph (1) and any supplements and comments
p.000001: thereto;
p.000001: (ii) the Secretary's response to such petition, if issued; and
p.000001: (iii) other information, as designated by the Secretary, related to the Secretary's
p.000001: determinations regarding the issues raised in such petition, as long as the
p.000001: information was considered by the agency no later than the date of final agency
p.000001: action as defined under subparagraph (2)(A), and regardless of whether the
...

p.000001: Pub. L. 108–173, title XI, §1103(b), Dec. 8, 2003, 117 Stat. 2461, provided that: “The
p.000001: amendment made by subsection (a) [amending this section] does not alter the standards for
p.000001: approval of drugs under section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
p.000001: 355(j)).”
p.000001: FEDERAL TRADE COMMISSION REVIEW
p.000001: Pub. L. 108–173, title XI, subtitle B, Dec. 8, 2003, 117 Stat. 2461, provided that:
p.000001: “SEC. 1111. DEFINITIONS.
p.000001: “In this subtitle:
p.000001: “(1) ANDA.—The term ‘ANDA’ means an abbreviated drug application, as defined under
p.000001: section 201(aa) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 321(aa)].
p.000001: “(2) ASSISTANT ATTORNEY GENERAL .—The term ‘Assistant Attorney General’ means the
p.000001: Assistant Attorney General in charge of the Antitrust Division of the Department of Justice.
p.000001: “(3) BRAND NAME DRUG.—The term ‘brand name drug’ means a drug for which an application
p.000001: is approved under section 505(c) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C.
p.000001: 355(c)], including an application referred to in section 505(b)(2) of such Act [21 U.S.C. 355(b)
p.000001: (2)].
p.000001: “(4) BRAND NAME DRUG COMPANY.—The term ‘brand name drug company’ means the party
p.000001: that holds the approved application referred to in paragraph (3) for a brand name drug that is a
p.000001: listed drug in an ANDA, or a party that is the owner of a patent for which information is
p.000001: submitted for such drug under subsection (b) or (c) of section 505 of the Federal Food, Drug,
p.000001: and Cosmetic Act [21 U.S.C. 355(b), (c)].
p.000001: “(5) COMMISSION.—The term ‘Commission’ means the Federal Trade Commission.
p.000001: “(6) GENERIC DRUG.—The term ‘generic drug’ means a drug for which an application under
p.000001: section 505(j) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(j)] is approved.
p.000001: “(7) GENERIC DRUG APPLICANT.—The term ‘generic drug applicant’ means a person who has
p.000001: filed or received approval for an ANDA under section 505(j) of the Federal Food, Drug, and
p.000001: Cosmetic Act [21 U.S.C. 355(j)].
p.000001: “(8) LISTED DRUG.—The term ‘listed drug’ means a brand name drug that is listed under
p.000001: section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355(j)(7)].
p.000001: “SEC. 1112. NOTIFICATION OF AGREEMENTS.
p.000001: “(a) AGREEMENT WITH BRAND NAME DRUG COMPANY.—
...

p.000001: (B) when required by the strategy, as provided for in such timetable under subsection
p.000001: (d);
p.000001: (C) within a time period to be determined by the Secretary, if the Secretary, in
p.000001: consultation with the offices described in subsection (c)(2), determines that new safety
p.000001: or effectiveness information indicates that—
p.000001: (i) an element under subsection (d) or (e) should be modified or included in the
p.000001: strategy; or
p.000001: (ii) an element under subsection (f) should be modified or included in the strategy;
p.000001: or
p.000001:
p.000001: (D) within 15 days when ordered by the Secretary, in consultation with the offices
p.000001: described in subsection (c)(2), if the Secretary determines that there may be a cause
p.000001: for action by the Secretary under section 355(e) of this title.
p.000001: (3) Requirements for assessments
p.000001: An assessment under paragraph (1) or (2) of an approved risk evaluation and
p.000001: mitigation strategy for a drug shall include—
p.000001: (A) with respect to any goal under subsection (f), an assessment of the extent to
p.000001: which the elements to assure safe use are meeting the goal or whether the goal or
p.000001: such elements should be modified;
p.000001: (B) with respect to any postapproval study required under section 355(o) of this title
p.000001: or otherwise undertaken by the responsible person to investigate a safety issue, the
p.000001: status of such study, including whether any difficulties completing the study have been
p.000001: encountered; and
p.000001: (C) with respect to any postapproval clinical trial required under section 355(o) of this
p.000001: title or otherwise undertaken by the responsible party to investigate a safety issue, the
p.000001: status of such clinical trial, including whether enrollment has begun, the number of
p.000001: participants enrolled, the expected completion date, whether any difficulties completing
p.000001: the clinical trial have been encountered, and registration information with respect to
p.000001: requirements under subsections (i) and (j) of section 282 of title 42.
p.000001: (4) Modification
p.000001: A modification (whether an enhancement or a reduction) to the approved risk
p.000001: evaluation and mitigation strategy for a drug may include the addition or modification of
p.000001: any element under subsection (d) or the addition, modification, or removal of any element
p.000001: under subsection (e) or (f), such as—
p.000001: (A) modifying the timetable for assessments of the strategy as provided in subsection
p.000001: (d)(3), including to eliminate assessments; or
p.000001: (B) adding, modifying, or removing an element to assure safe use under subsection
p.000001: (f).
p.000001: (h) Review of proposed strategies; review of assessments of approved strategies
p.000001: (1) In general
p.000001: The Secretary, in consultation with the offices described in subsection (c)(2), shall
p.000001: promptly review each proposed risk evaluation and mitigation strategy for a drug
p.000001: submitted under subsection (a) and each assessment of an approved risk evaluation and
p.000001: mitigation strategy for a drug submitted under subsection (g).
p.000001: (2) Discussion
...

p.000001: expedited review would help to avoid or mitigate existing or potential drug shortages. In prioritizing
p.000001: and allocating its limited resources, the FDA should consider both the severity of the shortage and
p.000001: the importance of the affected drug to public health.
p.000001: SEC. 4. Review of Certain Behaviors by Market Participants. The FDA shall communicate to the
p.000001: Department of Justice (DOJ) any findings that shortages have led market participants to stockpile
p.000001: the affected drugs or sell them at exorbitant prices. The DOJ shall then determine whether these
p.000001: activities are consistent with applicable law. Based on its determination, DOJ, in coordination with
p.000001: other State and Federal regulatory agencies as appropriate, should undertake whatever
p.000001: enforcement actions, if any, it deems appropriate.
p.000001: SEC. 5. General Provisions. (a) Nothing in this order shall be construed to impair or otherwise
p.000001: affect:
p.000001: (i) authority granted by law to an agency, or the head thereof; or
p.000001: (ii) functions of the Director of the Office of Management and Budget relating to budgetary,
p.000001: administrative, or legislative proposals.
p.000001: (b) This order shall be implemented consistent with applicable law and subject to the availability
p.000001: of appropriations.
p.000001: (c) This order is not intended to, and does not, create any right or benefit, substantive or
p.000001: procedural, enforceable at law or in equity by any party against the United States, its departments,
p.000001: agencies, or entities, its officers, employees, or agents, or any other person.
p.000001: BARACK OBAMA.
p.000001:
p.000001:
p.000001:
p.000001: §357. Repealed. Pub. L. 105–115, title I, §125(b)(1), Nov. 21, 1997, 111
p.000001: Stat. 2325
p.000001: Section, act June 25, 1938, ch. 675, §507, as added July 6, 1945, ch. 281, §3, 59 Stat. 463;
p.000001: amended Mar. 10, 1947, ch. 16, §3, 61 Stat. 12; July 13, 1949, ch. 305, §2, 63 Stat. 409; Aug. 5,
p.000001: 1953, ch. 334, §2, 67 Stat. 389; Pub. L. 87–781, title I, §§105(a), (b), (d)–(f), 106(a), (b), Oct. 10,
p.000001: 1962, 76 Stat. 785, 786, 787; Pub. L. 90–399, §105(b), July 13, 1968, 82 Stat. 352; Pub. L. 102–
p.000001: 300, §6(b)(2), June 16, 1992, 106 Stat. 240; Pub. L. 103–80, §3(p), Aug. 13, 1993, 107 Stat. 777,
p.000001: related to certification of drugs containing penicillin, streptomycin, chlortetracycline,
p.000001: chloramphenicol, bacitracin, or any other antibiotic drug.
p.000001:
p.000001:
p.000001: §358. Authority to designate official names
p.000001: (a) Necessity or desirability; use in official compendiums; infringement of trademarks
p.000001: The Secretary may designate an official name for any drug or device if he determines that
p.000001: such action is necessary or desirable in the interest of usefulness and simplicity. Any official
p.000001: name designated under this section for any drug or device shall be the only official name of
p.000001: that drug or device used in any official compendium published after such name has been
...

p.001962: approval of such application for such drug.
p.001962: (C) Within 180 days of the initial receipt of an application under subsection (b)(2) of this
p.001962: section or within such additional period as may be agreed upon by the Secretary and the
p.001962: applicant, the Secretary shall approve or disapprove the application.
p.001962: (D) The approval of an application filed under subsection (b)(2) of this section shall be
p.001962: made effective on the last applicable date determined under the following:
p.001962: (i) If the applicant only made a certification described in clause (i) or (ii) of subsection
p.001962: (n)(1)(G) of this section or in both such clauses, the approval may be made effective
p.001962: immediately.
p.001962: (ii) If the applicant made a certification described in clause (iii) of subsection (n)(1)(G)
p.001962: of this section, the approval may be made effective on the date certified under clause (iii).
p.001962: (iii) If the applicant made a certification described in clause (iv) of subsection (n)(1)(G)
p.001962: of this section, the approval shall be made effective immediately unless an action is
p.001962: brought for infringement of a patent which is the subject of the certification before the
p.001962: expiration of 45 days from the date the notice provided under subsection (n)(2)(B)(i) of
p.001962: this section is received. If such an action is brought before the expiration of such days,
p.001962: the approval shall be made effective upon the expiration of the 30 month period
p.001962: beginning on the date of the receipt of the notice provided under subsection (n)(2)(B) of
p.001962: this section or such shorter or longer period as the court may order because either party
p.001962: to the action failed to reasonably cooperate in expediting the action, except that if before
p.001962: the expiration of such period—
p.001962: (I) the court decides that such patent is invalid or not infringed, the approval shall be
p.001962: made effective on the date of the court decision,
p.001962: (II) the court decides that such patent has been infringed, the approval shall be made
p.001962: effective on such date as the court orders under section 271(e)(4)(A) of title 35, or
p.001962: (III) the court grants a preliminary injunction prohibiting the applicant from engaging
p.001962: in the commercial manufacture or sale of the drug until the court decides the issues of
p.001962: patent validity and infringement and if the court decides that such patent is invalid or
p.001962: not infringed, the approval shall be made effective on the date of such court decision.
p.001962: In such an action, each of the parties shall reasonably cooperate in expediting the action.
p.001962: Until the expiration of 45 days from the date the notice made under subsection (n)(2)(B)
p.001962: of this section is received, no action may be brought under section 2201 of title 28 for a
p.001962: declaratory judgment with respect to the patent. Any action brought under section 2201 of
p.001962: title 28 shall be brought in the judicial district where the defendant has its principal place
p.001962: of business or a regular and established place of business.
p.001962: (iv) If the application contains a certification described in clause (iv) of subsection (n)(1)
p.001962: (G) of this section and is for a drug for which a previous application has been filed under
p.001962: this subsection containing such a certification, the application shall be made effective not
p.001962: earlier than 180 days after—
...

p.001962: such device has been in the possession of the device user for one year or more—
p.001962: (i) at the time of notification ordered under subsection (a) of this section, or
p.001962: (ii) at the time the device user receives actual notice of the unreasonable risk with
p.001962: respect to which the order was issued under paragraph (1),
p.001962:
p.001962: whichever first occurs).
p.001962:
p.001962: (3) No charge shall be made to any person (other than a manufacturer, importer,
p.001962: distributor or retailer) for availing himself of any remedy, described in paragraph (2) and
p.001962: provided under an order issued under paragraph (1), and the person subject to the order
p.001962: shall reimburse each person (other than a manufacturer, importer, distributor, or retailer)
p.001962: who is entitled to such a remedy for any reasonable and foreseeable expenses actually
p.001962: incurred by such person in availing himself of such remedy.
p.001962: (c) Reimbursement
p.001962: An order issued under subsection (b) of this section with respect to a device may require
p.001962: any person who is a manufacturer, importer, distributor, or retailer of the device to
p.001962: reimburse any other person who is a manufacturer, importer, distributor, or retailer of such
p.001962: device for such other person's expenses actually incurred in connection with carrying out
p.001962: the order if the Secretary determines such reimbursement is required for the protection of
p.001962: the public health. Any such requirement shall not affect any rights or obligations under any
p.001962: contract to which the person receiving reimbursement or the person making such
p.001962: reimbursement is a party.
p.001962: (d) Effect on other liability
p.001962: Compliance with an order issued under this section shall not relieve any person from
p.001962: liability under Federal or State law. In awarding damages for economic loss in an action
p.001962: brought for the enforcement of any such liability, the value to the plaintiff in such action of
p.001962: any remedy provided him under such order shall be taken into account.
p.001962: (e) Recall authority
p.001962: (1) If the Secretary finds that there is a reasonable probability that a device intended for
p.001962: human use would cause serious, adverse health consequences or death, the Secretary
p.001962: shall issue an order requiring the appropriate person (including the manufacturers,
p.001962: importers, distributors, or retailers of the device)—
p.001962: (A) to immediately cease distribution of such device, and
p.001962: (B) to immediately notify health professionals and device user facilities of the order and
p.001962: to instruct such professionals and facilities to cease use of such device.
p.001962:
p.001962: The order shall provide the person subject to the order with an opportunity for an informal
p.001962: hearing, to be held not later than 10 days after the date of the issuance of the order, on the
p.001962: actions required by the order and on whether the order should be amended to require a
p.001962: recall of such device. If, after providing an opportunity for such a hearing, the Secretary
p.001962: determines that inadequate grounds exist to support the actions required by the order, the
p.001962: Secretary shall vacate the order.
p.001962: (2)(A) If, after providing an opportunity for an informal hearing under paragraph (1), the
p.001962: Secretary determines that the order should be amended to include a recall of the device
...

p.001962: were reasonable grounds for the failure to adduce such evidence in the proceeding before
p.001962: the Secretary, the court may order such additional evidence (and evidence in rebuttal
p.001962: thereof) to be taken before the Secretary, and to be adduced upon the hearing, in such
p.001962: manner and upon such terms and conditions as to the court may seem proper. The
p.001962: Secretary may modify his findings, or make new findings, by reason of the additional
p.001962: evidence so taken, and he shall file such modified or new findings, and his
p.001962: recommendations, if any, for the modification or setting aside of his original regulation, with
p.001962: the return of such additional evidence.
p.001962: (3) Upon the filing of the petition referred to in paragraph (1) of this subsection, the court
p.001962: shall have jurisdiction to review the regulation in accordance with chapter 7 of title 5 and to
p.001962: grant appropriate relief as provided in such chapter.
p.001962: (4) The judgment of the court affirming or setting aside, in whole or in part, any such
p.001962: regulation of the Secretary shall be final, subject to review by the Supreme Court of the
p.001962: United States upon certiorari or certification as provided in section 1254 of title 28.
p.001962: (5) Any action instituted under this subsection shall survive, notwithstanding any change
p.001962: in the person occupying the office of Secretary or any vacancy in such office.
p.001962: (6) The remedies provided for in this subsection shall be in addition to and not in
p.001962: substitution for any other remedies provided by law.
p.001962: (e) Availability of record
p.001962: A certified copy of the transcript of the record and administrative proceedings under this
p.001962: section shall be furnished by the Secretary to any interested party at his request, and
p.001962: payment of the costs thereof, and shall be admissible in any criminal, exclusion of imports,
p.001962: or other proceeding arising under or in respect of this part irrespective of whether
p.001962: proceedings with respect to the regulation have previously been initiated or become final
p.001962: under this section.
p.001962: (f) Technical Electronic Product Radiation Safety Standards Committee
p.001962: (1)(A) The Secretary shall establish a Technical Electronic Product Radiation Safety
p.001962: Standards Committee (hereafter in this part referred to as the “Committee”) which he shall
p.001962: consult before prescribing any standard under this section. The Committee shall be
p.001962: appointed by the Secretary, after consultation with public and private agencies concerned
p.001962: with the technical aspect of electronic product radiation safety, and shall be composed of
p.001962: fifteen members each of whom shall be technically qualified by training and experience in
p.001962: one or more fields of science or engineering applicable to electronic product radiation
p.001962: safety, as follows:
p.001962: (i) Five members shall be selected from governmental agencies, including State and
p.001962: Federal Governments;
p.001962: (ii) Five members shall be selected from the affected industries after consultation with
p.001962: industry representatives; and
p.001962: (iii) Five members shall be selected from the general public, of which at least one shall
p.001962: be a representative of organized labor.
p.001962:
p.001962: (B) The Committee may propose electronic product radiation safety standards to the
p.001962: Secretary for his consideration. All proceedings of the Committee shall be recorded and the
p.001962: record of each such proceeding shall be available for public inspection.
...

p.000398: Secretary may modify his findings as to the facts, or make new findings, by reason of the
p.000398: additional evidence so taken, and he shall file such modified or new findings, and his
p.000398: recommendation, if any, for the modification or setting aside of his original order, with the
p.000398: return of such additional evidence.
p.000398: (3) Upon the filing of the petition referred to in paragraph (1) of this subsection, the court
p.000398: shall have jurisdiction to affirm the order, or to set it aside in whole or in part, temporarily or
p.000398: permanently. If the order of the Secretary refuses to issue, amend, or repeal a regulation
p.000398: and such order is not in accordance with law the court shall by its judgment order the
p.000398: Secretary to take action, with respect to such regulation, in accordance with law. The
p.000398: findings of the Secretary as to the facts, if supported by substantial evidence, shall be
p.000398: conclusive.
p.000398: (4) The judgment of the court affirming or setting aside, in whole or in part, any such
p.000398: order of the Secretary shall be final, subject to review by the Supreme Court of the United
p.000398: States upon certiorari or certification as provided in section 1254 of title 28.
p.000398: (5) Any action instituted under this subsection shall survive notwithstanding any change in
p.000398: the person occupying the office of Secretary or any vacancy in such office.
p.000398: (6) The remedies provided for in this subsection shall be in addition to and not in
p.000398: substitution for any other remedies provided by law.
p.000398: (g) Copies of records of hearings
p.000398: A certified copy of the transcript of the record and proceedings under subsection (e) of
p.000398: this section shall be furnished by the Secretary to any interested party at his request, and
p.000398: payment of the costs thereof, and shall be admissible in any criminal, libel for
p.000398: condemnation, exclusion of imports, or other proceeding arising under or in respect to this
p.000398: chapter, irrespective of whether proceedings with respect to the order have previously been
p.000398: instituted or become final under subsection (f) of this section.
p.000398: (h) Guidance documents
p.000398: (1)(A) The Secretary shall develop guidance documents with public participation and
p.000398: ensure that information identifying the existence of such documents and the documents
p.000398: themselves are made available to the public both in written form and, as feasible, through
p.000398: electronic means. Such documents shall not create or confer any rights for or on any
p.000398: person, although they present the views of the Secretary on matters under the jurisdiction
p.000398: of the Food and Drug Administration.
p.000398: (B) Although guidance documents shall not be binding on the Secretary, the Secretary
p.000398: shall ensure that employees of the Food and Drug Administration do not deviate from such
p.000398: guidances without appropriate justification and supervisory concurrence. The Secretary
p.000398: shall provide training to employees in how to develop and use guidance documents and
p.000398: shall monitor the development and issuance of such documents.
p.000398: (C) For guidance documents that set forth initial interpretations of a statute or regulation,
...

p.000398: (12) No later than four years after October 26, 2002, the Comptroller General shall report
p.000398: to the Committee on Energy and Commerce of the House of Representatives and the
p.000398: Committee on Health, Education, Labor and Pensions of the Senate—
p.000398: (A) the number of inspections conducted by accredited persons pursuant to this
p.000398: subsection and the number of inspections conducted by Federal employees pursuant to
p.000398: section 360(h) of this title and of device establishments required to register under section
p.000398: 360(i) of this title;
p.000398: (B) the number of persons who sought accreditation under this subsection, as well as
p.000398: the number of persons who were accredited under this subsection;
p.000398: (C) the reasons why persons who sought accreditation, but were denied accreditation,
p.000398: were denied;
p.000398: (D) the number of audits conducted by the Secretary of accredited persons, the quality
p.000398: of inspections conducted by accredited persons, whether accredited persons are meeting
p.000398: their obligations under this chapter, and whether the number of audits conducted is
p.000398: sufficient to permit these assessments;
p.000398: (E) whether this subsection is achieving the goal of ensuring more information about
p.000398: device establishment compliance is being presented to the Secretary, and whether that
p.000398: information is of a quality consistent with information obtained by the Secretary pursuant
p.000398: to inspections conducted by Federal employees;
p.000398: (F) whether this subsection is advancing efforts to allow device establishments to rely
p.000398: upon third-party inspections for purposes of compliance with the laws of foreign
p.000398: governments; and
p.000398: (G) whether the Congress should continue, modify, or terminate the program under this
p.000398: subsection.
p.000398:
p.000398: (13) The Secretary shall include in the annual report required under section 393(g) of this
p.000398: title the names of all accredited persons and the particular activities under this subsection
p.000398: for which each such person is accredited and the name of each accredited person whose
p.000398: accreditation has been withdrawn during the year.
p.000398: (14) Notwithstanding any provision of this subsection, this subsection does not have any
p.000398: legal effect on any agreement described in section 383(b) of this title between the Secretary
p.000398: and a foreign country.
p.000398: (June 25, 1938, ch. 675, §704, 52 Stat. 1057; Aug. 7, 1953, ch. 350, §1, 67 Stat. 476; Pub.
p.000398: L. 87–781, title II, §201(a), (b), Oct. 10, 1962, 76 Stat. 792, 793; Pub. L. 94–295, §6, May
p.000398: 28, 1976, 90 Stat. 581; Pub. L. 96–359, §4, Sept. 26, 1980, 94 Stat. 1193; Pub. L. 103–80,
p.000398: §3(aa), Aug. 13, 1993, 107 Stat. 778; Pub. L. 105–115, title I, §125(b)(2)(L), title II, §210(b),
p.000398: title IV, §412(b), Nov. 21, 1997, 111 Stat. 2326, 2344, 2375; Pub. L. 107–188, title III,
p.000398: §306(b), June 12, 2002, 116 Stat. 670; Pub. L. 107–250, title II, §201(a), (b), Oct. 26, 2002,
p.000398: 116 Stat. 1602, 1609; Pub. L. 108–214, §2(b)(1), Apr. 1, 2004, 118 Stat. 573; Pub. L. 110–
p.000398: 85, title II, §228, Sept. 27, 2007, 121 Stat. 855; Pub. L. 111–31, div. A, title I, §103(i), June
p.000398: 22, 2009, 123 Stat. 1837; Pub. L. 111–353, title I, §101(b), Jan. 4, 2011, 124 Stat. 3887.)
p.000398: AMENDMENTS
p.000398: 2011—Subsec. (a)(1). Pub. L. 111–353, which directed the amendment of subsec. (a)(1)(B) by
...

p.000398: pars. (1) to (4), and struck out “are held” before “after such introduction”.
p.000398: Subsec. (b). Pub. L. 87–781, §201(b), inserted “consulting laboratory” after “warehouse”.
p.000398: 1953—Act Aug. 7, 1953, designated existing provisions as subsec. (a) and amended them by
p.000398: substituting provisions permitting entry and inspection upon presentation of appropriate
p.000398: credentials and a written notice to the owner, operator, or agent in charge for provisions which
p.000398: authorized entry and inspection only after making a request and obtaining permission from the
p.000398: owner, operator, or custodian, and inserting provisions requiring a separate written notice for each
p.000398: inspection but not for each entry made during the period covered by the inspection, and directing
p.000398: that the inspection shall be conducted within reasonable limits, in a reasonable manner and
p.000398: completed with reasonable promptness, and added subsecs. (b) to (d).
p.000398: EFFECTIVE DATE OF 1997 AMENDMENT
p.000398: Amendment by sections 210(b) and 412(b) of Pub. L. 105–115 effective 90 days after Nov. 21,
p.000398: 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as a note under
p.000398: section 321 of this title.
p.000398: EFFECTIVE DATE OF 1962 AMENDMENT
p.000398: Amendment by Pub. L. 87–781 effective Oct. 10, 1962, see section 203 of Pub. L. 87–781, set
p.000398: out as a note under section 332 of this title.
p.000398: CONSTRUCTION OF 2011 AMENDMENT
p.000398: Nothing in amendment by Pub. L. 111–353 to be construed to apply to certain alcohol-related
p.000398: facilities, to alter jurisdiction and authorities established under certain other Acts, or in a manner
p.000398: inconsistent with international agreements to which the United States is a party, see sections
p.000398: 2206, 2251, and 2252 of this title.
p.000398: TRANSFER OF FUNCTIONS
p.000398: For transfer of functions of Federal Security Administrator to Secretary of Health, Education,
p.000398: and Welfare [now Health and Human Services], and of Food and Drug Administration in the
p.000398: Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this
p.000398: title.
p.000398: AUTHORITY OF SECRETARY PRIOR TO OCTOBER 10, 1962
p.000398: Section 201(d) of Pub. L. 87–781 provided that: “Nothing in the amendments made by
p.000398: subsections (a) and (b) of this section [amending this section] shall be construed to negate or
p.000398: derogate from any authority of the Secretary existing prior to the enactment of this Act [Oct. 10,
p.000398: 1962].”
p.000398:
p.000398:
p.000398: §374a. Inspections relating to food allergens
p.000398: The Secretary of Health and Human Services shall conduct inspections consistent with
p.000398: the authority under section 374 of this title of facilities in which foods are manufactured,
p.000398: processed, packed, or held—
p.000398: (1) to ensure that the entities operating the facilities comply with practices to reduce or
p.000398: eliminate cross-contact of a food with residues of major food allergens that are not
p.000398: intentional ingredients of the food; and
p.000398: (2) to ensure that major food allergens are properly labeled on foods.
p.000398: (Pub. L. 108–282, title II, §205, Aug. 2, 2004, 118 Stat. 909.)
p.000398: CODIFICATION
...

p.000398: Food and Drug Administration, advisory committees, and costs related to such officers,
p.000398: employees, and committees and to contracts with such contractors,
p.000398: (B) management of information, and the acquisition, maintenance, and repair of
p.000398: computer resources,
p.000398: (C) leasing, maintenance, renovation, and repair of facilities and acquisition,
p.000398: maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary
p.000398: materials and supplies, and
p.000398: (D) collecting fees under section 379h of this title and accounting for resources
p.000398: allocated for the review of human drug applications and supplements.
p.000398:
p.000398: (8) The term “adjustment factor” applicable to a fiscal year is the Consumer Price Index
p.000398: for all urban consumers (all items; United States city average) for October of the
p.000398: preceding fiscal year divided by such Index for October 1996.
p.000398: (9) The term “person” includes an affiliate thereof.
p.000398: (10) The term “active”, with respect to a commercial investigational new drug
p.000398: application, means such an application to which information was submitted during the
p.000398: relevant period.
p.000398: (11) The term “affiliate” means a business entity that has a relationship with a second
p.000398: business entity if, directly or indirectly—
p.000398: (A) one business entity controls, or has the power to control, the other business
p.000398: entity; or
p.000398: (B) a third party controls, or has power to control, both of the business entities.
p.000398: (June 25, 1938, ch. 675, §735, as added Pub. L. 102–571, title I, §103, Oct. 29, 1992, 106
p.000398: Stat. 4491; amended Pub. L. 105–115, title I, §§102, 125(b)(2)(M), Nov. 21, 1997, 111 Stat.
p.000398: 2298, 2326; Pub. L. 107–188, title V, §503, June 12, 2002, 116 Stat. 688; Pub. L. 110–85,
p.000398: title I, §102, Sept. 27, 2007, 121 Stat. 825; Pub. L. 111–148, title VII, §7002(f)(3)(A), Mar.
p.000398: 23, 2010, 124 Stat. 818.)
p.000398: AMENDMENT OF SECTION
p.000398: For termination of amendment by section 106(a) of Pub. L. 110–85, see Effective and
p.000398: Termination Dates of 2007 Amendment note below.
p.000398: For termination of amendment by section 509 of Pub. L. 107–188, see Effective and
p.000398: Termination Dates of 2002 Amendment note below.
p.000398: For termination of amendment by section 107 of Pub. L. 105–115, see Effective and
p.000398: Termination Dates of 1997 Amendment note below.
p.000398: TERMINATION OF SECTION
p.000398: For termination of section by section 105 of Pub. L. 102–571, see Termination Date note
p.000398: below.
p.000398: AMENDMENTS
p.000398: 2010—Par. (1)(B). Pub. L. 111–148 substituted “subsection (a) or (k) of section 262 of title 42”
p.000398: for “section 262 of title 42”.
p.000398: 2007—Pub. L. 110–85, §§102(1), 106(a), in introductory provisions, temporarily substituted “For
p.000398: purposes of this subpart” for “For purposes of this part”. See Effective and Termination Dates of
p.000398: 2007 Amendment note below.
p.000398: Par. (1). Pub. L. 110–85, §§102(2)(D), 106(a), temporarily substituted “subparagraph (B)” for
p.000398: “subparagraph (C)” in concluding provisions. See Effective and Termination Dates of 2007
p.000398: Amendment note below.
p.000398: Par. (1)(A). Pub. L. 110–85, §§102(2)(A), 106(a), temporarily substituted “355(b) of this title, or”
...

p.000398: and their suggestions for changes to this subpart as expressed under paragraph (2).
p.000398: (4) Public review of recommendations
p.000398: After negotiations with the regulated industry, the Secretary shall—
p.000398: (A) present the recommendations developed under paragraph (1) to the
p.000398: Congressional committees specified in such paragraph;
p.000398: (B) publish such recommendations in the Federal Register;
p.000398: (C) provide for a period of 30 days for the public to provide written comments on
p.000398: such recommendations;
p.000398: (D) hold a meeting at which the public may present its views on such
p.000398: recommendations; and
p.000398: (E) after consideration of such public views and comments, revise such
p.000398: recommendations as necessary.
p.000398: (5) Transmittal of recommendations
p.000398: Not later than January 15, 2012, the Secretary shall transmit to the Congress the
p.000398: revised recommendations under paragraph (4), a summary of the views and comments
p.000398: received under such paragraph, and any changes made to the recommendations in
p.000398: response to such views and comments.
p.000398: (6) Minutes of negotiation meetings
p.000398: (A) Public availability
p.000398: Before presenting the recommendations developed under paragraphs (1) through (5)
p.000398: to the Congress, the Secretary shall make publicly available, on the public Web site of
p.000398: the Food and Drug Administration, minutes of all negotiation meetings conducted under
p.000398: this subsection between the Food and Drug Administration and the regulated industry.
p.000398: (B) Content
p.000398: The minutes described under subparagraph (A) shall summarize any substantive
p.000398: proposal made by any party to the negotiations as well as significant controversies or
p.000398: differences of opinion during the negotiations and their resolution.
p.000398: (June 25, 1938, ch. 675, §736B, as added Pub. L. 110–85, title I, §105, Sept. 27, 2007, 121
p.000398: Stat. 840.)
p.000398: TERMINATION OF SECTION
p.000398: For termination of section by section 106(b) of Pub. L. 110–85, see Effective and
p.000398: Termination Dates note below.
p.000398: REFERENCES IN TEXT
p.000398: Section 101(c) of the Food and Drug Administration Amendments Act of 2007, referred to in
p.000398: subsec. (a), is section 101(c) of Pub. L. 110–85, which is set out as a note under section 379g of
p.000398: this title.
p.000398: EFFECTIVE AND TERMINATION DATES
p.000398: Pub. L. 110–85, title I, §106(b), Sept. 27, 2007, 121 Stat. 842, provided that: “The amendment
p.000398: made by section 105 [enacting this section] ceases to be effective January 31, 2013.”
p.000398: Section effective Oct. 1, 2007, with fees under this subpart to be assessed for all human drug
p.000398: applications received on or after Oct. 1, 2007, see section 107 of Pub. L. 110–85, set out as an
p.000398: Effective and Termination Dates of 2007 Amendment note under section 379g of this title.
p.000398: SUBPART 3—FEES RELATING TO DEVICES
p.000398: TERMINATION OF SUBPART
p.000398: For termination of subpart by section 107 of Pub. L. 107–250, see Effective and
p.000398: Termination Dates note set out under section 379i of this title.
p.000398:
p.000398:
p.000398: §379i. Definitions
p.000398: For purposes of this subpart:
p.000398: (1) The term “premarket application” means—
p.000398: (A) an application for approval of a device submitted under section 360e(c) of this
...

p.000398: applications” means the expenses incurred in connection with the process for the review
p.000398: of device applications for—
p.000398: (A) officers and employees of the Food and Drug Administration, contractors of the
p.000398: Food and Drug Administration, advisory committees, and costs related to such officers,
p.000398: employees, and committees and to contracts with such contractors;
p.000398: (B) management of information, and the acquisition, maintenance, and repair of
p.000398: computer resources;
p.000398: (C) leasing, maintenance, renovation, and repair of facilities and acquisition,
p.000398: maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary
p.000398: materials and supplies; and
p.000398: (D) collecting fees and accounting for resources allocated for the review of premarket
p.000398: applications, premarket reports, supplements, and submissions.
p.000398:
p.000398: (10) The term “adjustment factor” applicable to a fiscal year is the Consumer Price
p.000398: Index for all urban consumers (all items; United States city average) for October of the
p.000398: preceding fiscal year divided by such Index for October 2001.
p.000398: (11) The term “person” includes an affiliate thereof.
p.000398: (12) The term “affiliate” means a business entity that has a relationship with a second
p.000398: business entity (whether domestic or international) if, directly or indirectly—
p.000398: (A) one business entity controls, or has the power to control, the other business
p.000398: entity; or
p.000398: (B) a third party controls, or has power to control, both of the business entities.
p.000398:
p.000398: (13) The term “establishment subject to a registration fee” means an establishment that
p.000398: is required to register with the Secretary under section 360 of this title and is one of the
p.000398: following types of establishments:
p.000398: (A) Manufacturer
p.000398: An establishment that makes by any means any article that is a device, including an
p.000398: establishment that sterilizes or otherwise makes such article for or on behalf of a
p.000398: specification developer or any other person.
p.000398: (B) Single-use device reprocessor
p.000398: An establishment that, within the meaning of section 321(ll)(2)(A) of this title,
p.000398: performs additional processing and manufacturing operations on a single-use device
p.000398: that has previously been used on a patient.
p.000398: (C) Specification developer
p.000398: An establishment that develops specifications for a device that is distributed under
p.000398: the establishment's name but which performs no manufacturing, including an
p.000398: establishment that, in addition to developing specifications, also arranges for the
p.000398: manufacturing of devices labeled with another establishment's name by a contract
p.000398: manufacturer.
p.000398: (June 25, 1938, ch. 675, §737, as added Pub. L. 107–250, title I, §102(a), Oct. 26, 2002,
p.000398: 116 Stat. 1589; amended Pub. L. 108–214, §2(a)(1), (d)(3)(A), Apr. 1, 2004, 118 Stat. 572,
p.000398: 577; Pub. L. 110–85, title II, §211, Sept. 27, 2007, 121 Stat. 843.)
p.000398: AMENDMENT OF SECTION
p.000398: For termination of amendment by section 217 of Pub. L. 110–85, see Effective and
p.000398: Termination Dates of 2007 Amendment note below.
...

p.000398: and their suggestions for changes to this subpart as expressed under paragraph (2).
p.000398: (4) Public review of recommendations
p.000398: After negotiations with the regulated industry, the Secretary shall—
p.000398: (A) present the recommendations developed under paragraph (1) to the
p.000398: Congressional committees specified in such paragraph;
p.000398: (B) publish such recommendations in the Federal Register;
p.000398: (C) provide for a period of 30 days for the public to provide written comments on
p.000398: such recommendations;
p.000398: (D) hold a meeting at which the public may present its views on such
p.000398: recommendations; and
p.000398: (E) after consideration of such public views and comments, revise such
p.000398: recommendations as necessary.
p.000398: (5) Transmittal of recommendations
p.000398: Not later than January 15, 2012, the Secretary shall transmit to Congress the revised
p.000398: recommendations under paragraph (4), a summary of the views and comments received
p.000398: under such paragraph, and any changes made to the recommendations in response to
p.000398: such views and comments.
p.000398: (6) Minutes of negotiation meetings
p.000398: (A) Public availability
p.000398: Before presenting the recommendations developed under paragraphs (1) through (5)
p.000398: to the Congress, the Secretary shall make publicly available, on the public Web site of
p.000398: the Food and Drug Administration, minutes of all negotiation meetings conducted under
p.000398: this subsection between the Food and Drug Administration and the regulated industry.
p.000398: (B) Content
p.000398: The minutes described under subparagraph (A) shall summarize any substantive
p.000398: proposal made by any party to the negotiations as well as significant controversies or
p.000398: differences of opinion during the negotiations and their resolution.
p.000398: (June 25, 1938, ch. 675, §738A, as added Pub. L. 110–85, title II, §213, Sept. 27, 2007, 121
p.000398: Stat. 850.)
p.000398: TERMINATION OF SECTION
p.000398: For termination of section by section 217 of Pub. L. 110–85, see Effective and
p.000398: Termination Dates note below.
p.000398: REFERENCES IN TEXT
p.000398: Section 201(c) of the Food and Drug Administration Amendments Act of 2007, referred to in
p.000398: subsec. (a)(1), is section 201(c) of Pub. L. 110–85, which is set out as a note under section 379i of
p.000398: this title.
p.000398: EFFECTIVE AND TERMINATION DATES
p.000398: Section effective Oct. 1, 2007, except for certain premarket fees under this subpart, and ceases
p.000398: to be effective Jan. 31, 2013, see sections 216 and 217 of Pub. L. 110–85, set out as Effective
p.000398: and Termination Dates of 2007 Amendment notes under section 379i of this title.
p.000398:
p.000398:
p.000398:
p.000398: SUBPART 4—FEES RELATING TO ANIMAL DRUGS
p.000398: TERMINATION OF SUBPART
p.000398: For termination of subpart by section 5 of Pub. L. 108–130, see Termination Date note
p.000398: set out under section 379j–11 of this title.
p.000398: For savings provisions, see section 106 of Pub. L. 110–316, set out as a note under
p.000398: section 379j–11 of this title.
p.000398:
p.000398:
p.000398: §379j–11. Definitions
p.000398: For purposes of this subpart:
p.000398: (1) The term “animal drug application” means an application for approval of any new
...

p.000398: paragraph (2).
p.000398: (4) Public review of recommendations
p.000398: After negotiations with the regulated industry, the Secretary shall—
p.000398: (A) present the recommendations developed under paragraph (1) to the
p.000398: Congressional committees specified in such paragraph;
p.000398: (B) publish such recommendations in the Federal Register;
p.000398: (C) provide for a period of 30 days for the public to provide written comments on
p.000398: such recommendations;
p.000398: (D) hold a meeting at which the public may present its views on such
p.000398: recommendations; and
p.000398: (E) after consideration of such public views and comments, revise such
p.000398: recommendations as necessary.
p.000398: (5) Transmittal of recommendations
p.000398: Not later than January 15, 2013, the Secretary shall transmit to the Congress the
p.000398: revised recommendations under paragraph (4), a summary of the views and comments
p.000398: received under such paragraph, and any changes made to the recommendations in
p.000398: response to such views and comments.
p.000398: (6) Minutes of negotiation meetings
p.000398: (A) Public availability
p.000398: Before presenting the recommendations developed under paragraphs (1) through (5)
p.000398: to the Congress, the Secretary shall make publicly available, on the Internet Web site
p.000398: of the Food and Drug Administration, minutes of all negotiation meetings conducted
p.000398: under this subsection between the Food and Drug Administration and the regulated
p.000398: industry.
p.000398: (B) Content
p.000398: The minutes described under subparagraph (A) shall summarize any substantive
p.000398: proposal made by any party to the negotiations as well as significant controversies or
p.000398: differences of opinion during the negotiations and their resolution.
p.000398: (June 25, 1938, ch. 675, §740A, as added Pub. L. 110–316, title I, §104, Aug. 14, 2008, 122
p.000398: Stat. 3511.)
p.000398: TERMINATION OF SECTION
p.000398: For termination of section by section 108(b) of Pub. L. 110–316, see Effective and
p.000398: Termination Dates note below.
p.000398: REFERENCES IN TEXT
p.000398: Section 101(b) of the Animal Drug User Fee Amendments of 2008, referred to in subsec. (a), is
p.000398: section 101(b) of Pub. L. 110–316, which is set out as a note under section 379j–11 of this title.
p.000398: EFFECTIVE AND TERMINATION DATES
p.000398: Section effective Oct. 1, 2008, with fees under this subpart to be assessed for all animal drug
p.000398: applications and supplemental animal drug applications received on or after Oct. 1, 2008, and
p.000398: ceases to be effective Jan. 31, 2014, see sections 107 and 108(b) of Pub. L. 110–316, set out as
p.000398: Effective and Termination Dates of 2008 Amendment notes under section 379j–11 of this title.
p.000398:
p.000398:
p.000398:
p.000398: SUBPART 5—FEES RELATING TO GENERIC NEW ANIMAL DRUGS
p.000398: TERMINATION OF SUBPART
p.000398: For termination of subpart by section 204 of Pub. L. 110–316, see Termination Date
p.000398: notes set out under sections 379j–21 and 379j–22 of this title.
p.000398:
p.000398:
p.000398: §379j–21. Authority to assess and use generic new animal drug fees
p.000398: (a) Types of fees
...

p.000398: reauthorization and their suggestions for changes to this subpart as expressed under
p.000398: paragraph (2).
p.000398: (4) Public review of recommendations
p.000398: After negotiations with the regulated industry, the Secretary shall—
p.000398: (A) present the recommendations developed under paragraph (1) to the
p.000398: congressional committees specified in such paragraph;
p.000398: (B) publish such recommendations in the Federal Register;
p.000398: (C) provide for a period of 30 days for the public to provide written comments on
p.000398: such recommendations;
p.000398: (D) hold a meeting at which the public may present its views on such
p.000398: recommendations; and
p.000398: (E) after consideration of such public views and comments, revise such
p.000398: recommendations as necessary.
p.000398: (5) Transmittal of recommendations
p.000398: Not later than January 15, 2013, the Secretary shall transmit to Congress the revised
p.000398: recommendations under paragraph (4), a summary of the views and comments received
p.000398: under such paragraph, and any changes made to the recommendations in response to
p.000398: such views and comments.
p.000398: (6) Minutes of negotiation meetings
p.000398: (A) Public availability
p.000398: Before presenting the recommendations developed under paragraphs (1) through (5)
p.000398: to Congress, the Secretary shall make publicly available, on the Internet Web site of
p.000398: the Food and Drug Administration, minutes of all negotiation meetings conducted under
p.000398: this subsection between the Food and Drug Administration and the regulated industry.
p.000398: (B) Content
p.000398: The minutes described under subparagraph (A) shall summarize any substantive
p.000398: proposal made by any party to the negotiations as well as significant controversies or
p.000398: differences of opinion during the negotiations and their resolution.
p.000398: (June 25, 1938, ch. 675, §742, as added Pub. L. 110–316, title II, §203, Aug. 14, 2008, 122
p.000398: Stat. 3522.)
p.000398: TERMINATION OF SECTION
p.000398: For termination of section by section 204(b) of Pub. L. 110–316, see Termination Date
p.000398: note below.
p.000398: REFERENCES IN TEXT
p.000398: Section 201(3) of the Animal Generic Drug User Fee Act of 2008, referred to in subsec. (a),
p.000398: probably means section 201(b)(3) of Pub. L. 110–316, which is set out as a note under section
p.000398: 379j–21 of this title.
p.000398: PRIOR PROVISIONS
p.000398: A prior section 742 of act June 25, 1938, was renumbered section 746 and is classified to
p.000398: section 379l of this title.
p.000398: TERMINATION DATE
p.000398: Pub. L. 110–316, title II, §204(b), Aug. 14, 2008, 122 Stat. 3524, provided that: “The
p.000398: amendment made by section 203 [enacting this section] shall cease to be effective January 31,
p.000398: 2014.”
p.000398:
p.000398: 1 See References in Text note below.
p.000398:
p.000398:
p.000398:
p.000398: SUBPART 6—FEES RELATED TO FOOD
p.000398:
p.000398:
p.000398: §379j–31. Authority to collect and use fees
p.000398: (a) In general
p.000398: (1) Purpose and authority
p.000398: For fiscal year 2010 and each subsequent fiscal year, the Secretary shall, in
p.000398: accordance with this section, assess and collect fees from—
p.000398: (A) the responsible party for each domestic facility (as defined in section 350d(b) of
p.000398: this title) and the United States agent for each foreign facility subject to a reinspection
p.000398: in such fiscal year, to cover reinspection-related costs for such year;
p.000398: (B) the responsible party for a domestic facility (as defined in section 350d(b) of this
p.000398: title) and an importer who does not comply with a recall order under section 350l of this
p.000398: title or under section 350a(f) of this title in such fiscal year, to cover food recall activities
p.000398: associated with such order performed by the Secretary, including technical assistance,
p.000398: follow-up effectiveness checks, and public notifications, for such year;
p.000398: (C) each importer participating in the voluntary qualified importer program under
p.000398: section 384b of this title in such year, to cover the administrative costs of such program
p.000398: for such year; and
p.000398: (D) each importer subject to a reinspection in such fiscal year, to cover reinspection-
p.000398: related costs for such year.
p.000398: (2) Definitions
p.000398: For purposes of this section—
p.000398: (A) the term “reinspection” means—
p.000398: (i) with respect to domestic facilities (as defined in section 350d(b) of this title), 1 or
p.000398: more inspections conducted under section 374 of this title subsequent to an
p.000398: inspection conducted under such provision which identified noncompliance materially
p.000398: related to a food safety requirement of this chapter, specifically to determine whether
p.000398: compliance has been achieved to the Secretary's satisfaction; and
p.000398: (ii) with respect to importers, 1 or more examinations conducted under section 381
p.000398: of this title subsequent to an examination conducted under such provision which
p.000398: identified noncompliance materially related to a food safety requirement of this
p.000398: chapter, specifically to determine whether compliance has been achieved to the
p.000398: Secretary's satisfaction;
p.000398:
p.000398: (B) the term “reinspection-related costs” means all expenses, including administrative
p.000398: expenses, incurred in connection with—
p.000398: (i) arranging, conducting, and evaluating the results of reinspections; and
p.000398: (ii) assessing and collecting reinspection fees under this section; and
p.000398:
p.000398: (C) the term “responsible party” has the meaning given such term in section 350f(a)
p.000398: (1) of this title.
p.000398: (b) Establishment of fees
p.000398: (1) In general
p.000398: Subject to subsections (c) and (d), the Secretary shall establish the fees to be collected
p.000398: under this section for each fiscal year specified in subsection (a)(1), based on the
p.000398: methodology described under paragraph (2), and shall publish such fees in a Federal
p.000398: Register notice not later than 60 days before the start of each such year.
p.000398: (2) Fee methodology
p.000398: (A) Fees
p.000398: Fees amounts established for collection—
p.000398: (i) under subparagraph (A) of subsection (a)(1) for a fiscal year shall be based on
p.000398: the Secretary's estimate of 100 percent of the costs of the reinspection-related
p.000398: activities (including by type or level of reinspection activity, as the Secretary
p.000398: determines applicable) described in such subparagraph (A) for such year;
p.000398: (ii) under subparagraph (B) of subsection (a)(1) for a fiscal year shall be based on
p.000398: the Secretary's estimate of 100 percent of the costs of the activities described in
p.000398: such subparagraph (B) for such year;
p.000398: (iii) under subparagraph (C) of subsection (a)(1) for a fiscal year shall be based on
p.000398: the Secretary's estimate of 100 percent of the costs of the activities described in
p.000398: such subparagraph (C) for such year; and
p.000398: (iv) under subparagraph (D) of subsection (a)(1) for a fiscal year shall be based on
p.000398: the Secretary's estimate of 100 percent of the costs of the activities described in
p.000398: such subparagraph (D) for such year.
p.000398: (B) Other considerations
p.000398: (i) Voluntary qualified importer program
p.000398: In establishing the fee amounts under subparagraph (A)(iii) for a fiscal year, the
...

p.000398: (1) the time and manner in which fees assessed under this section shall be collected.
p.000398: (2) Collection of unpaid fees
p.000398: In any case where the Secretary does not receive payment of a fee assessed under
p.000398: this section within 30 days after it is due, such fee shall be treated as a claim of the
p.000398: United States Government subject to provisions of subchapter II of chapter 37 of title 31.
p.000398: (f) Annual report to Congress
p.000398: Not later than 120 days after each fiscal year for which fees are assessed under this
p.000398: section, the Secretary shall submit a report to the Committee on Health, Education, Labor,
p.000398: and Pensions of the Senate and the Committee on Energy and Commerce of the House of
p.000398: Representatives, to include a description of fees assessed and collected for each such year
p.000398: and a summary description of the entities paying such fees and the types of business in
p.000398: which such entities engage.
p.000398: (g) Authorization of appropriations
p.000398: For fiscal year 2010 and each fiscal year thereafter, there is authorized to be
p.000398: appropriated for fees under this section an amount equal to the total revenue amount
p.000398: determined under subsection (b) for the fiscal year, as adjusted or otherwise affected under
p.000398: the other provisions of this section.
p.000398: (June 25, 1938, ch. 675, §743, as added Pub. L. 111–353, title I, §107(a), Jan. 4, 2011, 124
p.000398: Stat. 3906.)
p.000398: CONSTRUCTION
p.000398: Nothing in this section to be construed to apply to certain alcohol-related facilities, to alter
p.000398: jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with
p.000398: international agreements to which the United States is a party, see sections 2206, 2251, and 2252
p.000398: of this title.
p.000398:
p.000398: 1 So in original. No subcl. (I) has been enacted.
p.000398:
p.000398: 2 So in original. Probably should be “clauses”.
p.000398:
p.000398:
p.000398:
p.000398: PART D—INFORMATION AND EDUCATION
p.000398:
p.000398:
p.000398: §379k. Information system
p.000398: The Secretary shall establish and maintain an information system to track the status and
p.000398: progress of each application or submission (including a petition, notification, or other similar
p.000398: form of request) submitted to the Food and Drug Administration requesting agency action.
p.000398: (June 25, 1938, ch. 675, §745, formerly §741, as added Pub. L. 105–115, title IV, §407(a),
p.000398: Nov. 21, 1997, 111 Stat. 2370; renumbered §745, Pub. L. 110–316, title II, §202(a), Aug.
p.000398: 14, 2008, 122 Stat. 3515.)
p.000398: AMENDMENT OF SECTION
p.000398: For termination of amendment renumbering this section by section 204(a) of Pub. L. 110–
p.000398: 316, see Termination Date of 2008 Amendment note below.
p.000398: TERMINATION DATE OF 2008 AMENDMENT
p.000398: Amendment by Pub. L. 110–316 to cease to be effective Oct. 1, 2013, see section 204(a) of
p.000398: Pub. L. 110–316, set out as a Termination Date note under section 379j–21 of this title.
p.000398: EFFECTIVE DATE
p.000398: Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of
p.000398: Pub. L. 105–115, set out as an Effective Date of 1997 Amendment note under section 321 of this
p.000398: title.
p.000398: REPORT ON STATUS OF SYSTEM
p.000398: Section 407(b) of Pub. L. 105–115 provided that not later than 1 year after Nov. 21, 1997,
p.000398: Secretary of Health and Human Services was to submit report to Congress on status of system to
...

p.000398: order, or other requirement, related to a mandatory system for adverse event reports for
p.000398: nonprescription drugs, that is different from, in addition to, or otherwise not identical to,
p.000398: this section.
p.000398: (2) Effect of section
p.000398: (A) In general
p.000398: Nothing in this section shall affect the authority of the Secretary to provide adverse
p.000398: event reports and information to any health, food, or drug officer or employee of any
p.000398: State, territory, or political subdivision of a State or territory, under a memorandum of
p.000398: understanding between the Secretary and such State, territory, or political subdivision.
p.000398: (B) Personally-identifiable information
p.000398: Notwithstanding any other provision of law, personally-identifiable information in
p.000398: adverse event reports provided by the Secretary to any health, food, or drug officer or
p.000398: employee of any State, territory, or political subdivision of a State or territory, shall not
p.000398: —
p.000398: (i) be made publicly available pursuant to any State or other law requiring
p.000398: disclosure of information or records; or
p.000398: (ii) otherwise be disclosed or distributed to any party without the written consent of
p.000398: the Secretary and the person submitting such information to the Secretary.
p.000398: (C) Use of safety reports
p.000398: Nothing in this section shall permit a State, territory, or political subdivision of a State
p.000398: or territory, to use any safety report received from the Secretary in a manner
p.000398: inconsistent with subsection (g) or section 379v of this title.
p.000398: (i) Authorization of appropriations
p.000398: There are authorized to be appropriated to carry out this section such sums as may be
p.000398: necessary.
p.000398: (June 25, 1938, ch. 675, §760, as added Pub. L. 109–462, §2(a), Dec. 22, 2006, 120 Stat.
p.000398: 3469.)
p.000398: EFFECTIVE DATE
p.000398: Section effective 1 year after Dec. 22, 2006, see section 2(e)(1) of Pub. L. 109–462, set out as
p.000398: an Effective Date of 2006 Amendment note under section 352 of this title.
p.000398: MODIFICATIONS
p.000398: Pub. L. 109–462, §2(b), Dec. 22, 2006, 120 Stat. 3472, provided that: “The Secretary of Health
p.000398: and Human Services may modify requirements under the amendments made by this section
p.000398: [enacting this section and amending sections 331 and 352 of this title] in accordance with section
p.000398: 553 of title 5, United States Code, to maintain consistency with international harmonization efforts
p.000398: over time.”
p.000398: GUIDANCE
p.000398: Pub. L. 109–462, §2(e)(3), Dec. 22, 2006, 120 Stat. 3472, provided that: “Not later than 270
p.000398: days after the date of enactment of this Act [Dec. 22, 2006], the Secretary of Health and Human
p.000398: Services shall issue guidance on the minimum data elements that should be included in a serious
...

p.000398: order, or other requirement, related to a mandatory system for adverse event reports for
p.000398: dietary supplements, that is different from, in addition to, or otherwise not identical to, this
p.000398: section.
p.000398: (2) Effect of section
p.000398: (A) In general
p.000398: Nothing in this section shall affect the authority of the Secretary to provide adverse
p.000398: event reports and information to any health, food, or drug officer or employee of any
p.000398: State, territory, or political subdivision of a State or territory, under a memorandum of
p.000398: understanding between the Secretary and such State, territory, or political subdivision.
p.000398: (B) Personally-identifiable information
p.000398: Notwithstanding any other provision of law, personally-identifiable information in
p.000398: adverse event reports provided by the Secretary to any health, food, or drug officer or
p.000398: employee of any State, territory, or political subdivision of a State or territory, shall not
p.000398: —
p.000398: (i) be made publicly available pursuant to any State or other law requiring
p.000398: disclosure of information or records; or
p.000398: (ii) otherwise be disclosed or distributed to any party without the written consent of
p.000398: the Secretary and the person submitting such information to the Secretary.
p.000398: (C) Use of safety reports
p.000398: Nothing in this section shall permit a State, territory, or political subdivision of a State
p.000398: or territory, to use any safety report received from the Secretary in a manner
p.000398: inconsistent with subsection (g) or section 379v of this title.
p.000398: (i) Authorization of appropriations
p.000398: There are authorized to be appropriated to carry out this section such sums as may be
p.000398: necessary.
p.000398: (June 25, 1938, ch. 675, §761, as added Pub. L. 109–462, §3(a), Dec. 22, 2006, 120 Stat.
p.000398: 3472.)
p.000398: EFFECTIVE DATE
p.000398: Section effective 1 year after Dec. 22, 2006, see section 3(d)(1) of Pub. L. 109–462, set out as
p.000398: an Effective Date of 2006 Amendment note under section 343 of this title.
p.000398:
p.000398:
p.000398:
p.000398: PART I—REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG ADMINISTRATION
p.000398:
p.000398:
p.000398: §379dd. Establishment and functions of the Foundation
p.000398: (a) In general
p.000398: A nonprofit corporation to be known as the Reagan-Udall Foundation for the Food and
p.000398: Drug Administration (referred to in this part as the “Foundation”) shall be established in
p.000398: accordance with this section. The Foundation shall be headed by an Executive Director,
p.000398: appointed by the members of the Board of Directors under subsection (e).1 The Foundation
p.000398: shall not be an agency or instrumentality of the United States Government.
p.000398: (b) Purpose of Foundation
...

p.000398: greater than the compensation of the Commissioner.
p.000398: (h) Administrative powers
p.000398: In carrying out this part, the Board, acting through the Executive Director, may—
p.000398: (1) adopt, alter, and use a corporate seal, which shall be judicially noticed;
p.000398: (2) hire, promote, compensate, and discharge 1 or more officers, employees, and
p.000398: agents, as may be necessary, and define their duties;
p.000398: (3) prescribe the manner in which—
p.000398: (A) real or personal property of the Foundation is acquired, held, and transferred;
p.000398: (B) general operations of the Foundation are to be conducted; and
p.000398: (C) the privileges granted to the Board by law are exercised and enjoyed;
p.000398:
p.000398: (4) with the consent of the applicable executive department or independent agency,
p.000398: use the information, services, and facilities of such department or agencies in carrying out
p.000398: this section;
p.000398: (5) enter into contracts with public and private organizations for the writing, editing,
p.000398: printing, and publishing of books and other material;
p.000398: (6) hold, administer, invest, and spend any gift, devise, or bequest of real or personal
p.000398: property made to the Foundation under subsection (i);
p.000398: (7) enter into such other contracts, leases, cooperative agreements, and other
p.000398: transactions as the Board considers appropriate to conduct the activities of the
p.000398: Foundation;
p.000398: (8) modify or consent to the modification of any contract or agreement to which it is a
p.000398: party or in which it has an interest under this part;
p.000398: (9) take such action as may be necessary to obtain patents and licenses for devices
p.000398: and procedures developed by the Foundation and its employees;
p.000398: (10) sue and be sued in its corporate name, and complain and defend in courts of
p.000398: competent jurisdiction;
p.000398: (11) appoint other groups of advisors as may be determined necessary to carry out the
p.000398: functions of the Foundation; and
p.000398: (12) exercise other powers as set forth in this section, and such other incidental powers
p.000398: as are necessary to carry out its powers, duties, and functions in accordance with this
p.000398: part.
p.000398: (i) Acceptance of funds from other sources
p.000398: The Executive Director may solicit and accept on behalf of the Foundation, any funds,
p.000398: gifts, grants, devises, or bequests of real or personal property made to the Foundation,
p.000398: including from private entities, for the purposes of carrying out the duties of the Foundation.
p.000398: (j) Service of Federal employees
p.000398: Federal Government employees may serve on committees advisory to the Foundation
p.000398: and otherwise cooperate with and assist the Foundation in carrying out its functions, so long
p.000398: as such employees do not direct or control Foundation activities.
p.000398: (k) Detail of Government employees; fellowships
p.000398: (1) Detail from Federal agencies
...

p.000398: for import shall be not fewer than eight hours and not more than five days, which shall remain in
p.000398: effect until the final regulations are made effective.”
p.000398: SAVINGS PROVISION
p.000398: Amendment by Pub. L. 91–513 not to affect or abate any prosecutions for violation of law or any
p.000398: civil seizure or forfeitures and injunctive proceedings commenced prior to the effective date of
p.000398: such amendment, and all administrative proceedings pending before the Bureau of Narcotic and
p.000398: Dangerous Drugs [now Drug Enforcement Administration] on Oct. 27, 1970, to be continued and
p.000398: brought to final determination in accord with laws and regulations in effect prior to Oct. 27, 1970,
p.000398: see section 702 of Pub. L. 91–513, set out as a note under section 321 of this title.
p.000398: CONSTRUCTION OF 2011 AMENDMENT
p.000398: Pub. L. 111–353, title III, §303(d), Jan. 4, 2011, 124 Stat. 3957, provided that: “Nothing in the
p.000398: amendments made by this section [amending this section] shall limit the authority of the Secretary
p.000398: to conduct inspections of imported food or to take such other steps as the Secretary deems
p.000398: appropriate to determine the admissibility of imported food.”
p.000398: Nothing in amendments by sections 107(b), 204(j)(2), 301(c), and 303(a)–(c) of Pub. L. 111–
p.000398: 353 to be construed to apply to certain alcohol-related facilities, see section 2206 of this title.
p.000398: Nothing in amendments by Pub. L. 111–353 to be construed to alter jurisdiction and authorities
p.000398: established under certain other Acts or in a manner inconsistent with international agreements to
p.000398: which the United States is a party, see sections 2251 and 2252 of this title.
p.000398: CONSTRUCTION OF AMENDMENTS BY PUB. L. 107–188
p.000398: Pub. L. 107–188, title III, §308(c), June 12, 2002, 116 Stat. 673, provided that: “With respect to
p.000398: articles of food that are imported or offered for import into the United States, nothing in this section
p.000398: [amending this section and section 343 of this title] shall be construed to limit the authority of the
p.000398: Secretary of Health and Human Services or the Secretary of the Treasury to require the marking
p.000398: of refused articles of food under any other provision of law.”
p.000398: TRANSFER OF FUNCTIONS
p.000398: Secretary and Department of Health, Education, and Welfare redesignated Secretary and
p.000398: Department of Health and Human Services by Pub. L. 96–88, title V, §509(b), Oct. 17, 1979, 93
p.000398: Stat. 695, which is classified to section 3508(b) of Title 20, Education.
p.000398: For transfer of functions of Federal Security Administrator to Secretary of Health, Education,
p.000398: and Welfare [now Health and Human Services], and of Food and Drug Administration in the
p.000398: Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this
p.000398: title.
p.000398: PORT SHOPPING
p.000398: Pub. L. 111–353, title I, §115, Jan. 4, 2011, 124 Stat. 3922, provided that: “Until the date on
p.000398: which the Secretary promulgates a final rule that implements the amendments made by section
...

p.000398:
p.000398: The exemption under paragraph (3) shall apply only with respect to microbiological
p.000398: hazards that are regulated under the standards for Thermally Processed Low-Acid Foods
p.000398: Packaged in Hermetically Sealed Containers under part 113 of chapter 2 21, Code of
p.000398: Federal Regulations (or any successor regulations).
p.000398: (f) Additional exemptions
p.000398: The Secretary, by notice published in the Federal Register, shall establish an exemption
p.000398: from the requirements of this section for articles of food imported in small quantities for
p.000398: research and evaluation purposes or for personal consumption, provided that such foods
p.000398: are not intended for retail sale and are not sold or distributed to the public.
p.000398: (g) Publication of list of participants
p.000398: The Secretary shall publish and maintain on the Internet Web site of the Food and Drug
p.000398: Administration a current list that includes the name of, location of, and other information
p.000398: deemed necessary by the Secretary about, importers participating under this section.
p.000398: (June 25, 1938, ch. 675, §805, as added Pub. L. 111–353, title III, §301(a), Jan. 4, 2011,
p.000398: 124 Stat. 3953.)
p.000398: EFFECTIVE DATE
p.000398: Section effective 2 years after Jan. 4, 2011, see section 301(d) of Pub. L. 111–353, set out as
p.000398: an Effective Date of 2011 Amendment note under section 331 of this title.
p.000398: CONSTRUCTION
p.000398: Nothing in this section to be construed to apply to certain alcohol-related facilities, to alter
p.000398: jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with
p.000398: international agreements to which the United States is a party, see sections 2206, 2251, and 2252
p.000398: of this title.
p.000398:
p.000398: 1 So in original.
p.000398:
p.000398: 2 So in original. Probably should be “title”.
p.000398:
p.000398:
p.000398:
p.000398: §384b. Voluntary qualified importer program
p.000398: (a) In general
p.000398: Beginning not later than 18 months after January 4, 2011, the Secretary shall—
p.000398: (1) establish a program, in consultation with the Secretary of Homeland Security—
p.000398: (A) to provide for the expedited review and importation of food offered for importation
p.000398: by importers who have voluntarily agreed to participate in such program; and
p.000398: (B) consistent with section 384d of this title, establish a process for the issuance of a
p.000398: facility certification to accompany food offered for importation by importers who have
p.000398: voluntarily agreed to participate in such program; and
p.000398:
p.000398: (2) issue a guidance document related to participation in, revocation of such
p.000398: participation in, reinstatement in, and compliance with, such program.
p.000398: (b) Voluntary participation
p.000398: An importer may request the Secretary to provide for the expedited review and
p.000398: importation of designated foods in accordance with the program established by the
p.000398: Secretary under subsection (a).
p.000398: (c) Notice of intent to participate
p.000398: An importer that intends to participate in the program under this section in a fiscal year
p.000398: shall submit a notice and application to the Secretary of such intent at the time and in a
p.000398: manner established by the Secretary.
p.000398: (d) Eligibility
p.000398: Eligibility shall be limited to an importer offering food for importation from a facility that has
p.000398: a certification described in subsection (a). In reviewing the applications and making
...

p.000398: compliance with United States food safety standards for a designated food.
p.000398: (4) The compliance of the importer with the requirements of section 384a of this title.
p.000398: (5) The recordkeeping, testing, inspections and audits of facilities, traceability of articles
p.000398: of food, temperature controls, and sourcing practices of the importer.
p.000398: (6) The potential risk for intentional adulteration of the food.
p.000398: (7) Any other factor that the Secretary determines appropriate.
p.000398: (e) Review and revocation
p.000398: Any importer qualified by the Secretary in accordance with the eligibility criteria set forth
p.000398: in this section shall be reevaluated not less often than once every 3 years and the Secretary
p.000398: shall promptly revoke the qualified importer status of any importer found not to be in
p.000398: compliance with such criteria.
p.000398: (f) False statements
p.000398: Any statement or representation made by an importer to the Secretary shall be subject to
p.000398: section 1001 of title 18.
p.000398: (g) Definition
p.000398: For purposes of this section, the term “importer” means the person that brings food, or
p.000398: causes food to be brought, from a foreign country into the customs territory of the United
p.000398: States.
p.000398: (June 25, 1938, ch. 675, §806, as added Pub. L. 111–353, title III, §302, Jan. 4, 2011, 124
p.000398: Stat. 3955.)
p.000398: CONSTRUCTION
p.000398: Nothing in this section to be construed to alter jurisdiction and authorities established under
p.000398: certain other Acts or in a manner inconsistent with international agreements to which the United
p.000398: States is a party, see sections 2251 and 2252 of this title.
p.000398:
p.000398:
p.000398: §384c. Inspection of foreign food facilities
p.000398: (a) Inspection
p.000398: The Secretary—
p.000398: (1) may enter into arrangements and agreements with foreign governments to facilitate
p.000398: the inspection of foreign facilities registered under section 350d of this title; and
p.000398: (2) shall direct resources to inspections of foreign facilities, suppliers, and food types,
p.000398: especially such facilities, suppliers, and food types that present a high risk (as identified
p.000398: by the Secretary), to help ensure the safety and security of the food supply of the United
p.000398: States.
p.000398: (b) Effect of inability to inspect
p.000398: Notwithstanding any other provision of law, food shall be refused admission into the
p.000398: United States if it is from a foreign factory, warehouse, or other establishment of which the
p.000398: owner, operator, or agent in charge, or the government of the foreign country, refuses to
p.000398: permit entry of United States inspectors or other individuals duly designated by the
p.000398: Secretary, upon request, to inspect such factory, warehouse, or other establishment. For
p.000398: purposes of this subsection, such an owner, operator, or agent in charge shall be
p.000398: considered to have refused an inspection if such owner, operator, or agent in charge does
p.000398: not permit an inspection of a factory, warehouse, or other establishment during the 24-hour
p.000398: period after such request is submitted, or after such other time period, as agreed upon by
p.000398: the Secretary and the foreign factory, warehouse, or other establishment.
p.000398: (June 25, 1938, ch. 675, §807, as added Pub. L. 111–353, title III, §306(a), Jan. 4, 2011,
p.000398: 124 Stat. 3958.)
p.000398: CONSTRUCTION
p.000398: Nothing in this section to be construed to apply to certain alcohol-related facilities, to alter
p.000398: jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with
p.000398: international agreements to which the United States is a party, see sections 2206, 2251, and 2252
p.000398: of this title.
p.000398: §384d. Accreditation of third-party auditors
p.000398: (a) Definitions
p.000398: In this section:
p.000398: (1) Audit agent
p.000398: The term “audit agent” means an individual who is an employee or agent of an
p.000398: accredited third-party auditor and, although not individually accredited, is qualified to
p.000398: conduct food safety audits on behalf of an accredited third-party auditor.
p.000398: (2) Accreditation body
p.000398: The term “accreditation body” means an authority that performs accreditation of third-
p.000398: party auditors.
p.000398: (3) Third-party auditor
p.000398: The term “third-party auditor” means a foreign government, agency of a foreign
p.000398: government, foreign cooperative, or any other third party, as the Secretary determines
p.000398: appropriate in accordance with the model standards described in subsection (b)(2), that
p.000398: is eligible to be considered for accreditation to conduct food safety audits to certify that
p.000398: eligible entities meet the applicable requirements of this section. A third-party auditor may
p.000398: be a single individual. A third-party auditor may employ or use audit agents to help
p.000398: conduct consultative and regulatory audits.
p.000398: (4) Accredited third-party auditor
p.000398: The term “accredited third-party auditor” means a third-party auditor accredited by an
p.000398: accreditation body to conduct audits of eligible entities to certify that such eligible entities
p.000398: meet the applicable requirements of this section. An accredited third-party auditor may be
p.000398: an individual who conducts food safety audits to certify that eligible entities meet the
p.000398: applicable requirements of this section.
p.000398: (5) Consultative audit
p.000398: The term “consultative audit” means an audit of an eligible entity—
p.000398: (A) to determine whether such entity is in compliance with the provisions of this
p.000398: chapter and with applicable industry standards and practices; and
p.000398: (B) the results of which are for internal purposes only.
p.000398: (6) Eligible entity
p.000398: The term “eligible entity” means a foreign entity, including a foreign facility registered
p.000398: under section 350d of this title, in the food import supply chain that chooses to be audited
p.000398: by an accredited third-party auditor or the audit agent of such accredited third-party
p.000398: auditor.
p.000398: (7) Regulatory audit
p.000398: The term “regulatory audit” means an audit of an eligible entity—
p.000398: (A) to determine whether such entity is in compliance with the provisions of this
p.000398: chapter; and
p.000398: (B) the results of which determine—
p.000398: (i) whether an article of food manufactured, processed, packed, or held by such
p.000398: entity is eligible to receive a food certification under section 381(q) of this title; or
p.000398: (ii) whether a facility is eligible to receive a facility certification under section
p.000398: 384b(a) of this title for purposes of participating in the program under section 384b of
p.000398: this title.
p.000398: (b) Accreditation system
p.000398: (1) Accreditation bodies
p.000398: (A) Recognition of accreditation bodies
p.000398: (i) In general
p.000398: Not later than 2 years after January 4, 2011, the Secretary shall establish a system
p.000398: for the recognition of accreditation bodies that accredit third-party auditors to certify
p.000398: that eligible entities meet the applicable requirements of this section.
p.000398: (ii) Direct accreditation
p.000398: If, by the date that is 2 years after the date of establishment of the system
p.000398: described in clause (i), the Secretary has not identified and recognized an
p.000398: accreditation body to meet the requirements of this section, the Secretary may
p.000398: directly accredit third-party auditors.
p.000398: (B) Notification
p.000398: Each accreditation body recognized by the Secretary shall submit to the Secretary a
p.000398: list of all accredited third-party auditors accredited by such body and the audit agents of
p.000398: such auditors.
p.000398: (C) Revocation of recognition as an accreditation body
p.000398: The Secretary shall promptly revoke the recognition of any accreditation body found
p.000398: not to be in compliance with the requirements of this section.
p.000398: (D) Reinstatement
p.000398: The Secretary shall establish procedures to reinstate recognition of an accreditation
p.000398: body if the Secretary determines, based on evidence presented by such accreditation
p.000398: body, that revocation was inappropriate or that the body meets the requirements for
p.000398: recognition under this section.
p.000398: (2) Model accreditation standards
p.000398: Not later than 18 months after January 4, 2011, the Secretary shall develop model
p.000398: standards, including requirements for regulatory audit reports, and each recognized
p.000398: accreditation body shall ensure that third-party auditors and audit agents of such auditors
p.000398: meet such standards in order to qualify such third-party auditors as accredited third-party
p.000398: auditors under this section. In developing the model standards, the Secretary shall look to
p.000398: standards in place on January 4, 2011, for guidance, to avoid unnecessary duplication of
p.000398: efforts and costs.
p.000398: (c) Third-party auditors
p.000398: (1) Requirements for accreditation as a third-party auditor
p.000398: (A) Foreign governments
p.000398: Prior to accrediting a foreign government or an agency of a foreign government as an
p.000398: accredited third-party auditor, the accreditation body (or, in the case of direct
p.000398: accreditation under subsection (b)(1)(A)(ii), the Secretary) shall perform such reviews
p.000398: and audits of food safety programs, systems, and standards of the government or
p.000398: agency of the government as the Secretary deems necessary, including requirements
p.000398: under the model standards developed under subsection (b)(2), to determine that the
p.000398: foreign government or agency of the foreign government is capable of adequately
p.000398: ensuring that eligible entities or foods certified by such government or agency meet the
p.000398: requirements of this chapter with respect to food manufactured, processed, packed, or
p.000398: held for import into the United States.
p.000398: (B) Foreign cooperatives and other third parties
p.000398: Prior to accrediting a foreign cooperative that aggregates the products of growers or
p.000398: processors, or any other third party to be an accredited third-party auditor, the
p.000398: accreditation body (or, in the case of direct accreditation under subsection (b)(1)(A)(ii),
p.000398: the Secretary) shall perform such reviews and audits of the training and qualifications
p.000398: of audit agents used by that cooperative or party and conduct such reviews of internal
p.000398: systems and such other investigation of the cooperative or party as the Secretary
p.000398: deems necessary, including requirements under the model standards developed under
p.000398: subsection (b)(2), to determine that each eligible entity certified by the cooperative or
p.000398: party has systems and standards in use to ensure that such entity or food meets the
p.000398: requirements of this chapter.
p.000398: (2) Requirement to issue certification of eligible entities or foods
p.000398: (A) In general
p.000398: An accreditation body (or, in the case of direct accreditation under subsection (b)(1)
p.000398: (A)(ii), the Secretary) may not accredit a third-party auditor unless such third-party
p.000398: auditor agrees to issue a written and, as appropriate, electronic food certification,
p.000398: described in section 381(q) of this title, or facility certification under section 384b(a) of
p.000398: this title, as appropriate, to accompany each food shipment for import into the United
p.000398: States from an eligible entity, subject to requirements set forth by the Secretary. Such
p.000398: written or electronic certification may be included with other documentation regarding
p.000398: such food shipment. The Secretary shall consider certifications under section 381(q) of
p.000398: this title and participation in the voluntary qualified importer program described in
p.000398: section 384b of this title when targeting inspection resources under section 350j of this
p.000398: title.
p.000398: (B) Purpose of certification
p.000398: The Secretary shall use certification provided by accredited third-party auditors to—
p.000398: (i) determine, in conjunction with any other assurances the Secretary may require
p.000398: under section 381(q) of this title, whether a food satisfies the requirements of such
p.000398: section; and
p.000398: (ii) determine whether a facility is eligible to be a facility from which food may be
p.000398: offered for import under the voluntary qualified importer program under section 384b
p.000398: of this title.
p.000398: (C) Requirements for issuing certification
p.000398: (i) In general
p.000398: An accredited third-party auditor shall issue a food certification under section
p.000398: 381(q) of this title or a facility certification described under subparagraph (B) only
p.000398: after conducting a regulatory audit and such other activities that may be necessary to
p.000398: establish compliance with the requirements of such sections.
p.000398: (ii) Provision of certification
p.000398: Only an accredited third-party auditor or the Secretary may provide a facility
p.000398: certification under section 384b(a) of this title. Only those parties described in 1
p.000398: 381(q)(3) of this title or the Secretary may provide a food certification under 1
p.000398: 381(q) 2 of this title.
p.000398: (3) Audit report submission requirements
p.000398: (A) Requirements in general
p.000398: As a condition of accreditation, not later than 45 days after conducting an audit, an
p.000398: accredited third-party auditor or audit agent of such auditor shall prepare, and, in the
p.000398: case of a regulatory audit, submit, the audit report for each audit conducted, in a form
p.000398: and manner designated by the Secretary, which shall include—
p.000398: (i) the identity of the persons at the audited eligible entity responsible for
p.000398: compliance with food safety requirements;
p.000398: (ii) the dates of the audit;
p.000398: (iii) the scope of the audit; and
p.000398: (iv) any other information required by the Secretary that relates to or may influence
p.000398: an assessment of compliance with this chapter.
p.000398: (B) Records
p.000398: Following any accreditation of a third-party auditor, the Secretary may, at any time,
p.000398: require the accredited third-party auditor to submit to the Secretary an onsite audit
p.000398: report and such other reports or documents required as part of the audit process, for
p.000398: any eligible entity certified by the third-party auditor or audit agent of such auditor. Such
p.000398: report may include documentation that the eligible entity is in compliance with any
p.000398: applicable registration requirements.
p.000398: (C) Limitation
p.000398: The requirement under subparagraph (B) shall not include any report or other
p.000398: documents resulting from a consultative audit by the accredited third-party auditor,
p.000398: except that the Secretary may access the results of a consultative audit in accordance
p.000398: with section 350c of this title.
p.000398: (4) Requirements of accredited third-party auditors and audit agents of such
p.000398: auditors
p.000398: (A) Risks to public health
p.000398: If, at any time during an audit, an accredited third-party auditor or audit agent ofsuch
p.000398: auditor discovers a condition that could cause or contribute to a serious risk to the
p.000398: public health, such auditor shall immediately notify the Secretary of—
p.000398: (i) the identification of the eligible entity subject to the audit; and
p.000398: (ii) such condition.
p.000398: (B) Types of audits
p.000398: An accredited third-party auditor or audit agent of such auditor may perform
p.000398: consultative and regulatory audits of eligible entities.
p.000398: (C) Limitations
p.000398: (i) In general
p.000398: An accredited third party auditor may not perform a regulatory audit of an eligible
p.000398: entity if such agent has performed a consultative audit or a regulatory audit of such
p.000398: eligible entity during the previous 13-month period.
p.000398: (ii) Waiver
p.000398: The Secretary may waive the application of clause (i) if the Secretary determines
p.000398: that there is insufficient access to accredited third-party auditors in a country or
p.000398: region.
p.000398: (5) Conflicts of interest
p.000398: (A) Third-party auditors
p.000398: An accredited third-party auditor shall—
p.000398: (i) not be owned, managed, or controlled by any person that owns or operates an
p.000398: eligible entity to be certified by such auditor;
p.000398: (ii) in carrying out audits of eligible entities under this section, have procedures to
p.000398: ensure against the use of any officer or employee of such auditor that has a financial
p.000398: conflict of interest regarding an eligible entity to be certified by such auditor; and
p.000398: (iii) annually make available to the Secretary disclosures of the extent to which
p.000398: such auditor and the officers and employees of such auditor have maintained
p.000398: compliance with clauses (i) and (ii) relating to financial conflicts of interest.
p.000398: (B) Audit agents
p.000398: An audit agent shall—
p.000398: (i) not own or operate an eligible entity to be audited by such agent;
p.000398: (ii) in carrying out audits of eligible entities under this section, have procedures to
p.000398: ensure that such agent does not have a financial conflict of interest regarding an
p.000398: eligible entity to be audited by such agent; and
p.000398: (iii) annually make available to the Secretary disclosures of the extent to which
p.000398: such agent has maintained compliance with clauses (i) and (ii) relating to financial
p.000398: conflicts of interest.
p.000398: (C) Regulations
p.000398: The Secretary shall promulgate regulations not later than 18 months after January 4,
p.000398: 2011, to implement this section and to ensure that there are protections against
p.000398: conflicts of interest between an accredited third-party auditor and the eligible entity to
p.000398: be certified by such auditor or audited by such audit agent. Such regulations shall
p.000398: include—
p.000398: (i) requiring that audits performed under this section be unannounced;
p.000398: (ii) a structure to decrease the potential for conflicts of interest, including timing
p.000398: and public disclosure, for fees paid by eligible entities to accredited third-party
p.000398: auditors; and
p.000398: (iii) appropriate limits on financial affiliations between an accredited third-party
p.000398: auditor or audit agents of such auditor and any person that owns or operates an
p.000398: eligible entity to be certified by such auditor, as described in subparagraphs (A) and
p.000398: (B).
p.000398: (6) Withdrawal of accreditation
p.000398: (A) In general
p.000398: The Secretary shall withdraw accreditation from an accredited third-party auditor—
p.000398: (i) if food certified under section 381(q) of this title or from a facility certified under
p.000398: paragraph (2)(B) by such third-party auditor is linked to an outbreak of foodborne
p.000398: illness that has a reasonable probability of causing serious adverse health
p.000398: consequences or death in humans or animals;
p.000398: (ii) following an evaluation and finding by the Secretary that the third-party auditor
p.000398: no longer meets the requirements for accreditation; or
p.000398: (iii) following a refusal to allow United States officials to conduct such audits and
p.000398: investigations as may be necessary to ensure continued compliance with the
p.000398: requirements set forth in this section.
p.000398: (B) Additional basis for withdrawal of accreditation
p.000398: The Secretary may withdraw accreditation from an accredited third-party auditor in
p.000398: the case that such third-party auditor is accredited by an accreditation body for which
p.000398: recognition as an accreditation body under subsection (b)(1)(C) is revoked, if the
p.000398: Secretary determines that there is good cause for the withdrawal.
p.000398: (C) Exception
p.000398: The Secretary may waive the application of subparagraph (A)(i) if the Secretary—
p.000398: (i) conducts an investigation of the material facts related to the outbreak of human
p.000398: or animal illness; and
p.000398: (ii) reviews the steps or actions taken by the third party auditor to justify the
p.000398: certification and determines that the accredited third-party auditor satisfied the
p.000398: requirements under section 381(q) of this title of certifying the food, or the
p.000398: requirements under paragraph (2)(B) of certifying the entity.
p.000398: (7) Reaccreditation
p.000398: The Secretary shall establish procedures to reinstate the accreditation of a third-party
p.000398: auditor for which accreditation has been withdrawn under paragraph (6)—
p.000398: (A) if the Secretary determines, based on evidence presented, that the third-party
p.000398: auditor satisfies the requirements of this section and adequate grounds for revocation
p.000398: no longer exist; and
p.000398: (B) in the case of a third-party auditor accredited by an accreditation body for which
p.000398: recognition as an accreditation body under subsection (b)(1)(C) is revoked—
p.000398: (i) if the third-party auditor becomes accredited not later than 1 year after
p.000398: revocation of accreditation under paragraph (6)(A), through direct accreditation under
p.000398: subsection (b)(1)(A)(ii) or by an accreditation body in good standing; or
p.000398: (ii) under such conditions as the Secretary may require for a third-party auditor
p.000398: under paragraph (6)(B).
p.000398: (8) Neutralizing costs
p.000398: The Secretary shall establish by regulation a reimbursement (user fee) program, similar
p.000398: to the method described in section 1622(h) of title 7,2 by which the Secretary assesses
p.000398: fees and requires accredited third-party auditors and audit agents to reimburse the Food
p.000398: and Drug Administration for the work performed to establish and administer the
p.000398: accreditation system under this section. The Secretary shall make operating this program
p.000398: revenue-neutral and shall not generate surplus revenue from such a reimbursement
p.000398: mechanism. Fees authorized under this paragraph shall be collected and available for
p.000398: obligation only to the extent and in the amount provided in advance in appropriation Acts.
p.000398: Such fees are authorized to remain available until expended.
p.000398: (d) Recertification of eligible entities
p.000398: An eligible entity shall apply for annual recertification by an accredited third-party auditor if
p.000398: such entity—
p.000398: (1) intends to participate in 3 voluntary qualified importer program under section 384b of
p.000398: this title; or
p.000398: (2) is required to provide to the Secretary a certification under section 381(q) of this title
p.000398: for any food from such entity.
p.000398: (e) False statements
p.000398: Any statement or representation made—
p.000398: (1) by an employee or agent of an eligible entity to an accredited third-party auditor or
p.000398: audit agent; or
p.000398: (2) by an accredited third-party auditor to the Secretary,
p.000398:
p.000398: shall be subject to section 1001 of title 18.
p.000398: (f) Monitoring
p.000398: To ensure compliance with the requirements of this section, the Secretary shall—
p.000398: (1) periodically, or at least once every 4 years, reevaluate the accreditation bodies
p.000398: described in subsection (b)(1);
p.000398: (2) periodically, or at least once every 4 years, evaluate the performance of each
p.000398: accredited third-party auditor, through the review of regulatory audit reports by such
p.000398: auditors, the compliance history as available of eligible entities certified by such auditors,
p.000398: and any other measures deemed necessary by the Secretary;
p.000398: (3) at any time, conduct an onsite audit of any eligible entity certified by an accredited
p.000398: third-party auditor, with or without the auditor present; and
p.000398: (4) take any other measures deemed necessary by the Secretary.
p.000398: (g) Publicly available registry
p.000398: The Secretary shall establish a publicly available registry of accreditation bodies and of
p.000398: accredited third-party auditors, including the name of, contact information for, and other
p.000398: information deemed necessary by the Secretary about such bodies and auditors.
p.000398: (h) Limitations
p.000398: (1) No effect on section 374 inspections
p.000398: The audits performed under this section shall not be considered inspections under
p.000398: section 374 of this title.
p.000398: (2) No effect on inspection authority
p.000398: Nothing in this section affects the authority of the Secretary to inspect any eligible
p.000398: entity pursuant to this chapter.
p.000398: (June 25, 1938, ch. 675, §808, as added Pub. L. 111–353, title III, §307, Jan. 4, 2011, 124
p.000398: Stat. 3959.)
p.000398: REFERENCES IN TEXT
p.000398: Section 381(q) of this title, referred to in subsec. (c)(2)(C)(ii), was in the original “301(g)”, and
p.000398: was translated as reading “801(q)”, meaning section 801(q) of act June 25, 1938, ch. 675, which
p.000398: is classified to section 381(q) of this title, to reflect the probable intent of Congress, because
p.000398: section 381(q) of this title relates to food certification, whereas section 301(g) of act June 25,
p.000398: 1938, ch. 675, which is classified to section 331(g) of this title, does not relate to food certification.
p.000398: Section 1622(h) of title 7, referred to in subsec. (c)(8), was in the original “section 203(h) of the
p.000398: Agriculture Marketing Act of 1946”, and was translated as reading “section 203(h) of the
p.000398: Agricultural Marketing Act of 1946”, meaning section 203(h) of act Aug. 14, 1946, ch. 966, which
p.000398: is classified to section 1622(h) of Title 7, Agriculture, to reflect the probable intent of Congress.
p.000398: CONSTRUCTION
p.000398: Nothing in this section to be construed to apply to certain alcohol-related facilities, to alter
p.000398: jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with
p.000398: international agreements to which the United States is a party, see sections 2206, 2251, and 2252
p.000398: of this title.
p.000398:
p.000398: 1 So in original. Probably should be followed by “section”.
p.000398:
p.000398: 2 See References in Text note below.
p.000398:
p.000398: 3 So in original. Probably should be followed by “the”.
p.000398:
p.000398:
p.000398:
p.000398: SUBCHAPTER IX—TOBACCO PRODUCTS
p.000398: PRIOR PROVISIONS
p.000398: A prior subchapter IX of this chapter, consisting of sections 391 to 399a of this title, was
p.000398: redesignated subchapter X by Pub. L. 111–31, div. A, title I, §101(b)(1), June 22, 2009, 123 Stat.
p.000398: 1784.
p.000398:
p.000398:
p.000398: §387. Definitions
p.000398: In this subchapter:
p.000398: (1) Additive
p.000398: The term “additive” means any substance the intended use of which results or may
p.000398: reasonably be expected to result, directly or indirectly, in its becoming a component or
p.000398: otherwise affecting the characteristic of any tobacco product (including any substances
p.000398: intended for use as a flavoring or coloring or in producing, manufacturing, packing,
p.000398: processing, preparing, treating, packaging, transporting, or holding), except that such
p.000398: term does not include tobacco or a pesticide chemical residue in or on raw tobacco or a
p.000398: pesticide chemical.
p.000398: (2) Brand
p.000398: The term “brand” means a variety of tobacco product distinguished by the tobacco
p.000398: used, tar content, nicotine content, flavoring used, size, filtration, packaging, logo,
p.000398: registered trademark, brand name, identifiable pattern of colors, or any combination of
p.000398: such attributes.
p.000398: (3) Cigarette
p.000398: The term “cigarette”—
p.000398: (A) means a product that—
p.000398: (i) is a tobacco product; and
...

p.000398: that is at a level greater than is specified by any tolerance applicable under Federal law
p.000398: to domestically grown tobacco.
p.000398: (2) Revision of tobacco product standards
p.000398: The Secretary may revise the tobacco product standards in paragraph (1) in
p.000398: accordance with subsection (c).
p.000398: (3) Tobacco product standards
p.000398: (A) In general
p.000398: The Secretary may adopt tobacco product standards in addition to those in
p.000398: paragraph (1) if the Secretary finds that a tobacco product standard is appropriate for
p.000398: the protection of the public health.
p.000398: (B) Determinations
p.000398: (i) Considerations
p.000398: In making a finding described in subparagraph (A), the Secretary shall consider
p.000398: scientific evidence concerning—
p.000398: (I) the risks and benefits to the population as a whole, including users and
p.000398: nonusers of tobacco products, of the proposed standard;
p.000398: (II) the increased or decreased likelihood that existing users of tobacco products
p.000398: will stop using such products; and
p.000398: (III) the increased or decreased likelihood that those who do not use tobacco
p.000398: products will start using such products.
p.000398: (ii) Additional considerations
p.000398: In the event that the Secretary makes a determination, set forth in a proposed
p.000398: tobacco product standard in a proposed rule, that it is appropriate for the protection
p.000398: of public health to require the reduction or elimination of an additive, constituent
p.000398: (including a smoke constituent), or other component of a tobacco product because
p.000398: the Secretary has found that the additive, constituent, or other component is or may
p.000398: be harmful, any party objecting to the proposed standard on the ground that the
p.000398: proposed standard will not reduce or eliminate the risk of illness or injury may
p.000398: provide for the Secretary's consideration scientific evidence that demonstrates that
p.000398: the proposed standard will not reduce or eliminate the risk of illness or injury.
p.000398: (4) Content of tobacco product standards
p.000398: A tobacco product standard established under this section for a tobacco product—
p.000398: (A) shall include provisions that are appropriate for the protection of the public health,
p.000398: including provisions, where appropriate—
p.000398: (i) for nicotine yields of the product;
p.000398: (ii) for the reduction or elimination of other constituents, including smoke
p.000398: constituents, or harmful components of the product; or
p.000398: (iii) relating to any other requirement under subparagraph (B);
p.000398:
p.000398: (B) shall, where appropriate for the protection of the public health, include—
p.000398: (i) provisions respecting the construction, components, ingredients, additives,
p.000398: constituents, including smoke constituents, and properties of the tobacco product;
p.000398: (ii) provisions for the testing (on a sample basis or, if necessary, on an individual
p.000398: basis) of the tobacco product;
p.000398: (iii) provisions for the measurement of the tobacco product characteristics of the
p.000398: tobacco product;
p.000398: (iv) provisions requiring that the results of each or of certain of the tests of the
...

p.000398: Pub. L. 108–282, title I, §102(b)(7), Aug. 2, 2004, 118 Stat. 905, provided that: “The Secretary
p.000398: of Health and Human Services shall establish within the Center for Veterinary Medicine (of the
p.000398: Food and Drug Administration), an Office of Minor Use and Minor Species Animal Drug
p.000398: Development that reports directly to the Director of the Center for Veterinary Medicine. This office
p.000398: shall be responsible for overseeing the development and legal marketing of new animal drugs for
p.000398: minor uses and minor species. There is authorized to be appropriated to carry out this subsection
p.000398: $1,200,000 for fiscal year 2004 and such sums as may be necessary for each fiscal year
p.000398: thereafter.”
p.000398: REGULATIONS FOR SUNSCREEN PRODUCTS
p.000398: Section 129 of Pub. L. 105–115 provided that: “Not later than 18 months after the date of
p.000398: enactment of this Act [Nov. 21, 1997], the Secretary of Health and Human Services shall issue
p.000398: regulations for over-the-counter sunscreen products for the prevention or treatment of sunburn.”
p.000398: CONSTRUCTION OF 2011 AMENDMENT
p.000398: Nothing in amendment by Pub. L. 111–353 to be construed to apply to certain alcohol-related
p.000398: facilities, to alter jurisdiction and authorities established under certain other Acts, or in a manner
p.000398: inconsistent with international agreements to which the United States is a party, see sections
p.000398: 2206, 2251, and 2252 of this title.
p.000398: FDA STUDY OF MERCURY COMPOUNDS IN DRUGS AND FOOD
p.000398: Section 413 of Pub. L. 105–115 provided that:
p.000398: “(a) LIST AND ANALYSIS.—The Secretary of Health and Human Services shall, acting through the
p.000398: Food and Drug Administration—
p.000398: “(1) compile a list of drugs and foods that contain intentionally introduced mercury
p.000398: compounds, and
p.000398: “(2) provide a quantitative and qualitative analysis of the mercury compounds in the list
p.000398: under paragraph (1).
p.000398: The Secretary shall compile the list required by paragraph (1) within 2 years after the date of
p.000398: enactment of the Food and Drug Administration Modernization Act of 1997 [Nov. 21, 1997] and
p.000398: shall provide the analysis required by paragraph (2) within 2 years after such date of enactment.
p.000398: “(b) STUDY.—The Secretary of Health and Human Services, acting through the Food and Drug
p.000398: Administration, shall conduct a study of the effect on humans of the use of mercury compounds in
p.000398: nasal sprays. Such study shall include data from other studies that have been made of such use.
p.000398: “(c) STUDY OF MERCURY SALES.—
p.000398: “(1) STUDY.—The Secretary of Health and Human Services, acting through the Food and
p.000398: Drug Administration and subject to appropriations, shall conduct, or shall contract with the
p.000398: Institute of Medicine of the National Academy of Sciences to conduct, a study of the effect on
p.000398: humans of the use of elemental, organic, or inorganic mercury when offered for sale as a drug
...

p.000398: June 12, 2002, 116 Stat. 673; renumbered §1009 and amended Pub. L. 111–31, div. A, title
p.000398: I, §§101(b)(2), 103(n), June 22, 2009, 123 Stat. 1784, 1838; Pub. L. 111–353, title II,
p.000398: §210(a), Jan. 4, 2011, 124 Stat. 3948.)
p.000398: REFERENCES IN TEXT
p.000398: The FDA Food Safety Modernization Act, referred to in subsec. (f), is Pub. L. 111–353, Jan. 4,
p.000398: 2011, 124 Stat. 3885, which enacted chapter 27 (§2201 et seq.) and sections 350g to 350l–1,
p.000398: 379j–31, 384a to 384d, 399c, and 399d of this title, section 7625 of Title 7, Agriculture, and
p.000398: section 280g–16 of Title 42, The Public Health and Welfare, amended sections 331, 333, 334,
p.000398: 350b to 350d, 350f, 374, 381, 393, and 399 of this title and section 247b–20 of Title 42, and
p.000398: enacted provisions set out as notes under sections 331, 334, 342, 350b, 350d, 350e, 350g to
p.000398: 350j, 350l, and 381 of this title. For complete classification of this Act to the Code, see Short Title
p.000398: note set out under section 2201 of this title and Tables.
p.000398: AMENDMENTS
p.000398: 2011—Pub. L. 111–353 amended section generally. Prior to amendment, section related to
p.000398: grants to States for inspections.
p.000398: 2009—Subsec. (b). Pub. L. 111–31, §103(n), made technical amendment to reference in
p.000398: original act which appears in text as reference to section 398 of this title.
p.000398: CONSTRUCTION OF 2011 AMENDMENT
p.000398: Nothing in amendment by Pub. L. 111–353 to be construed to apply to certain alcohol-related
p.000398: facilities, to alter jurisdiction and authorities established under certain other Acts, or in a manner
p.000398: inconsistent with international agreements to which the United States is a party, see sections
p.000398: 2206, 2251, and 2252 of this title.
p.000398:
p.000398:
p.000398: §399a. Office of the Chief Scientist
p.000398: (a) Establishment; appointment
p.000398: The Secretary shall establish within the Office of the Commissioner an office to be known
p.000398: as the Office of the Chief Scientist. The Secretary shall appoint a Chief Scientist to lead
p.000398: such Office.
p.000398: (b) Duties of the Office
p.000398: The Office of the Chief Scientist shall—
p.000398: (1) oversee, coordinate, and ensure quality and regulatory focus of the intramural
p.000398: research programs of the Food and Drug Administration;
p.000398: (2) track and, to the extent necessary, coordinate intramural research awards made by
p.000398: each center of the Administration or science-based office within the Office of the
p.000398: Commissioner, and ensure that there is no duplication of research efforts supported by
p.000398: the Reagan-Udall Foundation for the Food and Drug Administration;
p.000398: (3) develop and advocate for a budget to support intramural research;
p.000398: (4) develop a peer review process by which intramural research can be evaluated;
p.000398: (5) identify and solicit intramural research proposals from across the Food and Drug
p.000398: Administration through an advisory board composed of employees of the Administration
p.000398: that shall include—
p.000398: (A) representatives of each of the centers and the science-based offices within the
p.000398: Office of the Commissioner; and
p.000398: (B) experts on trial design, epidemiology, demographics, pharmacovigilance, basic
p.000398: science, and public health; and
p.000398:
...

p.000398: accordance with section 7625 of title 7.
p.000398: (e) Authorization of appropriations
p.000398: There are authorized to be appropriated such sums as may be necessary to carry out this
p.000398: section for fiscal years 2011 through 2015.
p.000398: (June 25, 1938, ch. 675, §1011, as added Pub. L. 111–353, title II, §209(a), Jan. 4, 2011,
p.000398: 124 Stat. 3945.)
p.000398: REFERENCES IN TEXT
p.000398: The FDA Food Safety Modernization Act, referred to in subsec. (c), is Pub. L. 111–353, Jan. 4,
p.000398: 2011, 124 Stat. 3885, which enacted chapter 27 (§2201 et seq.) and sections 350g to 350l–1,
p.000398: 379j–31, 384a to 384d, 399c, and 399d of this title, section 7625 of Title 7, Agriculture, and
p.000398: section 280g–16 of Title 42, The Public Health and Welfare, amended sections 331, 333, 334,
p.000398: 350b to 350d, 350f, 374, 381, 393, and 399 of this title and section 247b–20 of Title 42, and
p.000398: enacted provisions set out as notes under sections 331, 334, 342, 350b, 350d, 350e, 350g to
p.000398: 350j, 350l, and 381 of this title. For complete classification of this Act to the Code, see Short Title
p.000398: note set out under section 2201 of this title and Tables.
p.000398: CODIFICATION
p.000398: Another section 1011 of act June 25, 1938, ch. 675, was enacted by Pub. L. 111–148, title III,
p.000398: §3509(g), Mar. 23, 2010, 124 Stat. 536, and is classified to section 399b of this title.
p.000398: CONSTRUCTION
p.000398: Nothing in this section to be construed to apply to certain alcohol-related facilities, to alter
p.000398: jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with
p.000398: international agreements to which the United States is a party, see sections 2206, 2251, and 2252
p.000398: of this title.
p.000398:
p.000398:
p.000398: §399d. Employee protections
p.000398: (a) In general
p.000398: No entity engaged in the manufacture, processing, packing, transporting, distribution,
p.000398: reception, holding, or importation of food may discharge an employee or otherwise
p.000398: discriminate against an employee with respect to compensation, terms, conditions, or
p.000398: privileges of employment because the employee, whether at the employee's initiative or in
p.000398: the ordinary course of the employee's duties (or any person acting pursuant to a request of
p.000398: the employee)—
p.000398: (1) provided, caused to be provided, or is about to provide or cause to be provided to
p.000398: the employer, the Federal Government, or the attorney general of a State information
p.000398: relating to any violation of, or any act or omission the employee reasonably believes to be
p.000398: a violation of any provision of this chapter or any order, rule, regulation, standard, or ban
p.000398: under this chapter, or any order, rule, regulation, standard, or ban under this chapter; 1
p.000398: (2) testified or is about to testify in a proceeding concerning such violation;
p.000398: (3) assisted or participated or is about to assist or participate in such a proceeding; or
p.000398: (4) objected to, or refused to participate in, any activity, policy, practice, or assigned
p.000398: task that the employee (or other such person) reasonably believed to be in violation of
p.000398: any provision of this chapter, or any order, rule, regulation, standard, or ban under this
p.000398: chapter.
p.000398: (b) Process
p.000398: (1) In general
p.000398: A person who believes that he or she has been discharged or otherwise discriminated
p.000398: against by any person in violation of subsection (a) may, not later than 180 days after the
...

p.000398: (i) to take affirmative action to abate the violation;
p.000398: (ii) to reinstate the complainant to his or her former position together with
p.000398: compensation (including back pay) and restore the terms, conditions, and privileges
p.000398: associated with his or her employment; and
p.000398: (iii) to provide compensatory damages to the complainant.
p.000398: (C) Penalty
p.000398: If such an order is issued under this paragraph, the Secretary, at the request of the
p.000398: complainant, shall assess against the person against whom the order is issued a sum
p.000398: equal to the aggregate amount of all costs and expenses (including attorneys’ and
p.000398: expert witness fees) reasonably incurred, as determined by the Secretary, by the
p.000398: complainant for, or in connection with, the bringing of the complaint upon which the
p.000398: order was issued.
p.000398: (D) Bad faith claim
p.000398: If the Secretary finds that a complaint under paragraph (1) is frivolous or has been
p.000398: brought in bad faith, the Secretary may award to the prevailing employer a reasonable
p.000398: attorneys’ fee, not exceeding $1,000, to be paid by the complainant.
p.000398: (4) Action in court
p.000398: (A) In general
p.000398: If the Secretary has not issued a final decision within 210 days after the filing of the
p.000398: complaint, or within 90 days after receiving a written determination, the complainant
p.000398: may bring an action at law or equity for de novo review in the appropriate district court
p.000398: of the United States with jurisdiction, which shall have jurisdiction over such an action
p.000398: without regard to the amount in controversy, and which action shall, at the request of
p.000398: either party to such action, be tried by the court with a jury. The proceedings shall be
p.000398: governed by the same legal burdens of proof specified in paragraph (2)(C).
p.000398: (B) Relief
p.000398: The court shall have jurisdiction to grant all relief necessary to make the employee
p.000398: whole, including injunctive relief and compensatory damages, including—
p.000398: (i) reinstatement with the same seniority status that the employee would have had,
p.000398: but for the discharge or discrimination;
p.000398: (ii) the amount of back pay, with interest; and
p.000398: (iii) compensation for any special damages sustained as a result of the discharge
p.000398: or discrimination, including litigation costs, expert witness fees, and reasonable
p.000398: attorney's fees.
p.000398: (5) Review
p.000398: (A) In general
p.000398: Unless the complainant brings an action under paragraph (4), any person adversely
p.000398: affected or aggrieved by a final order issued under paragraph (3) may obtain review of
p.000398: the order in the United States Court of Appeals for the circuit in which the violation,
p.000398: with respect to which the order was issued, allegedly occurred or the circuit in which
p.000398: the complainant resided on the date of such violation. The petition for review must be
p.000398: filed not later than 60 days after the date of the issuance of the final order of the
p.000398: Secretary. Review shall conform to chapter 7 of title 5. The commencement of
p.000398: proceedings under this subparagraph shall not, unless ordered by the court, operate as
p.000398: a stay of the order.
p.000398: (B) No judicial review
p.000398: An order of the Secretary with respect to which review could have been obtained
p.000398: under subparagraph (A) shall not be subject to judicial review in any criminal or other
p.000398: civil proceeding.
p.000398: (6) Failure to comply with order
p.000398: Whenever any person has failed to comply with an order issued under paragraph (3),
p.000398: the Secretary may file a civil action in the United States district court for the district in
p.000398: which the violation was found to occur, or in the United States district court for the District
p.000398: of Columbia, to enforce such order. In actions brought under this paragraph, the district
p.000398: courts shall have jurisdiction to grant all appropriate relief including, but not limited to,
p.000398: injunctive relief and compensatory damages.
p.000398: (7) Civil action to require compliance
p.000398: (A) In general
p.000398: A person on whose behalf an order was issued under paragraph (3) may commence
p.000398: a civil action against the person to whom such order was issued to require compliance
p.000398: with such order. The appropriate United States district court shall have jurisdiction,
p.000398: without regard to the amount in controversy or the citizenship of the parties, to enforce
p.000398: such order.
p.000398: (B) Award
p.000398: The court, in issuing any final order under this paragraph, may award costs of
p.000398: litigation (including reasonable attorneys’ and expert witness fees) to any party
p.000398: whenever the court determines such award is appropriate.
p.000398: (c) Effect of section
p.000398: (1) Other laws
p.000398: Nothing in this section preempts or diminishes any other safeguards against
p.000398: discrimination, demotion, discharge, suspension, threats, harassment, reprimand,
p.000398: retaliation, or any other manner of discrimination provided by Federal or State law.
p.000398: (2) Rights of employees
p.000398: Nothing in this section shall be construed to diminish the rights, privileges, or remedies
p.000398: of any employee under any Federal or State law or under any collective bargaining
p.000398: agreement. The rights and remedies in this section may not be waived by any agreement,
p.000398: policy, form, or condition of employment.
p.000398: (d) Enforcement
p.000398: Any nondiscretionary duty imposed by this section shall be enforceable in a mandamus
p.000398: proceeding brought under section 1361 of title 28.
p.000398: (e) Limitation
p.000398: Subsection (a) shall not apply with respect to an employee of an entity engaged in the
p.000398: manufacture, processing, packing, transporting, distribution, reception, holding, or
p.000398: importation of food who, acting without direction from such entity (or such entity's agent),
p.000398: deliberately causes a violation of any requirement relating to any violation or alleged
p.000398: violation of any order, rule, regulation, standard, or ban under this chapter.
p.000398: (June 25, 1938, ch. 675, §1012, as added Pub. L. 111–353, title IV, §402, Jan. 4, 2011, 124
p.000398: Stat. 3968.)
p.000398: CONSTRUCTION
p.000398: Nothing in this section to be construed to alter jurisdiction and authorities established under
p.000398: certain other Acts or in a manner inconsistent with international agreements to which the United
p.000398: States is a party, see sections 2251 and 2252 of this title.
p.000398:
p.000398: 1 So in original.
...

Searching for indicator political:

(return to top)
p.001994: shall carry out activities which educate consumers about—
p.001994: “(1) the availability of nutrition information in the label or labeling of food, and
p.001994: “(2) the importance of that information in maintaining healthy dietary practices.”
p.001994: STUDIES CONCERNING CARCINOGENIC AND OTHER TOXIC SUBSTANCES IN FOOD AND IMPURITIES IN AND
p.001994: TOXICITY OF SACCHARIN
p.001994: Section 2 of Pub. L. 95–203 directed Secretary of Health, Education, and Welfare to conduct a
p.001994: study concerning carcinogenic and other toxic substances in food and impurities in and toxicity of
p.001994: saccharin and make a report respecting the carcinogenic and other substances to Committee on
p.001994: Human Resources of the Senate within 12 months of Nov. 23, 1977, and a report respecting
p.001994: saccharin to such committee within 15 months of Nov. 23, 1977.
p.001994: REPORT TO CONGRESSIONAL COMMITTEES RESPECTING ACTION TAKEN PURSUANT TO FORMER PAR. (O )(2)
p.001994: Section 4(a)(3) of Pub. L. 95–203 provided that the Secretary was to report to specified
p.001994: congressional committees any action taken under former par. (o)(2) of this section.
p.001994: STATE OR TERRITORIAL REQUIREMENTS
p.001994: Section 2 of Pub. L. 86–537 provided that: “Nothing in the amendments made by the first
p.001994: section of this Act [amending this section] shall affect any requirement of the laws of any State or
p.001994: Territory.”
p.001994:
p.001994: 1 So in original. Probably should be followed by a comma.
p.001994:
p.001994:
p.001994:
p.001994: §343–1. National uniform nutrition labeling
p.001994: (a) Except as provided in subsection (b) of this section, no State or political subdivision of
p.001994: a State may directly or indirectly establish under any authority or continue in effect as to
p.001994: any food in interstate commerce—
p.001994: (1) any requirement for a food which is the subject of a standard of identity established
p.001994: under section 341 of this title that is not identical to such standard of identity or that is not
p.001994: identical to the requirement of section 343(g) of this title, except that this paragraph does
p.001994: not apply to a standard of identity of a State or political subdivision of a State for maple
p.001994: syrup that is of the type required by sections 341 and 343(g) of this title,
p.001994: (2) any requirement for the labeling of food of the type required by section 343(c),
p.001994: 343(e), 343(i)(2), 343(w), or 343(x) of this title that is not identical to the requirement of
p.001994: such section, except that this paragraph does not apply to a requirement of a State or
p.001994: political subdivision of a State that is of the type required by section 343(c) of this title and
p.001994: that is applicable to maple syrup,
p.001994: (3) any requirement for the labeling of food of the type required by section 343(b),
p.001994: 343(d), 343(f), 343(h), 343(i)(1), or 343(k) of this title that is not identical to the
p.001994: requirement of such section, except that this paragraph does not apply to a requirement
p.001994: of a State or political subdivision of a State that is of the type required by section 343(h)
p.001994: (1) of this title and that is applicable to maple syrup,
p.001994: (4) any requirement for nutrition labeling of food that is not identical to the requirement
p.001994: of section 343(q) of this title, except that this paragraph does not apply to food that is
p.001994: offered for sale in a restaurant or similar retail food establishment that is not part of a
p.001994: chain with 20 or more locations doing business under the same name (regardless of the
p.001994: type of ownership of the locations) and offering for sale substantially the same menu
p.001994: items unless such restaurant or similar retail food establishment complies with the
p.001994: voluntary provision of nutrition information requirements under section 343(q)(5)(H)(ix) of
p.001994: this title, or
p.001994: (5) any requirement respecting any claim of the type described in section 343(r)(1) of
p.001994: this title made in the label or labeling of food that is not identical to the requirement of
p.001994: section 343(r) of this title, except a requirement respecting a claim made in the label or
p.001994: labeling of food which is exempt under section 343(r)(5)(B) of this title.
p.001994:
p.001994: Paragraph (3) shall take effect in accordance with section 6(b) of the Nutrition Labeling
p.001994: and Education Act of 1990.
p.001994: (b) Upon petition of a State or a political subdivision of a State, the Secretary may
p.001994: exempt from subsection (a) of this section, under such conditions as may be prescribed by
p.001994: regulation, any State or local requirement that—
p.001994: (1) would not cause any food to be in violation of any applicable requirement under
p.001994: Federal law,
p.001994: (2) would not unduly burden interstate commerce, and
p.001994: (3) is designed to address a particular need for information which need is not met by
p.001994: the requirements of the sections referred to in subsection (a) of this section.
p.001994: (June 25, 1938, ch. 675, §403A, as added Pub. L. 101–535, §6(a), Nov. 8, 1990, 104 Stat.
p.001994: 2362; amended Pub. L. 102–108, §2(b), Aug. 17, 1991, 105 Stat. 549; Pub. L. 103–396,
p.001994: §3(a), Oct. 22, 1994, 108 Stat. 4154; Pub. L. 108–282, title II, §203(c)(2), Aug. 2, 2004, 118
p.001994: Stat. 908; Pub. L. 111–148, title IV, §4205(c), Mar. 23, 2010, 124 Stat. 576.)
p.001994: REFERENCES IN TEXT
p.001994: Section 6(b) of the Nutrition Labeling and Education Act of 1990 [Pub. L. 101–535], referred to
p.001994: in subsec. (a), is set out below.
p.001994: AMENDMENTS
p.001994: 2010—Subsec. (a)(4). Pub. L. 111–148 substituted “except that this paragraph does not apply
p.001994: to food that is offered for sale in a restaurant or similar retail food establishment that is not part of
p.001994: a chain with 20 or more locations doing business under the same name (regardless of the type of
p.001994: ownership of the locations) and offering for sale substantially the same menu items unless such
p.001994: restaurant or similar retail food establishment complies with the voluntary provision of nutrition
p.001994: information requirements under section 343(q)(5)(H)(ix) of this title” for “except a requirement for
p.001994: nutrition labeling of food which is exempt under subclause (i) or (ii) of section 343(q)(5)(A) of this
p.001994: title”.
p.001994: 2004—Subsec. (a)(2). Pub. L. 108–282 substituted “343(i)(2), 343(w), or 343(x)” for “or 343(i)
p.001994: (2)”.
p.001994: 1994—Subsec. (a)(1). Pub. L. 103–396, §3(a)(1), inserted at end “except that this paragraph
p.001994: does not apply to a standard of identity of a State or political subdivision of a State for maple syrup
p.001994: that is of the type required by sections 341 and 343(g) of this title,”.
p.001994: Subsec. (a)(2). Pub. L. 103–396, §3(a)(2), inserted at end “except that this paragraph does not
p.001994: apply to a requirement of a State or political subdivision of a State that is of the type required by
p.001994: section 343(c) of this title and that is applicable to maple syrup,”.
p.001994: Subsec. (a)(3). Pub. L. 103–396, §3(a)(3), inserted at end “except that this paragraph does not
p.001994: apply to a requirement of a State or political subdivision of a State that is of the type required by
p.001994: section 343(h)(1) of this title and that is applicable to maple syrup,”.
p.001994: 1991—Subsec. (a)(5). Pub. L. 102–108 substituted “section 343(r)(5)(B) of this title” for “clause
p.001994: (B) of such section”.
p.001994: EFFECTIVE DATE OF 2004 AMENDMENT
p.001994: Amendment by Pub. L. 108–282 applicable to any food that is labeled on or after Jan. 1, 2006,
p.001994: see section 203(d) of Pub. L. 108–282, set out as a note under section 321 of this title.
p.001994: EFFECTIVE DATE
p.001994: Section 10(b) of Pub. L. 101–535, as amended by Pub. L. 102–571, title I, §107(16), title II,
p.001994: §202(a)(4), Oct. 29, 1992, 106 Stat. 4499, 4501, provided that:
p.001994: “(1) IN GENERAL.—Except as provided in paragraph (2), the amendments made by section 6
p.001994: [enacting this section] shall take effect—
p.001994: “(A) with respect to a requirement of a State or political subdivision described in paragraph
p.001994: (1) of section 403A(a) of the Federal Food, Drug, and Cosmetic Act [subsec. (a)(1) of this
p.001994: section], on the date of the enactment of this Act [Nov. 8, 1990],
p.001994: “(B) with respect to a requirement of a State or political subdivision described in paragraph
p.001994: (2) of section 403A(a) of the Federal Food, Drug, and Cosmetic Act, one year after the date of
p.001994: the enactment of this Act,
p.001994: “(C) with respect to a requirement of a State or political subdivision described in paragraph
p.001994: (3) of section 403A(a) of the Federal Food, Drug, and Cosmetic Act, as prescribed by section
p.001994: 6(b) of the Nutrition Labeling and Education Act of 1990 [Pub. L. 101–535, set out below],
p.001994: “(D) with respect to a requirement of a State or political subdivision described in paragraph
p.001994: (4) of section 403A(a) of the Federal Food, Drug, and Cosmetic Act, on the date regulations to
p.001994: implement section 403(q) of such Act [21 U.S.C. 343(q)] take effect, and
p.001994: “(E) with respect to a requirement of a State or political subdivision described in paragraph
p.001994: (5) of section 403A(a) of the Federal Food, Drug, and Cosmetic Act, on the date regulations to
p.001994: implement section 403(r) of such Act take effect.
p.001994: “(2) EXCEPTION.—If a State or political subdivision submits a petition under section 403A(b) of the
p.001994: Federal Food, Drug, and Cosmetic Act for a requirement described in section 403A(a) of such Act
p.001994: within 18 months of the date of the enactment of this Act, paragraphs (3) through (5) of such
p.001994: section 403A(a) shall not apply with respect to such State or political subdivision requirement until
p.001994: —
p.001994: “(A) 24 months after the date of the enactment of this Act, or
p.001994: “(B) action on the petition,
p.001994: whichever occurs later.
p.001994: “(3) REQUIREMENTS PERTAINING TO CERTAIN CLAIMS.—Notwithstanding subparagraphs (D) and (E) of
p.001994: paragraph (1) and except with respect to claims approved in accordance with section 202(b) of
p.001994: the Dietary Supplement Act of 1992 [Pub. L. 102–571, set out as a note under section 343 of this
p.001994: title], the requirements described in paragraphs (4) and (5) of section 403A(a) of the Federal
p.001994: Food, Drug, and Cosmetic Act (21 U.S.C. 343–1(a)(4) and (5)) that pertain to dietary supplements
p.001994: of vitamins, minerals, herbs, or other similar nutritional substances shall not take effect until the
p.001994: date final regulations take effect to implement subsection (q) or (r), as appropriate, of section 403
p.001994: of such Act with respect to such dietary supplements.”
p.001994: Section 6(b) of Pub. L. 101–535 provided that:
p.001994: “(1) For the purpose of implementing section 403A(a)(3) [21 U.S.C. 343–1(a)(3)], the Secretary
p.001994: of Health and Human Services shall enter into a contract with a public or nonprofit private entity to
p.001994: conduct a study of—
p.001994: “(A) State and local laws which require the labeling of food that is of the type required by
p.001994: sections 403(b), 403(d), 403(f), 403(h), 403(i)(1), and 403(k) of the Federal Food, Drug, and
p.001994: Cosmetic Act [21 U.S.C. 343(b), (d), (f), (h), (i)(1), (k)], and
p.001994: “(B) the sections of the Federal Food, Drug, and Cosmetic Act referred to in subparagraph
p.001994: (A) and the regulations issued by the Secretary to enforce such sections to determine whether
p.001994: such sections and regulations adequately implement the purposes of such sections.
p.001994: “(2) The contract under paragraph (1) shall provide that the study required by such paragraph
p.001994: shall be completed within 6 months of the date of the enactment of this Act [Nov. 8, 1990].
p.001994: “(3)(A) Within 9 months of the date of the enactment of this Act, the Secretary shall publish a
p.001994: proposed list of sections which are adequately being implemented by regulations as determined
p.001994: under paragraph (1)(B) and sections which are not adequately being implemented by regulations
p.001994: as so determined. After publication of the lists, the Secretary shall provide 60 days for comments
p.001994: on such lists.
p.001994: “(B) Within 24 months of the date of the enactment of this Act, the Secretary shall publish a final
p.001994: list of sections which are adequately being implemented by regulations and a list of sections which
p.001994: are not adequately being implemented by regulations. With respect to a section which is found by
p.001994: the Secretary to be adequately implemented, no State or political subdivision of a State may
p.001994: establish or continue in effect as to any food in interstate commerce any requirement which is not
p.001994: identical to the requirement of such section.
p.001994: “(C) Within 24 months of the date of the enactment of this Act, the Secretary shall publish
p.001994: proposed revisions to the regulations found to be inadequate under subparagraph (B) and within
p.001994: 30 months of such date shall issue final revisions. Upon the effective date of such final revisions,
p.001994: no State or political subdivision may establish or continue in effect any requirement which is not
p.001994: identical to the requirement of the section which had its regulations revised in accordance with this
p.001994: subparagraph.
p.001994: “(D)(i) If the Secretary does not issue a final list in accordance with subparagraph (B), the
p.001994: proposed list issued under subparagraph (A) shall be considered the final list and States and
p.001994: political subdivisions shall be preempted with respect to sections found to be adequate in such
p.001994: proposed list in accordance with subparagraph (B).
p.001994: “(ii) If the Secretary does not issue final revisions of regulations in accordance with
p.001994: subparagraph (C), the proposed revisions issued under such subparagraph shall be considered
p.001994: the final revisions and States and political subdivisions shall be preempted with respect to
p.001994: sections the regulations of which are revised by the proposed revisions.
p.001994: “(E) Subsection (b) of section 403A of the Federal Food, Drug, and Cosmetic Act shall apply
p.001994: with respect to the prohibition prescribed by subparagraphs (B) and (C).”
p.001994: CONSTRUCTION OF PUB. L. 101–535
p.001994: Section 6(c) of Pub. L. 101–535 provided that:
p.001994: “(1) The Nutrition Labeling and Education Act of 1990 [Pub. L. 101–535, see Short Title of 1990
p.001994: Amendment note set out under section 301 of this title] shall not be construed to preempt any
p.001994: provision of State law, unless such provision is expressly preempted under section 403A of the
p.001994: Federal Food, Drug, and Cosmetic Act [this section].
p.001994: “(2) The amendment made by subsection (a) [enacting this section] and the provisions of
p.001994: subsection (b) [set out as a note above] shall not be construed to apply to any requirement
p.001994: respecting a statement in the labeling of food that provides for a warning concerning the safety of
p.001994: the food or component of the food.
p.001994: “(3) The amendment made by subsection (a), the provisions of subsection (b) and paragraphs
p.001994: (1) and (2) of this subsection shall not be construed to affect preemption, express or implied, of
p.001994: any such requirement of a State or political subdivision, which may arise under the Constitution,
p.001994: any provision of the Federal Food, Drug, and Cosmetic Act [this chapter] not amended by
p.001994: subsection (a), any other Federal law, or any Federal regulation, order, or other final agency
p.001994: action reviewable under chapter 7 of title 5, United States Code.”
p.001994: Amendments by Pub. L. 101–535 not to be construed to alter the authority of the Secretary of
p.001994: Health and Human Services and the Secretary of Agriculture under the Federal Food, Drug, and
p.001994: Cosmetic Act (21 U.S.C. 301 et seq.), the Federal Meat Inspection Act (21 U.S.C. 601 et seq.),
p.001994: the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), and the Egg Products Inspection Act
p.001994: (21 U.S.C. 1031 et seq.), see section 9 of Pub. L. 101–535, set out as a note under section 343 of
p.001994: this title.
p.001994: DELAYED APPLICABILITY OF CERTAIN PROVISIONS
p.001994: Pub. L. 102–408, title III, §310, Oct. 13, 1992, 106 Stat. 2090, provided that: “Notwithstanding
p.001994: any other provision of law, section 403A(a)(1) of the Federal Food, Drug, and Cosmetic Act (21
p.001994: U.S.C. 343–1(a)(1)) shall not apply with respect to any requirement of any State or political
p.001994: subdivision regarding maple syrup until September 1, 1994.”
p.001994:
p.001994:
p.001994: §343–2. Dietary supplement labeling exemptions
p.001994: (a) In general
p.001994: A publication, including an article, a chapter in a book, or an official abstract of a peer-
p.001994: reviewed scientific publication that appears in an article and was prepared by the author or
p.001994: the editors of the publication, which is reprinted in its entirety, shall not be defined as
p.001994: labeling when used in connection with the sale of a dietary supplement to consumers when
p.001994: it—
p.001994: (1) is not false or misleading;
p.001994: (2) does not promote a particular manufacturer or brand of a dietary supplement;
p.001994: (3) is displayed or presented, or is displayed or presented with other such items on the
p.001994: same subject matter, so as to present a balanced view of the available scientific
p.001994: information on a dietary supplement;
p.001994: (4) if displayed in an establishment, is physically separate from the dietary
p.001994: supplements; and
p.001994: (5) does not have appended to it any information by sticker or any other method.
p.001994: (b) Application
p.001994: Subsection (a) of this section shall not apply to or restrict a retailer or wholesaler of
p.001994: dietary supplements in any way whatsoever in the sale of books or other publications as a
p.001994: part of the business of such retailer or wholesaler.
p.001994: (c) Burden of proof
p.001994: In any proceeding brought under subsection (a) of this section, the burden of proof shall
p.001994: be on the United States to establish that an article or other such matter is false or
p.001994: misleading.
p.001994: (June 25, 1938, ch. 675, §403B, as added Pub. L. 103–417, §5, Oct. 25, 1994, 108 Stat.
p.001994: 4328.)
p.001994:
p.001994:
p.001994: §343–3. Disclosure
...

p.001994: (B) was approved for such use in a reregistration eligibility determination issued
p.001994: under section 4(g) of that Act [7 U.S.C. 136a–1(g)] on or after August 3, 1996.
p.001994: (2) “Qualifying Federal determination” defined
p.001994: For purposes of this subsection, the term “qualifying Federal determination” means a
p.001994: tolerance or exemption from the requirement for a tolerance for a qualifying pesticide
p.001994: chemical residue that—
p.001994: (A) is issued under this section after August 3, 1996, and determined by the
p.001994: Administrator to meet the standard under subsection (b)(2)(A) (in the case of a
p.001994: tolerance) or (c)(2) (in the case of an exemption) of this section; or
p.001994: (B)(i) pursuant to subsection (j) of this section is remaining in effect or is deemed to
p.001994: have been issued under this section, or is regarded under subsection (k) of this section
p.001994: as exempt from the requirement for a tolerance; and
p.001994: (ii) is determined by the Administrator to meet the standard under subsection (b)(2)
p.001994: (A) (in the case of a tolerance) or (c)(2) (in the case of an exemption) of this section.
p.001994: (3) Limitation
p.001994: The Administrator may make the determination described in paragraph (2)(B)(ii) only
p.001994: by issuing a rule in accordance with the procedure set forth in subsection (d) or (e) of this
p.001994: section and only if the Administrator issues a proposed rule and allows a period of not
p.001994: less than 30 days for comment on the proposed rule. Any such rule shall be reviewable in
p.001994: accordance with subsections (g) and (h) of this section.
p.001994: (4) State authority
p.001994: Except as provided in paragraphs (5), (6), and (8) no State or political subdivision may
p.001994: establish or enforce any regulatory limit on a qualifying pesticide chemical residue in or
p.001994: on any food if a qualifying Federal determination applies to the presence of such
p.001994: pesticide chemical residue in or on such food, unless such State regulatory limit is
p.001994: identical to such qualifying Federal determination. A State or political subdivision shall be
p.001994: deemed to establish or enforce a regulatory limit on a pesticide chemical residue in or on
p.001994: a food if it purports to prohibit or penalize the production, processing, shipping, or other
p.001994: handling of a food because it contains a pesticide residue (in excess of a prescribed
p.001994: limit).
p.001994: (5) Petition procedure
p.001994: (A) In general
p.001994: Any State may petition the Administrator for authorization to establish in such State a
p.001994: regulatory limit on a qualifying pesticide chemical residue in or on any food that is not
p.001994: identical to the qualifying Federal determination applicable to such qualifying pesticide
p.001994: chemical residue.
p.001994: (B) Petition requirements
p.001994: Any petition under subparagraph (A) shall—
p.001994: (i) satisfy any requirements prescribed, by rule, by the Administrator; and
p.001994: (ii) be supported by scientific data about the pesticide chemical residue that is the
p.001994: subject of the petition or about chemically related pesticide chemical residues, data
p.001994: on the consumption within such State of food bearing the pesticide chemical residue,
p.001994: and data on exposure of humans within such State to the pesticide chemical residue.
p.001994: (C) Authorization
p.001994: The Administrator may, by order, grant the authorization described in subparagraph
p.001994: (A) if the Administrator determines that the proposed State regulatory limit—
p.001994: (i) is justified by compelling local conditions; and
p.001994: (ii) would not cause any food to be a violation of Federal law.
p.001994: (D) Treatment
p.001994: In lieu of any action authorized under subparagraph (C), the Administrator may treat
p.001994: a petition under this paragraph as a petition under subsection (d) of this section to
p.001994: modify or revoke a tolerance or an exemption. If the Administrator determines to treat a
p.001994: petition under this paragraph as a petition under subsection (d) of this section, the
p.001994: Administrator shall thereafter act on the petition pursuant to subsection (d) of this
p.001994: section.
p.001994: (E) Review
p.001994: Any order of the Administrator granting or denying the authorization described in
p.001994: subparagraph (A) shall be subject to review in the manner described in subsections (g)
p.001994: and (h) of this section.
p.001994: (6) Urgent petition procedure
p.001994: Any State petition to the Administrator pursuant to paragraph (5) that demonstrates
p.001994: that consumption of a food containing such pesticide residue level during the period of
p.001994: the food's likely availability in the State will pose a significant public health threat from
p.001994: acute exposure shall be considered an urgent petition. If an order by the Administrator to
p.001994: grant or deny the requested authorization in an urgent petition is not made within 30 days
p.001994: of receipt of the petition, the petitioning State may establish and enforce a temporary
p.001994: regulatory limit on a qualifying pesticide chemical residue in or on the food. The
p.001994: temporary regulatory limit shall be validated or terminated by the Administrator's final
p.001994: order on the petition.
p.001994: (7) Residues from lawful application
p.001994: No State or political subdivision may enforce any regulatory limit on the level of a
p.001994: pesticide chemical residue that may appear in or on any food if, at the time of the
p.001994: application of the pesticide that resulted in such residue, the sale of such food with such
p.001994: residue level was lawful under this section and under the law of such State, unless the
p.001994: State demonstrates that consumption of the food containing such pesticide residue level
p.001994: during the period of the food's likely availability in the State will pose an unreasonable
p.001994: dietary risk to the health of persons within such State.
p.001994: (8) Savings
p.001994: Nothing in this chapter preempts the authority of any State or political subdivision to
p.001994: require that a food containing a pesticide chemical residue bear or be the subject of a
p.001994: warning or other statement relating to the presence of the pesticide chemical residue in
p.001994: or on such food.
p.001994: (o) Consumer right to know
p.001994: Not later than 2 years after August 3, 1996, and annually thereafter, the Administrator
p.001994: shall, in consultation with the Secretary of Agriculture and the Secretary of Health and
p.001994: Human Services, publish in a format understandable to a lay person, and distribute to large
p.001994: retail grocers for public display (in a manner determined by the grocer), the following
p.001994: information, at a minimum:
p.001994: (1) A discussion of the risks and benefits of pesticide chemical residues in or on food
p.001994: purchased by consumers.
p.001994: (2) A listing of actions taken under subparagraph (B) of subsection (b)(2) of this section
p.001994: that may result in pesticide chemical residues in or on food that present a yearly or
p.001994: lifetime risk above the risk allowed under subparagraph (A) of such subsection, and the
p.001994: food on which the pesticide chemicals producing the residues are used.
p.001994: (3) Recommendations to consumers for reducing dietary exposure to pesticide
p.001994: chemical residues in a manner consistent with maintaining a healthy diet, including a list
p.001994: of food that may reasonably substitute for food listed under paragraph (2).
p.001994:
p.001994: Nothing in this subsection shall prevent retail grocers from providing additional
p.001994: information.
p.001994: (p) Estrogenic substances screening program
p.001994: (1) Development
p.001994: Not later than 2 years after August 3, 1996, the Administrator shall in consultation with
...

p.001994: (1) prescribe such practices as the Secretary determines to be appropriate relating to—
p.001994: (A) sanitation;
p.001994: (B) packaging, isolation, and other protective measures;
p.001994: (C) limitations on the use of vehicles;
p.001994: (D) information to be disclosed—
p.001994: (i) to a carrier by a person arranging for the transport of food; and
p.001994: (ii) to a manufacturer or other person that—
p.001994: (I) arranges for the transportation of food by a carrier; or
p.001994: (II) furnishes a tank vehicle or bulk vehicle for the transportation of food; and
p.001994:
p.001994: (E) recordkeeping; and
p.001994:
p.001994: (2) include—
p.001994: (A) a list of nonfood products that the Secretary determines may, if shipped in a bulk
p.001994: vehicle, render adulterated food that is subsequently transported in the same vehicle;
p.001994: and
p.001994: (B) a list of nonfood products that the Secretary determines may, if shipped in a
p.001994: motor vehicle or rail vehicle (other than a tank vehicle or bulk vehicle), render
p.001994: adulterated food that is simultaneously or subsequently transported in the same
p.001994: vehicle.
p.001994: (d) Waivers
p.001994: (1) In general
p.001994: The Secretary may waive any requirement under this section, with respect to any class
p.001994: of persons, vehicles, food, or nonfood products, if the Secretary determines that the
p.001994: waiver—
p.001994: (A) will not result in the transportation of food under conditions that would be unsafe
p.001994: for human or animal health; and
p.001994: (B) will not be contrary to the public interest.
p.001994: (2) Publication
p.001994: The Secretary shall publish in the Federal Register any waiver and the reasons for the
p.001994: waiver.
p.001994: (e) Preemption
p.001994: (1) In general
p.001994: A requirement of a State or political subdivision of a State that concerns the
p.001994: transportation of food is preempted if—
p.001994: (A) complying with a requirement of the State or political subdivision and a
p.001994: requirement of this section, or a regulation prescribed under this section, is not
p.001994: possible; or
p.001994: (B) the requirement of the State or political subdivision as applied or enforced is an
p.001994: obstacle to accomplishing and carrying out this section or a regulation prescribed under
p.001994: this section.
p.001994: (2) Applicability
p.001994: This subsection applies to transportation that occurs on or after the effective date of the
p.001994: regulations promulgated under subsection (b) of this section.
p.001994: (f) Assistance of other agencies
p.001994: The Secretary of Transportation, the Secretary of Agriculture, the Administrator of the
p.001994: Environmental Protection Agency, and the heads of other Federal agencies, as appropriate,
p.001994: shall provide assistance on request, to the extent resources are available, to the Secretary
p.001994: for the purposes of carrying out this section.
p.001994: (June 25, 1938, ch. 675, §416, as added Pub. L. 109–59, title VII, §7202(b), Aug. 10, 2005,
p.001994: 119 Stat. 1911.)
p.001994: EFFECTIVE DATE
p.001994: Section effective Oct. 1, 2005, see section 7204 of Pub. L. 109–59, set out as an Effective Date
p.001994: of 2005 Amendment note under section 331 of this title.
p.001994: REGULATIONS
p.001994: Pub. L. 111–353, title I, §111(a), Jan. 4, 2011, 124 Stat. 3916, provided that: “Not later than 18
p.001994: months after the date of enactment of this Act [Jan. 4, 2011], the Secretary shall promulgate
p.001994: regulations described in section 416(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
p.001994: 350e(b)).”
p.001994:
p.001994:
p.001994: §350f. Reportable food registry
p.001994: (a) Definitions
p.001994: In this section:
p.001994: (1) Responsible party
...

p.001962: Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)(2)) has been granted.”
p.001962: Pub. L. 107–250, title II, §213, Oct. 26, 2002, 116 Stat. 1614, provided that: “Not later than 270
p.001962: days after the date of the enactment of this Act [Oct. 26, 2002], the Secretary of Health and
p.001962: Human Services shall issue guidance on the following:
p.001962: “(1) The type of information necessary to provide reasonable assurance of the safety and
p.001962: effectiveness of medical devices intended for use in pediatric populations.
p.001962: “(2) Protections for pediatric subjects in clinical investigations of the safety or effectiveness
p.001962: of such devices.”
p.001962: REPORT ON HUMANITARIAN DEVICE EXEMPTIONS
p.001962: Section 14(c) of Pub. L. 101–629 directed Secretary of Health and Human Services, within 4
p.001962: years after issuance of regulations under 21 U.S.C. 360j(m)(6), to report to Congress on types of
p.001962: devices exempted, an evaluation of effects of such section, and a recommendation on extension
p.001962: of the section.
p.001962: REFERENCES IN OTHER LAWS TO GS–16, 17, OR 18 PAY RATES
p.001962: References in laws to the rates of pay for GS–16, 17, or 18, or to maximum rates of pay under
p.001962: the General Schedule, to be considered references to rates payable under specified sections of
p.001962: Title 5, Government Organization and Employees, see section 529 [title I, §101(c)(1)] of Pub. L.
p.001962: 101–509, set out in a note under section 5376 of Title 5.
p.001962:
p.001962:
p.001962: §360k. State and local requirements respecting devices
p.001962: (a) General rule
p.001962: Except as provided in subsection (b) of this section, no State or political subdivision of a
p.001962: State may establish or continue in effect with respect to a device intended for human use
p.001962: any requirement—
p.001962: (1) which is different from, or in addition to, any requirement applicable under this
p.001962: chapter to the device, and
p.001962: (2) which relates to the safety or effectiveness of the device or to any other matter
p.001962: included in a requirement applicable to the device under this chapter.
p.001962: (b) Exempt requirements
p.001962: Upon application of a State or a political subdivision thereof, the Secretary may, by
p.001962: regulation promulgated after notice and opportunity for an oral hearing, exempt from
p.001962: subsection (a) of this section, under such conditions as may be prescribed in such
p.001962: regulation, a requirement of such State or political subdivision applicable to a device
p.001962: intended for human use if—
p.001962: (1) the requirement is more stringent than a requirement under this chapter which
p.001962: would be applicable to the device if an exemption were not in effect under this subsection;
p.001962: or
p.001962: (2) the requirement—
p.001962: (A) is required by compelling local conditions, and
p.001962: (B) compliance with the requirement would not cause the device to be in violation of
p.001962: any applicable requirement under this chapter.
p.001962: (June 25, 1938, ch. 675, §521, as added Pub. L. 94–295, §2, May 28, 1976, 90 Stat. 574.)
p.001962:
p.001962:
p.001962: §360l. Postmarket surveillance
p.001962: (a) Postmarket surveillance
p.001962: (1) In general
p.001962: (A) Conduct
p.001962: The Secretary may by order require a manufacturer to conduct postmarket
p.001962: surveillance for any device of the manufacturer that is a class II or class III device—
p.001962: (i) the failure of which would be reasonably likely to have serious adverse health
p.001962: consequences;
p.001962: (ii) that is expected to have significant use in pediatric populations; or
p.001962: (iii) that is intended to be—
p.001962: (I) implanted in the human body for more than 1 year; or
p.001962: (II) a life-sustaining or life-supporting device used outside a device user facility.
p.001962: (B) Condition
p.001962: The Secretary may order a postmarket surveillance under subparagraph (A) as a
p.001962: condition to approval or clearance of a device described in subparagraph (A)(ii).
p.001962: (2) Rule of construction
p.001962: The provisions of paragraph (1) shall have no effect on authorities otherwise provided
p.001962: under the 1 chapter or regulations issued under this chapter.
p.001962: (b) Surveillance approval
p.001962: (1) In general
p.001962: Each manufacturer required to conduct a surveillance of a device shall, within 30 days
...

p.001962: officer or employee of any such authority as an officer of the Department.
p.001962: (June 25, 1938, ch. 675, §541, formerly act July 1, 1944, ch. 373, title III, §541, formerly
p.001962: §360E, as added Pub. L. 90–602, §2(3), Oct. 18, 1968, 82 Stat. 1186; renumbered §541
p.001962: and amended Pub. L. 101–629, §19(a)(1)(B), (3), (4), Nov. 28, 1990, 104 Stat. 4529, 4530;
p.001962: Pub. L. 103–80, §4(a)(2), Aug. 13, 1993, 107 Stat. 779.)
p.001962: CODIFICATION
p.001962: Section was classified to section 263m of Title 42, The Public Health and Welfare, prior to
p.001962: renumbering by Pub. L. 101–629.
p.001962: AMENDMENTS
p.001962: 1993—Pub. L. 103–80 amended directory language of Pub. L. 101–629, §19(a)(4), which
p.001962: renumbered section 263m of Title 42, The Public Health and Welfare, as this section.
p.001962: 1990—Pub. L. 101–629, §19(a)(1)(B), substituted “this part” for “this subpart”.
p.001962: NONINTERFERENCE WITH OTHER FEDERAL AGENCIES
p.001962: Enactment of this section not to be construed to supersede or limit the functions under any
p.001962: other provision of law of any officer or agency of the United States, see section 4 of Pub. L. 90–
p.001962: 602, set out as a note under section 360hh of this title.
p.001962:
p.001962:
p.001962: §360ss. State standards
p.001962: Whenever any standard prescribed pursuant to section 360kk of this title with respect to
p.001962: an aspect of performance of an electronic product is in effect, no State or political
p.001962: subdivision of a State shall have any authority either to establish, or to continue in effect,
p.001962: any standard which is applicable to the same aspect of performance of such product and
p.001962: which is not identical to the Federal standard. Nothing in this part shall be construed to
p.001962: prevent the Federal Government or the government of any State or political subdivision
p.001962: thereof from establishing a requirement with respect to emission of radiation from electronic
p.001962: products procured for its own use if such requirement imposes a more restrictive standard
p.001962: than that required to comply with the otherwise applicable Federal standard.
p.001962: (June 25, 1938, ch. 675, §542, formerly act July 1, 1944, ch. 373, title III, §542, formerly
p.001962: §360F, as added Pub. L. 90–602, §2(3), Oct. 18, 1968, 82 Stat. 1186; renumbered §542
p.001962: and amended Pub. L. 101–629, §19(a)(1)(B), (2)(H), (3), (4), Nov. 28, 1990, 104 Stat. 4529,
p.001962: 4530; Pub. L. 103–80, §4(a)(2), Aug. 13, 1993, 107 Stat. 779.)
p.001962: CODIFICATION
p.001962: Section was classified to section 263n of Title 42, The Public Health and Welfare, prior to
p.001962: renumbering by Pub. L. 101–629.
p.001962: AMENDMENTS
p.001962: 1993—Pub. L. 103–80 amended directory language of Pub. L. 101–629, §19(a)(4), which
p.001962: renumbered section 263n of Title 42, The Public Health and Welfare, as this section.
p.001962: 1990—Pub. L. 101–629, §19(a)(1)(B), (2)(H), substituted “section 360kk” for “section 263f” and
p.001962: “this part” for “this subpart”.
p.001962: NONINTERFERENCE WITH OTHER FEDERAL AGENCIES
p.001962: Enactment of this section not to be construed to supersede or limit the functions under any
p.001962: other provision of law of any officer or agency of the United States, see section 4 of Pub. L. 90–
p.001962: 602, set out as a note under section 360hh of this title.
p.001962:
p.001962:
p.001962:
p.001962: PART D—DISSEMINATION OF TREATMENT INFORMATION
p.001962:
p.001962:
p.001962: §§360aaa to 360aaa–6. Omitted
p.001962: CODIFICATION
...

p.000398: to be responsible for—
p.000398: “(1) encouraging the prompt review of supplemental applications for approved articles; and
p.000398: “(2) working with sponsors to facilitate the development and submission of data to support
p.000398: supplemental applications.
p.000398: “(d) COLLABORATION.—The Secretary shall implement programs and policies that will foster
p.000398: collaboration between the Food and Drug Administration, the National Institutes of Health,
p.000398: professional medical and scientific societies, and other persons, to identify published and
p.000398: unpublished studies that may support a supplemental application, and to encourage sponsors to
p.000398: make supplemental applications or conduct further research in support of a supplemental
p.000398: application based, in whole or in part, on such studies.”
p.000398: HEARINGS PENDING ON APRIL 15, 1954, WITH RESPECT TO FOOD STANDARDS
p.000398: Provisions of this chapter in effect prior to Apr. 15, 1954, as applicable with respect to hearings
p.000398: begun prior to such date under subsection (e) of this section, regarding food standards, see
p.000398: Savings Provisions note set out under section 341 of this title.
p.000398:
p.000398:
p.000398: §372. Examinations and investigations
p.000398: (a) Authority to conduct
p.000398: (1)(A) The Secretary is authorized to conduct examinations and investigations for the
p.000398: purposes of this chapter through officers and employees of the Department or through any
p.000398: health, food, or drug officer or employee of any State, Territory, or political subdivision
p.000398: thereof, duly commissioned by the Secretary as an officer of the Department.
p.000398: (B)(i) For a tobacco product, to the extent feasible, the Secretary shall contract with the
p.000398: States in accordance with this paragraph to carry out inspections of retailers within that
p.000398: State in connection with the enforcement of this chapter.
p.000398: (ii) The Secretary shall not enter into any contract under clause (i) with the government of
p.000398: any of the several States to exercise enforcement authority under this chapter on Indian
p.000398: country without the express written consent of the Indian tribe involved.
p.000398: (2)(A) In addition to the authority established in paragraph (1), the Secretary, pursuant to
p.000398: a memorandum of understanding between the Secretary and the head of another Federal
p.000398: department or agency, is authorized to conduct examinations and investigations for the
p.000398: purposes of this chapter through the officers and employees of such other department or
p.000398: agency, subject to subparagraph (B). Such a memorandum shall include provisions to
p.000398: ensure adequate training of such officers and employees to conduct the examinations and
p.000398: investigations. The memorandum of understanding shall contain provisions regarding
p.000398: reimbursement. Such provisions may, at the sole discretion of the head of the other
p.000398: department or agency, require reimbursement, in whole or in part, from the Secretary for the
...

p.000398:
p.000398:
p.000398: §379o. Environmental impact
p.000398: Notwithstanding any other provision of law, an environmental impact statement prepared
p.000398: in accordance with the regulations published in part 25 of title 21, Code of Federal
p.000398: Regulations (as in effect on August 31, 1997) in connection with an action carried out under
p.000398: (or a recommendation or report relating to) this chapter, shall be considered to meet the
p.000398: requirements for a detailed statement under section 4332(2)(C) of title 42.
p.000398: (June 25, 1938, ch. 675, §749, formerly §746, as added Pub. L. 105–115, title IV, §411,
p.000398: Nov. 21, 1997, 111 Stat. 2373; renumbered §749, Pub. L. 110–316, title II, §202(a), Aug.
p.000398: 14, 2008, 122 Stat. 3515.)
p.000398: AMENDMENT OF SECTION
p.000398: For termination of amendment renumbering this section by section 204(a) of Pub. L. 110–
p.000398: 316, see Termination Date of 2008 Amendment note below.
p.000398: TERMINATION DATE OF 2008 AMENDMENT
p.000398: Amendment by Pub. L. 110–316 to cease to be effective Oct. 1, 2013, see section 204(a) of
p.000398: Pub. L. 110–316, set out as a Termination Date note under section 379j–21 of this title.
p.000398: EFFECTIVE DATE
p.000398: Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of
p.000398: Pub. L. 105–115, set out as an Effective Date of 1997 Amendment note under section 321 of this
p.000398: title.
p.000398:
p.000398:
p.000398:
p.000398: PART F—NATIONAL UNIFORMITY FOR NONPRESCRIPTION DRUGS AND PREEMPTION FOR
p.000398: LABELING OR PACKAGING OF COSMETICS
p.000398:
p.000398:
p.000398: §379r. National uniformity for nonprescription drugs
p.000398: (a) In general
p.000398: Except as provided in subsection (b), (c)(1), (d), (e), or (f) of this section, no State or
p.000398: political subdivision of a State may establish or continue in effect any requirement—
p.000398: (1) that relates to the regulation of a drug that is not subject to the requirements of
p.000398: section 353(b)(1) or 353(f)(1)(A) of this title; and
p.000398: (2) that is different from or in addition to, or that is otherwise not identical with, a
p.000398: requirement under this chapter, the Poison Prevention Packaging Act of 1970 (15 U.S.C.
p.000398: 1471 et seq.), or the Fair Packaging and Labeling Act (15 U.S.C. 1451 et seq.).
p.000398: (b) Exemption
p.000398: (1) In general
p.000398: Upon application of a State or political subdivision thereof, the Secretary may by
p.000398: regulation, after notice and opportunity for written and oral presentation of views, exempt
p.000398: from subsection (a) of this section, under such conditions as may be prescribed in such
p.000398: regulation, a State or political subdivision requirement that—
p.000398: (A) protects an important public interest that would otherwise be unprotected,
p.000398: including the health and safety of children;
p.000398: (B) would not cause any drug to be in violation of any applicable requirement or
p.000398: prohibition under Federal law; and
p.000398: (C) would not unduly burden interstate commerce.
p.000398: (2) Timely action
p.000398: The Secretary shall make a decision on the exemption of a State or political
p.000398: subdivision requirement under paragraph (1) not later than 120 days after receiving the
p.000398: application of the State or political subdivision under paragraph (1).
p.000398: (c) Scope
p.000398: (1) In general
p.000398: This section shall not apply to—
p.000398: (A) any State or political subdivision requirement that relates to the practice of
p.000398: pharmacy; or
p.000398: (B) any State or political subdivision requirement that a drug be dispensed only upon
p.000398: the prescription of a practitioner licensed by law to administer such drug.
p.000398: (2) Safety or effectiveness
p.000398: For purposes of subsection (a) of this section, a requirement that relates to the
p.000398: regulation of a drug shall be deemed to include any requirement relating to public
p.000398: information or any other form of public communication relating to a warning of any kind for
p.000398: a drug.
p.000398: (d) Exceptions
p.000398: (1) In general
p.000398: In the case of a drug described in subsection (a)(1) of this section that is not the
p.000398: subject of an application approved under section 355 of this title or section 357 of this title
p.000398: (as in effect on the day before November 21, 1997) or a final regulation promulgated by
p.000398: the Secretary establishing conditions under which the drug is generally recognized as
p.000398: safe and effective and not misbranded, subsection (a) of this section shall apply only with
p.000398: respect to a requirement of a State or political subdivision of a State that relates to the
p.000398: same subject as, but is different from or in addition to, or that is otherwise not identical
p.000398: with—
p.000398: (A) a regulation in effect with respect to the drug pursuant to a statute described in
p.000398: subsection (a)(2) of this section; or
p.000398: (B) any other requirement in effect with respect to the drug pursuant to an
p.000398: amendment to such a statute made on or after November 21, 1997.
p.000398: (2) State initiatives
p.000398: This section shall not apply to a State requirement adopted by a State public initiative
p.000398: or referendum enacted prior to September 1, 1997.
p.000398: (e) No effect on product liability law
p.000398: Nothing in this section shall be construed to modify or otherwise affect any action or the
p.000398: liability of any person under the product liability law of any State.
p.000398: (f) State enforcement authority
p.000398: Nothing in this section shall prevent a State or political subdivision thereof from enforcing,
p.000398: under any relevant civil or other enforcement authority, a requirement that is identical to a
p.000398: requirement of this chapter.
p.000398: (June 25, 1938, ch. 675, §751, as added Pub. L. 105–115, title IV, §412(a), Nov. 21, 1997,
p.000398: 111 Stat. 2373.)
p.000398: REFERENCES IN TEXT
p.000398: The Poison Prevention Packaging Act of 1970, referred to in subsec. (a)(2), is Pub. L. 91–601,
p.000398: Dec. 30, 1970, 84 Stat. 1670, as amended, which is classified principally to chapter 39A (§1471
p.000398: et seq.) of Title 15, Commerce and Trade. For complete classification of this Act to the Code, see
p.000398: Short Title note set out under section 1471 of Title 15 and Tables.
p.000398: The Fair Packaging and Labeling Act, referred to in subsec. (a)(2), is Pub. L. 89–755, Nov. 3,
p.000398: 1966, 80 Stat. 1296, as amended, which is classified generally to chapter 39 (§1451 et seq.) of
p.000398: Title 15, Commerce and Trade. For complete classification of this Act to the Code, see Short Title
p.000398: note set out under section 1451 of Title 15 and Tables.
p.000398: EFFECTIVE DATE
p.000398: Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of
p.000398: Pub. L. 105–115, set out as an Effective Date of 1997 Amendment note under section 321 of this
p.000398: title.
p.000398:
p.000398:
p.000398: §379s. Preemption for labeling or packaging of cosmetics
p.000398: (a) In general
p.000398: Except as provided in subsection (b), (d), or (e) of this section, no State or political
p.000398: subdivision of a State may establish or continue in effect any requirement for labeling or
p.000398: packaging of a cosmetic that is different from or in addition to, or that is otherwise not
p.000398: identical with, a requirement specifically applicable to a particular cosmetic or class of
p.000398: cosmetics under this chapter, the Poison Prevention Packaging Act of 1970 (15 U.S.C.
p.000398: 1471 et seq.), or the Fair Packaging and Labeling Act (15 U.S.C. 1451 et seq.).
p.000398: (b) Exemption
p.000398: Upon application of a State or political subdivision thereof, the Secretary may by
p.000398: regulation, after notice and opportunity for written and oral presentation of views, exempt
p.000398: from subsection (a) of this section, under such conditions as may be prescribed in such
p.000398: regulation, a State or political subdivision requirement for labeling or packaging that—
p.000398: (1) protects an important public interest that would otherwise be unprotected;
p.000398: (2) would not cause a cosmetic to be in violation of any applicable requirement or
p.000398: prohibition under Federal law; and
p.000398: (3) would not unduly burden interstate commerce.
p.000398: (c) Scope
p.000398: For purposes of subsection (a) of this section, a reference to a State requirement that
p.000398: relates to the packaging or labeling of a cosmetic means any specific requirement relating
p.000398: to the same aspect of such cosmetic as a requirement specifically applicable to that
p.000398: particular cosmetic or class of cosmetics under this chapter for packaging or labeling,
p.000398: including any State requirement relating to public information or any other form of public
p.000398: communication.
p.000398: (d) No effect on product liability law
p.000398: Nothing in this section shall be construed to modify or otherwise affect any action or the
p.000398: liability of any person under the product liability law of any State.
p.000398: (e) State initiative
p.000398: This section shall not apply to a State requirement adopted by a State public initiative or
p.000398: referendum enacted prior to September 1, 1997.
p.000398: (June 25, 1938, ch. 675, §752, as added Pub. L. 105–115, title IV, §412(d), Nov. 21, 1997,
p.000398: 111 Stat. 2376.)
p.000398: REFERENCES IN TEXT
p.000398: The Poison Prevention Packaging Act of 1970, referred to in subsec. (a), is Pub. L. 91–601,
p.000398: Dec. 30, 1970, 84 Stat. 1670, as amended, which is classified principally to chapter 39A (§1471
p.000398: et seq.) of Title 15, Commerce and Trade. For complete classification of this Act to the Code, see
p.000398: Short Title note set out under section 1471 of Title 15 and Tables.
...

p.000398: statement, which shall be a part of any report that is released for public disclosure, that
p.000398: denies that the report or the records constitute an admission that the product involved
p.000398: caused or contributed to the adverse event; and
p.000398: (2) a record about an individual under section 552a of title 5 (commonly referred to as
p.000398: the “Privacy Act of 1974”) and a medical or similar file the disclosure of which would
p.000398: constitute a violation of section 552 of such title 5 (commonly referred to as the “Freedom
p.000398: of Information Act”), and shall not be publicly disclosed unless all personally identifiable
p.000398: information is redacted.
p.000398: (g) Rule of construction
p.000398: The submission of any adverse event report in compliance with this section shall not be
p.000398: construed as an admission that the nonprescription drug involved caused or contributed to
p.000398: the adverse event.
p.000398: (h) Preemption
p.000398: (1) In general
p.000398: No State or local government shall establish or continue in effect any law, regulation,
p.000398: order, or other requirement, related to a mandatory system for adverse event reports for
p.000398: nonprescription drugs, that is different from, in addition to, or otherwise not identical to,
p.000398: this section.
p.000398: (2) Effect of section
p.000398: (A) In general
p.000398: Nothing in this section shall affect the authority of the Secretary to provide adverse
p.000398: event reports and information to any health, food, or drug officer or employee of any
p.000398: State, territory, or political subdivision of a State or territory, under a memorandum of
p.000398: understanding between the Secretary and such State, territory, or political subdivision.
p.000398: (B) Personally-identifiable information
p.000398: Notwithstanding any other provision of law, personally-identifiable information in
p.000398: adverse event reports provided by the Secretary to any health, food, or drug officer or
p.000398: employee of any State, territory, or political subdivision of a State or territory, shall not
p.000398: —
p.000398: (i) be made publicly available pursuant to any State or other law requiring
p.000398: disclosure of information or records; or
p.000398: (ii) otherwise be disclosed or distributed to any party without the written consent of
p.000398: the Secretary and the person submitting such information to the Secretary.
p.000398: (C) Use of safety reports
p.000398: Nothing in this section shall permit a State, territory, or political subdivision of a State
p.000398: or territory, to use any safety report received from the Secretary in a manner
p.000398: inconsistent with subsection (g) or section 379v of this title.
p.000398: (i) Authorization of appropriations
p.000398: There are authorized to be appropriated to carry out this section such sums as may be
p.000398: necessary.
p.000398: (June 25, 1938, ch. 675, §760, as added Pub. L. 109–462, §2(a), Dec. 22, 2006, 120 Stat.
p.000398: 3469.)
p.000398: EFFECTIVE DATE
p.000398: Section effective 1 year after Dec. 22, 2006, see section 2(e)(1) of Pub. L. 109–462, set out as
p.000398: an Effective Date of 2006 Amendment note under section 352 of this title.
p.000398: MODIFICATIONS
p.000398: Pub. L. 109–462, §2(b), Dec. 22, 2006, 120 Stat. 3472, provided that: “The Secretary of Health
p.000398: and Human Services may modify requirements under the amendments made by this section
p.000398: [enacting this section and amending sections 331 and 352 of this title] in accordance with section
p.000398: 553 of title 5, United States Code, to maintain consistency with international harmonization efforts
p.000398: over time.”
p.000398: GUIDANCE
p.000398: Pub. L. 109–462, §2(e)(3), Dec. 22, 2006, 120 Stat. 3472, provided that: “Not later than 270
p.000398: days after the date of enactment of this Act [Dec. 22, 2006], the Secretary of Health and Human
p.000398: Services shall issue guidance on the minimum data elements that should be included in a serious
p.000398: adverse event report described under the amendments made by this Act [see Short Title of 2006
p.000398: Amendment note set out under section 301 of this title].”
p.000398: Pub. L. 109–462, §3(d)(3), Dec. 22, 2006, 120 Stat. 3475, enacted provisions substantially
p.000398: identical to those enacted by Pub. L. 109–462, §2(b), set out above.
p.000398:
p.000398:
p.000398: §379aa–1. Serious adverse event reporting for dietary supplements
...

p.000398: (1) a safety report under section 379v of this title and may be accompanied by a
p.000398: statement, which shall be a part of any report that is released for public disclosure, that
p.000398: denies that the report or the records constitute an admission that the product involved
p.000398: caused or contributed to the adverse event; and
p.000398: (2) a record about an individual under section 552a of title 5 (commonly referred to as
p.000398: the “Privacy Act of 1974”) and a medical or similar file the disclosure of which would
p.000398: constitute a violation of section 552 of such title 5 (commonly referred to as the “Freedom
p.000398: of Information Act”), and shall not be publicly disclosed unless all personally identifiable
p.000398: information is redacted.
p.000398: (g) Rule of construction
p.000398: The submission of any adverse event report in compliance with this section shall not be
p.000398: construed as an admission that the dietary supplement involved caused or contributed to
p.000398: the adverse event.
p.000398: (h) Preemption
p.000398: (1) In general
p.000398: No State or local government shall establish or continue in effect any law, regulation,
p.000398: order, or other requirement, related to a mandatory system for adverse event reports for
p.000398: dietary supplements, that is different from, in addition to, or otherwise not identical to, this
p.000398: section.
p.000398: (2) Effect of section
p.000398: (A) In general
p.000398: Nothing in this section shall affect the authority of the Secretary to provide adverse
p.000398: event reports and information to any health, food, or drug officer or employee of any
p.000398: State, territory, or political subdivision of a State or territory, under a memorandum of
p.000398: understanding between the Secretary and such State, territory, or political subdivision.
p.000398: (B) Personally-identifiable information
p.000398: Notwithstanding any other provision of law, personally-identifiable information in
p.000398: adverse event reports provided by the Secretary to any health, food, or drug officer or
p.000398: employee of any State, territory, or political subdivision of a State or territory, shall not
p.000398: —
p.000398: (i) be made publicly available pursuant to any State or other law requiring
p.000398: disclosure of information or records; or
p.000398: (ii) otherwise be disclosed or distributed to any party without the written consent of
p.000398: the Secretary and the person submitting such information to the Secretary.
p.000398: (C) Use of safety reports
p.000398: Nothing in this section shall permit a State, territory, or political subdivision of a State
p.000398: or territory, to use any safety report received from the Secretary in a manner
p.000398: inconsistent with subsection (g) or section 379v of this title.
p.000398: (i) Authorization of appropriations
p.000398: There are authorized to be appropriated to carry out this section such sums as may be
p.000398: necessary.
p.000398: (June 25, 1938, ch. 675, §761, as added Pub. L. 109–462, §3(a), Dec. 22, 2006, 120 Stat.
p.000398: 3472.)
p.000398: EFFECTIVE DATE
p.000398: Section effective 1 year after Dec. 22, 2006, see section 3(d)(1) of Pub. L. 109–462, set out as
p.000398: an Effective Date of 2006 Amendment note under section 343 of this title.
p.000398:
p.000398:
p.000398:
p.000398: PART I—REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG ADMINISTRATION
p.000398:
p.000398:
p.000398: §379dd. Establishment and functions of the Foundation
p.000398: (a) In general
p.000398: A nonprofit corporation to be known as the Reagan-Udall Foundation for the Food and
p.000398: Drug Administration (referred to in this part as the “Foundation”) shall be established in
p.000398: accordance with this section. The Foundation shall be headed by an Executive Director,
p.000398: appointed by the members of the Board of Directors under subsection (e).1 The Foundation
p.000398: shall not be an agency or instrumentality of the United States Government.
p.000398: (b) Purpose of Foundation
p.000398: The purpose of the Foundation is to advance the mission of the Food and Drug
p.000398: Administration to modernize medical, veterinary, food, food ingredient, and cosmetic
p.000398: product development, accelerate innovation, and enhance product safety.
p.000398: (c) Duties of the Foundation
p.000398: The Foundation shall—
...

p.000398: 2009, 123 Stat. 1820.)
p.000398: REFERENCES IN TEXT
p.000398: The Family Smoking Prevention and Tobacco Control Act, referred to in subsec. (f), is div. A of
p.000398: Pub. L. 111–31, June 22, 2009, 123 Stat. 1776. For complete classification of this Act to the
p.000398: Code, see Short Title of 2009 Amendment note set out under section 301 of this title and Tables.
p.000398: MODIFICATION OF DEADLINES FOR SECRETARIAL ACTION
p.000398: With respect to any time periods specified in an amendment by div. A of Pub. L. 111–31 that
p.000398: begin on June 22, 2009, within which the Secretary of Health and Human Services is required to
p.000398: carry out and complete specified activities, with certain limitations, the calculation of such time
p.000398: periods shall commence on the first day of the first fiscal quarter following the initial 2 consecutive
p.000398: fiscal quarters of fiscal year 2010 for which the Secretary has collected fees under section 387s of
p.000398: this title, and the Secretary may extend or reduce the duration of one or more such time periods,
p.000398: except that no such period shall be extended for more than 90 days, see section 6 of Pub. L. 111–
p.000398: 31, set out as a note under section 387 of this title.
p.000398:
p.000398:
p.000398: §387p. Preservation of State and local authority
p.000398: (a) In general
p.000398: (1) Preservation
p.000398: Except as provided in paragraph (2)(A), nothing in this subchapter, or rules
p.000398: promulgated under this subchapter, shall be construed to limit the authority of a Federal
p.000398: agency (including the Armed Forces), a State or political subdivision of a State, or the
p.000398: government of an Indian tribe to enact, adopt, promulgate, and enforce any law, rule,
p.000398: regulation, or other measure with respect to tobacco products that is in addition to, or
p.000398: more stringent than, requirements established under this subchapter, including a law,
p.000398: rule, regulation, or other measure relating to or prohibiting the sale, distribution,
p.000398: possession, exposure to, access to, advertising and promotion of, or use of tobacco
p.000398: products by individuals of any age, information reporting to the State, or measures
p.000398: relating to fire safety standards for tobacco products. No provision of this subchapter shall
p.000398: limit or otherwise affect any State, tribal, or local taxation of tobacco products.
p.000398: (2) Preemption of certain State and local requirements
p.000398: (A) In general
p.000398: No State or political subdivision of a State may establish or continue in effect with
p.000398: respect to a tobacco product any requirement which is different from, or in addition to,
p.000398: any requirement under the provisions of this subchapter relating to tobacco product
p.000398: standards, premarket review, adulteration, misbranding, labeling, registration, good
p.000398: manufacturing standards, or modified risk tobacco products.
p.000398: (B) Exception
p.000398: Subparagraph (A) does not apply to requirements relating to the sale, distribution,
p.000398: possession, information reporting to the State, exposure to, access to, the advertising
p.000398: and promotion of, or use of, tobacco products by individuals of any age, or relating to
p.000398: fire safety standards for tobacco products. Information disclosed to a State under
p.000398: subparagraph (A) that is exempt from disclosure under section 552(b)(4) of title 5 shall
p.000398: be treated as a trade secret and confidential information by the State.
p.000398: (b) Rule of construction regarding product liability
p.000398: No provision of this subchapter relating to a tobacco product shall be construed to modify
p.000398: or otherwise affect any action or the liability of any person under the product liability law of
p.000398: any State.
p.000398: (June 25, 1938, ch. 675, §916, as added Pub. L. 111–31, div. A, title I, §101(b)(3), June 22,
p.000398: 2009, 123 Stat. 1823.)
p.000398:
p.000398:
p.000398: §387q. Tobacco Products Scientific Advisory Committee
p.000398: (a) Establishment
p.000398: Not later than 6 months after June 22, 2009, the Secretary shall establish a 12-member
p.000398: advisory committee, to be known as the Tobacco Products Scientific Advisory Committee
...

Political / stateless persons

Searching for indicator nation:

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p.000398: continue to be enforced to the fullest extent possible.”
p.000398: CONSTRUCTION
p.000398: Pub. L. 111–31, div. A, §4, June 22, 2009, 123 Stat. 1782, provided that:
p.000398: “(a) INTENDED EFFECT.—Nothing in this division [see Short Title of 2009 Amendment note set out
p.000398: under section 301 of this title] (or an amendment made by this division) shall be construed to—
p.000398: “(1) establish a precedent with regard to any other industry, situation, circumstance, or legal
p.000398: action; or
p.000398: “(2) affect any action pending in Federal, State, or tribal court, or any agreement, consent
p.000398: decree, or contract of any kind.
p.000398: “(b) AGRICULTURAL ACTIVITIES .—The provisions of this division (or an amendment made by this
p.000398: division) which authorize the Secretary to take certain actions with regard to tobacco and tobacco
p.000398: products shall not be construed to affect any authority of the Secretary of Agriculture under
p.000398: existing law regarding the growing, cultivation, or curing of raw tobacco.
p.000398: “(c) REVENUE ACTIVITIES.—The provisions of this division (or an amendment made by this
p.000398: division) which authorize the Secretary to take certain actions with regard to tobacco products
p.000398: shall not be construed to affect any authority of the Secretary of the Treasury under chapter 52 of
p.000398: the Internal Revenue Code of 1986 [26 U.S.C. 5701 et seq.].”
p.000398: FINDINGS
p.000398: Pub. L. 111–31, div. A, §2, June 22, 2009, 123 Stat. 1776, provided that: “The Congress finds
p.000398: the following:
p.000398: “(1) The use of tobacco products by the Nation's children is a pediatric disease of
p.000398: considerable proportions that results in new generations of tobacco-dependent children and
p.000398: adults.
p.000398: “(2) A consensus exists within the scientific and medical communities that tobacco products
p.000398: are inherently dangerous and cause cancer, heart disease, and other serious adverse health
p.000398: effects.
p.000398: “(3) Nicotine is an addictive drug.
p.000398: “(4) Virtually all new users of tobacco products are under the minimum legal age to
p.000398: purchase such products.
p.000398: “(5) Tobacco advertising and marketing contribute significantly to the use of nicotine-
p.000398: containing tobacco products by adolescents.
p.000398: “(6) Because past efforts to restrict advertising and marketing of tobacco products have
p.000398: failed adequately to curb tobacco use by adolescents, comprehensive restrictions on the sale,
p.000398: promotion, and distribution of such products are needed.
p.000398: “(7) Federal and State governments have lacked the legal and regulatory authority and
p.000398: resources they need to address comprehensively the public health and societal problems
p.000398: caused by the use of tobacco products.
p.000398: “(8) Federal and State public health officials, the public health community, and the public at
p.000398: large recognize that the tobacco industry should be subject to ongoing oversight.
p.000398: “(9) Under article I, section 8 of the Constitution, the Congress is vested with the
p.000398: responsibility for regulating interstate commerce and commerce with Indian tribes.
p.000398: “(10) The sale, distribution, marketing, advertising, and use of tobacco products are
p.000398: activities in and substantially affecting interstate commerce because they are sold, marketed,
p.000398: advertised, and distributed in interstate commerce on a nationwide basis, and have a
p.000398: substantial effect on the Nation's economy.
p.000398: “(11) The sale, distribution, marketing, advertising, and use of such products substantially
p.000398: affect interstate commerce through the health care and other costs attributable to the use of
p.000398: tobacco products.
p.000398: “(12) It is in the public interest for Congress to enact legislation that provides the Food and
p.000398: Drug Administration with the authority to regulate tobacco products and the advertising and
p.000398: promotion of such products. The benefits to the American people from enacting such legislation
p.000398: would be significant in human and economic terms.
p.000398: “(13) Tobacco use is the foremost preventable cause of premature death in America. It
p.000398: causes over 400,000 deaths in the United States each year, and approximately 8,600,000
p.000398: Americans have chronic illnesses related to smoking.
p.000398: “(14) Reducing the use of tobacco by minors by 50 percent would prevent well over
p.000398: 10,000,000 of today's children from becoming regular, daily smokers, saving over 3,000,000 of
p.000398: them from premature death due to tobacco-induced disease. Such a reduction in youth smoking
p.000398: would also result in approximately $75,000,000,000 in savings attributable to reduced health
p.000398: care costs.
p.000398: “(15) Advertising, marketing, and promotion of tobacco products have been especially
p.000398: directed to attract young persons to use tobacco products, and these efforts have resulted in
p.000398: increased use of such products by youth. Past efforts to oversee these activities have not been
...

Political / vulnerable

Searching for indicator vulnerable:

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p.001994: producer, scientific, and industry groups, as appropriate.
p.001994: (b) The Secretaries of Agriculture and of Health and Human Services and the Assistant to the
p.001994: President for Science and Technology/Director of the Office of Science and Technology Policy
p.001994: shall serve as Joint Chairs of the Council.
p.001994: SEC. 2. Purpose. The purpose of the Council shall be to develop a comprehensive strategic plan
p.001994: for Federal food safety activities, taking into consideration the findings and recommendations of
p.001994: the National Academy of Sciences report “Ensuring Safe Food from Production to Consumption”
p.001994: and other input from the public on how to improve the effectiveness of the current food safety
p.001994: system. The Council shall make recommendations to the President on how to advance Federal
p.001994: efforts to implement a comprehensive science-based strategy to improve the safety of the food
p.001994: supply and to enhance coordination among Federal agencies, State, local, and tribal
p.001994: governments, and the private sector. The Council shall advise Federal agencies in setting priority
p.001994: areas for investment in food safety.
p.001994: SEC. 3. Specific Activities and Functions. (a) The Council shall develop a comprehensive
p.001994: strategic Federal food safety plan that contains specific recommendations on needed changes,
p.001994: including measurable outcome goals. The principal goal of the plan should be the establishment
p.001994: of a seamless, science-based food safety system. The plan should address the steps necessary
p.001994: to achieve this goal, including the key public health, resource, and management issues regarding
p.001994: food safety. The planning process should consider both short-term and long-term issues including
p.001994: new and emerging threats and the special needs of vulnerable populations such as children and
p.001994: the elderly. In developing this plan, the Council shall consult with all interested parties, including
p.001994: State and local agencies, tribes, consumers, producers, industry, and academia.
p.001994: (b) Consistent with the comprehensive strategic Federal food safety plan described in section
p.001994: 3(a) of this order, the Council shall advise agencies of priority areas for investment in food safety
p.001994: and ensure that Federal agencies annually develop coordinated food safety budgets for
p.001994: submission to the OMB that sustain and strengthen existing capacities, eliminate duplication, and
p.001994: ensure the most effective use of resources for improving food safety. The Council shall also
p.001994: ensure that Federal agencies annually develop a unified budget for submission to the OMB for the
p.001994: President's Food Safety Initiative and such other food safety issues as the Council determines
p.001994: appropriate.
p.001994: (c) The Council shall ensure that the Joint Institute for Food Safety Research (JIFSR), in
p.001994: consultation with the National Science and Technology Council, establishes mechanisms to guide
p.001994: Federal research efforts toward the highest priority food safety needs. The JIFSR shall report to
p.001994: the Council on a regular basis on its efforts: (i) to develop a strategic plan for conducting food
p.001994: safety research activities consistent with the President's Food Safety Initiative and such other food
p.001994: safety activities as the JIFSR determines appropriate; and (ii) to coordinate efficiently, within the
p.001994: executive branch and with the private sector and academia, all Federal food safety research.
...

p.001994: Pub. L. 111–353, title I, §105(d), Jan. 4, 2011, 124 Stat. 3905, provided that: “Nothing in the
p.001994: amendments made by this section [enacting this section and amending section 331 of this title]
p.001994: limits the authority of the Secretary [of Health and Human Services] under the Federal Food,
p.001994: Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or the Public Health Service Act (42 U.S.C. 201 et
p.001994: seq.) to revise, issue, or enforce product and category-specific regulations, such as the Seafood
p.001994: Hazard Analysis Critical Controls Points Program, the Juice Hazard Analysis Critical Control
p.001994: [Points] Program, and the Thermally Processed Low-Acid Foods Packaged in Hermetically
p.001994: Sealed Containers standards.”
p.001994:
p.001994: 1 So in original. Probably should be “or certify compliance”.
p.001994:
p.001994:
p.001994:
p.001994: §350i. Protection against intentional adulteration
p.001994: (a) Determinations
p.001994: (1) In general
p.001994: The Secretary shall—
p.001994: (A) conduct a vulnerability assessment of the food system, including by
p.001994: consideration of the Department of Homeland Security biological, chemical,
p.001994: radiological, or other terrorism risk assessments;
p.001994: (B) consider the best available understanding of uncertainties, risks, costs, and
p.001994: benefits associated with guarding against intentional adulteration of food at vulnerable
p.001994: points; and
p.001994: (C) determine the types of science-based mitigation strategies or measures that are
p.001994: necessary to protect against the intentional adulteration of food.
p.001994: (2) Limited distribution
p.001994: In the interest of national security, the Secretary, in consultation with the Secretary of
p.001994: Homeland Security, may determine the time, manner, and form in which determinations
p.001994: made under paragraph (1) are made publicly available.
p.001994: (b) Regulations
p.001994: Not later than 18 months after January 4, 2011, the Secretary, in coordination with the
p.001994: Secretary of Homeland Security and in consultation with the Secretary of Agriculture, shall
p.001994: promulgate regulations to protect against the intentional adulteration of food subject to this
p.001994: chapter. Such regulations shall—
p.001994: (1) specify how a person shall assess whether the person is required to implement
p.001994: mitigation strategies or measures intended to protect against the intentional adulteration
p.001994: of food; and
p.001994: (2) specify appropriate science-based mitigation strategies or measures to prepare and
p.001994: protect the food supply chain at specific vulnerable points, as appropriate.
p.001994: (c) Applicability
p.001994: Regulations promulgated under subsection (b) shall apply only to food for which there is a
p.001994: high risk of intentional contamination, as determined by the Secretary, in consultation with
p.001994: the Secretary of Homeland Security, under subsection (a), that could cause serious adverse
p.001994: health consequences or death to humans or animals and shall include those foods—
p.001994: (1) for which the Secretary has identified clear vulnerabilities (including short shelf-life
p.001994: or susceptibility to intentional contamination at critical control points); and
p.001994: (2) in bulk or batch form, prior to being packaged for the final consumer.
p.001994: (d) Exception
p.001994: This section shall not apply to farms, except for those that produce milk.
p.001994: (e) Definition
p.001994: For purposes of this section, the term “farm” has the meaning given that term in section
p.001994: 1.227 of title 21, Code of Federal Regulations (or any successor regulation).
p.001994: (June 25, 1938, ch. 675, §420, as added Pub. L. 111–353, title I, §106(a), Jan. 4, 2011, 124
p.001994: Stat. 3905.)
p.001994: CONSTRUCTION
p.001994: Nothing in this section to be construed to apply to certain alcohol-related facilities, to alter
p.001994: jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with
p.001994: international agreements to which the United States is a party, see sections 2206, 2251, and 2252
p.001994: of this title.
p.001994: GUIDANCE DOCUMENTS
p.001994: Pub. L. 111–353, title I, §106(b), Jan. 4, 2011, 124 Stat. 3906, provided that:
p.001994: “(1) IN GENERAL.—Not later than 1 year after the date of enactment of this Act [Jan. 4, 2011], the
...

Searching for indicator vulnerability:

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p.001994: Act [21 U.S.C. 350h] (as added by subsection (a)), the Secretary of Health and Human Services
p.001994: shall issue a small entity compliance policy guide setting forth in plain language the requirements
p.001994: of such section 419 and to assist small entities in complying with standards for safe production
p.001994: and harvesting and other activities required under such section.”
p.001994: NO EFFECT ON HACCP AUTHORITIES
p.001994: Pub. L. 111–353, title I, §105(d), Jan. 4, 2011, 124 Stat. 3905, provided that: “Nothing in the
p.001994: amendments made by this section [enacting this section and amending section 331 of this title]
p.001994: limits the authority of the Secretary [of Health and Human Services] under the Federal Food,
p.001994: Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or the Public Health Service Act (42 U.S.C. 201 et
p.001994: seq.) to revise, issue, or enforce product and category-specific regulations, such as the Seafood
p.001994: Hazard Analysis Critical Controls Points Program, the Juice Hazard Analysis Critical Control
p.001994: [Points] Program, and the Thermally Processed Low-Acid Foods Packaged in Hermetically
p.001994: Sealed Containers standards.”
p.001994:
p.001994: 1 So in original. Probably should be “or certify compliance”.
p.001994:
p.001994:
p.001994:
p.001994: §350i. Protection against intentional adulteration
p.001994: (a) Determinations
p.001994: (1) In general
p.001994: The Secretary shall—
p.001994: (A) conduct a vulnerability assessment of the food system, including by
p.001994: consideration of the Department of Homeland Security biological, chemical,
p.001994: radiological, or other terrorism risk assessments;
p.001994: (B) consider the best available understanding of uncertainties, risks, costs, and
p.001994: benefits associated with guarding against intentional adulteration of food at vulnerable
p.001994: points; and
p.001994: (C) determine the types of science-based mitigation strategies or measures that are
p.001994: necessary to protect against the intentional adulteration of food.
p.001994: (2) Limited distribution
p.001994: In the interest of national security, the Secretary, in consultation with the Secretary of
p.001994: Homeland Security, may determine the time, manner, and form in which determinations
p.001994: made under paragraph (1) are made publicly available.
p.001994: (b) Regulations
p.001994: Not later than 18 months after January 4, 2011, the Secretary, in coordination with the
p.001994: Secretary of Homeland Security and in consultation with the Secretary of Agriculture, shall
p.001994: promulgate regulations to protect against the intentional adulteration of food subject to this
p.001994: chapter. Such regulations shall—
p.001994: (1) specify how a person shall assess whether the person is required to implement
p.001994: mitigation strategies or measures intended to protect against the intentional adulteration
p.001994: of food; and
p.001994: (2) specify appropriate science-based mitigation strategies or measures to prepare and
...

Health / Cognitive Impairment

Searching for indicator impaired:

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p.000001: by section 917), shall, not later than 6 months after the date of the enactment of this Act [Sept. 27,
p.000001: 2007], conduct a study to determine if the statement in section 502(n) of such Act [21 U.S.C.
p.000001: 352(n)] (as added by subsection (a)) required with respect to published direct-to-consumer
p.000001: advertisements is appropriate for inclusion in such television advertisements.
p.000001: “(2) CONTENT.—As part of the study under paragraph (1), such Secretary shall consider whether
p.000001: the information in the statement described in paragraph (1) would detract from the presentation of
p.000001: risk information in a direct-to-consumer television advertisement. If such Secretary determines the
p.000001: inclusion of such statement is appropriate in direct-to-consumer television advertisements, such
p.000001: Secretary shall issue regulations requiring the implementation of such statement in direct-to-
p.000001: consumer television advertisements, including determining a reasonable length of time for
p.000001: displaying the statement in such advertisements. The Secretary shall report to the appropriate
p.000001: committees of Congress the findings of such study and any plans to issue regulations under this
p.000001: paragraph.”
p.000001: Pub. L. 108–173, title I, §107(f), Dec. 8, 2003, 117 Stat. 2171, directed the Secretary of Health
p.000001: and Human Services to undertake a study of how to make prescription pharmaceutical
p.000001: information, including drug labels and usage instructions, accessible to blind and visually-impaired
p.000001: individuals, and to submit a report to Congress not later than 18 months after Dec. 8, 2003.
p.000001: Section 114(b) of Pub. L. 105–115 provided that: “The Comptroller General of the United States
p.000001: shall conduct a study of the implementation of the provisions added by the amendment made by
p.000001: subsection (a) [amending this section]. Not later than 4 years and 6 months after the date of
p.000001: enactment of this Act [Nov. 21, 1997], the Comptroller General of the United States shall prepare
p.000001: and submit to Congress a report containing the findings of the study.”
p.000001: COUNTERFEITING OF DRUGS; CONGRESSIONAL FINDINGS AND DECLARATION OF POLICY
p.000001: Section 9(a) of Pub. L. 89–74, July 15, 1965, 79 Stat. 234, provided that: “The Congress finds
p.000001: and declares that there is a substantial traffic in counterfeit drugs simulating the brand or other
p.000001: identifying mark or device of the manufacturer of the genuine article; that such traffic poses a
p.000001: serious hazard to the health of innocent consumers of such drugs because of the lack of proper
p.000001: qualifications, facilities, and manufacturing controls on the part of the counterfeiter, whose
p.000001: operations are clandestine; that, while such drugs are deemed misbranded within the meaning of
p.000001: section 502(i) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 352(i)], the controls for the
p.000001: suppression of the traffic in such drugs are inadequate because of the difficulty of determining the
p.000001: place of interstate origin of such drugs and, if that place is discovered, the fact that the
p.000001: implements for counterfeiting are not subject to seizure, and that these factors require enactment
...

Searching for indicator impairment:

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p.000001: introduction or delivery for introduction into interstate commerce for commercial distribution
p.000001: of a device intended for human use shall, at least ninety days before making such
p.000001: introduction or delivery, report to the Secretary or person who is accredited under section
p.000001: 360m(a) of this title (in such form and manner as the Secretary shall by regulation
p.000001: prescribe)—
p.000001: (1) the class in which the device is classified under section 360c of this title or if such
p.000001: person determines that the device is not classified under such section, a statement of
p.000001: that determination and the basis for such person's determination that the device is or is
p.000001: not so classified, and
p.000001: (2) action taken by such person to comply with requirements under section 360d or
p.000001: 360e of this title which are applicable to the device.
p.000001:
p.000001: A notification submitted under this subsection that contains clinical trial data for an
p.000001: applicable device clinical trial (as defined in section 282(j)(1) of title 42) shall be
p.000001: accompanied by the certification required under section 282(j)(5)(B) of such title. Such
p.000001: certification shall not be considered an element of such notification.
p.000001: (l) Exemption from reporting requirements
p.000001: A report under subsection (k) of this section is not required for a device intended for
p.000001: human use that is exempted from the requirements of this subsection under subsection (m)
p.000001: of this section or is within a type that has been classified into class I under section 360c of
p.000001: this title. The exception established in the preceding sentence does not apply to any class I
p.000001: device that is intended for a use which is of substantial importance in preventing impairment
p.000001: of human health, or to any class I device that presents a potential unreasonable risk of
p.000001: illness or injury.
p.000001: (m) List of exempt class II devices; determination by Secretary; publication in Federal
p.000001: Register
p.000001: (1) Not later than 60 days after November 21, 1997, the Secretary shall publish in the
p.000001: Federal Register a list of each type of class II device that does not require a report under
p.000001: subsection (k) of this section to provide reasonable assurance of safety and effectiveness.
p.000001: Each type of class II device identified by the Secretary as not requiring the report shall be
p.000001: exempt from the requirement to provide a report under subsection (k) of this section as of
p.000001: the date of the publication of the list in the Federal Register. The Secretary shall publish
p.000001: such list on the Internet site of the Food and Drug Administration. The list so published shall
p.000001: be updated not later than 30 days after each revision of the list by the Secretary.
p.000001: (2) Beginning on the date that is 1 day after the date of the publication of a list under this
p.000001: subsection, the Secretary may exempt a class II device from the requirement to submit a
p.000001: report under subsection (k) of this section, upon the Secretary's own initiative or a petition
p.000001: of an interested person, if the Secretary determines that such report is not necessary to
p.000001: assure the safety and effectiveness of the device. The Secretary shall publish in the
p.000001: Federal Register notice of the intent of the Secretary to exempt the device, or of the
p.000001: petition, and provide a 30-day period for public comment. Within 120 days after the
...

p.001962: Section 106 of Pub. L. 100–670 provided that: “Notwithstanding section 512(b)(2) of the Federal
p.001962: Food, Drug, and Cosmetic Act [21 U.S.C. 360b(b)(2)], the Secretary of Health and Human
p.001962: Services may not approve an abbreviated application submitted under such section for a new
p.001962: animal drug which is primarily manufactured using recombinant DNA, recombinant RNA,
p.001962: hybridoma technology, or other processes involving site specific genetic manipulation techniques.”
p.001962:
p.001962: 1 See References in Text note below.
p.001962:
p.001962: 2 So in original. Probably should be “Alimentarius”.
p.001962:
p.001962: 3 So in original. Probably should be “clause (iii)(III)”.
p.001962:
p.001962:
p.001962:
p.001962: §360c. Classification of devices intended for human use
p.001962: (a) Classes of devices
p.001962: (1) There are established the following classes of devices intended for human use:
p.001962: (A) CLASS I, GENERAL CONTROLS.—
p.001962: (i) A device for which the controls authorized by or under section 351, 352, 360, 360f,
p.001962: 360h, 360i, or 360j of this title or any combination of such sections are sufficient to
p.001962: provide reasonable assurance of the safety and effectiveness of the device.
p.001962: (ii) A device for which insufficient information exists to determine that the controls
p.001962: referred to in clause (i) are sufficient to provide reasonable assurance of the safety and
p.001962: effectiveness of the device or to establish special controls to provide such assurance,
p.001962: but because it—
p.001962: (I) is not purported or represented to be for a use in supporting or sustaining
p.001962: human life or for a use which is of substantial importance in preventing impairment of
p.001962: human health, and
p.001962: (II) does not present a potential unreasonable risk of illness or injury,
p.001962:
p.001962: is to be regulated by the controls referred to in clause (i).
p.001962:
p.001962: (B) CLASS II, SPECIAL CONTROLS.—A device which cannot be classified as a class I device
p.001962: because the general controls by themselves are insufficient to provide reasonable
p.001962: assurance of the safety and effectiveness of the device, and for which there is sufficient
p.001962: information to establish special controls to provide such assurance, including the
p.001962: promulgation of performance standards, postmarket surveillance, patient registries,
p.001962: development and dissemination of guidelines (including guidelines for the submission of
p.001962: clinical data in premarket notification submissions in accordance with section 360(k) of
p.001962: this title), recommendations, and other appropriate actions as the Secretary deems
p.001962: necessary to provide such assurance. For a device that is purported or represented to be
p.001962: for a use in supporting or sustaining human life, the Secretary shall examine and identify
p.001962: the special controls, if any, that are necessary to provide adequate assurance of safety
p.001962: and effectiveness and describe how such controls provide such assurance.
p.001962: (C) CLASS III, PREMARKET APPROVAL.—A device which because—
p.001962: (i) it (I) cannot be classified as a class I device because insufficient information exists
p.001962: to determine that the application of general controls are sufficient to provide
p.001962: reasonable assurance of the safety and effectiveness of the device, and (II) cannot be
p.001962: classified as a class II device because insufficient information exists to determine that
p.001962: the special controls described in subparagraph (B) would provide reasonable
p.001962: assurance of its safety and effectiveness, and
p.001962: (ii)(I) is purported or represented to be for a use in supporting or sustaining human
p.001962: life or for a use which is of substantial importance in preventing impairment of human
p.001962: health, or
p.001962: (II) presents a potential unreasonable risk of illness or injury,
p.001962:
p.001962: is to be subject, in accordance with section 360e of this title, to premarket approval to
p.001962: provide reasonable assurance of its safety and effectiveness.
p.001962:
p.001962: If there is not sufficient information to establish a performance standard for a device to
p.001962: provide reasonable assurance of its safety and effectiveness, the Secretary may conduct
p.001962: such activities as may be necessary to develop or obtain such information.
p.001962: (2) For purposes of this section and sections 360d and 360e of this title, the safety and
p.001962: effectiveness of a device are to be determined—
p.001962: (A) with respect to the persons for whose use the device is represented or intended,
p.001962: (B) with respect to the conditions of use prescribed, recommended, or suggested in the
p.001962: labeling of the device, and
p.001962: (C) weighing any probable benefit to health from the use of the device against any
p.001962: probable risk of injury or illness from such use.
p.001962:
p.001962: (3)(A) Except as authorized by subparagraph (B), the effectiveness of a device is, for
p.001962: purposes of this section and sections 360d and 360e of this title, to be determined, in
p.001962: accordance with regulations promulgated by the Secretary, on the basis of well-controlled
p.001962: investigations, including 1 or more clinical investigations where appropriate, by experts
p.001962: qualified by training and experience to evaluate the effectiveness of the device, from which
...

p.001962: injury if the malfunction were to recur, which report under this subparagraph—
p.001962: (i) shall be submitted in accordance with part 803 of title 21, Code of Federal
p.001962: Regulations (or successor regulations), unless the Secretary grants an exemption or
p.001962: variance from, or an alternative to, a requirement under such regulations pursuant to
p.001962: section 803.19 of such part, if the device involved is—
p.001962: (I) a class III device;
p.001962: (II) a class II device that is permanently implantable, is life supporting, or is life
p.001962: sustaining; or
p.001962: (III) a type of device which the Secretary has, by notice published in the Federal
p.001962: Register or letter to the person who is the manufacturer or importer of the device,
p.001962: indicated should be subject to such part 803 in order to protect the public health;
p.001962:
p.001962: (ii) shall, if the device is not subject to clause (i), be submitted in accordance with
p.001962: criteria established by the Secretary for reports made pursuant to this clause, which
p.001962: criteria shall require the reports to be in summary form and made on a quarterly
p.001962: basis; or
p.001962: (iii) shall, if the device is imported into the United States and for which part 803 of
p.001962: title 21, Code of Federal Regulations (or successor regulations) requires an importer
p.001962: to submit a report to the manufacturer, be submitted by the importer to the
p.001962: manufacturer in accordance with part 803 of title 21, Code of Federal Regulations (or
p.001962: successor regulations) 1
p.001962:
p.001962: (2) shall define the term “serious injury” to mean an injury that—
p.001962: (A) is life threatening,
p.001962: (B) results in permanent impairment of a body function or permanent damage to a
p.001962: body structure, or
p.001962: (C) necessitates medical or surgical intervention to preclude permanent impairment
p.001962: of a body function or permanent damage to a body structure;
p.001962:
p.001962: (3) shall require reporting of other significant adverse device experiences as
p.001962: determined by the Secretary to be necessary to be reported;
p.001962: (4) shall not impose requirements unduly burdensome to a device manufacturer or
p.001962: importer taking into account his cost of complying with such requirements and the need
p.001962: for the protection of the public health and the implementation of this chapter;
p.001962: (5) which prescribe the procedure for making requests for reports or information shall
p.001962: require that each request made under such regulations for submission of a report or
p.001962: information to the Secretary state the reason or purpose for such request and identify to
p.001962: the fullest extent practicable such report or information;
p.001962: (6) which require submission of a report or information to the Secretary shall state the
p.001962: reason or purpose for the submission of such report or information and identify to the
p.001962: fullest extent practicable such report or information;
p.001962: (7) may not require that the identity of any patient be disclosed in records, reports, or
p.001962: information required under this subsection unless required for the medical welfare of an
p.001962: individual, to determine the safety or effectiveness of a device, or to verify a record,
p.001962: report, or information submitted under this chapter; and
p.001962: (8) may not require a manufacturer or importer of a class I device to—
p.001962: (A) maintain for such a device records respecting information not in the possession
p.001962: of the manufacturer or importer, or
p.001962: (B) to submit for such a device to the Secretary any report or information—
...

p.001962: serious illnesses or serious injuries.
p.001962: (B) During the period of planning the program under subparagraph (A), paragraphs (1)
p.001962: through (4) continue to apply.
p.001962: (C) During the period in which the Secretary is providing for a transition to the full
p.001962: implementation of the program, paragraphs (1) through (4) apply except to the extent that
p.001962: the Secretary determines otherwise.
p.001962: (D) On and after the date on which the program is fully implemented, paragraphs (1)
p.001962: through (4) do not apply to a user facility unless the facility is included in the subset
p.001962: referred to in subparagraph (A).
p.001962: (E) Not later than 2 years after November 21, 1997, the Secretary shall submit to the
p.001962: Committee on Commerce of the House of Representatives, and to the Committee on
p.001962: Labor and Human Resources of the Senate, a report describing the plan developed by
p.001962: the Secretary under subparagraph (A) and the progress that has been made toward the
p.001962: implementation of the plan.
p.001962:
p.001962: (6) For purposes of this subsection:
p.001962: (A) The term “device user facility” means a hospital, ambulatory surgical facility, nursing
p.001962: home, or outpatient treatment facility which is not a physician's office. The Secretary may
p.001962: by regulation include an outpatient diagnostic facility which is not a physician's office in
p.001962: such term.
p.001962: (B) The terms “serious illness” and “serious injury” mean illness or injury, respectively,
p.001962: that—
p.001962: (i) is life threatening,
p.001962: (ii) results in permanent impairment of a body function or permanent damage to a
p.001962: body structure, or
p.001962: (iii) necessitates medical or surgical intervention to preclude permanent impairment
p.001962: of a body function or permanent damage to a body structure.
p.001962: (c) Persons exempt
p.001962: Subsection (a) of this section shall not apply to—
p.001962: (1) any practitioner who is licensed by law to prescribe or administer devices intended
p.001962: for use in humans and who manufactures or imports devices solely for use in the course
p.001962: of his professional practice;
p.001962: (2) any person who manufactures or imports devices intended for use in humans solely
p.001962: for such person's use in research or teaching and not for sale (including any person who
p.001962: uses a device under an exemption granted under section 360j(g) of this title); and
p.001962: (3) any other class of persons as the Secretary may by regulation exempt from
p.001962: subsection (a) of this section upon a finding that compliance with the requirements of
p.001962: such subsection by such class with respect to a device is not necessary to (A) assure that
p.001962: a device is not adulterated or misbranded or (B) otherwise to assure its safety and
p.001962: effectiveness.
p.001962: (d) Repealed. Pub. L. 105–115, title II, §213(a)(2), Nov. 21, 1997, 111 Stat. 2347
p.001962: (e) Device tracking
p.001962: (1) The Secretary may by order require a manufacturer to adopt a method of tracking a
p.001962: class II or class III device—
p.001962: (A) the failure of which would be reasonably likely to have serious adverse health
p.001962: consequences; or
p.001962: (B) which is—
p.001962: (i) intended to be implanted in the human body for more than one year, or
p.001962: (ii) a life sustaining or life supporting device used outside a device user facility.
p.001962:
p.001962: (2) Any patient receiving a device subject to tracking under paragraph (1) may refuse to
p.001962: release, or refuse permission to release, the patient's name, address, social security
...

Health / Drug Dependence

Searching for indicator dependence:

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p.001994: 384. Importation of prescription drugs.
p.001994: 384a. Foreign supplier verification program.
p.001994: 384b. Voluntary qualified importer program.
p.001994: 384c. Inspection of foreign food facilities.
p.001994: 384d. Accreditation of third-party auditors.
p.001994:
p.001994:
p.001994: SUBCHAPTER IX—TOBACCO PRODUCTS
p.001994: 387. Definitions.
p.001994: 387a. FDA authority over tobacco products.
p.001994: 387a–1. Final rule.
p.001994: 387b. Adulterated tobacco products.
p.001994: 387c. Misbranded tobacco products.
p.001994: 387d. Submission of health information to the Secretary.
p.001994: 387e. Annual registration.
p.001994: 387f. General provisions respecting control of tobacco products.
p.001994: 387f–1. Enforcement action plan for advertising and promotion restrictions.
p.001994: 387g. Tobacco product standards.
p.001994: 387h. Notification and other remedies.
p.001994: 387i. Records and reports on tobacco products.
p.001994: 387j. Application for review of certain tobacco products.
p.001994: 387k. Modified risk tobacco products.
p.001994: 387l. Judicial review.
p.001994: 387m. Equal treatment of retail outlets.
p.001994: 387n. Jurisdiction of and coordination with the Federal Trade Commission.
p.001994: 387o. Regulation requirement.
p.001994: 387p. Preservation of State and local authority.
p.001994: 387q. Tobacco Products Scientific Advisory Committee.
p.001994: 387r. Drug products used to treat tobacco dependence.
p.001994: 387s. User fees.
p.001994: 387t. Labeling, recordkeeping, records inspection.
p.001994: 387u. Studies of progress and effectiveness.
p.001994:
p.001994:
p.001994: SUBCHAPTER X—MISCELLANEOUS
p.001994: 391. Separability clause.
p.001994: 392. Exemption of meats and meat food products.
p.001994: 393. Food and Drug Administration.
p.001994: 393a. Office of Pediatric Therapeutics.
p.001994: 394. Scientific review groups.
p.001994: 395. Loan repayment program.
p.001994: 396. Practice of medicine.
p.001994: 397. Contracts for expert review.
p.001994: 398. Notices to States regarding imported food.
p.001994: 399. Grants to enhance food safety.
p.001994: 399a. Office of the Chief Scientist.
p.001994: 399b. Office of Women's Health.
p.001994: 399c. Improving the training of State, local, territorial, and tribal food safety officials.
p.001994: 399d. Employee protections.
p.001994:
p.001994:
p.001994:
p.001994:
p.001994: SUBCHAPTER I—SHORT TITLE
p.001994:
p.001994:
p.001994: §301. Short title
p.001994: This chapter may be cited as the Federal Food, Drug, and Cosmetic Act.
p.001994: (June 25, 1938, ch. 675, §1, 52 Stat. 1040.)
p.001994: EFFECTIVE DATE; POSTPONEMENT IN CERTAIN CASES
p.001994: Act June 23, 1939, ch. 242, §§1, 2, 53 Stat. 853, 854, provided that:
p.001994: “[SEC. 1] (a) The effective date of the following provisions of the Federal Food, Drug, and
p.001994: Cosmetic Act is hereby postponed until January 1, 1940: Sections 402(c) [342(c) of this title];
...

p.000398: consumer in violation of this chapter or would otherwise result in misbranding or
p.000398: adulteration within the meaning of this chapter.
p.000398: (7) If, in the judgment of the Secretary, a tolerance limitation is required in order to assure
p.000398: that a proposed use of a color additive will be safe, the Secretary—
p.000398: (A) shall not list the additive for such use if he finds that the data before him do not
p.000398: establish that such additive, if used within a safe tolerance limitation, would achieve the
p.000398: intended physical or other technical effect; and
p.000398: (B) shall not fix such tolerance limitation at a level higher than he finds to be reasonably
p.000398: required to accomplish the intended physical or other technical effect.
p.000398:
p.000398: (8) If, having regard to the aggregate quantity of color additive likely to be consumed in
p.000398: the diet or to be applied to the human body, the Secretary finds that the data before him fail
p.000398: to show that it would be safe and otherwise permissible to list a color additive (or
p.000398: pharmacologically related color additives) for all the uses proposed therefor and at the
p.000398: levels of concentration proposed, the Secretary shall, in determining for which use or uses
p.000398: such additive (or such related additives) shall be or remain listed, or how the aggregate
p.000398: allowable safe tolerance for such additive or additives shall be allocated by him among the
p.000398: uses under consideration, take into account, among other relevant factors (and subject to
p.000398: the paramount criterion of safety), (A) the relative marketability of the articles involved as
p.000398: affected by the proposed uses of the color additive (or of such related additives) in or on
p.000398: such articles, and the relative dependence of the industries concerned on such uses; (B)
p.000398: the relative aggregate amounts of such color additive which he estimates would be
p.000398: consumed in the diet or applied to the human body by reason of the various uses and levels
p.000398: of concentration proposed; and (C) the availability, if any, of other color additives suitable
p.000398: and safe for one or more of the uses proposed.
p.000398: (c) Certification of colors
p.000398: The Secretary shall further, by regulation, provide (1) for the certification, with safe
p.000398: diluents or without diluents, of batches of color additives listed pursuant to subsection (b) of
p.000398: this section and conforming to the requirements for such additives established by
p.000398: regulations under such subsection and this subsection, and (2) for exemption from the
p.000398: requirement of certification in the case of any such additive, or any listing or use thereof, for
p.000398: which he finds such requirement not to be necessary in the interest of the protection of the
p.000398: public health: Provided, That, with respect to any use in or on food for which a listed color
p.000398: additive is deemed to be safe by reason of the proviso to paragraph (4) of subsection (b),
p.000398: the requirement of certification shall be deemed not to be necessary in the interest of public
p.000398: health protection.
p.000398: (d) Procedure for issuance, amendment, or repeal of regulations
p.000398: The provisions of section 371(e), (f), and (g) of this title shall, subject to the provisions of
p.000398: subparagraph (C) of subsection (b)(5) of this section, apply to and in all respects govern
p.000398: proceedings for the issuance, amendment, or repeal of regulations under subsection (b) or
...

p.000398: who use cigarettes and smokeless tobacco and in preventing the life-threatening health
p.000398: consequences associated with tobacco use. An overwhelming majority of Americans who use
p.000398: tobacco products begin using such products while they are minors and become addicted to the
p.000398: nicotine in those products before reaching the age of 18. Tobacco advertising and promotion
p.000398: play a crucial role in the decision of these minors to begin using tobacco products. Less
p.000398: restrictive and less comprehensive approaches have not [been] and will not be effective in
p.000398: reducing the problems addressed by such regulations. The reasonable restrictions on the
p.000398: advertising and promotion of tobacco products contained in such regulations will lead to a
p.000398: significant decrease in the number of minors using and becoming addicted to those products.
p.000398: “(32) The regulations described in paragraph (30) impose no more extensive restrictions on
p.000398: communication by tobacco manufacturers and sellers than are necessary to reduce the number
p.000398: of children and adolescents who use cigarettes and smokeless tobacco and to prevent the life-
p.000398: threatening health consequences associated with tobacco use. Such regulations are narrowly
p.000398: tailored to restrict those advertising and promotional practices which are most likely to be seen
p.000398: or heard by youth and most likely to entice them into tobacco use, while affording tobacco
p.000398: manufacturers and sellers ample opportunity to convey information about their products to adult
p.000398: consumers.
p.000398: “(33) Tobacco dependence is a chronic disease, one that typically requires repeated
p.000398: interventions to achieve long-term or permanent abstinence.
p.000398: “(34) Because the only known safe alternative to smoking is cessation, interventions should
p.000398: target all smokers to help them quit completely.
p.000398: “(35) Tobacco products have been used to facilitate and finance criminal activities both
p.000398: domestically and internationally. Illicit trade of tobacco products has been linked to organized
p.000398: crime and terrorist groups.
p.000398: “(36) It is essential that the Food and Drug Administration review products sold or
p.000398: distributed for use to reduce risks or exposures associated with tobacco products and that it be
p.000398: empowered to review any advertising and labeling for such products. It is also essential that
p.000398: manufacturers, prior to marketing such products, be required to demonstrate that such products
p.000398: will meet a series of rigorous criteria, and will benefit the health of the population as a whole,
p.000398: taking into account both users of tobacco products and persons who do not currently use
p.000398: tobacco products.
p.000398: “(37) Unless tobacco products that purport to reduce the risks to the public of tobacco use
p.000398: actually reduce such risks, those products can cause substantial harm to the public health to
p.000398: the extent that the individuals, who would otherwise not consume tobacco products or would
p.000398: consume such products less, use tobacco products purporting to reduce risk. Those who use
...

p.000398: Agreement in 1998. USA v. Philip Morris, USA, Inc., et al. (Civil Action No. 99–2496 (GK),
p.000398: August 17, 2006).
p.000398: “(49) In August 2006 a United States district court judge found that the major United States
p.000398: cigarette companies have designed their cigarettes to precisely control nicotine delivery levels
p.000398: and provide doses of nicotine sufficient to create and sustain addiction while also concealing
p.000398: much of their nicotine-related research. USA v. Philip Morris, USA, Inc., et al. (Civil Action No.
p.000398: 99–2496 (GK), August 17, 2006).”
p.000398: PURPOSE
p.000398: Pub. L. 111–31, div. A, §3, June 22, 2009, 123 Stat. 1781, provided that: “The purposes of this
p.000398: division [see Short Title of 2009 Amendment note set out under section 301 of this title] are—
p.000398: “(1) to provide authority to the Food and Drug Administration to regulate tobacco products
p.000398: under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), by recognizing it as
p.000398: the primary Federal regulatory authority with respect to the manufacture, marketing, and
p.000398: distribution of tobacco products as provided for in this division;
p.000398: “(2) to ensure that the Food and Drug Administration has the authority to address issues of
p.000398: particular concern to public health officials, especially the use of tobacco by young people and
p.000398: dependence on tobacco;
p.000398: “(3) to authorize the Food and Drug Administration to set national standards controlling the
p.000398: manufacture of tobacco products and the identity, public disclosure, and amount of ingredients
p.000398: used in such products;
p.000398: “(4) to provide new and flexible enforcement authority to ensure that there is effective
p.000398: oversight of the tobacco industry's efforts to develop, introduce, and promote less harmful
p.000398: tobacco products;
p.000398: “(5) to vest the Food and Drug Administration with the authority to regulate the levels of tar,
p.000398: nicotine, and other harmful components of tobacco products;
p.000398: “(6) in order to ensure that consumers are better informed, to require tobacco product
p.000398: manufacturers to disclose research which has not previously been made available, as well as
p.000398: research generated in the future, relating to the health and dependency effects or safety of
p.000398: tobacco products;
p.000398: “(7) to continue to permit the sale of tobacco products to adults in conjunction with
p.000398: measures to ensure that they are not sold or accessible to underage purchasers;
p.000398: “(8) to impose appropriate regulatory controls on the tobacco industry;
p.000398: “(9) to promote cessation to reduce disease risk and the social costs associated with
p.000398: tobacco-related diseases; and
p.000398: “(10) to strengthen legislation against illicit trade in tobacco products.”
p.000398: MODIFICATION OF DEADLINES FOR SECRETARIAL ACTION
...

p.000398: to, or does not contain or is free of, a substance or substances.
p.000398: (B) Limitation
p.000398: No tobacco product shall be considered to be “sold or distributed for use to reduce
p.000398: harm or the risk of tobacco-related disease associated with commercially marketed
p.000398: tobacco products”, except as described in subparagraph (A).
p.000398: (C) Smokeless tobacco product
p.000398: No smokeless tobacco product shall be considered to be “sold or distributed for use
p.000398: to reduce harm or the risk of tobacco-related disease associated with commercially
p.000398: marketed tobacco products” solely because its label, labeling, or advertising uses the
p.000398: following phrases to describe such product and its use: “smokeless tobacco”,
p.000398: “smokeless tobacco product”, “not consumed by smoking”, “does not produce smoke”,
p.000398: “smokefree”, “smoke-free”, “without smoke”, “no smoke”, or “not smoke”.
p.000398: (3) Effective date
p.000398: The provisions of paragraph (2)(A)(ii) shall take effect 12 months after June 22, 2009,
p.000398: for those products whose label, labeling, or advertising contains the terms described in
p.000398: such paragraph on June 22, 2009. The effective date shall be with respect to the date of
p.000398: manufacture, provided that, in any case, beginning 30 days after such effective date, a
p.000398: manufacturer shall not introduce into the domestic commerce of the United States any
p.000398: product, irrespective of the date of manufacture, that is not in conformance with
p.000398: paragraph (2)(A)(ii).
p.000398: (c) Tobacco dependence products
p.000398: A product that is intended to be used for the treatment of tobacco dependence, including
p.000398: smoking cessation, is not a modified risk tobacco product under this section if it has been
p.000398: approved as a drug or device by the Food and Drug Administration and is subject to the
p.000398: requirements of subchapter V.
p.000398: (d) Filing
p.000398: Any person may file with the Secretary an application for a modified risk tobacco product.
p.000398: Such application shall include—
p.000398: (1) a description of the proposed product and any proposed advertising and labeling;
p.000398: (2) the conditions for using the product;
p.000398: (3) the formulation of the product;
p.000398: (4) sample product labels and labeling;
p.000398: (5) all documents (including underlying scientific information) relating to research
p.000398: findings conducted, supported, or possessed by the tobacco product manufacturer
p.000398: relating to the effect of the product on tobacco-related diseases and health-related
p.000398: conditions, including information both favorable and unfavorable to the ability of the
p.000398: product to reduce risk or exposure and relating to human health;
p.000398: (6) data and information on how consumers actually use the tobacco product; and
p.000398: (7) such other information as the Secretary may require.
p.000398: (e) Public availability
p.000398: The Secretary shall make the application described in subsection (d) publicly available
p.000398: (except matters in the application which are trade secrets or otherwise confidential,
p.000398: commercial information) and shall request comments by interested persons on the
...

p.000398: conduct postmarket surveillance and studies and to submit to the Secretary the
p.000398: results of such surveillance and studies to determine the impact of the order on
p.000398: consumer perception, behavior, and health and to enable the Secretary to review the
p.000398: accuracy of the determinations upon which the order was based in accordance with
p.000398: a protocol approved by the Secretary.
p.000398: (iii) Annual submission
p.000398: The results of such postmarket surveillance and studies described in clause (ii)
p.000398: shall be submitted annually.
p.000398: (3) Basis
p.000398: The determinations under paragraphs (1) and (2) shall be based on—
p.000398: (A) the scientific evidence submitted by the applicant; and
p.000398: (B) scientific evidence and other information that is made available to the Secretary.
p.000398: (4) Benefit to health of individuals and of population as a whole
p.000398: In making the determinations under paragraphs (1) and (2), the Secretary shall take
p.000398: into account—
p.000398: (A) the relative health risks to individuals of the tobacco product that is the subject of
p.000398: the application;
p.000398: (B) the increased or decreased likelihood that existing users of tobacco products
p.000398: who would otherwise stop using such products will switch to the tobacco product that is
p.000398: the subject of the application;
p.000398: (C) the increased or decreased likelihood that persons who do not use tobacco
p.000398: products will start using the tobacco product that is the subject of the application;
p.000398: (D) the risks and benefits to persons from the use of the tobacco product that is the
p.000398: subject of the application as compared to the use of products for smoking cessation
p.000398: approved under subchapter V to treat nicotine dependence; and
p.000398: (E) comments, data, and information submitted by interested persons.
p.000398: (h) Additional conditions for marketing
p.000398: (1) Modified risk products
p.000398: The Secretary shall require for the marketing of a product under this section that any
p.000398: advertising or labeling concerning modified risk products enable the public to
p.000398: comprehend the information concerning modified risk and to understand the relative
p.000398: significance of such information in the context of total health and in relation to all of the
p.000398: diseases and health-related conditions associated with the use of tobacco products.
p.000398: (2) Comparative claims
p.000398: (A) In general
p.000398: The Secretary may require for the marketing of a product under this subsection that
p.000398: a claim comparing a tobacco product to 1 or more other commercially marketed
p.000398: tobacco products shall compare the tobacco product to a commercially marketed
p.000398: tobacco product that is representative of that type of tobacco product on the market (for
p.000398: example the average value of the top 3 brands of an established regular tobacco
p.000398: product).
p.000398: (B) Quantitative comparisons
p.000398: The Secretary may also require, for purposes of subparagraph (A), that the percent
p.000398: (or fraction) of change and identity of the reference tobacco product and a quantitative
p.000398: comparison of the amount of the substance claimed to be reduced shall be stated in
p.000398: immediate proximity to the most prominent claim.
p.000398: (3) Label disclosure
p.000398: (A) In general
p.000398: The Secretary may require the disclosure on the label of other substances in the
...

p.000398: (vi) 1 individual as a representative of the interests of the tobacco growers.
p.000398: (B) Nonvoting members
p.000398: The members of the committee appointed under clauses (iv), (v), and (vi) of
p.000398: subparagraph (A) shall serve as consultants to those described in clauses (i) through
p.000398: (iii) of subparagraph (A) and shall be nonvoting representatives.
p.000398: (C) Conflicts of interest
p.000398: No members of the committee, other than members appointed pursuant to clauses
p.000398: (iv), (v), and (vi) of subparagraph (A) shall, during the member's tenure on the
p.000398: committee or for the 18-month period prior to becoming such a member, receive any
p.000398: salary, grants, or other payments or support from any business that manufactures,
p.000398: distributes, markets, or sells cigarettes or other tobacco products.
p.000398: (2) Limitation
p.000398: The Secretary may not appoint to the Advisory Committee any individual who is in the
p.000398: regular full-time employ of the Food and Drug Administration or any agency responsible
p.000398: for the enforcement of this chapter. The Secretary may appoint Federal officials as ex
p.000398: officio members.
p.000398: (3) Chairperson
p.000398: The Secretary shall designate 1 of the members appointed under clauses (i), (ii), and
p.000398: (iii) of paragraph (1)(A) to serve as chairperson.
p.000398: (c) Duties
p.000398: The Tobacco Products Scientific Advisory Committee shall provide advice, information,
p.000398: and recommendations to the Secretary—
p.000398: (1) as provided in this subchapter;
p.000398: (2) on the effects of the alteration of the nicotine yields from tobacco products;
p.000398: (3) on whether there is a threshold level below which nicotine yields do not produce
p.000398: dependence on the tobacco product involved; and
p.000398: (4) on its review of other safety, dependence, or health issues relating to tobacco
p.000398: products as requested by the Secretary.
p.000398: (d) Compensation; support; FACA
p.000398: (1) Compensation and travel
p.000398: Members of the Advisory Committee who are not officers or employees of the United
p.000398: States, while attending conferences or meetings of the committee or otherwise engaged
p.000398: in its business, shall be entitled to receive compensation at rates to be fixed by the
p.000398: Secretary, which may not exceed the daily equivalent of the rate in effect under the
p.000398: Senior Executive Schedule under section 5382 of title 5, for each day (including travel
p.000398: time) they are so engaged; and while so serving away from their homes or regular places
p.000398: of business each member may be allowed travel expenses, including per diem in lieu of
p.000398: subsistence, as authorized by section 5703 of title 5 for persons in the Government
p.000398: service employed intermittently.
p.000398: (2) Administrative support
p.000398: The Secretary shall furnish the Advisory Committee clerical and other assistance.
p.000398: (3) Nonapplication of FACA
p.000398: Section 14 of the Federal Advisory Committee Act does not apply to the Advisory
p.000398: Committee.
p.000398: (e) Proceedings of advisory panels and committees
p.000398: The Advisory Committee shall make and maintain a transcript of any proceeding of the
p.000398: panel or committee. Each such panel and committee shall delete from any transcript made
p.000398: under this subsection information which is exempt from disclosure under section 552(b) of
p.000398: title 5.
p.000398: (June 25, 1938, ch. 675, §917, as added Pub. L. 111–31, div. A, title I, §101(b)(3), June 22,
p.000398: 2009, 123 Stat. 1824.)
p.000398: REFERENCES IN TEXT
p.000398: Section 14 of the Federal Advisory Committee Act, referred to in subsec. (d)(3), is section 14 of
p.000398: Pub. L. 92–463, which is set out in the Appendix to Title 5, Government Organization and
p.000398: Employees.
p.000398: MODIFICATION OF DEADLINES FOR SECRETARIAL ACTION
p.000398: With respect to any time periods specified in an amendment by div. A of Pub. L. 111–31 that
p.000398: begin on June 22, 2009, within which the Secretary of Health and Human Services is required to
p.000398: carry out and complete specified activities, with certain limitations, the calculation of such time
p.000398: periods shall commence on the first day of the first fiscal quarter following the initial 2 consecutive
p.000398: fiscal quarters of fiscal year 2010 for which the Secretary has collected fees under section 387s of
p.000398: this title, and the Secretary may extend or reduce the duration of one or more such time periods,
p.000398: except that no such period shall be extended for more than 90 days, see section 6 of Pub. L. 111–
p.000398: 31, set out as a note under section 387 of this title.
p.000398:
p.000398:
p.000398: §387r. Drug products used to treat tobacco dependence
p.000398: (a) In general
p.000398: The Secretary shall—
p.000398: (1) at the request of the applicant, consider designating products for smoking
p.000398: cessation, including nicotine replacement products as fast track research and approval
p.000398: products within the meaning of section 356 of this title;
p.000398: (2) consider approving the extended use of nicotine replacement products (such as
p.000398: nicotine patches, nicotine gum, and nicotine lozenges) for the treatment of tobacco
p.000398: dependence; and
p.000398: (3) review and consider the evidence for additional indications for nicotine replacement
p.000398: products, such as for craving relief or relapse prevention.
p.000398: (b) Report on innovative products
p.000398: (1) In general
p.000398: Not later than 3 years after June 22, 2009, the Secretary, after consultation with
p.000398: recognized scientific, medical, and public health experts (including both Federal agencies
p.000398: and nongovernmental entities, the Institute of Medicine of the National Academy of
p.000398: Sciences, and the Society for Research on Nicotine and Tobacco), shall submit to the
p.000398: Congress a report that examines how best to regulate, promote, and encourage the
p.000398: development of innovative products and treatments (including nicotine-based and non-
p.000398: nicotine-based products and treatments) to better achieve, in a manner that best protects
p.000398: and promotes the public health—
p.000398: (A) total abstinence from tobacco use;
p.000398: (B) reductions in consumption of tobacco; and
p.000398: (C) reductions in the harm associated with continued tobacco use.
p.000398: (2) Recommendations
p.000398: The report under paragraph (1) shall include the recommendations of the Secretary on
p.000398: how the Food and Drug Administration should coordinate and facilitate the exchange of
p.000398: information on such innovative products and treatments among relevant offices and
p.000398: centers within the Administration and within the National Institutes of Health, the Centers
p.000398: for Disease Control and Prevention, and other relevant agencies.
p.000398: (June 25, 1938, ch. 675, §918, as added Pub. L. 111–31, div. A, title I, §101(b)(3), June 22,
p.000398: 2009, 123 Stat. 1825.)
p.000398: MODIFICATION OF DEADLINES FOR SECRETARIAL ACTION
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p.000398: the primary Federal regulatory authority with respect to the manufacture, marketing, and
p.000398: distribution of tobacco products as provided for in this division;
p.000398: “(2) to ensure that the Food and Drug Administration has the authority to address issues of
p.000398: particular concern to public health officials, especially the use of tobacco by young people and
p.000398: dependence on tobacco;
p.000398: “(3) to authorize the Food and Drug Administration to set national standards controlling the
p.000398: manufacture of tobacco products and the identity, public disclosure, and amount of ingredients
p.000398: used in such products;
p.000398: “(4) to provide new and flexible enforcement authority to ensure that there is effective
p.000398: oversight of the tobacco industry's efforts to develop, introduce, and promote less harmful
p.000398: tobacco products;
p.000398: “(5) to vest the Food and Drug Administration with the authority to regulate the levels of tar,
p.000398: nicotine, and other harmful components of tobacco products;
p.000398: “(6) in order to ensure that consumers are better informed, to require tobacco product
p.000398: manufacturers to disclose research which has not previously been made available, as well as
p.000398: research generated in the future, relating to the health and dependency effects or safety of
p.000398: tobacco products;
p.000398: “(7) to continue to permit the sale of tobacco products to adults in conjunction with
p.000398: measures to ensure that they are not sold or accessible to underage purchasers;
p.000398: “(8) to impose appropriate regulatory controls on the tobacco industry;
p.000398: “(9) to promote cessation to reduce disease risk and the social costs associated with
p.000398: tobacco-related diseases; and
p.000398: “(10) to strengthen legislation against illicit trade in tobacco products.”
p.000398: MODIFICATION OF DEADLINES FOR SECRETARIAL ACTION
p.000398: Pub. L. 111–31, div. A, §6, June 22, 2009, 123 Stat. 1783, provided that:
p.000398: “(a) DELAYED COMMENCEMENT OF DATES FOR SECRETARIAL ACTION.—
p.000398: “(1) IN GENERAL.—Except as provided in subsection (c), with respect to any time periods
p.000398: specified in this division [see Short Title of 2009 Amendment note set out under section 301 of
p.000398: this title] (or in an amendment made by this division) that begin on the date of enactment of this
p.000398: Act [June 22, 2009], within which the Secretary of Health and Human Services is required to
p.000398: carry out and complete specified activities, the calculation of such time periods shall commence
p.000398: on the date described in subsection (b).
p.000398: “(2) LIMITATION.—Subsection (a) shall only apply with respect to obligations of the Secretary
p.000398: of Health and Human Services that must be completed within a specified time period and shall
p.000398: not apply to the obligations of any other person or to any other provision of this division
p.000398: (including the amendments made by this division) that do not create such obligations of the
p.000398: Secretary and are not contingent on actions by the Secretary.
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Health / Drug Usage

Searching for indicator drug:

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p.001994: 21 U.S.C.
p.001994: United States Code, 2011 Edition
p.001994: Title 21 - FOOD AND DRUGS
p.001994: CHAPTER 9 - FEDERAL FOOD, DRUG, AND COSMETIC ACT
p.001994: From the U.S. Government Publishing Office, www.gpo.gov
p.001994:
p.001994:
p.001994:
p.001994:
p.001994: CHAPTER 9—FEDERAL FOOD, DRUG, AND COSMETIC ACT
p.001994: SUBCHAPTER I—SHORT TITLE
p.001994: Sec.
p.001994: 301. Short title.
p.001994:
p.001994:
p.001994: SUBCHAPTER II—DEFINITIONS
p.001994: 321. Definitions; generally.
p.001994: 321a. “Butter” defined.
p.001994: 321b. “Package” defined.
p.001994: 321c. Nonfat dry milk; “milk” defined.
p.001994: 321d. Market names for catfish and ginseng.
p.001994:
p.001994:
p.001994: SUBCHAPTER III—PROHIBITED ACTS AND PENALTIES
p.001994: 331. Prohibited acts.
p.001994: 332. Injunction proceedings.
p.001994: 333. Penalties.
p.001994: 333a. Repealed.
p.001994: 334. Seizure.
p.001994: 335. Hearing before report of criminal violation.
p.001994: 335a. Debarment, temporary denial of approval, and suspension.
p.001994: 335b. Civil penalties.
p.001994: 335c. Authority to withdraw approval of abbreviated drug applications.
p.001994: 336. Report of minor violations.
p.001994: 337. Proceedings in name of United States; provision as to subpoenas.
p.001994:
p.001994:
p.001994: SUBCHAPTER IV—FOOD
p.001994: 341. Definitions and standards for food.
p.001994: 342. Adulterated food.
p.001994: 343. Misbranded food.
p.001994: 343–1. National uniform nutrition labeling.
p.001994: 343–2. Dietary supplement labeling exemptions.
p.001994: 343–3. Disclosure.
p.001994: 343a. Repealed.
p.001994: 344. Emergency permit control.
p.001994: 345. Regulations making exemptions.
p.001994: 346. Tolerances for poisonous or deleterious substances in food; regulations.
p.001994: 346a. Tolerances and exemptions for pesticide chemical residues.
p.001994: 346b. Authorization of appropriations.
p.001994: 347. Intrastate sales of colored oleomargarine.
p.001994: 347a. Congressional declaration of policy regarding oleomargarine sales.
p.001994: 347b. Contravention of State laws.
p.001994: 348. Food additives.
p.001994: 349. Bottled drinking water standards; publication in Federal Register.
p.001994: 350. Vitamins and minerals.
p.001994: 350a. Infant formulas.
p.001994: 350b. New dietary ingredients.
p.001994: 350c. Maintenance and inspection of records.
p.001994: 350d. Registration of food facilities.
p.001994: 350e. Sanitary transportation practices.
p.001994: 350f. Reportable food registry.
p.001994: 350g. Hazard analysis and risk-based preventive controls.
...

p.001994: 360ccc. Conditional approval of new animal drugs for minor use and minor species.
p.001994: 360ccc–1. Index of legally marketed unapproved new animal drugs for minor species.
p.001994: 360ccc–2. Designated new animal drugs for minor use or minor species.
p.001994:
p.001994:
p.001994: SUBCHAPTER VI—COSMETICS
p.001994: 361. Adulterated cosmetics.
p.001994: 362. Misbranded cosmetics.
p.001994: 363. Regulations making exemptions.
p.001994: 364. Repealed.
p.001994:
p.001994:
p.001994: SUBCHAPTER VII—GENERAL AUTHORITY
p.001994: PART A—GENERAL ADMINISTRATIVE PROVISIONS
p.001994: 371. Regulations and hearings.
p.001994: 372. Examinations and investigations.
p.001994: 372a. Transferred.
p.001994: 373. Records.
p.001994: 374. Inspection.
p.001994: 374a. Inspections relating to food allergens.
p.001994: 375. Publicity.
p.001994: 376. Examination of sea food on request of packer; marking food with results; fees;
p.001994: penalties.
p.001994: 377. Revision of United States Pharmacopoeia; development of analysis and
p.001994: mechanical and physical tests.
p.001994: 378. Advertising of foods.
p.001994: 379. Confidential information.
p.001994: 379a. Presumption of existence of jurisdiction.
p.001994: 379b. Consolidated administrative and laboratory facility.
p.001994: 379c. Transferred.
p.001994: 379d. Automation of Food and Drug Administration.
p.001994: 379d–1. Conflicts of interest.
p.001994: 379d–2. Policy on the review and clearance of scientific articles published by FDA
p.001994: employees.
p.001994:
p.001994: PART B—COLORS
p.001994: 379e. Listing and certification of color additives for foods, drugs, devices, and
p.001994: cosmetics.
p.001994:
p.001994: PART C—FEES
p.001994: SUBPART 1—FREEDOM OF INFORMATION FEES
p.001994: 379f. Recovery and retention of fees for freedom of information requests.
p.001994:
p.001994: SUBPART 2—FEES RELATING TO DRUGS
p.001994: 379g. Definitions.
p.001994: 379h. Authority to assess and use drug fees.
p.001994: 379h–1. Fees relating to advisory review of prescription-drug television advertising.
p.001994: 379h–2. Reauthorization; reporting requirements.
p.001994:
p.001994: SUBPART 3—FEES RELATING TO DEVICES
p.001994: 379i. Definitions.
p.001994: 379j. Authority to assess and use device fees.
p.001994: 379j–1. Reauthorization; reporting requirements.
p.001994:
p.001994: SUBPART 4—FEES RELATING TO ANIMAL DRUGS
p.001994: 379j–11. Definitions.
p.001994: 379j–12. Authority to assess and use animal drug fees.
p.001994: 379j–13. Reauthorization; reporting requirements.
p.001994:
p.001994: SUBPART 5—FEES RELATING TO GENERIC NEW ANIMAL DRUGS
p.001994: 379j–21. Authority to assess and use generic new animal drug fees.
p.001994: 379j–22. Reauthorization; reporting requirements.
p.001994:
p.001994: SUBPART 6—FEES RELATED TO FOOD
p.001994: 379j–31. Authority to collect and use fees.
p.001994: PART D—INFORMATION AND EDUCATION
p.001994: 379k. Information system.
p.001994: 379l. Education.
p.001994:
p.001994: PART E—ENVIRONMENTAL IMPACT REVIEW
p.001994: 379o. Environmental impact.
p.001994:
p.001994: PART F—NATIONAL UNIFORMITY FOR NONPRESCRIPTION DRUGS AND PREEMPTION FOR LABELING OR
p.001994: PACKAGING OF COSMETICS
p.001994: 379r. National uniformity for nonprescription drugs.
p.001994: 379s. Preemption for labeling or packaging of cosmetics.
p.001994:
p.001994: PART G—SAFETY REPORTS
p.001994: 379v. Safety report disclaimers.
p.001994:
p.001994: PART H—SERIOUS ADVERSE EVENT REPORTS
p.001994: 379aa. Serious adverse event reporting for nonprescription drugs.
p.001994: 379aa–1. Serious adverse event reporting for dietary supplements.
p.001994:
p.001994: PART I—REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG ADMINISTRATION
p.001994: 379dd. Establishment and functions of the Foundation.
p.001994: 379dd–1. Location of Foundation.
p.001994: 379dd–2. Activities of the Food and Drug Administration.
p.001994:
p.001994:
p.001994: SUBCHAPTER VIII—IMPORTS AND EXPORTS
p.001994: 381. Imports and exports.
p.001994: 382. Exports of certain unapproved products.
p.001994: 383. Office of International Relations.
p.001994: 384. Importation of prescription drugs.
p.001994: 384a. Foreign supplier verification program.
p.001994: 384b. Voluntary qualified importer program.
p.001994: 384c. Inspection of foreign food facilities.
p.001994: 384d. Accreditation of third-party auditors.
p.001994:
p.001994:
p.001994: SUBCHAPTER IX—TOBACCO PRODUCTS
p.001994: 387. Definitions.
p.001994: 387a. FDA authority over tobacco products.
p.001994: 387a–1. Final rule.
p.001994: 387b. Adulterated tobacco products.
p.001994: 387c. Misbranded tobacco products.
p.001994: 387d. Submission of health information to the Secretary.
p.001994: 387e. Annual registration.
p.001994: 387f. General provisions respecting control of tobacco products.
p.001994: 387f–1. Enforcement action plan for advertising and promotion restrictions.
p.001994: 387g. Tobacco product standards.
p.001994: 387h. Notification and other remedies.
p.001994: 387i. Records and reports on tobacco products.
p.001994: 387j. Application for review of certain tobacco products.
p.001994: 387k. Modified risk tobacco products.
p.001994: 387l. Judicial review.
p.001994: 387m. Equal treatment of retail outlets.
p.001994: 387n. Jurisdiction of and coordination with the Federal Trade Commission.
p.001994: 387o. Regulation requirement.
p.001994: 387p. Preservation of State and local authority.
p.001994: 387q. Tobacco Products Scientific Advisory Committee.
p.001994: 387r. Drug products used to treat tobacco dependence.
p.001994: 387s. User fees.
p.001994: 387t. Labeling, recordkeeping, records inspection.
p.001994: 387u. Studies of progress and effectiveness.
p.001994:
p.001994:
p.001994: SUBCHAPTER X—MISCELLANEOUS
p.001994: 391. Separability clause.
p.001994: 392. Exemption of meats and meat food products.
p.001994: 393. Food and Drug Administration.
p.001994: 393a. Office of Pediatric Therapeutics.
p.001994: 394. Scientific review groups.
p.001994: 395. Loan repayment program.
p.001994: 396. Practice of medicine.
p.001994: 397. Contracts for expert review.
p.001994: 398. Notices to States regarding imported food.
p.001994: 399. Grants to enhance food safety.
p.001994: 399a. Office of the Chief Scientist.
p.001994: 399b. Office of Women's Health.
p.001994: 399c. Improving the training of State, local, territorial, and tribal food safety officials.
p.001994: 399d. Employee protections.
p.001994:
p.001994:
p.001994:
p.001994:
p.001994: SUBCHAPTER I—SHORT TITLE
p.001994:
p.001994:
p.001994: §301. Short title
p.001994: This chapter may be cited as the Federal Food, Drug, and Cosmetic Act.
p.001994: (June 25, 1938, ch. 675, §1, 52 Stat. 1040.)
p.001994: EFFECTIVE DATE; POSTPONEMENT IN CERTAIN CASES
p.001994: Act June 23, 1939, ch. 242, §§1, 2, 53 Stat. 853, 854, provided that:
p.001994: “[SEC. 1] (a) The effective date of the following provisions of the Federal Food, Drug, and
p.001994: Cosmetic Act is hereby postponed until January 1, 1940: Sections 402(c) [342(c) of this title];
p.001994: 403(e)(1) [343(e)(1) of this title]; 403(g), (h), (i), (j), and (k) [343(g) to (k) of this title]; 501(a), (4)
p.001994: [351(a)(4) of this title]; 502(b), (d), (e), (f), (g), and (h) [352(b), (d) to (h) of this title]; 601(e) [361(e)
p.001994: of this title]; and 602(b) [362(b) of this title].
p.001994: “(b) The Secretary of Agriculture shall promulgate regulations further postponing to July 1,
p.001994: 1940[,] the effective date of the provisions of sections 403(e)(1) [343(e)(1) of this title]; 403(g), (h),
p.001994: (i), (j), and (k) [343(g) to (k)]; 502(b), (d), (e), (f), (g), and (h) [352(b), (d) to (h) of this title]; and
p.001994: 602(b) [362(b) of this title] of such Act with respect to lithographed labeling which was
p.001994: manufactured prior to February 1, 1939, and to containers bearing labeling which, prior to
p.001994: February 1, 1939, was lithographed, etched, stamped, pressed, printed, fused or blown on or in
p.001994: such containers, where compliance with such provisions would be unduly burdensome by reason
p.001994: of causing the loss of valuable stocks of such labeling or containers, and where such
p.001994: postponement would not prevent the public interest being adequately served: Provided, That in no
p.001994: case shall such regulations apply to labeling which would not have complied with the
p.001994: requirements of the Food and Drugs Act of June 30, 1906, as amended.
p.001994: “SEC. 2. (a) The provisions of section 8 [section 10 of this title], paragraph fifth, under the
p.001994: heading ‘In the case of food:’, of the Food and Drugs Act of June 30, 1906, as amended, and
p.001994: regulations promulgated thereunder, and all other provisions of such Act to the extent that they
p.001994: may relate to the enforcement of such section 8 [section 10 of this title] and of such regulations,
p.001994: shall remain in force until January 1, 1940.
p.001994: “(b) The provisions of such Act of June 30, 1906, as amended, [sections 1 to 5, 7 to 15, and
p.001994: 372a of this title] to the extent that they impose, or authorize the imposition of, any requirement
p.001994: imposed by section 403(k) of the Federal Food, Drug, and Cosmetic Act [section 343(k) of this
p.001994: title], shall remain in force until January 1, 1940.
p.001994: “(c) Notwithstanding the provisions of section 1 of this Act, such section shall not apply—
p.001994: “(1) to the provisions of section 502(d) and (e) of the Federal Food, Drug, and Cosmetic Act
p.001994: [352(d), (e) of this title], insofar as such provisions relate to any substance named in section 8
p.001994: [section 10 of this title], paragraph second, under the heading ‘In the case of drugs:’, of the
p.001994: Food and Drugs Act of June 30, 1906, as amended, or a derivative of any such substance; or
p.001994: “(2) to the provisions of section 502(b), (d), (e), (f), (g), and (h) of the Federal Food, Drug,
p.001994: and Cosmetic Act [352(b), (d) to (h) of this title], insofar as such provisions relate to drugs to
p.001994: which section 505 [355 of this title] of such Act applies.”
p.001994: EFFECTIVE DATE
p.001994: Act June 25, 1938, ch. 675, §1002(a), formerly §902(a), 52 Stat. 1059; renumbered §1002(a),
p.001994: Pub. L. 111–31, div. A, title I, §101(b)(2), June 22, 2009, 123 Stat. 1784, provided that: “This Act
p.001994: [enacting this chapter and repealing sections 1 to 5 and 7 to 15 of this title], shall take effect
p.001994: twelve months after the date of its enactment [June 25, 1938]. The Federal Food and Drugs Act of
p.001994: June 30, 1906, as amended (U.S.C., 1934 ed., title 21, secs. 1–15), shall remain in force until
p.001994: such effective date, and, except as otherwise provided in this subsection, is hereby repealed
p.001994: effective upon such date: Provided, That the provisions of section 701 [section 371 of this title]
p.001994: shall become effective on the enactment of this Act, and thereafter the Secretary is authorized
p.001994: hereby to (1) conduct hearings and to promulgate regulations which shall become effective on or
p.001994: after the effective date of this Act as the Secretary shall direct, and (2) designate prior to the
p.001994: effective date of this Act food having common or usual names and exempt such food from the
p.001994: requirements of clause (2) of section 403(i) [section 343(i) of this title] for a reasonable time to
p.001994: permit the formulation, promulgation, and effective application of definitions and standards of
p.001994: identity therefor as provided by section 401 [section 341 of this title]: Provided further, That
p.001994: sections 502(j), 505, and 601(a) [sections 352(j), 355, 361(a), respectively of this title], and all
p.001994: other provisions of this Act to the extent that they may relate to the enforcement of such sections,
...

p.001994: March 4, 1923 (U.S.C., 1934 ed., title 21, sec. 6 [section 321a of this title]; 42 Stat. 1500, ch. 268),
p.001994: defining butter and providing a standard therefor; the Act of July 24, 1919 (U.S.C., 1934 ed., title
p.001994: 21, sec. 10 [section 321b of this title]; 41 Stat. 271, ch. 26], defining wrapped meats as in package
p.001994: form; and the amendment to the Food and Drugs Act, section 10A, approved August 27, 1935
p.001994: (U.S.C. 1934 ed., Sup. III, title 21, sec. 14a [section 372a of this title]) shall remain in force and
p.001994: effect and be applicable to the provisions of this Act.”
p.001994: SHORT TITLE OF 2009 AMENDMENT
p.001994: Pub. L. 111–31, div. A, §1(a), June 22, 2009, 123 Stat. 1776, provided that: “This division
p.001994: [enacting subchapter IX of this chapter, amending sections 321, 331, 333, 334, 355, 360m, 372 to
p.001994: 374, 375, 379a, 381, 391 to 393, 394 to 399a, and 679 of this title and sections 1333, 1334, 4402,
p.001994: 4406, and 4408 of Title 15, Commerce and Trade, enacting provisions set out as notes under
p.001994: sections 331, 333, 387, and 387c of this title and sections 1333 and 4402 of Title 15, and
p.001994: amending provisions set out as notes under this section and section 392 of this title] may be cited
p.001994: as the ‘Family Smoking Prevention and Tobacco Control Act’.”
p.001994: SHORT TITLE OF 2008 AMENDMENT
p.001994: Pub. L. 110–316, title I, §101(a), Aug. 14, 2008, 122 Stat. 3509, provided that: “This title
p.001994: [enacting section 379j–13 of this title, amending sections 360b, 379j–11, and 379j–12 of this title,
p.001994: and enacting provisions set out as notes under sections 360b and 379j–11 of this title] may be
p.001994: cited as the ‘Animal Drug User Fee Amendments of 2008’.”
p.001994: Pub. L. 110–316, title II, §201(a), Aug. 14, 2008, 122 Stat. 3515, provided that: “This title
p.001994: [enacting sections 379j–21 and 379j–22 of this title, amending sections 379k, 379l, and 379o of
p.001994: this title, and enacting provisions set out as notes under sections 379j–21 and 379j–22 of this title]
p.001994: may be cited as the ‘Animal Generic Drug User Fee Act of 2008’.”
p.001994: SHORT TITLE OF 2007 AMENDMENT
p.001994: Pub. L. 110–85, §1, Sept. 27, 2007, 121 Stat. 823, provided that: “This Act [enacting part I of
p.001994: subchapter VII of this chapter, chapter 26 of this title, sections 350f, 353b, 355–1, 355d, 355e,
p.001994: 360a, 360e–1, 360n, 360bbb–5, 360bbb–6, 379d–1, 379d–2, 379h–1, 379h–2, 379j–1, and 399a
p.001994: of this title, and section 247d–5a of Title 42, The Public Health and Welfare, amending sections
p.001994: 321, 331, 333, 334, 352, 355, 355a, 355c, 360, 360e, 360i, 360j, 360l, 360m, 360ee, 374, 379g,
p.001994: 379h, 379i, 379j, 379j–11, 379l, 381, and 393a of this title and sections 247d–3b, 262, 282, 283,
p.001994: 283a–2, 283a–3, 284m, 285g–10, 288–6, and 290b of Title 42, enacting provisions set out as
p.001994: notes under this section and sections 331, 350f, 352, 355, 355a, 355c, 360j, 379g, 379h, 379h–2,
p.001994: 379i, and 2110 of this title and section 282 of Title 42, and amending provisions set out as notes
p.001994: under section 284m of Title 42] may be cited as the ‘Food and Drug Administration Amendments
p.001994: Act of 2007’.”
p.001994: Pub. L. 110–85, title I, §101(a), Sept. 27, 2007, 121 Stat. 825, provided that: “This title [enacting
p.001994: sections 379h–1 and 379h–2 of this title, amending sections 379g, 379h, and 379j–11 of this title,
p.001994: and enacting provisions set out as notes under sections 379g, 379h, and 379h–2 of this title] may
p.001994: be cited as the ‘Prescription Drug User Fee Amendments of 2007’.”
p.001994: Pub. L. 110–85, title II, §201(a), Sept. 27, 2007, 121 Stat. 842, provided that: “This title
p.001994: [enacting section 379j–1 of this title, amending sections 333, 360, 360i, 360m, 374, 379i, and 379j
p.001994: of this title, and enacting provisions set out as notes under section 379i of this title] may be cited
p.001994: as the ‘Medical Device User Fee Amendments of 2007’.”
p.001994: Pub. L. 110–85, title III, §301, Sept. 27, 2007, 121 Stat. 859, provided that: “This title [enacting
p.001994: section 360e–1 of this title, amending sections 360j, 360l, and 393a of this title and section 282 of
p.001994: Title 42, The Public Health and Welfare, enacting provisions set out as notes under section 360j of
p.001994: this title and section 282 of Title 42, and amending provisions set out as a note under section
p.001994: 284m of Title 42] may be cited as the ‘Pediatric Medical Device Safety and Improvement Act of
p.001994: 2007’.”
p.001994: Pub. L. 110–85, title IV, §401, Sept. 27, 2007, 121 Stat. 866, provided that: “This title [enacting
p.001994: section 355d of this title, amending section 355c of this title, and enacting provisions set out as a
p.001994: note under section 355c of this title] may be cited as the ‘Pediatric Research Equity Act of 2007’.”
p.001994: Pub. L. 110–85, title V, §501, Sept. 27, 2007, 121 Stat. 876, provided that: “This title [amending
p.001994: section 355a of this title and sections 284m, 285g–10, 288–6, and 290b of Title 42, The Public
p.001994: Health and Welfare, enacting provisions set out as a note under section 355a of this title, and
p.001994: amending provisions set out as a note under section 284m of Title 42] may be cited as the ‘Best
p.001994: Pharmaceuticals for Children Act of 2007’.”
p.001994: SHORT TITLE OF 2006 AMENDMENT
p.001994: Pub. L. 109–462, §1, Dec. 22, 2006, 120 Stat. 3469, provided that: “This Act [enacting sections
p.001994: 379aa and 379aa–1 of this title, amending sections 331, 343, 352, and 381 of this title, and
p.001994: enacting provisions set out as notes under sections 331, 343, 352, 379aa, and 381 of this title]
p.001994: may be cited as the ‘Dietary Supplement and Nonprescription Drug Consumer Protection Act’.”
p.001994: SHORT TITLE OF 2005 AMENDMENTS
p.001994: Pub. L. 109–59, title VII, §7201, Aug. 10, 2005, 119 Stat. 1911, provided that: “This subtitle
p.001994: [subtitle B (§§7201–7204) of title VII of Pub. L. 109–59, enacting section 350e of this title,
p.001994: amending sections 331, 342, and 373 of this title and section 5701 of Title 49, Transportation,
p.001994: omitting sections 5702 to 5714 of Title 49, and enacting provisions set out as a note under section
p.001994: 331 of this title] may be cited as the ‘Sanitary Food Transportation Act of 2005’.”
p.001994: Pub. L. 109–43, §1, Aug. 1, 2005, 119 Stat. 439, provided that: “This Act [amending sections
p.001994: 352 and 379j of this title, enacting provisions set out as a note under section 352 of this title, and
p.001994: amending provisions set out as notes under sections 352 and 379i of this title] may be cited as the
p.001994: ‘Medical Device User Fee Stabilization Act of 2005’.”
p.001994: SHORT TITLE OF 2004 AMENDMENTS
p.001994: Pub. L. 108–282, title I, §101, Aug. 2, 2004, 118 Stat. 891, provided that: “This title [enacting
p.001994: sections 360ccc to 360ccc–2 of this title, amending sections 321, 331, 352, 353, 354, and 360b of
p.001994: this title, enacting provisions set out as notes under sections 360ccc and 393 of this title, and
p.001994: amending provisions set out as a note under section 360b of this title] may be cited as the ‘Minor
p.001994: Use and Minor Species Animal Health Act of 2004’.”
p.001994: Pub. L. 108–282, title II, §201, Aug. 2, 2004, 118 Stat. 905, provided that: “This title [enacting
p.001994: section 374a of this title and section 242r of Title 42, The Public Health and Welfare, amending
p.001994: sections 321, 343, and 343–1 of this title, and enacting provisions set out as notes under sections
p.001994: 321 and 343 of this title and sections 243 and 300d–2 of Title 42] may be cited as the ‘Food
p.001994: Allergen Labeling and Consumer Protection Act of 2004’.”
p.001994: Pub. L. 108–214, §1, Apr. 1, 2004, 118 Stat. 572, provided that: “This Act [amending sections
p.001994: 331, 352, 360, 360e, 374, 379i, and 379j of this title and provisions set out as notes under
p.001994: sections 352, 360l, and 379j of this title] may be cited as the ‘Medical Devices Technical
p.001994: Corrections Act’.”
p.001994: SHORT TITLE OF 2003 AMENDMENTS
p.001994: Pub. L. 108–155, §1, Dec. 3, 2003, 117 Stat. 1936, provided that: “This Act [enacting section
p.001994: 355c of this title, amending sections 355, 355a, and 355b of this title and sections 262 and 284m
p.001994: of Title 42, The Public Health and Welfare, enacting provisions set out as a note under section
p.001994: 355c of this title, and amending provisions set out as notes under section 355a of this title and
p.001994: section 284m of Title 42] may be cited as the ‘Pediatric Research Equity Act of 2003’.”
p.001994: Pub. L. 108–130, §1, Nov. 18, 2003, 117 Stat. 1361, provided that: “This Act [enacting sections
p.001994: 379j–11 and 379j–12 of this title and provisions set out as notes under section 379j–11 of this
p.001994: title] may be cited as the ‘Animal Drug User Fee Act of 2003’.”
p.001994: SHORT TITLE OF 2002 AMENDMENTS
p.001994: Pub. L. 107–281, §1, Nov. 6, 2002, 116 Stat. 1992, provided that: “This Act [amending sections
p.001994: 360cc and 360ee of this title and enacting provisions set out as a note under section 360ee of this
p.001994: title] may be cited as the ‘Rare Diseases Orphan Product Development Act of 2002’.”
p.001994: Pub. L. 107–250, §1(a), Oct. 26, 2002, 116 Stat. 1588, provided that: “This Act [enacting
p.001994: sections 379i and 379j of this title and section 289g–3 of Title 42, The Public Health and Welfare,
p.001994: amending sections 321, 331, 333, 335a, 352, 353, 360, 360c, 360e, 360m, and 374 of this title,
p.001994: and enacting provisions set out as notes under sections 352, 360e, 360j, 360l, 379i, and 379j of
p.001994: this title and section 289g–3 of Title 42] may be cited as the ‘Medical Device User Fee and
p.001994: Modernization Act of 2002’.”
p.001994: Pub. L. 107–188, title V, §501, June 12, 2002, 116 Stat. 687, provided that: “This subtitle
p.001994: [subtitle A (§§501–509) of title V of Pub. L. 107–188, amending sections 356b, 379g, and 379h of
p.001994: this title and enacting provisions set out as notes under sections 356b and 379g of this title] may
p.001994: be cited as the ‘Prescription Drug User Fee Amendments of 2002’.”
p.001994: Pub. L. 107–109, §1, Jan. 4, 2002, 115 Stat. 1408, provided that: “This Act [enacting sections
p.001994: 355b and 393a of this title and section 284m of Title 42, The Public Health and Welfare, amending
p.001994: sections 321, 355, 355a, and 379h of this title and sections 282, 284k, 284l, 285a–2, and 290b of
p.001994: Title 42, and enacting provisions set out as notes under sections 355 and 355a of this title and
p.001994: sections 284m and 289 of Title 42] may be cited as the ‘Best Pharmaceuticals for Children Act’.”
p.001994: SHORT TITLE OF 2000 AMENDMENT
p.001994: Pub. L. 106–387, §1(a) [title VII, §745(a)], Oct. 28, 2000, 114 Stat. 1549, 1549A–35, provided
p.001994: that: “This section [enacting section 384 of this title, amending sections 331, 333, and 381 of this
p.001994: title, and enacting provisions set out as a note under section 384 of this title] may be cited as the
p.001994: ‘Medicine Equity and Drug Safety Act of 2000’.”
p.001994: Pub. L. 106–387, §1(a) [title VII, §746(a)], Oct. 28, 2000, 114 Stat. 1549, 1549A–40, provided
p.001994: that: “This section [amending section 381 of this title and enacting provisions set out as a note
p.001994: under section 381 of this title] may be cited as the ‘Prescription Drug Import Fairness Act of
p.001994: 2000’.”
p.001994: SHORT TITLE OF 1998 AMENDMENT
p.001994: Pub. L. 105–324, §1, Oct. 30, 1998, 112 Stat. 3035, provided that: “This Act [amending sections
p.001994: 321 and 346a of this title] may be cited as the ‘Antimicrobial Regulation Technical Corrections Act
p.001994: of 1998’.”
p.001994: SHORT TITLE OF 1997 AMENDMENT
p.001994: Pub. L. 105–115, §1(a), Nov. 21, 1997, 111 Stat. 2296, provided that: “This Act [enacting
p.001994: sections 343–3, 353a, 355a, 356 to 356c, 360m, 360aaa to 360aaa–6, 360bbb to 360bbb–2,
p.001994: 379k, 379l, 379o, 379r, 379s, 379v, 396, and 397 of this title and sections 247b–8 and 299a–3 of
p.001994: Title 42, The Public Health and Welfare, amending sections 321, 331, 334, 335a, 343, 348, 351 to
p.001994: 353, 355, 360, 360b to 360e, 360g, 360i, 360j, 360l, 360aa to 360cc, 360ee, 371, 374, 379a,
p.001994: 379g, 379h, 381 to 383, 393, and 802 of this title, section 45C of Title 26, Internal Revenue Code,
p.001994: section 156 of Title 35, Patents, section 8126 of Title 38, Veterans’ Benefits, and sections 262,
p.001994: 263a, and 282 of Title 42, repealing sections 356 and 357 of this title, and enacting provisions set
p.001994: out as notes under sections 321, 348, 351, 352, 353a, 355 to 356b, 360i, 360l, 360m, 360aaa,
p.001994: 371, 379g, 379h, 379k, and 393 of this title and sections 247b–8 and 282 of Title 42] may be cited
p.001994: as the ‘Food and Drug Administration Modernization Act of 1997’.”
p.001994: SHORT TITLE OF 1996 AMENDMENTS
p.001994: Pub. L. 104–250, §1(a), Oct. 9, 1996, 110 Stat. 3151, provided that: “This Act [enacting section
p.001994: 354 of this title, amending sections 331, 353, and 360b of this title, and enacting provisions set out
p.001994: as notes under section 360b of this title] may be cited as the ‘Animal Drug Availability Act of
p.001994: 1996’.”
p.001994: Pub. L. 104–170, title IV, §401(a), Aug. 3, 1996, 110 Stat. 1513, provided that: “This title
p.001994: [amending sections 321, 331, 333, 342, and 346a of this title] may be cited as the ‘Food Quality
p.001994: Protection Act of 1996’.”
p.001994: [Another “Food Quality Protection Act of 1996”, was enacted by Pub. L. 104–170, §1, 110 Stat.
p.001994: 1489, which is set out as a note under section 136 of Title 7, Agriculture.]
p.001994: Pub. L. 104–134, title II, §2101(a), Apr. 26, 1996, 110 Stat. 1321–313, provided that: “This
p.001994: chapter [chapter 1A (§§2101–2105) of title II of Pub. L. 104–134, enacting section 382 of this title
p.001994: and amending sections 331 and 381 of this title and section 262 of Title 42, The Public Health and
p.001994: Welfare] may be cited as the ‘FDA Export Reform and Enhancement Act of 1996’.”
p.001994: SHORT TITLE OF 1994 AMENDMENTS
p.001994: Pub. L. 103–417, §1(a), Oct. 25, 1994, 108 Stat. 4325, provided that: “This Act [enacting
p.001994: sections 343–2 and 350b of this title and section 287c–11 of Title 42, The Public Health and
p.001994: Welfare, amending sections 321, 331, 342, 343, and 350 of this title and section 281 of Title 42,
p.001994: and enacting provisions set out as notes under sections 321 and 343 of this title] may be cited as
p.001994: the ‘Dietary Supplement Health and Education Act of 1994’.”
p.001994: Pub. L. 103–396, §1, Oct. 22, 1994, 108 Stat. 4153, provided that: “This Act [amending sections
p.001994: 331, 343–1, 360b, and 371 of this title and enacting provisions set out as notes under section
p.001994: 360b of this title] may be cited as the ‘Animal Medicinal Drug Use Clarification Act of 1994’.”
p.001994: SHORT TITLE OF 1993 AMENDMENT
p.001994: Pub. L. 103–80, §1, Aug. 13, 1993, 107 Stat. 773, provided that: “This Act [amending sections
p.001994: 321, 331 to 333, 334, 335b, 341 to 343, 346a, 350a, 352, 355 to 358, 360b to 360e, 360i, 360cc,
p.001994: 360hh to 360ss, 361, 371, 372, 373, 374, 376, 379e, and 381 of this title and section 263b of Title
p.001994: 42, The Public Health and Welfare, and enacting provisions set out as a note under section 343 of
p.001994: this title] may be cited as the ‘Nutrition Labeling and Education Act Amendments of 1993’.”
p.001994: SHORT TITLE OF 1992 AMENDMENTS
p.001994: Pub. L. 102–571, title I, §101(a), Oct. 29, 1992, 106 Stat. 4491, provided that: “This title
p.001994: [enacting sections 379g and 379h of this title, transferring sections 372a, 376, and 379c of this title
p.001994: to sections 376, 379e and 379f, respectively, of this title, amending sections 321, 331, 342, 343,
p.001994: 346a, 351, 352, 360j, 361, 362, 453, 601, and 1033 of this title, enacting provisions set out as
p.001994: notes under section 379g of this title, and amending provisions set out as notes under sections
p.001994: 343 and 343–1 of this title] may be cited as the ‘Prescription Drug User Fee Act of 1992’.”
p.001994: Pub. L. 102–571, title II, §201, Oct. 29, 1992, 106 Stat. 4500, provided that: “This title [enacting
p.001994: provisions set out as notes under sections 343 and 393 of this title and amending provisions set
p.001994: out as notes under sections 343 and 343–1 of this title] may be cited as the ‘Dietary Supplement
p.001994: Act of 1992’.”
p.001994: Pub. L. 102–353, §1(a), Aug. 26, 1992, 106 Stat. 941, provided that: “This Act [amending
p.001994: sections 333, 353, and 381 of this title and enacting provisions set out as a note under section 353
p.001994: of this title] may be cited as the ‘Prescription Drug Amendments of 1992’.”
p.001994: Pub. L. 102–300, §1(a), June 16, 1992, 106 Stat. 238, provided that: “This Act [amending
p.001994: sections 321, 331, 334, 346a, 352, 353, 356, 357, 360c, 360d, 360g to 360i, 360l, 360mm, 371 to
p.001994: 372a, 376, and 381 of this title and section 262 of Title 42, The Public Health and Welfare and
p.001994: enacting and amending provisions set out as notes under section 360i of this title] may be cited as
p.001994: the ‘Medical Device Amendments of 1992’.”
p.001994: Pub. L. 102–282, §1(a), May 13, 1992, 106 Stat. 149, provided that: “This Act [enacting sections
p.001994: 335a to 335c of this title, amending sections 321, 336, 337, and 355 of this title, and enacting
p.001994: provisions set out as notes under section 335a of this title] may be cited as the ‘Generic Drug
p.001994: Enforcement Act of 1992’.”
p.001994: SHORT TITLE OF 1990 AMENDMENTS
p.001994: Pub. L. 101–635, §1(a), Nov. 28, 1990, 104 Stat. 4583, provided that: “This Act [enacting
p.001994: sections 379b to 379d and 394 of this title] may be cited as the ‘Food and Drug Administration
p.001994: Revitalization Act’.”
p.001994: Pub. L. 101–629, §1(a), Nov. 28, 1990, 104 Stat. 4511, provided that: “This Act [enacting
p.001994: sections 360l and 383 of this title, amending sections 321, 333, 351, 353, and 360c to 360j of this
p.001994: title and sections 263b to 263n of Title 42, The Public Health and Welfare, redesignating sections
p.001994: 263b to 263n of Title 42 as sections 360gg to 360ss of this title, repealing section 263b of Title 42,
p.001994: and enacting provisions set out as notes under sections 333, 360c, 360i, 360j, 360hh and 383 of
p.001994: this title] may be cited as the ‘Safe Medical Devices Act of 1990’.”
p.001994: Pub. L. 101–535, §1(a), Nov. 8, 1990, 104 Stat. 2353, provided that: “This Act [enacting section
p.001994: 343–1 of this title, amending sections 321, 337, 343, 345, and 371 of this title, and enacting
p.001994: provisions set out as notes under sections 343 and 343–1 of this title] may be cited as the
p.001994: ‘Nutrition Labeling and Education Act of 1990’.”
p.001994: SHORT TITLE OF 1988 AMENDMENTS
p.001994: Pub. L. 100–670, §1(a), Nov. 16, 1988, 102 Stat. 3971, provided that: “This Act [amending
p.001994: sections 321, 353, and 360b of this title, section 2201 of Title 28, Judiciary and Judicial Procedure,
p.001994: and sections 156 and 271 of Title 35, Patents, and enacting provisions set out as notes under
p.001994: section 360b of this title] may be cited as the ‘Generic Animal Drug and Patent Term Restoration
p.001994: Act’.”
p.001994: Pub. L. 100–607, title V, §501, Nov. 4, 1988, 102 Stat. 3120, provided that: “This title [enacting
p.001994: section 393 of this title, amending sections 5315 and 5316 of Title 5, Government Organization
p.001994: and Employees, and enacting provisions set out as notes under section 393 of this title] may be
p.001994: cited as the ‘Food and Drug Administration Act of 1988’.”
p.001994: Pub. L. 100–293, §1(a), Apr. 22, 1988, 102 Stat. 95, provided that: “This Act [amending sections
p.001994: 331, 333, 353, and 381 of this title and enacting provisions set out as notes under section 353 of
p.001994: this title] may be cited as the ‘Prescription Drug Marketing Act of 1987’.”
p.001994: Pub. L. 100–290, §1, Apr. 18, 1988, 102 Stat. 90, provided that: “This Act [amending sections
p.001994: 360bb and 360ee of this title, enacting provisions set out as a note under section 360aa of this
p.001994: title, and amending provisions set out as a note under section 236 of Title 42, The Public Health
p.001994: and Welfare] may be cited as the ‘Orphan Drug Amendments of 1988’.”
p.001994: SHORT TITLE OF 1986 AMENDMENT
p.001994: Pub. L. 99–660, title I, §101(a), Nov. 14, 1986, 100 Stat. 3743, provided that: “This title
p.001994: [enacting section 382 of this title, amending sections 241 and 262 of Title 42, The Public Health
p.001994: and Welfare, and enacting provisions set out as notes under section 333 of this title and section
p.001994: 262 of Title 42] may be cited as the ‘Drug Export Amendments Act of 1986’.”
p.001994: SHORT TITLE OF 1985 AMENDMENT
p.001994: Pub. L. 99–91, §1, Aug. 15, 1985, 99 Stat. 387, provided that: “This Act [amending sections
p.001994: 360aa to 360cc, and 360ee of this title, and sections 295g–1 and 6022 of Title 42, The Public
p.001994: Health and Welfare, and enacting provisions set out as notes under section 360aa of this title and
p.001994: section 236 of Title 42] may be cited as the ‘Orphan Drug Amendments of 1985’.”
p.001994: SHORT TITLE OF 1984 AMENDMENT
p.001994: Pub. L. 98–417, §1, Sept. 24, 1984, 98 Stat. 1585, provided: “That this Act [enacting section
p.001994: 156 of Title 35, Patents, amending sections 355 and 360cc of this title, sections 68b, 68c, and 70b
p.001994: of Title 15, Commerce and Trade, section 2201 of Title 28, Judiciary and Judicial Procedure, and
p.001994: sections 271 and 282 of Title 35, and enacting provisions set out as notes under section 355 of
p.001994: this title and section 68b of Title 15] may be cited as the ‘Drug Price Competition and Patent Term
p.001994: Restoration Act of 1984’.”
p.001994: SHORT TITLE OF 1983 AMENDMENTS
p.001994: Pub. L. 98–22, §1, Apr. 22, 1983, 97 Stat. 173, provided: “That this Act [amending provisions
p.001994: set out as a note under section 348 of this title] may be cited as the ‘Saccharin Study and Labeling
p.001994: Act Amendment of 1983’.”
p.001994: Pub. L. 97–414, §1(a), Jan. 4, 1983, 96 Stat. 2049, provided that: “This Act [enacting part B of
p.001994: subchapter V of chapter 9 of this title, section 44H of Title 26, Internal Revenue Code, section 155
p.001994: of Title 35, Patents, and sections 236, 255, and 298b–4 of Title 42, The Public Health and Welfare,
p.001994: amending sections 1274, 1472, 2055, 2060, 2064, 2068, and 2080 of Title 15, Commerce and
p.001994: Trade, section 904 of this title, sections 280C and 6096 of Title 26, and sections 209, 231, 242k,
p.001994: 242m, 243, 254c, 254j, 254m, 254o, 254p, 256, 294j, 295g–1, 295g–4, 295h, 295h–1a, 297–1,
p.001994: 300, 300a–1, 300a–3, 300b, 300e–1, 300m, 300n–5, 300q–2, 300u–5, 300w–3, 300x–1, 300x–4,
p.001994: 300y–11, 4577, and 4588 of Title 42, enacting provisions set out as notes under section 360aa of
p.001994: this title, section 44H of Title 26, and sections 241, 255, 287i, and 300x–1 of Title 42, and
p.001994: repealing provisions set out as a note under section 300t–11 of Title 42] may be cited as the
p.001994: ‘Orphan Drug Act’.”
p.001994: SHORT TITLE OF 1981 AMENDMENT
p.001994: Pub. L. 97–42, §1, Aug. 14, 1981, 95 Stat. 946, provided: “That this Act [amending provisions
p.001994: set out as a note under section 348 of this title] may be cited as the ‘Saccharin Study and Labeling
p.001994: Act Amendment of 1981’.”
p.001994: SHORT TITLE OF 1980 AMENDMENT
p.001994: Pub. L. 96–359, §1, Sept. 26, 1980, 94 Stat. 1190, provided: “That this Act [enacting section
p.001994: 350a of this title, amending sections 321, 331, 374, 830, 841 to 843, and 873 of this title, and
p.001994: enacting a provision set out as a note under section 350a of this title] may be cited as the ‘Infant
p.001994: Formula Act of 1980’.”
p.001994: SHORT TITLE OF 1977 AMENDMENT
p.001994: Pub. L. 95–203, §1, Nov. 23, 1977, 91 Stat. 1451, provided that: “This Act [enacting section
p.001994: 343a of this title, amending sections 321 and 343 of this title, enacting provisions set out as notes
p.001994: under sections 343 and 348 of this title, and amending provisions set out as notes under sections
p.001994: 218 and 289l–1 of Title 42, The Public Health and Welfare] may be cited as the ‘Saccharin Study
p.001994: and Labeling Act’.”
p.001994: SHORT TITLE OF 1976 AMENDMENT
p.001994: Pub. L. 94–295, §1(a), May 28, 1976, 90 Stat. 539, provided that: “This Act [enacting sections
p.001994: 360c to 360k, 379, and 379a of this title and section 3512 of Title 42, The Public Health and
p.001994: Welfare, and amending sections 321, 331, 334, 351, 352, 358, 360, 374, 379e, and 381 of this title
p.001994: and section 55 of Title 15, Commerce and Trade] may be cited as the ‘Medical Device
p.001994: Amendments of 1976’.”
p.001994: SHORT TITLE OF 1972 AMENDMENT
p.001994: Pub. L. 92–387, §1, Aug. 16, 1972, 86 Stat. 559, provided that: “This Act [amending sections
p.001994: 331, 335, and 360 of this title and enacting provisions set out as notes under section 360 of this
p.001994: title] may be cited as the ‘Drug Listing Act of 1972’.”
p.001994: SHORT TITLE OF 1968 AMENDMENTS
p.001994: Pub. L. 90–602, §1, Oct. 18, 1968, 82 Stat. 1173, provided that: “This Act [enacting provisions
p.001994: now comprising part C (§§360hh–360ss) of subchapter III of this chapter and provisions set out as
p.001994: notes under section 360hh of this title] may be cited as the ‘Radiation Control for Health and
p.001994: Safety Act of 1968’.”
p.001994: Pub. L. 90–399, §1, July 13, 1968, 82 Stat. 342, provided: “That this Act [enacting section 360b
p.001994: of this title, amending sections 321, 331, 342, 351, 352, 357, 381, and 392 of this title, and
p.001994: enacting provisions set out as a note under section 360b of this title] may be cited as the ‘Animal
p.001994: Drug Amendments of 1968’.”
p.001994: SHORT TITLE OF 1965 AMENDMENT
p.001994: Pub. L. 89–74, §1, July 15, 1965, 79 Stat. 226, provided: “That this Act [amending sections 321,
p.001994: 331, 333, 334, 360, and 372 of this title and section 1114 of Title 18, Crimes and Criminal
p.001994: Procedure, and enacting provisions set out as notes under sections 321 and 352 of this title] may
p.001994: be cited as the ‘Drug Abuse Control Amendments of 1965’.”
p.001994: SHORT TITLE OF 1962 AMENDMENT
p.001994: Pub. L. 87–781, §1, Oct. 10, 1962, 76 Stat. 780, provided in part that such Act [enacting
p.001994: sections 358 to 360 of this title, amending sections 321, 331, 332, 348, 351 to 353, 355, 357, 372,
p.001994: 374, 379e, and 381 of this title, and enacting provisions set out as notes under sections 321, 331,
p.001994: 332, 352, 355, 358, 360, and 374 of this title] may be cited as the ‘Drug Amendments of 1962’.”
p.001994: SHORT TITLE OF 1960 AMENDMENT
p.001994: Pub. L. 86–618, §1, July 12, 1960, 74 Stat. 397, provided: “That this Act [amending sections
p.001994: 321, 331, 333, 342, 346, 351, 352, 361, 362, 371, and 379e of this title, repealing sections 354
p.001994: and 364 of this title, and enacting notes set out under this section] may be cited as the ‘Color
p.001994: Additive Amendments of 1960’.”
p.001994: SHORT TITLE OF 1958 AMENDMENT
p.001994: Pub. L. 85–929, §1, Sept. 6, 1958, 72 Stat. 1784, provided: “That this Act [amending sections
p.001994: 321, 331, 342, 346, 348 of this title and section 210 of Title 42, The Public Health and Welfare,
p.001994: and enacting provisions set out as notes under sections 321, 342, and 451 of this title] may be
p.001994: cited as the ‘Food Additives Amendment of 1958’.”
p.001994: SEVERABILITY
p.001994: Pub. L. 110–85, title XI, §1105, Sept. 27, 2007, 121 Stat. 975, provided that: “If any provision of
p.001994: this Act [see Short Title of 2007 Amendment note above], an amendment made [by] this Act, or
p.001994: the application of such provision or amendment to any person or circumstance is held to be
p.001994: unconstitutional, the remainder of this Act, the amendments made by this Act, and the application
p.001994: of the provisions of such to any person or circumstances shall not be affected thereby.”
p.001994: HAZARDOUS SUBSTANCES
p.001994: Federal Hazardous Substances Act as not modifying this chapter, see Pub. L. 86–613, §18, July
p.001994: 12, 1960, 74 Stat. 380, set out as an Effect Upon Federal and State Laws note under section 1261
p.001994: of Title 15, Commerce and Trade.
p.001994:
p.001994:
p.001994:
p.001994: SUBCHAPTER II—DEFINITIONS
p.001994:
p.001994:
p.001994: §321. Definitions; generally
p.001994: For the purposes of this chapter—
p.001994: (a)(1) The term “State”, except as used in the last sentence of section 372(a) of this title,
p.001994: means any State or Territory of the United States, the District of Columbia, and the
p.001994: Commonwealth of Puerto Rico.
p.001994: (2) The term “Territory” means any Territory or possession of the United States, including
p.001994: the District of Columbia, and excluding the Commonwealth of Puerto Rico and the Canal
p.001994: Zone.
p.001994: (b) The term “interstate commerce” means (1) commerce between any State or Territory
p.001994: and any place outside thereof, and (2) commerce within the District of Columbia or within
p.001994: any other Territory not organized with a legislative body.
p.001994: (c) The term “Department” means Department of Health and Human Services.
p.001994: (d) The term “Secretary” means the Secretary of Health and Human Services.
p.001994: (e) The term “person” includes individual, partnership, corporation, and association.
p.001994: (f) The term “food” means (1) articles used for food or drink for man or other animals, (2)
p.001994: chewing gum, and (3) articles used for components of any such article.
p.001994: (g)(1) The term “drug” means (A) articles recognized in the official United States
p.001994: Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official
p.001994: National Formulary, or any supplement to any of them; and (B) articles intended for use in
p.001994: the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals;
p.001994: and (C) articles (other than food) intended to affect the structure or any function of the body
p.001994: of man or other animals; and (D) articles intended for use as a component of any article
p.001994: specified in clause (A), (B), or (C). A food or dietary supplement for which a claim, subject to
p.001994: sections 343(r)(1)(B) and 343(r)(3) of this title or sections 343(r)(1)(B) and 343(r)(5)(D) of
p.001994: this title, is made in accordance with the requirements of section 343(r) of this title is not a
p.001994: drug solely because the label or the labeling contains such a claim. A food, dietary
p.001994: ingredient, or dietary supplement for which a truthful and not misleading statement is made
p.001994: in accordance with section 343(r)(6) of this title is not a drug under clause (C) solely
p.001994: because the label or the labeling contains such a statement.
p.001994: (2) The term “counterfeit drug” means a drug which, or the container or labeling of which,
p.001994: without authorization, bears the trademark, trade name, or other identifying mark, imprint, or
p.001994: device, or any likeness thereof, of a drug manufacturer, processor, packer, or distributor
p.001994: other than the person or persons who in fact manufactured, processed, packed, or
p.001994: distributed such drug and which thereby falsely purports or is represented to be the product
p.001994: of, or to have been packed or distributed by, such other drug manufacturer, processor,
p.001994: packer, or distributor.
p.001994: (h) The term “device” (except when used in paragraph (n) of this section and in sections
p.001994: 331(i), 343(f), 352(c), and 362(c) of this title) means an instrument, apparatus, implement,
p.001994: machine, contrivance, implant, in vitro reagent, or other similar or related article, including
p.001994: any component, part, or accessory, which is—
p.001994: (1) recognized in the official National Formulary, or the United States Pharmacopeia,
p.001994: or any supplement to them,
p.001994: (2) intended for use in the diagnosis of disease or other conditions, or in the cure,
p.001994: mitigation, treatment, or prevention of disease, in man or other animals, or
p.001994: (3) intended to affect the structure or any function of the body of man or other animals,
p.001994: and
p.001994:
p.001994: which does not achieve its primary intended purposes through chemical action within or
p.001994: on the body of man or other animals and which is not dependent upon being metabolized
p.001994: for the achievement of its primary intended purposes.
p.001994: (i) The term “cosmetic” means (1) articles intended to be rubbed, poured, sprinkled, or
p.001994: sprayed on, introduced into, or otherwise applied to the human body or any part thereof for
p.001994: cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles
p.001994: intended for use as a component of any such articles; except that such term shall not
p.001994: include soap.
p.001994: (j) The term “official compendium” means the official United States Pharmacopoeia,
p.001994: official Homoeopathic Pharmacopoeia of the United States, official National Formulary, or
p.001994: any supplement to any of them.
p.001994: (k) The term “label” means a display of written, printed, or graphic matter upon the
p.001994: immediate container of any article; and a requirement made by or under authority of this
p.001994: chapter that any word, statement, or other information appear on the label shall not be
p.001994: considered to be complied with unless such word, statement, or other information also
p.001994: appears on the outside container or wrapper, if any there be, of the retail package of such
p.001994: article, or is easily legible through the outside container or wrapper.
p.001994: (l) The term “immediate container” does not include package liners.
p.001994: (m) The term “labeling” means all labels and other written, printed, or graphic matter (1)
p.001994: upon any article or any of its containers or wrappers, or (2) accompanying such article.
p.001994: (n) If an article is alleged to be misbranded because the labeling or advertising is
p.001994: misleading, then in determining whether the labeling or advertising is misleading there shall
p.001994: be taken into account (among other things) not only representations made or suggested by
p.001994: statement, word, design, device, or any combination thereof, but also the extent to which
p.001994: the labeling or advertising fails to reveal facts material in the light of such representations or
p.001994: material with respect to consequences which may result from the use of the article to which
p.001994: the labeling or advertising relates under the conditions of use prescribed in the labeling or
p.001994: advertising thereof or under such conditions of use as are customary or usual.
p.001994: (o) The representation of a drug, in its labeling, as an antiseptic shall be considered to be
p.001994: a representation that it is a germicide, except in the case of a drug purporting to be, or
p.001994: represented as, an antiseptic for inhibitory use as a wet dressing, ointment, dusting powder,
p.001994: or such other use as involves prolonged contact with the body.
p.001994: (p) The term “new drug” means—
p.001994: (1) Any drug (except a new animal drug or an animal feed bearing or containing a new
p.001994: animal drug) the composition of which is such that such drug is not generally recognized,
p.001994: among experts qualified by scientific training and experience to evaluate the safety and
p.001994: effectiveness of drugs, as safe and effective for use under the conditions prescribed,
p.001994: recommended, or suggested in the labeling thereof, except that such a drug not so
p.001994: recognized shall not be deemed to be a “new drug” if at any time prior to June 25, 1938, it
p.001994: was subject to the Food and Drugs Act of June 30, 1906, as amended, and if at such time
p.001994: its labeling contained the same representations concerning the conditions of its use; or
p.001994: (2) Any drug (except a new animal drug or an animal feed bearing or containing a new
p.001994: animal drug) the composition of which is such that such drug, as a result of investigations
p.001994: to determine its safety and effectiveness for use under such conditions, has become so
p.001994: recognized, but which has not, otherwise than in such investigations, been used to a
p.001994: material extent or for a material time under such conditions.
p.001994:
p.001994: (q)(1)(A) Except as provided in clause (B), the term “pesticide chemical” means any
p.001994: substance that is a pesticide within the meaning of the Federal Insecticide, Fungicide, and
p.001994: Rodenticide Act [7 U.S.C. 136 et seq.], including all active and inert ingredients of such
p.001994: pesticide. Notwithstanding any other provision of law, the term “pesticide” within such
p.001994: meaning includes ethylene oxide and propylene oxide when such substances are applied
p.001994: on food.
p.001994: (B) In the case of the use, with respect to food, of a substance described in clause (A) to
p.001994: prevent, destroy, repel, or mitigate microorganisms (including bacteria, viruses, fungi,
p.001994: protozoa, algae, and slime), the following applies for purposes of clause (A):
p.001994: (i) The definition in such clause for the term “pesticide chemical” does not include the
p.001994: substance if the substance is applied for such use on food, or the substance is included
p.001994: for such use in water that comes into contact with the food, in the preparing, packing, or
...

p.001994: may reasonably be expected to result, directly or indirectly, in its becoming a component or
p.001994: otherwise affecting the characteristics of any food (including any substance intended for use
p.001994: in producing, manufacturing, packing, processing, preparing, treating, packaging,
p.001994: transporting, or holding food; and including any source of radiation intended for any such
p.001994: use), if such substance is not generally recognized, among experts qualified by scientific
p.001994: training and experience to evaluate its safety, as having been adequately shown through
p.001994: scientific procedures (or, in the case of a substance used in food prior to January 1, 1958,
p.001994: through either scientific procedures or experience based on common use in food) to be safe
p.001994: under the conditions of its intended use; except that such term does not include—
p.001994: (1) a pesticide chemical residue in or on a raw agricultural commodity or processed
p.001994: food; or
p.001994: (2) a pesticide chemical; or
p.001994: (3) a color additive; or
p.001994: (4) any substance used in accordance with a sanction or approval granted prior to
p.001994: September 6, 1958, pursuant to this chapter, the Poultry Products Inspection Act [21
p.001994: U.S.C. 451 et seq.] or the Meat Inspection Act of March 4, 1907, as amended and
p.001994: extended [21 U.S.C. 601 et seq.];
p.001994: (5) a new animal drug; or
p.001994: (6) an ingredient described in paragraph (ff) in, or intended for use in, a dietary
p.001994: supplement.
p.001994:
p.001994: (t)(1) The term “color additive” means a material which—
p.001994: (A) is a dye, pigment, or other substance made by a process of synthesis or similar
p.001994: artifice, or extracted, isolated, or otherwise derived, with or without intermediate or final
p.001994: change of identity, from a vegetable, animal, mineral, or other source, and
p.001994: (B) when added or applied to a food, drug, or cosmetic, or to the human body or any
p.001994: part thereof, is capable (alone or through reaction with other substance) of imparting
p.001994: color thereto;
p.001994:
p.001994: except that such term does not include any material which the Secretary, by regulation,
p.001994: determines is used (or intended to be used) solely for a purpose or purposes other than
p.001994: coloring.
p.001994: (2) The term “color” includes black, white, and intermediate grays.
p.001994: (3) Nothing in subparagraph (1) of this paragraph shall be construed to apply to any
p.001994: pesticide chemical, soil or plant nutrient, or other agricultural chemical solely because of its
p.001994: effect in aiding, retarding, or otherwise affecting, directly or indirectly, the growth or other
p.001994: natural physiological processes of produce of the soil and thereby affecting its color,
p.001994: whether before or after harvest.
p.001994: (u) The term “safe” as used in paragraph (s) of this section and in sections 348, 360b,
p.001994: 360ccc, and 379e of this title, has reference to the health of man or animal.
p.001994: (v) The term “new animal drug” means any drug intended for use for animals other than
p.001994: man, including any drug intended for use in animal feed but not including such animal feed,
p.001994: —
p.001994: (1) the composition of which is such that such drug is not generally recognized, among
p.001994: experts qualified by scientific training and experience to evaluate the safety and
p.001994: effectiveness of animal drugs, as safe and effective for use under the conditions
p.001994: prescribed, recommended, or suggested in the labeling thereof; except that such a drug
p.001994: not so recognized shall not be deemed to be a “new animal drug” if at any time prior to
p.001994: June 25, 1938, it was subject to the Food and Drug Act of June 30, 1906, as amended,
p.001994: and if at such time its labeling contained the same representations concerning the
p.001994: conditions of its use; or
p.001994: (2) the composition of which is such that such drug, as a result of investigations to
p.001994: determine its safety and effectiveness for use under such conditions, has become so
p.001994: recognized but which has not, otherwise than in such investigations, been used to a
p.001994: material extent or for a material time under such conditions.
p.001994:
p.001994: Provided that any drug intended for minor use or use in a minor species that is not the
p.001994: subject of a final regulation published by the Secretary through notice and comment
p.001994: rulemaking finding that the criteria of paragraphs (1) and (2) have not been met (or that the
p.001994: exception to the criterion in paragraph (1) has been met) is a new animal drug.
p.001994: (w) The term “animal feed”, as used in paragraph (w) 1 of this section, in section 360b of
p.001994: this title, and in provisions of this chapter referring to such paragraph or section, means an
p.001994: article which is intended for use for food for animals other than man and which is intended
p.001994: for use as a substantial source of nutrients in the diet of the animal, and is not limited to a
p.001994: mixture intended to be the sole ration of the animal.
p.001994: (x) The term “informal hearing” means a hearing which is not subject to section 554, 556,
p.001994: or 557 of title 5 and which provides for the following:
p.001994: (1) The presiding officer in the hearing shall be designated by the Secretary from
p.001994: officers and employees of the Department who have not participated in any action of the
p.001994: Secretary which is the subject of the hearing and who are not directly responsible to an
p.001994: officer or employee of the Department who has participated in any such action.
p.001994: (2) Each party to the hearing shall have the right at all times to be advised and
p.001994: accompanied by an attorney.
p.001994: (3) Before the hearing, each party to the hearing shall be given reasonable notice of
p.001994: the matters to be considered at the hearing, including a comprehensive statement of the
p.001994: basis for the action taken or proposed by the Secretary which is the subject of the
p.001994: hearing and a general summary of the information which will be presented by the
p.001994: Secretary at the hearing in support of such action.
p.001994: (4) At the hearing the parties to the hearing shall have the right to hear a full and
p.001994: complete statement of the action of the Secretary which is the subject of the hearing
p.001994: together with the information and reasons supporting such action, to conduct reasonable
p.001994: questioning, and to present any oral or written information relevant to such action.
p.001994: (5) The presiding officer in such hearing shall prepare a written report of the hearing to
p.001994: which shall be attached all written material presented at the hearing. The participants in
p.001994: the hearing shall be given the opportunity to review and correct or supplement the
p.001994: presiding officer's report of the hearing.
p.001994: (6) The Secretary may require the hearing to be transcribed. A party to the hearing
p.001994: shall have the right to have the hearing transcribed at his expense. Any transcription of a
p.001994: hearing shall be included in the presiding officer's report of the hearing.
p.001994:
p.001994: (y) The term “saccharin” includes calcium saccharin, sodium saccharin, and ammonium
p.001994: saccharin.
p.001994: (z) The term “infant formula” means a food which purports to be or is represented for
p.001994: special dietary use solely as a food for infants by reason of its simulation of human milk or
p.001994: its suitability as a complete or partial substitute for human milk.
p.001994: (aa) The term “abbreviated drug application” means an application submitted under
p.001994: section 355(j) of this title for the approval of a drug that relies on the approved application of
p.001994: another drug with the same active ingredient to establish safety and efficacy, and—
p.001994: (1) in the case of section 335a of this title, includes a supplement to such an application
p.001994: for a different or additional use of the drug but does not include a supplement to such an
p.001994: application for other than a different or additional use of the drug, and
p.001994: (2) in the case of sections 335b and 335c of this title, includes any supplement to such
p.001994: an application.
p.001994:
p.001994: (bb) The term “knowingly” or “knew” means that a person, with respect to information—
p.001994: (1) has actual knowledge of the information, or
p.001994: (2) acts in deliberate ignorance or reckless disregard of the truth or falsity of the
p.001994: information.
p.001994:
p.001994: (cc) For purposes of section 335a of this title, the term “high managerial agent”—
p.001994: (1) means—
p.001994: (A) an officer or director of a corporation or an association,
p.001994: (B) a partner of a partnership, or
p.001994: (C) any employee or other agent of a corporation, association, or partnership,
p.001994:
p.001994: having duties such that the conduct of such officer, director, partner, employee, or agent
p.001994: may fairly be assumed to represent the policy of the corporation, association, or
p.001994: partnership, and
p.001994: (2) includes persons having management responsibility for—
p.001994: (A) submissions to the Food and Drug Administration regarding the development or
p.001994: approval of any drug product,
p.001994: (B) production, quality assurance, or quality control of any drug product, or
p.001994: (C) research and development of any drug product.
p.001994:
p.001994: (dd) For purposes of sections 335a and 335b of this title, the term “drug product” means a
p.001994: drug subject to regulation under section 355, 360b, or 382 of this title or under section 262
p.001994: of title 42.
p.001994: (ee) The term “Commissioner” means the Commissioner of Food and Drugs.
p.001994: (ff) The term “dietary supplement”—
p.001994: (1) means a product (other than tobacco) intended to supplement the diet that bears or
p.001994: contains one or more of the following dietary ingredients:
p.001994: (A) a vitamin;
p.001994: (B) a mineral;
p.001994: (C) an herb or other botanical;
p.001994: (D) an amino acid;
p.001994: (E) a dietary substance for use by man to supplement the diet by increasing the total
p.001994: dietary intake; or
p.001994: (F) a concentrate, metabolite, constituent, extract, or combination of any ingredient
p.001994: described in clause (A), (B), (C), (D), or (E);
p.001994:
p.001994: (2) means a product that—
p.001994: (A)(i) is intended for ingestion in a form described in section 350(c)(1)(B)(i) of this
p.001994: title; or
p.001994: (ii) complies with section 350(c)(1)(B)(ii) of this title;
p.001994: (B) is not represented for use as a conventional food or as a sole item of a meal or
p.001994: the diet; and
p.001994: (C) is labeled as a dietary supplement; and
p.001994:
p.001994: (3) does—
p.001994: (A) include an article that is approved as a new drug under section 355 of this title or
p.001994: licensed as a biologic under section 262 of title 42 and was, prior to such approval,
p.001994: certification, or license, marketed as a dietary supplement or as a food unless the
p.001994: Secretary has issued a regulation, after notice and comment, finding that the article,
p.001994: when used as or in a dietary supplement under the conditions of use and dosages set
p.001994: forth in the labeling for such dietary supplement, is unlawful under section 342(f) of this
p.001994: title; and
p.001994: (B) not include—
p.001994: (i) an article that is approved as a new drug under section 355 of this title, certified
p.001994: as an antibiotic under section 357 of this title, or licensed as a biologic under section
p.001994: 262 of title 42, or
p.001994: (ii) an article authorized for investigation as a new drug, antibiotic, or biological for
p.001994: which substantial clinical investigations have been instituted and for which the
p.001994: existence of such investigations has been made public,
p.001994:
p.001994: which was not before such approval, certification, licensing, or authorization marketed as
p.001994: a dietary supplement or as a food unless the Secretary, in the Secretary's discretion, has
p.001994: issued a regulation, after notice and comment, finding that the article would be lawful
p.001994: under this chapter.2
p.001994: Except for purposes of paragraph (g) and section 350f of this title, a dietary supplement
p.001994: shall be deemed to be a food within the meaning of this chapter.
p.001994: (gg) The term “processed food” means any food other than a raw agricultural commodity
p.001994: and includes any raw agricultural commodity that has been subject to processing, such as
p.001994: canning, cooking, freezing, dehydration, or milling.
p.001994: (hh) The term “Administrator” means the Administrator of the United States
p.001994: Environmental Protection Agency.
p.001994: (ii) The term “compounded positron emission tomography drug”—
p.001994: (1) means a drug that—
p.001994: (A) exhibits spontaneous disintegration of unstable nuclei by the emission of
p.001994: positrons and is used for the purpose of providing dual photon positron emission
p.001994: tomographic diagnostic images; and
p.001994: (B) has been compounded by or on the order of a practitioner who is licensed by a
p.001994: State to compound or order compounding for a drug described in subparagraph (A),
p.001994: and is compounded in accordance with that State's law, for a patient or for research,
p.001994: teaching, or quality control; and
p.001994:
p.001994: (2) includes any nonradioactive reagent, reagent kit, ingredient, nuclide generator,
p.001994: accelerator, target material, electronic synthesizer, or other apparatus or computer
p.001994: program to be used in the preparation of such a drug.
p.001994:
p.001994: (jj) The term “antibiotic drug” means any drug (except drugs for use in animals other than
p.001994: humans) composed wholly or partly of any kind of penicillin, streptomycin, chlortetracycline,
p.001994: chloramphenicol, bacitracin, or any other drug intended for human use containing any
p.001994: quantity of any chemical substance which is produced by a micro-organism and which has
p.001994: the capacity to inhibit or destroy micro-organisms in dilute solution (including a chemically
p.001994: synthesized equivalent of any such substance) or any derivative thereof.
p.001994: (kk) PRIORITY SUPPLEMENT.—The term “priority supplement” means a drug application
p.001994: referred to in section 101(4) of the Food and Drug Administration Modernization Act of 1997
p.001994: (111 Stat. 2298).
p.001994: (ll)(1) The term “single-use device” means a device that is intended for one use, or on a
p.001994: single patient during a single procedure.
p.001994: (2)(A) The term “reprocessed”, with respect to a single-use device, means an original
p.001994: device that has previously been used on a patient and has been subjected to additional
p.001994: processing and manufacturing for the purpose of an additional single use on a patient. The
p.001994: subsequent processing and manufacture of a reprocessed single-use device shall result in
p.001994: a device that is reprocessed within the meaning of this definition.
p.001994: (B) A single-use device that meets the definition under clause (A) shall be considered a
p.001994: reprocessed device without regard to any description of the device used by the
p.001994: manufacturer of the device or other persons, including a description that uses the term
p.001994: “recycled” rather than the term “reprocessed”.
p.001994: (3) The term “original device” means a new, unused single-use device.
p.001994: (mm)(1) The term “critical reprocessed single-use device” means a reprocessed single-
p.001994: use device that is intended to contact normally sterile tissue or body spaces during use.
p.001994: (2) The term “semi-critical reprocessed single-use device” means a reprocessed single-
p.001994: use device that is intended to contact intact mucous membranes and not penetrate
p.001994: normally sterile areas of the body.
p.001994: (nn) The term “major species” means cattle, horses, swine, chickens, turkeys, dogs, and
p.001994: cats, except that the Secretary may add species to this definition by regulation.
p.001994: (oo) The term “minor species” means animals other than humans that are not major
p.001994: species.
p.001994: (pp) The term “minor use” means the intended use of a drug in a major species for an
p.001994: indication that occurs infrequently and in only a small number of animals or in limited
p.001994: geographical areas and in only a small number of animals annually.
p.001994: (qq) The term “major food allergen” means any of the following:
p.001994: (1) Milk, egg, fish (e.g., bass, flounder, or cod), Crustacean shellfish (e.g., crab, lobster,
p.001994: or shrimp), tree nuts (e.g., almonds, pecans, or walnuts), wheat, peanuts, and soybeans.
p.001994: (2) A food ingredient that contains protein derived from a food specified in paragraph
p.001994: (1), except the following:
p.001994: (A) Any highly refined oil derived from a food specified in paragraph (1) and any
p.001994: ingredient derived from such highly refined oil.
p.001994: (B) A food ingredient that is exempt under paragraph (6) or (7) of section 343(w) of
p.001994: this title.
p.001994:
p.001994: (rr)(1) The term “tobacco product” means any product made or derived from tobacco that
p.001994: is intended for human consumption, including any component, part, or accessory of a
p.001994: tobacco product (except for raw materials other than tobacco used in manufacturing a
p.001994: component, part, or accessory of a tobacco product).
p.001994: (2) The term “tobacco product” does not mean an article that is a drug under subsection
p.001994: (g)(1), a device under subsection (h), or a combination product described in section 353(g)
p.001994: of this title.
p.001994: (3) The products described in paragraph (2) shall be subject to subchapter V of this
p.001994: chapter.
p.001994: (4) A tobacco product shall not be marketed in combination with any other article or
p.001994: product regulated under this chapter (including a drug, biologic, food, cosmetic, medical
p.001994: device, or a dietary supplement).
p.001994: (June 25, 1938, ch. 675, §201, 52 Stat. 1040; July 22, 1954, ch. 559, §1, 68 Stat. 511; Pub.
p.001994: L. 85–929, §2, Sept. 6, 1958, 72 Stat. 1784; Pub. L. 86–618, title I, §101, July 12, 1960, 74
p.001994: Stat. 397; Pub. L. 87–781, title I, §102(a), title III, §307(a), Oct. 10, 1962, 76 Stat. 781, 796;
p.001994: Pub. L. 89–74, §§3(a), 9(b), July 15, 1965, 79 Stat. 227, 234; Pub. L. 90–399, §102, July
p.001994: 13, 1968, 82 Stat. 351; Pub. L. 90–639, §§1, 4(a), Oct. 24, 1968, 82 Stat. 1361, 1362; Pub.
p.001994: L. 91–513, title II, §701(a), (g), Oct. 27, 1970, 84 Stat. 1281, 1282; Pub. L. 92–516, §3(3),
p.001994: Oct. 21, 1972, 86 Stat. 998; Pub. L. 94–278, title V, §502(a)(2)(A), Apr. 22, 1976, 90 Stat.
p.001994: 411; Pub. L. 94–295, §3(a)(1)(A), (2), May 28, 1976, 90 Stat. 575; Pub. L. 95–203, §4(b)(3),
p.001994: Nov. 23, 1977, 91 Stat. 1453; Pub. L. 96–359, §3, Sept. 26, 1980, 94 Stat. 1193; Pub. L.
p.001994: 100–670, title I, §107(a)(1), Nov. 16, 1988, 102 Stat. 3984; Pub. L. 101–535, §5(b), Nov. 8,
p.001994: 1990, 104 Stat. 2362; Pub. L. 101–629, §16(b), Nov. 28, 1990, 104 Stat. 4526; Pub. L. 102–
p.001994: 282, §6, May 13, 1992, 106 Stat. 161; Pub. L. 102–300, §6(a), (b), June 16, 1992, 106 Stat.
p.001994: 240; Pub. L. 102–571, title I, §107(1), Oct. 29, 1992, 106 Stat. 4499; Pub. L. 103–80,
p.001994: §§3(b), (dd)(1), 4(b), Aug. 13, 1993, 107 Stat. 775, 779; Pub. L. 103–417, §§3(a), (b), 10(a),
p.001994: Oct. 25, 1994, 108 Stat. 4327, 4332; Pub. L. 104–170, title IV, §402, Aug. 3, 1996, 110 Stat.
p.001994: 1513; Pub. L. 105–115, title I, §§121(a), 125(b)(2)(A), (e), Nov. 21, 1997, 111 Stat. 2320,
p.001994: 2325, 2327; Pub. L. 105–324, §2(a), (c), Oct. 30, 1998, 112 Stat. 3035, 3037; Pub. L. 107–
p.001994: 109, §5(b)(1), Jan. 4, 2002, 115 Stat. 1413; Pub. L. 107–250, title III, §302(d), Oct. 26,
p.001994: 2002, 116 Stat. 1619; Pub. L. 108–282, title I, §102(b)(1), (5)(A), (B), title II, §203(c)(1),
p.001994: Aug. 2, 2004, 118 Stat. 891, 902, 908; Pub. L. 110–85, title X, §1005(c), Sept. 27, 2007,
p.001994: 121 Stat. 968; Pub. L. 111–31, div. A, title I, §101(a), June 22, 2009, 123 Stat. 1783.)
p.001994: REFERENCES IN TEXT
p.001994: The Food and Drugs Act of June 30, 1906, as amended, referred to in par. (p)(1), and the Food
p.001994: and Drug Act of June 30, 1906, as amended, referred to in par. (v)(1), is act June 30, 1906, ch.
p.001994: 3915, 34 Stat. 768, which was classified to subchapter I (§1 et seq.) of chapter 1 of this title, was
p.001994: repealed (except for section 14a which was transferred to section 376 of this title) by act June 25,
p.001994: 1938, ch. 675, §1002(a), formerly §902(a), 52 Stat. 1059; renumbered §1002(a), Pub. L. 111–31,
p.001994: div. A, title I, §101(b)(2), June 22, 2009, 123 Stat. 1784, and is covered by this chapter.
p.001994: The Federal Insecticide, Fungicide, and Rodenticide Act, referred to in par. (q)(1), is act June
p.001994: 25, 1947, ch. 125, as amended generally by Pub. L. 92–516, Oct. 21, 1972, 86 Stat. 973, which is
p.001994: classified generally to subchapter II (§136 et seq.) of chapter 6 of Title 7, Agriculture. For
p.001994: complete classification of this Act to the Code, see Short Title note set out under section 136 of
p.001994: Title 7 and Tables.
p.001994: The Poultry Products Inspection Act, referred to in par. (s)(4), is Pub. L. 85–172, Aug. 28, 1957,
p.001994: 71 Stat. 441, as amended, which is classified generally to chapter 10 (§451 et seq.) of this title.
p.001994: For complete classification of this Act to the Code, see Short Title note set out under section 451
p.001994: of this title and Tables.
p.001994: The Meat Inspection Act of March 4, 1907, as amended and extended, referred to in par. (s)(4),
p.001994: is act Mar. 4, 1907, ch. 2907, titles I to IV, as added Dec. 15, 1967, Pub. L. 90–201, 81 Stat. 584,
p.001994: which are classified generally to subchapters I to IV (§601 et seq.) of chapter 12 of this title. For
p.001994: complete classification of this Act to the Code, see Short Title note set out under section 601 of
p.001994: this title and Tables.
p.001994: Section 101(4) of the Food and Drug Administration Modernization Act of 1997, referred to in
p.001994: par. (kk), is section 101(4) of Pub. L. 105–115, which is set out as a note under section 379g of
p.001994: this title.
p.001994: AMENDMENTS
p.001994: 2009—Par. (rr). Pub. L. 111–31 added par. (rr).
p.001994: 2007—Par. (ff). Pub. L. 110–85 substituted “paragraph (g) and section 350f of this title” for
p.001994: “paragraph (g)” in concluding provisions.
p.001994: 2004–Par. (u). Pub. L. 108–282, §102(b)(5)(A), substituted “360b, 360ccc” for “360b”.
p.001994: Par. (v). Pub. L. 108–282, §102(b)(5)(B), inserted concluding provisions.
p.001994: Pars. (nn) to (pp). Pub. L. 108–282, §102(b)(1), added pars. (nn) to (pp).
p.001994: Par. (qq). Pub. L. 108–282, §203(c)(1), added par. (qq).
p.001994: 2002—Par. (kk). Pub. L. 107–109 added par. (kk).
p.001994: Pars. (ll), (mm). Pub. L. 107–250 added pars. (ll) and (mm).
p.001994: 1998—Par. (q)(1). Pub. L. 105–324, §2(a), added subpar. (1) and struck out former subpar. (1)
p.001994: which read as follows: “The term ‘pesticide chemical’ means any substance that is a pesticide
p.001994: within the meaning of the Federal Insecticide, Fungicide, and Rodenticide Act, including all active
p.001994: and inert ingredients of such pesticide.”
p.001994: Par. (q)(3). Pub. L. 105–324, §2(c), substituted “subparagraphs (1) and (2)” for “paragraphs (1)
p.001994: and (2)” in introductory provisions.
p.001994: 1997—Par. (aa). Pub. L. 105–115, §125(b)(2)(A), struck out “or 357” after “section 355(j)”.
p.001994: Par. (dd). Pub. L. 105–115, §125(b)(2)(A), struck out “357,” after “section 355,”.
p.001994: Par. (ff)(3)(A). Pub. L. 105–115, §125(b)(2)(A), struck out “, certified as an antibiotic under
p.001994: section 357 of this title,” before “or licensed as a biologic”.
p.001994: Par. (ii). Pub. L. 105–115, §121(a), added par. (ii).
p.001994: Par. (jj). Pub. L. 105–115, §125(e), added par. (jj).
p.001994: 1996—Par. (q). Pub. L. 104–170, §402(a), amended par. (q) generally. Prior to amendment,
p.001994: par. (q) read as follows: “The term ‘pesticide chemical’ means any substance which, alone, in
p.001994: chemical combination or in formulation with one or more other substances, is ‘a pesticide’ within
p.001994: the meaning of the Federal Insecticide, Fungicide, and Rodenticide Act as now in force or as
p.001994: hereafter amended, and which is used in the production, storage, or transportation of raw
p.001994: agricultural commodities.”
p.001994: Par. (s)(1), (2). Pub. L. 104–170, §402(b), amended subpars. (1) and (2) generally. Prior to
p.001994: amendment, subpars. (1) and (2) read as follows:
p.001994: “(1) a pesticide chemical in or on a raw agricultural commodity; or
p.001994: “(2) a pesticide chemical to the extent that it is intended for use or is used in the production,
p.001994: storage, or transportation of any raw agricultural commodity; or”.
p.001994: Pars. (gg), (hh). Pub. L. 104–170, §402(c), added pars. (gg) and (hh).
p.001994: 1994—Par. (g)(1). Pub. L. 103–417, §10(a), amended last sentence generally. Prior to
p.001994: amendment, last sentence read as follows: “A food for which a claim, subject to sections 343(r)(1)
p.001994: (B) and 343(r)(3) of this title or sections 343(r)(1)(B) and 343(r)(5)(D) of this title, is made in
p.001994: accordance with the requirements of section 343(r) of this title is not a drug under clause (B) solely
p.001994: because the label or labeling contains such a claim.”
p.001994: Par. (s)(6). Pub. L. 103–417, §3(b), added subpar. (6).
p.001994: Par. (ff). Pub. L. 103–417, §3(a), added par. (ff).
p.001994: 1993—Pars. (c), (d). Pub. L. 103–80, §3(dd)(1), substituted “Health and Human Services” for
p.001994: “Agriculture”.
p.001994: Par. (h). Pub. L. 103–80, §4(b), amended directory language of Pub. L. 102–300, §6(a)(1). See
p.001994: 1992 amendment note below.
p.001994: Pars. (v) to (ff). Pub. L. 103–80, §3(b), redesignated pars. (w) to (ff) as (v) to (ee), respectively.
p.001994: 1992—Pars. (c), (d). Pub. L. 102–300, §6(b)(1), which directed the substitution of “Health and
p.001994: Human Services” for “Health, Education, and Welfare”, could not be executed because such
p.001994: words did not appear in the original statutory text. See 1993 Amendment note above and Transfer
p.001994: of Functions notes below.
p.001994: Par. (h). Pub. L. 102–300, §6(a)(1), as amended by Pub. L. 103–80, §4(b), substituted “its
p.001994: primary” for “any of its principal” in two places in concluding provisions.
p.001994: Par. (u). Pub. L. 102–571 substituted “379e” for “376”.
p.001994: Par. (y)(1). Pub. L. 102–300, §6(b)(2), struck out “of Health, Education, and Welfare” after
p.001994: “employees of the Department”.
p.001994: Pars. (bb) to (ee). Pub. L. 102–282 added pars. (bb) to (ee).
p.001994: Par. (ff). Pub. L. 102–300, §6(a)(2), added par. (ff).
p.001994: 1990—Par. (g)(1). Pub. L. 101–629, §16(b)(1), struck out “; but does not include devices or their
p.001994: components, parts, or accessories” after “clause (A), (B), or (C)”.
p.001994: Pub. L. 101–535 inserted at end “A food for which a claim, subject to sections 343(r)(1)(B) and
p.001994: 343(r)(3) of this title or sections 343(r)(1)(B) and 343(r)(5)(D) of this title, is made in accordance
p.001994: with the requirements of section 343(r) of this title is not a drug under clause (B) solely because
p.001994: the label or labeling contains such a claim.”
p.001994: Par. (h)(3). Pub. L. 101–629, §16(b)(2), which directed the amendment of subpar. (3) by
p.001994: substituting “its primary” for “any of its principal”, could not be executed because “any of its
p.001994: principal” did not appear in subpar. (3).
p.001994: 1988—Par. (w)(3). Pub. L. 100–670 struck out subpar. (3) which read as follows: “which drug is
p.001994: composed wholly or partly of any kind of penicillin, streptomycin, chlortetracycline,
p.001994: chloramphenicol, or bacitracin, or any derivative thereof, except when there is in effect a published
p.001994: order of the Secretary declaring such drug not to be a new animal drug on the grounds that (A)
p.001994: the requirement of certification of batches of such drug, as provided for in section 360b(n) of this
p.001994: title, is not necessary to insure that the objectives specified in paragraph (3) thereof are achieved
p.001994: and (B) that neither subparagraph (1) nor (2) of this paragraph (w) applies to such drug.”
p.001994: 1980—Par. (aa). Pub. L. 96–359 added par. (aa).
p.001994: 1977—Par. (z). Pub. L. 95–203 added par. (z).
p.001994: 1976—Par. (h). Pub. L. 94–295, §3(a)(1)(A), expanded definition of “device” to include
p.001994: implements, machines, implants, in vitro reagents, and other similar or related articles, added
p.001994: recognition in the National Formulary or the United States Pharmacopeia, or any supplement to
p.001994: the Formulary or Pharmacopeia, to the enumeration of conditions under which a device may
p.001994: qualify for inclusion under this chapter, and inserted requirements that a device be one which does
p.001994: not achieve any of its principal intended purposes through chemical action within or on the body of
p.001994: man or other animals and which is not dependent upon being metabolized for the achievement of
p.001994: any of its principal intended purposes.
p.001994: Par. (n). Pub. L. 94–278 inserted “or advertising” after “labeling” wherever appearing.
p.001994: Par. (y). Pub. L. 94–295, §3(a)(2), added par. (y).
p.001994: 1972—Par. (q). Pub. L. 92–516 substituted reference to pesticide for reference to economic
p.001994: poison.
p.001994: 1970—Par. (a)(2). Pub. L. 91–513, §701(g), struck out reference to sections 321, 331(i), 331(p),
p.001994: 331(q), 332, 333, 334, 337, 360, 360a, 372, 373, 374, and 375 of this title as they apply to
p.001994: depressant or stimulant drugs.
p.001994: Par. (v). Pub. L. 91–513, §701(a), struck out par. (v) which defined “depressant or stimulant
p.001994: drug”.
p.001994: 1968—Par. (a)(2). Pub. L. 90–639, §4(a), extended provisions to cover depressant and
p.001994: stimulant drugs, the containers thereof, and equipment used in manufacturing, compounding, or
p.001994: processing such drugs, to the Canal Zone.
p.001994: Par. (p). Pub. L. 90–399, §102(a), (b), inserted “(except a new animal drug or an animal feed
p.001994: bearing or containing a new animal drug)” after “Any drug” in subpars. (1) and (2), respectively.
p.001994: Par. (s)(5). Pub. L. 90–399, §102(c), added subpar. (5).
p.001994: Par. (u). Pub. L. 90–399, §102(d), inserted reference to section 360b of this title.
p.001994: Par. (v)(3). Pub. L. 90–639, §1, inserted reference to lysergic acid diethylamide.
p.001994: Pars. (w), (x). Pub. L. 90–399, §102(e), added pars. (w) and (x).
p.001994: 1965—Par. (g). Pub. L. 89–74, §9(b), designated existing provisions as subpar. (1),
p.001994: redesignated cls. (1) to (4) thereof as (A) to (D), substituted “(A), (B), or (C)” for “(1), (2), or (3)”
p.001994: and added subpar. (2).
p.001994: Par. (v). Pub. L. 89–74, §3(a), added par. (v).
p.001994: 1962—Par. (a). Pub. L. 87–781, §307(a), designated existing provisions as subpar. (2), inserted
p.001994: “Commonwealth of Puerto Rico and the”, and added subpar. (1).
p.001994: Par. (p)(1). Pub. L. 87–781, §102(a)(1), inserted “and effectiveness” after “to evaluate the
p.001994: safety”, and “and effective” after “as safe”.
p.001994: Par. (p)(2). Pub. L. 87–781, §102(a)(2), inserted “and effectiveness” after “safety”.
p.001994: 1960—Par. (s). Pub. L. 86–618, §101(a), excluded color additives from definition of “food
p.001994: additive”.
p.001994: Par. (t). Pub. L. 86–618, §101(c), added par. (t). Former par. (t) redesignated (u).
p.001994: Par. (u). Pub. L. 86–618, §101(b), redesignated par. (t) as (u) and inserted reference to section
p.001994: 376 of this title.
p.001994: 1958—Pars. (s), (t). Pub. L. 85–929 added pars. (s) and (t).
p.001994: 1954—Pars. (q), (r). Act July 22, 1954, added pars. (q) and (r).
p.001994: EFFECTIVE DATE OF 2004 AMENDMENT
p.001994: Pub. L. 108–282, title II, §203(d), Aug. 2, 2004, 118 Stat. 908, provided that: “The amendments
p.001994: made by this section [amending this section and sections 343 and 343–1 of this title] shall apply to
p.001994: any food that is labeled on or after January 1, 2006.”
...

p.001994: Secretary under section 343(r)(2)(A)(i) of this title, see section 10(a) of Pub. L. 101–535, set out
p.001994: as a note under section 343 of this title.
p.001994: EFFECTIVE DATE OF 1976 AMENDMENT
p.001994: Amendment by Pub. L. 94–278 effective 180 days after Apr. 22, 1976, see section 502(c) of
p.001994: Pub. L. 94–278, set out as a note under section 334 of this title.
p.001994: EFFECTIVE DATE OF 1972 AMENDMENT
p.001994: Amendment by Pub. L. 92–516 effective at the close of Oct. 21, 1972, except if regulations are
p.001994: necessary for the implementation of any provision that becomes effective on Oct. 21, 1972, and
p.001994: continuation in effect of subchapter I of chapter 6 of Title 7, and regulations thereunder, relating to
p.001994: the control of economic poisons, as in existence prior to Oct. 21, 1972, until superseded by
p.001994: provisions of Pub. L. 92–516, and regulations thereunder, see section 4 of Pub. L. 92–516, set out
p.001994: as an Effective Date note under section 136 of Title 7, Agriculture.
p.001994: EFFECTIVE DATE OF 1970 AMENDMENT
p.001994: Amendment by Pub. L. 91–513 effective on first day of seventh calendar month that begins
p.001994: after Oct. 26, 1970, see section 704 of Pub. L. 91–513, set out as an Effective Date note under
p.001994: section 801 of this title.
p.001994: EFFECTIVE DATE OF 1968 AMENDMENTS; TRANSITIONAL PROVISIONS
p.001994: Section 6 of Pub. L. 90–639 provided that: “The amendments made by this Act [amending this
p.001994: section, sections 331, 333, 334, and 360a of this title, and provisions set out as a note under
p.001994: section 289a of Title 42, The Public Health and Welfare] shall apply only with respect to violations
p.001994: of the Federal Food, Drug, and Cosmetic Act [this chapter] committed after the date of the
p.001994: enactment of this Act [Oct. 24, 1968].”
p.001994: Amendment by Pub. L. 90–399 effective on first day of thirteenth calendar month after July 13,
p.001994: 1968, except that in the case of a drug (other than one subject to section 360b(n) of this title)
p.001994: intended for use in animals other than man which, on Oct. 9, 1962, was commercially used or
p.001994: sold in the United States, was not a new drug as defined in par. (p) of this section then in force,
p.001994: and was not covered by an effective application under section 355 of this title, the words
p.001994: “effectiveness” and “effective” contained in par. (v) of this section not applicable to such drug
p.001994: when intended solely for use under conditions prescribed, recommended, or suggested in labeling
p.001994: with respect to such drug on that day, see section 108(a), (b)(3) of Pub. L. 90–399, as amended,
p.001994: set out as an Effective Date and Transitional Provisions note under section 360b of this title.
p.001994: EFFECTIVE DATE OF 1965 AMENDMENT
p.001994: Section 11 of Pub. L. 89–74 provided that: “The foregoing provisions of this Act [see Short Title
p.001994: of 1965 Amendment note set out under section 301 of this title] shall take effect on the first day of
p.001994: the seventh calendar month [Feb. 1, 1966] following the month in which this Act is enacted [July
p.001994: 15, 1965]; except that (1) the Secretary shall permit persons, owning or operating any
p.001994: establishment engaged in manufacturing, preparing, propagating, compounding, processing,
p.001994: wholesaling, jobbing, or distributing any depressant or stimulant drug, as referred to in the
p.001994: amendments made by section 4 of this Act to section 510 of the Federal Food, Drug, and
p.001994: Cosmetic Act [section 360 of this title], to register their name, places of business, and
p.001994: establishments, and other information prescribed by such amendments, with the Secretary prior to
p.001994: such effective date, and (2) sections 201(v) and 511(g) of the Federal Food, Drug, and Cosmetic
p.001994: Act, as added by this act [par. (v) of this section and par. (g) of section 360a of this title], and the
p.001994: provisions of sections 8 [amending section 372 of this title and section 1114 of Title 18, Crimes
p.001994: and Criminal Procedure] and 10 [set out as a note under this section] shall take effect upon the
p.001994: date of enactment of this Act [July 15, 1965].”
p.001994: EFFECTIVE DATE OF 1962 AMENDMENT
p.001994: Section 107 of Pub. L. 87–781 provided that:
p.001994: “(a) Except as otherwise provided in this section, the amendments made by the foregoing
p.001994: sections of this part A [amending this section and sections 331, 332, 348, 351 to 353, 355, 357,
p.001994: 379e of this title, and enacting provisions set out as a note under section 355 of this title] shall
p.001994: take effect on the date of enactment of this Act [Oct. 10, 1962].
p.001994: “(b) The amendments made by sections 101, 103, 105, and 106 of this part A [amending
p.001994: sections 331, 332, 351, 352, 355, and 357 of this title] shall, with respect to any drug, take effect
p.001994: on the first day of the seventh calendar month following the month in which this Act is enacted
p.001994: [Oct. 1962].
p.001994: “(c)(1) As used in this subsection, the term ‘enactment date’ means the date of enactment of
p.001994: this Act; and the term ‘basic Act’ means the Federal Food, Drug, and Cosmetic Act [this chapter].
p.001994: “(2) An application filed pursuant to section 505(b) of the basic Act [section 355(b) of this title]
p.001994: which was ‘effective’ within the meaning of that Act on the day immediately preceding the
p.001994: enactment date shall be deemed as of the enactment date, to be an application ‘approved’ by the
p.001994: Secretary within the meaning of the basic Act as amended by this Act.
p.001994: “(3) In the case of any drug with respect to which an application filed under section 505(b) of the
p.001994: basic Act is deemed to be an approved application on the enactment date by virtue of paragraph
p.001994: (2) of this subsection—
p.001994: “(A) the amendments made by this Act to section 201(p), and to subsections (b) and (d) of
p.001994: section 505, of the basic Act [par. (p) of this section, and subsecs. (b) and (d) of section 355 of
p.001994: this title], insofar as such amendments relate to the effectiveness of drugs, shall not, so long as
p.001994: approval of such application is not withdrawn or suspended pursuant to section 505(e) of that
p.001994: Act [section 355(e) of this title], apply to such drug when intended solely for use under
p.001994: conditions prescribed, recommended, or suggested in labeling covered by such approved
p.001994: application, but shall apply to any changed use, or conditions of use, prescribed, recommended,
p.001994: or suggested in its labeling, including such conditions of use as are the subject of an
p.001994: amendment or supplement to such application pending on, or filed after, the enactment date;
p.001994: and
p.001994: “(B) clause (3) of the first sentence of section 505(e) of the basic Act, as amended by this
p.001994: Act [section 355(e) of this title], shall not apply to such drug when intended solely for use under
p.001994: conditions prescribed, recommended, or suggested in labeling covered by such approved
p.001994: application (except with respect to such use, or conditions of use, as are the subject of an
p.001994: amendment or supplement to such approved application, which amendment or supplement has
p.001994: been approved after the enactment date under section 505 of the basic Act as amended by this
p.001994: Act [section 355 of this title]) until whichever of the following first occurs: (i) the expiration of the
p.001994: two-year period beginning with the enactment date; (ii) the effective date of an order under
p.001994: section 505(e) of the basic Act [section 355(e) of this title], other than clause (3) of the first
p.001994: sentence of such section 505(e) [section 355(e) of this title], withdrawing or suspending the
p.001994: approval of such application.
p.001994: “(4) In the case of any drug which, on the day immediately preceding the enactment date, (A)
p.001994: was commercially used or sold in the United States, (B) was not a new drug as defined by section
p.001994: 201(p) of the basic Act as then in force [par. (p) of this section], and (C) was not covered by an
p.001994: effective application under section 505 of that Act [section 355 of this title], the amendments to
p.001994: section 201(p) [par. (p) of this section] made by this Act shall not apply to such drug when
p.001994: intended solely for use under conditions prescribed, recommended, or suggested in labeling with
p.001994: respect to such drug on that day.”
p.001994: EFFECTIVE DATE OF 1960 AMENDMENT
p.001994: Amendment by Pub. L. 86–618 effective July 12, 1960, subject to provisions of section 203 of
p.001994: Pub. L. 86–618, see section 202 of Pub. L. 86–618, set out as a note under section 379e of this
p.001994: title.
p.001994: EFFECTIVE DATE OF 1958 AMENDMENT
p.001994: Amendment by Pub. L. 85–929 effective Sept. 6, 1958, see section 6(a) of Pub. L. 85–929, set
p.001994: out as a note under section 342 of this title.
p.001994: EFFECTIVE DATE OF 1954 AMENDMENT
p.001994: For effective date of amendment by act July 22, 1954, see section 5 of that act, set out as a
p.001994: note under section 342 of this title.
p.001994: CONSTRUCTION OF AMENDMENTS BY PUB. L. 102–282
p.001994: Amendment by Pub. L. 102–282 not to preclude any other civil, criminal, or administrative
p.001994: remedy provided under Federal or State law, including any private right of action against any
p.001994: person for the same action subject to any action or civil penalty under an amendment made by
p.001994: Pub. L. 102–282, see section 7 of Pub. L. 102–282, set out as a note under section 335a of this
p.001994: title.
p.001994: CONSTRUCTION OF AMENDMENTS BY PUB. L. 101–535
p.001994: Amendments by Pub. L. 101–535 not to be construed to alter authority of Secretary of Health
p.001994: and Human Services and Secretary of Agriculture under the Federal Food, Drug, and Cosmetic
p.001994: Act (21 U.S.C. 301 et seq.), the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry
p.001994: Products Inspection Act (21 U.S.C. 451 et seq.), and the Egg Products Inspection Act (21 U.S.C.
p.001994: 1031 et seq.), see section 9 of Pub. L. 101–535, set out as a note under section 343 of this title.
p.001994: SAVINGS PROVISION
p.001994: Section 702 of Pub. L. 91–513, as amended by Pub. L. 93–481, §2, Oct. 26, 1974, 88 Stat.
p.001994: 1455, provided that:
p.001994: “(a) Prosecutions for any violation of law occurring prior to the effective date [see Effective Date
p.001994: of 1970 Amendment note above] of section 701 [repealing section 360a of this title, and amending
p.001994: sections 321, 331, 333, 334, 360, 372, and 381 of this title, sections 1114 and 1952 of Title 18,
p.001994: Crimes and Criminal Procedure, and section 242 of Title 42, The Public Health and Welfare] shall
p.001994: not be affected by the repeals or amendments made by such section, or abated by reason
p.001994: thereof.
p.001994: “(b) Civil seizures or forfeitures and injunctive proceedings commenced prior to the effective
p.001994: date of section 701 shall not be affected by the repeals or amendments made by such section, or
p.001994: abated by reason thereof.
p.001994: “(c) All administrative proceedings pending before the Bureau of Narcotics and Dangerous
p.001994: Drugs [now the Drug Enforcement Administration] on the date of enactment of this Act [Oct. 27,
p.001994: 1970] shall be continued and brought to final determination in accord with laws and regulations in
p.001994: effect prior to such date of enactment. Where a drug is finally determined under such proceedings
p.001994: to be a depressant or stimulant drug, as defined in section 201(v) of the Federal Food, Drug, and
p.001994: Cosmetic Act [par. (v) of this section], such drug shall automatically be controlled under this title
p.001994: [subchapter I of chapter 13 of this title] by the Attorney General without further proceedings and
p.001994: listed in the appropriate schedule after he has obtained the recommendation of the Secretary. Any
p.001994: drug with respect to which such a final determination has been made prior to the date of
p.001994: enactment of this Act which is not listed in section 202 [section 812 of this title] within schedules I
p.001994: through V shall automatically be controlled under this title [subchapter I of chapter 13 of this title]
p.001994: by the Attorney General without further proceedings, and be listed in the appropriate schedule,
p.001994: after he has obtained the recommendations of the Secretary.
p.001994: “(d) Notwithstanding subsection (a) of this section or section 1103 [of Pub. L. 91–513, set out as
p.001994: a note under sections 171 to 174 of this title], section 4202 of title 18, United States Code, shall
p.001994: apply to any individual convicted under any of the laws repealed by this title or title III [subchapter I
p.001994: or subchapter II of chapter 13 of this title] without regard to the terms of any sentence imposed on
p.001994: such individual under such law.”
p.001994: TRANSFER OF FUNCTIONS
p.001994: Secretary and Department of Health, Education, and Welfare redesignated Secretary and
p.001994: Department of Health and Human Services by Pub. L. 96–88, title V, §509(b), Oct. 17, 1979, 93
p.001994: Stat. 695, which is classified to section 3508(b) of Title 20, Education.
p.001994: Functions of Secretary of Health, Education, and Welfare [now Health and Human Services]
p.001994: under Federal Food, Drug, and Cosmetic Act, to the extent such functions related to
p.001994: administration and enforcement of the Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471
p.001994: et seq.), transferred to Consumer Product Safety Commission by section 2079 of Title 15,
p.001994: Commerce and Trade.
p.001994: Functions of Secretary of Health, Education, and Welfare [now Health and Human Services]
p.001994: under Drug Abuse Control Amendments of 1965 [see Short Title of 1965 Amendment note set out
p.001994: under section 301 of this title] transferred to Attorney General except function of regulating
p.001994: counterfeiting of those drugs which are not “depressant or stimulant” drugs, see section 2 of
p.001994: Reorg. Plan No. 1 of 1968, set out in the Appendix to Title 5, Government Organization and
p.001994: Employees.
p.001994: Functions of Federal Security Administrator transferred to Secretary of Health, Education, and
p.001994: Welfare and all agencies of Federal Security Agency transferred to Department of Health,
p.001994: Education, and Welfare by section 5 of Reorg. Plan No. 1 of 1953, set out in the Appendix to Title
p.001994: 5, Government Organization and Employees. Federal Security Agency and office of Administrator
p.001994: abolished by section 8 of Reorg. Plan No. 1 of 1953.
p.001994: Food and Drug Administration in Department of Agriculture and its functions, except those
p.001994: functions relating to administration of Insecticide Act of 1910 and Naval Stores Act, transferred to
p.001994: Federal Security Agency, to be administered under direction and supervision of Federal Security
p.001994: Administrator, by Reorg. Plan No. IV of 1940, set out in the Appendix to Title 5.
p.001994: REGULATION OF TOBACCO
p.001994: Section 422 of Pub. L. 105–115 provided that: “Nothing in this Act [see Short Title of 1997
p.001994: Amendment note set out under section 301 of this title] or the amendments made by this Act shall
p.001994: be construed to affect the question of whether the Secretary of Health and Human Services has
p.001994: any authority to regulate any tobacco product, tobacco ingredient, or tobacco additive. Such
p.001994: authority, if any, shall be exercised under the Federal Food, Drug, and Cosmetic Act [21 U.S.C.
p.001994: 301 et seq.] as in effect on the day before the date of the enactment of this Act [Nov. 21, 1997].”
p.001994: CONGRESSIONAL FINDINGS RELATING TO PUB. L. 103–417
p.001994: Section 2 of Pub. L. 103–417 provided that: “Congress finds that—
p.001994: “(1) improving the health status of United States citizens ranks at the top of the national
p.001994: priorities of the Federal Government;
p.001994: “(2) the importance of nutrition and the benefits of dietary supplements to health promotion
p.001994: and disease prevention have been documented increasingly in scientific studies;
p.001994: “(3)(A) there is a link between the ingestion of certain nutrients or dietary supplements and
p.001994: the prevention of chronic diseases such as cancer, heart disease, and osteoporosis; and
p.001994: “(B) clinical research has shown that several chronic diseases can be prevented simply with
p.001994: a healthful diet, such as a diet that is low in fat, saturated fat, cholesterol, and sodium, with a
p.001994: high proportion of plant-based foods;
p.001994: “(4) healthful diets may mitigate the need for expensive medical procedures, such as
p.001994: coronary bypass surgery or angioplasty;
p.001994: “(5) preventive health measures, including education, good nutrition, and appropriate use of
p.001994: safe nutritional supplements will limit the incidence of chronic diseases, and reduce long-term
p.001994: health care expenditures;
p.001994: “(6)(A) promotion of good health and healthy lifestyles improves and extends lives while
p.001994: reducing health care expenditures; and
p.001994: “(B) reduction in health care expenditures is of paramount importance to the future of the
p.001994: country and the economic well-being of the country;
p.001994: “(7) there is a growing need for emphasis on the dissemination of information linking
...

p.001994: nontraditional health care providers to avoid the excessive costs of traditional medical services
p.001994: and to obtain more holistic consideration of their needs;
p.001994: “(11) the United States will spend over $1,000,000,000,000 on health care in 1994, which is
p.001994: about 12 percent of the Gross National Product of the United States, and this amount and
p.001994: percentage will continue to increase unless significant efforts are undertaken to reverse the
p.001994: increase;
p.001994: “(12)(A) the nutritional supplement industry is an integral part of the economy of the United
p.001994: States;
p.001994: “(B) the industry consistently projects a positive trade balance; and
p.001994: “(C) the estimated 600 dietary supplement manufacturers in the United States produce
p.001994: approximately 4,000 products, with total annual sales of such products alone reaching at least
p.001994: $4,000,000,000;
p.001994: “(13) although the Federal Government should take swift action against products that are
p.001994: unsafe or adulterated, the Federal Government should not take any actions to impose
p.001994: unreasonable regulatory barriers limiting or slowing the flow of safe products and accurate
p.001994: information to consumers;
p.001994: “(14) dietary supplements are safe within a broad range of intake, and safety problems with
p.001994: the supplements are relatively rare; and
p.001994: “(15)(A) legislative action that protects the right of access of consumers to safe dietary
p.001994: supplements is necessary in order to promote wellness; and
p.001994: “(B) a rational Federal framework must be established to supersede the current ad hoc,
p.001994: patchwork regulatory policy on dietary supplements.”
p.001994: DISSEMINATION OF INFORMATION REGARDING THE DANGERS OF DRUG ABUSE
p.001994: Section 5 of Pub. L. 90–639 provided that: “It is the sense of the Congress that, because of the
p.001994: inadequate knowledge on the part of the people of the United States of the substantial adverse
p.001994: effects of misuse of depressant and stimulant drugs, and of other drugs liable to abuse, on the
p.001994: individual, his family, and the community, the highest priority should be given to Federal programs
p.001994: to disseminate information which may be used to educate the public, particularly young persons,
p.001994: regarding the dangers of drug abuse.”
p.001994: CONGRESSIONAL FINDINGS AND DECLARATION OF POLICY
p.001994: Section 2 of Pub. L. 89–74 provided that: “The Congress hereby finds and declares that there is
p.001994: a widespread illicit traffic in depressant and stimulant drugs moving in or otherwise affecting
p.001994: interstate commerce; that the use of such drugs, when not under the supervision of a licensed
p.001994: practitioner, often endangers safety on the highways (without distinction of interstate and
p.001994: intrastate traffic thereon) and otherwise has become a threat to the public health and safety,
p.001994: making additional regulation of such drugs necessary regardless of the intrastate or interstate
p.001994: origin of such drugs; that in order to make regulation and protection of interstate commerce in
p.001994: such drugs effective, regulation of intrastate commerce is also necessary because, among other
p.001994: things, such drugs, when held for illicit sale, often do not bear labeling showing their place of
p.001994: origin and because in the form in which they are so held or in which they are consumed a
p.001994: determination of their place of origin is often extremely difficult or impossible; and that regulation
p.001994: of interstate commerce without the regulation of intrastate commerce in such drugs, as provided
p.001994: in this Act [see Short Title of 1965 Amendment note set out under section 301 of this title], would
p.001994: discriminate against and adversely affect interstate commerce in such drugs.”
p.001994: EFFECT OF DRUG ABUSE CONTROL AMENDMENTS OF 1965 ON STATE LAWS
p.001994: Section 10 of Pub. L. 89–74 provided that:
p.001994: “(a) Nothing in this Act [enacting section 360a of this title, amending sections 321, 331, 333,
p.001994: 334, 360, and 372 of this title and section 1114 of Title 18, Crimes and Criminal Procedure, and
p.001994: enacting provisions set out as notes under sections 321, 352, and 360a of this title] shall be
p.001994: construed as authorizing the manufacture, compounding, processing, possession, sale, delivery,
p.001994: or other disposal of any drug in any State in contravention of the laws of such State.
p.001994: “(b) No provision of this Act nor any amendment made by it shall be construed as indicating an
p.001994: intent on the part of the Congress to occupy the field in which such provision or amendment
p.001994: operates to the exclusion of any State law on the same subject matter, unless there is a direct and
p.001994: positive conflict between such provision or amendment and such State law so that the two cannot
p.001994: be reconciled or consistently stand together.
p.001994: “(c) No amendment made by this Act shall be construed to prevent the enforcement in the
p.001994: courts of any State of any statute of such State prescribing any criminal penalty for any act made
p.001994: criminal by any such amendment.”
p.001994: EFFECT OF DRUG AMENDMENTS OF 1962 ON STATE LAWS
p.001994: Section 202 of Pub. L. 87–781 provided that: “Nothing in the amendments made by this Act
p.001994: [enacting sections 358 to 360, amending sections 321, 331, 332, 348, 351 to 353, 355, 357, 372,
p.001994: 374, 379e, and 381 of this title, and enacting provisions set out as notes under sections 321, 331,
p.001994: 332, 352, 355, 360, and 374 of this title] to the Federal Food, Drug, and Cosmetic Act [this
p.001994: chapter] shall be construed as invalidating any provision of State law which would be valid in the
p.001994: absence of such amendments unless there is a direct and positive conflict between such
p.001994: amendments and such provision of State law.”
p.001994: DEFINITIONS
p.001994: Section 2 of Pub. L. 105–115 provided that: “In this Act [see Short Title of 1997 Amendment
p.001994: note set out under section 301 of this title], the terms ‘drug’, ‘device’, ‘food’, and ‘dietary
p.001994: supplement’ have the meaning given such terms in section 201 of the Federal Food, Drug, and
p.001994: Cosmetic Act (21 U.S.C. 321).”
p.001994:
p.001994: 1 So in original. Probably should be paragraph “(v)”.
p.001994:
p.001994: 2 So in original. Provision probably should be set flush with subpar. (B).
p.001994:
p.001994:
p.001994:
p.001994: §321a. “Butter” defined
p.001994: For the purposes of the Food and Drug Act of June 30, 1906 (Thirty-fourth Statutes at
p.001994: Large, page 768) “butter” shall be understood to mean the food product usually known as
p.001994: butter, and which is made exclusively from milk or cream, or both, with or without common
p.001994: salt, and with or without additional coloring matter, and containing not less than 80 per
p.001994: centum by weight of milk fat, all tolerances having been allowed for.
p.001994: (Mar. 4, 1923, ch. 268, 42 Stat. 1500.)
p.001994: REFERENCES IN TEXT
p.001994: The Food and Drug Act of June 30, 1906, referred to in text, is act June 30, 1906, ch. 3915, 34
p.001994: Stat. 768, which was classified to subchapter I (§1 et seq.) of chapter 1 of this title, was repealed
p.001994: (except for section 14a which was transferred to section 376 of this title) by act June 25, 1938, ch.
p.001994: 675, §1002(a), formerly §902(a), 52 Stat. 1059; renumbered §1002(a), Pub. L. 111–31, div. A, title
p.001994: I, §101(b)(2), June 22, 2009, 123 Stat. 1784, and is covered by this chapter.
p.001994: CODIFICATION
p.001994: Section, which was not enacted as part of the Federal Food, Drug, and Cosmetic Act which
p.001994: comprises this chapter, was formerly classified to section 6 of this title. Section 1002(a) of act
p.001994: June 25, 1938, set out as an Effective Date note under section 301 of this title, provided that this
p.001994: section should remain in force and effect and be applicable to the provisions of this chapter.
p.001994:
p.001994:
p.001994: §321b. “Package” defined
p.001994: The word “package” where it occurs the second and last time in the act entitled “An act to
p.001994: amend section 8 of an act entitled, ‘An act for preventing the manufacture, sale, or
p.001994: transportation of adulterated or misbranded or poisonous deleterious foods, drugs,
p.001994: medicines, and liquors, and for regulating traffic therein, and for other purposes,’ ” approved
p.001994: March 3, 1913, shall include and shall be construed to include wrapped meats inclosed in
p.001994: papers or other materials as prepared by the manufacturers thereof for sale.
p.001994: (July 24, 1919, ch. 26, 41 Stat. 271.)
p.001994: REFERENCES IN TEXT
p.001994: An act approved March 3, 1913, referred to in text, is act Mar. 3, 1913, ch. 117, 37 Stat. 732,
p.001994: which amended section 10 of this title. For complete classification of this Act to the Code, see
p.001994: Tables.
p.001994: “An act for preventing the manufacture, sale, or transportation of adulterated or misbranded or
p.001994: poisonous deleterious foods, drugs, medicines, and liquors, and for regulating traffic therein, and
p.001994: for other purposes”, referred to in text, is act June 30, 1906, ch. 3915, 34 Stat. 768, which was
p.001994: classified to subchapter I (§1 et seq.) of chapter 1 of this title, was repealed (except for section
p.001994: 14a which was transferred to section 376 of this title) by act June 25, 1938, ch. 675, §1002(a),
p.001994: formerly §902(a), 52 Stat. 1059; renumbered §1002(a), Pub. L. 111–31, div. A, title I, §101(b)(2),
p.001994: June 22, 2009, 123 Stat. 1784, and is covered by this chapter.
p.001994: CODIFICATION
p.001994: Section, which was not enacted as part of the Federal Food, Drug, and Cosmetic Act which
p.001994: comprises this chapter, was formerly classified to the last sentence of paragraph third of section
p.001994: 10 of this title. Section 1002(a) of act June 25, 1938, set out as an Effective Date note under
p.001994: section 301 of this title, provided that this section should remain in force and effect and be
p.001994: applicable to the provisions of this chapter.
p.001994:
p.001994:
p.001994: §321c. Nonfat dry milk; “milk” defined
p.001994: For the purposes of the Federal Food, Drug, and Cosmetic Act of June 26, 1938, (ch.
p.001994: 675, sec. 1, 52 Stat. 1040) [21 U.S.C. 301 et seq.] nonfat dry milk is the product resulting
p.001994: from the removal of fat and water from milk, and contains the lactose, milk proteins, and
p.001994: milk minerals in the same relative proportions as in the fresh milk from which made. It
p.001994: contains not over 5 per centum by weight of moisture. The fat content is not over 1½ per
p.001994: centum by weight unless otherwise indicated.
p.001994: The term “milk”, when used herein, means sweet milk of cows.
p.001994: (Mar. 2, 1944, ch. 77, 58 Stat. 108; July 2, 1956, ch. 495, 70 Stat. 486.)
p.001994: REFERENCES IN TEXT
p.001994: The Federal Food, Drug, and Cosmetic Act of June 26, 1938 (ch. 675, sec. 1, 52 Stat. 1040),
p.001994: referred to in text, probably means act June 25, 1938, ch. 675, 52 Stat. 1040, as amended, which
p.001994: is classified generally to this chapter (§301 et seq.). For complete classification of this Act to the
p.001994: Code, see section 301 of this title and Tables.
p.001994: CODIFICATION
p.001994: Section was not enacted as a part of the Federal Food, Drug, and Cosmetic Act which
p.001994: comprises this chapter, but was made applicable thereto.
p.001994: AMENDMENTS
p.001994: 1956—Act July 2, 1956, substituted “nonfat dry milk” for “nonfat dry milk solids or defatted milk
p.001994: solids”.
p.001994:
p.001994:
p.001994: §321d. Market names for catfish and ginseng
p.001994: (a) Catfish labeling
p.001994: (1) In general
p.001994: Notwithstanding any other provision of law, for purposes of the Federal Food, Drug,
p.001994: and Cosmetic Act (21 U.S.C. 301 et seq.)—
p.001994: (A) the term “catfish” may only be considered to be a common or usual name (or part
p.001994: thereof) for fish classified within the family Ictaluridae; and
p.001994: (B) only labeling or advertising for fish classified within that family may include the
p.001994: term “catfish”.
p.001994: (2) Omitted
p.001994: (b) Ginseng labeling
p.001994: (1) In general
p.001994: Notwithstanding any other provision of law, for purposes of the Federal Food, Drug,
p.001994: and Cosmetic Act (21 U.S.C. 301 et seq.)—
p.001994: (A) the term “ginseng” may only be considered to be a common or usual name (or
p.001994: part thereof) for any herb or herbal ingredient derived from a plant classified within the
p.001994: genus Panax; and
p.001994: (B) only labeling or advertising for herbs or herbal ingredients classified within that
p.001994: genus may include the term “ginseng”.
p.001994: (2) Omitted
p.001994: (Pub. L. 107–171, title X, §10806, May 13, 2002, 116 Stat. 526.)
p.001994: REFERENCES IN TEXT
p.001994: The Federal Food, Drug, and Cosmetic Act, referred to in subsecs. (a)(1), (b)(1), is act June 25,
p.001994: 1938, ch. 675, 52 Stat. 1040, as amended, which is classified generally to this chapter. For
p.001994: complete classification of this Act to the Code, see section 301 of this title and Tables.
p.001994: CODIFICATION
p.001994: Section is comprised of section 10806 of Pub. L. 107–171. Subsecs. (a)(2) and (b)(2) of section
p.001994: 10806 of Pub. L. 107–171 amended section 343 of this title.
p.001994: Section was enacted as part of the Farm Security and Rural Investment Act of 2002, and not as
p.001994: part of Federal Food, Drug, and Cosmetic Act which comprises this chapter.
p.001994:
p.001994:
p.001994:
p.001994: SUBCHAPTER III—PROHIBITED ACTS AND PENALTIES
p.001994:
p.001994:
p.001994: §331. Prohibited acts
p.001994: The following acts and the causing thereof are prohibited:
p.001994: (a) The introduction or delivery for introduction into interstate commerce of any food,
p.001994: drug, device, tobacco product, or cosmetic that is adulterated or misbranded.
p.001994: (b) The adulteration or misbranding of any food, drug, device, tobacco product, or
p.001994: cosmetic in interstate commerce.
p.001994: (c) The receipt in interstate commerce of any food, drug, device, tobacco product, or
p.001994: cosmetic that is adulterated or misbranded, and the delivery or proffered delivery thereof for
p.001994: pay or otherwise.
p.001994: (d) The introduction or delivery for introduction into interstate commerce of any article in
p.001994: violation of section 344, 350d, 355, or 360bbb–3 of this title.
p.001994: (e) The refusal to permit access to or copying of any record as required by section 350a,
p.001994: 350c, 350f(j), 350e, 354, 360bbb–3, 373, 374(a), 379aa, or 379aa–1 of this title; or the
p.001994: failure to establish or maintain any record, or make any report, required under section 350a,
p.001994: 350c(b), 350f, 350e, 354, 355(i) or (k), 360b(a)(4)(C), 360b(j), (l) or (m), 360ccc–1(i),
p.001994: 360e(f), 360i, 360bbb–3, 379aa, 379aa–1, 387i, or 387t of this title or the refusal to permit
p.001994: access to or verification or copying of any such required record; or the violation of any
p.001994: recordkeeping requirement under section 2223 1 of this title (except when such violation is
p.001994: committed by a farm).
p.001994: (f) The refusal to permit entry or inspection as authorized by section 374 of this title.
p.001994: (g) The manufacture within any Territory of any food, drug, device, tobacco product, or
p.001994: cosmetic that is adulterated or misbranded.
p.001994: (h) The giving of a guaranty or undertaking referred to in section 333(c)(2) of this title,
p.001994: which guaranty or undertaking is false, except by a person who relied upon a guaranty or
p.001994: undertaking to the same effect signed by, and containing the name and address of, the
p.001994: person residing in the United States from whom he received in good faith the food, drug,
p.001994: device, tobacco product, or cosmetic; or the giving of a guaranty or undertaking referred to
p.001994: in section 333(c)(3) of this title, which guaranty or undertaking is false.
p.001994: (i)(1) Forging, counterfeiting, simulating, or falsely representing, or without proper
p.001994: authority using any mark, stamp, tag, label, or other identification device authorized or
p.001994: required by regulations promulgated under the provisions of section 344 or 379e of this title.
p.001994: (2) Making, selling, disposing of, or keeping in possession, control, or custody, or
p.001994: concealing any punch, die, plate, stone, or other thing designed to print, imprint, or
p.001994: reproduce the trademark, trade name, or other identifying mark, imprint, or device of
p.001994: another or any likeness of any of the foregoing upon any drug or container or labeling
p.001994: thereof so as to render such drug a counterfeit drug.
p.001994: (3) The doing of any act which causes a drug to be a counterfeit drug, or the sale or
p.001994: dispensing, or the holding for sale or dispensing, of a counterfeit drug.
p.001994: (j) The using by any person to his own advantage, or revealing, other than to the
p.001994: Secretary or officers or employees of the Department, or to the courts when relevant in any
p.001994: judicial proceeding under this chapter, any information acquired under authority of section
p.001994: 344, 348, 350a, 350c, 355, 360, 360b, 360c, 360d, 360e, 360f, 360h, 360i, 360j, 360ccc,
p.001994: 360ccc–1, 360ccc–2, 374, 379, 379e, 387d, 387e, 387f, 387g, 387h, 387i, or 387t(b) of this
p.001994: title concerning any method or process which as a trade secret is entitled to protection; or
p.001994: the violating of section 346a(i)(2) of this title or any regulation issued under that section..2
p.001994: This paragraph does not authorize the withholding of information from either House of
p.001994: Congress or from, to the extent of matter within its jurisdiction, any committee or
p.001994: subcommittee of such committee or any joint committee of Congress or any subcommittee
p.001994: of such joint committee.
p.001994: (k) The alteration, mutilation, destruction, obliteration, or removal of the whole or any part
p.001994: of the labeling of, or the doing of any other act with respect to, a food, drug, device, tobacco
p.001994: product, or cosmetic, if such act is done while such article is held for sale (whether or not
p.001994: the first sale) after shipment in interstate commerce and results in such article being
p.001994: adulterated or misbranded.
p.001994: (l) Repealed. Pub. L. 105–115, title IV, §421, Nov. 21, 1997, 111 Stat. 2380.
p.001994: (m) The sale or offering for sale of colored oleomargarine or colored margarine, or the
p.001994: possession or serving of colored oleomargarine or colored margarine in violation of
p.001994: subsections (b) or (c) of section 347 of this title.
p.001994: (n) The using, in labeling, advertising or other sales promotion of any reference to any
p.001994: report or analysis furnished in compliance with section 374 of this title.
p.001994: (o) In the case of a prescription drug distributed or offered for sale in interstate commerce,
p.001994: the failure of the manufacturer, packer, or distributor thereof to maintain for transmittal, or to
p.001994: transmit, to any practitioner licensed by applicable State law to administer such drug who
p.001994: makes written request for information as to such drug, true and correct copies of all printed
p.001994: matter which is required to be included in any package in which that drug is distributed or
p.001994: sold, or such other printed matter as is approved by the Secretary. Nothing in this
p.001994: paragraph shall be construed to exempt any person from any labeling requirement imposed
p.001994: by or under other provisions of this chapter.
p.001994: (p) The failure to register in accordance with section 360 or 387e of this title, the failure to
p.001994: provide any information required by section 360(j), 360(k), 387e(i), or 387e(j) of this title, or
p.001994: the failure to provide a notice required by section 360(j)(2) or 387e(i)(3) of this title.
p.001994: (q)(1) The failure or refusal—
p.001994: (A) to comply with any requirement prescribed under section 360h, 360j(g), 387c(b),
p.001994: 387g, 387h, or 387o of this title;
p.001994: (B) to furnish any notification or other material or information required by or under
p.001994: section 360i, 360j(g), 387d, 387i, or 387t of this title; or
p.001994: (C) to comply with a requirement under section 360l or 387m of this title.
p.001994:
p.001994: (2) With respect to any device or tobacco product, the submission of any report that is
p.001994: required by or under this chapter that is false or misleading in any material respect.
p.001994: (r) The movement of a device or tobacco product in violation of an order under section
p.001994: 334(g) of this title or the removal or alteration of any mark or label required by the order to
p.001994: identify the device or tobacco product as detained.
p.001994: (s) The failure to provide the notice required by section 350a(c) or 350a(e) of this title, the
p.001994: failure to make the reports required by section 350a(f)(1)(B) of this title, the failure to retain
p.001994: the records required by section 350a(b)(4) of this title, or the failure to meet the
p.001994: requirements prescribed under section 350a(f)(3) of this title.
p.001994: (t) The importation of a drug in violation of section 381(d)(1) of this title, the sale,
p.001994: purchase, or trade of a drug or drug sample or the offer to sell, purchase, or trade a drug or
p.001994: drug sample in violation of section 353(c) of this title, the sale, purchase, or trade of a
p.001994: coupon, the offer to sell, purchase, or trade such a coupon, or the counterfeiting of such a
p.001994: coupon in violation of section 353(c)(2) of this title, the distribution of a drug sample in
p.001994: violation of section 353(d) of this title or the failure to otherwise comply with the
p.001994: requirements of section 353(d) of this title, or the distribution of drugs in violation of section
p.001994: 353(e) of this title or the failure to otherwise comply with the requirements of section 353(e)
p.001994: of this title.
p.001994: (u) The failure to comply with any requirements of the provisions of, or any regulations or
p.001994: orders of the Secretary, under section 360b(a)(4)(A), 360b(a)(4)(D), or 360b(a)(5) of this
p.001994: title.
p.001994: (v) The introduction or delivery for introduction into interstate commerce of a dietary
p.001994: supplement that is unsafe under section 350b of this title.
p.001994: (w) The making of a knowingly false statement in any statement, certificate of analysis,
p.001994: record, or report required or requested under section 381(d)(3) of this title; the failure to
p.001994: submit a certificate of analysis as required under such section; the failure to maintain
p.001994: records or to submit records or reports as required by such section; the release into
p.001994: interstate commerce of any article or portion thereof imported into the United States under
p.001994: such section or any finished product made from such article or portion, except for export in
p.001994: accordance with section 381(e) or 382 of this title, or with section 262(h) of title 42; or the
p.001994: failure to so export or to destroy such an article or portions thereof, or such a finished
p.001994: product.
p.001994: (x) The falsification of a declaration of conformity submitted under section 360d(c) of this
p.001994: title or the failure or refusal to provide data or information requested by the Secretary under
p.001994: paragraph (3) of such section.
p.001994: (y) In the case of a drug, device, or food—
p.001994: (1) the submission of a report or recommendation by a person accredited under section
p.001994: 360m of this title that is false or misleading in any material respect;
p.001994: (2) the disclosure by a person accredited under section 360m of this title of confidential
p.001994: commercial information or any trade secret without the express written consent of the
p.001994: person who submitted such information or secret to such person; or
p.001994: (3) the receipt by a person accredited under section 360m of this title of a bribe in any
p.001994: form or the doing of any corrupt act by such person associated with a responsibility
p.001994: delegated to such person under this chapter.
p.001994:
p.001994: (z) Omitted.
p.001994: (aa) The importation of a prescription drug in violation of section 384 of this title, the
p.001994: falsification of any record required to be maintained or provided to the Secretary under such
p.001994: section, or any other violation of regulations under such section.
p.001994: (bb) The transfer of an article of food in violation of an order under section 334(h) of this
p.001994: title, or the removal or alteration of any mark or label required by the order to identify the
p.001994: article as detained.
p.001994: (cc) The importing or offering for import into the United States of an article of food by,
p.001994: with the assistance of, or at the direction of, a person debarred under section 335a(b)(3) of
p.001994: this title.
p.001994: (dd) The failure to register in accordance with section 350d of this title.
p.001994: (ee) The importing or offering for import into the United States of an article of food in
p.001994: violation of the requirements under section 381(m) of this title.
p.001994: (ff) The importing or offering for import into the United States of a drug or device with
p.001994: respect to which there is a failure to comply with a request of the Secretary to submit to the
p.001994: Secretary a statement under section 381(o) of this title.
p.001994: (gg) The knowing failure to comply with paragraph (7)(E) of section 374(g) of this title; the
p.001994: knowing inclusion by a person accredited under paragraph (2) of such section of false
p.001994: information in an inspection report under paragraph (7)(A) of such section; or the knowing
p.001994: failure of such a person to include material facts in such a report.
p.001994: (hh) The failure by a shipper, carrier by motor vehicle or rail vehicle, receiver, or any other
p.001994: person engaged in the transportation of food to comply with the sanitary transportation
p.001994: practices prescribed by the Secretary under section 350e of this title.
p.001994: (ii) The falsification of a report of a serious adverse event submitted to a responsible
p.001994: person (as defined under section 379aa or 379aa–1 of this title) or the falsification of a
p.001994: serious adverse event report (as defined under section 379aa or 379aa–1 of this title)
p.001994: submitted to the Secretary.
p.001994: (jj)(1) The failure to submit the certification required by section 282(j)(5)(B) of title 42, or
p.001994: knowingly submitting a false certification under such section.
p.001994: (2) The failure to submit clinical trial information required under subsection (j) of section
p.001994: 282 of title 42.
p.001994: (3) The submission of clinical trial information under subsection (j) of section 282 of title
p.001994: 42 that is false or misleading in any particular under paragraph (5)(D) of such subsection (j).
p.001994: (kk) The dissemination of a television advertisement without complying with section 353b
p.001994: of this title.
p.001994: (ll) The introduction or delivery for introduction into interstate commerce of any food to
p.001994: which has been added a drug approved under section 355 of this title, a biological product
p.001994: licensed under section 262 of title 42, or a drug or a biological product for which substantial
p.001994: clinical investigations have been instituted and for which the existence of such
p.001994: investigations has been made public, unless—
p.001994: (1) such drug or such biological product was marketed in food before any approval of
p.001994: the drug under section 355 of this title, before licensure of the biological product under
p.001994: such section 262 of title 42, and before any substantial clinical investigations involving the
p.001994: drug or the biological product have been instituted;
p.001994: (2) the Secretary, in the Secretary's discretion, has issued a regulation, after notice and
p.001994: comment, approving the use of such drug or such biological product in the food;
p.001994: (3) the use of the drug or the biological product in the food is to enhance the safety of
p.001994: the food to which the drug or the biological product is added or applied and not to have
p.001994: independent biological or therapeutic effects on humans, and the use is in conformity with
p.001994: —
p.001994: (A) a regulation issued under section 348 of this title prescribing conditions of safe
p.001994: use in food;
p.001994: (B) a regulation listing or affirming conditions under which the use of the drug or the
p.001994: biological product in food is generally recognized as safe;
p.001994: (C) the conditions of use identified in a notification to the Secretary of a claim of
p.001994: exemption from the premarket approval requirements for food additives based on the
p.001994: notifier's determination that the use of the drug or the biological product in food is
p.001994: generally recognized as safe, provided that the Secretary has not questioned the
p.001994: general recognition of safety determination in a letter to the notifier;
p.001994: (D) a food contact substance notification that is effective under section 348(h) of this
p.001994: title; or
p.001994: (E) such drug or biological product had been marketed for smoking cessation prior to
p.001994: September 27, 2007; or
p.001994:
p.001994: (4) the drug is a new animal drug whose use is not unsafe under section 360b of this
p.001994: title.
p.001994:
p.001994: (mm) The failure to submit a report or provide a notification required under section 350f(d)
p.001994: of this title.
p.001994: (nn) The falsification of a report or notification required under section 350f(d) of this title.
p.001994: (oo) The sale of tobacco products in violation of a no-tobacco-sale order issued under
p.001994: section 333(f) of this title.
p.001994: (pp) The introduction or delivery for introduction into interstate commerce of a tobacco
p.001994: product in violation of section 387k of this title.
p.001994: (qq)(1) Forging, counterfeiting, simulating, or falsely representing, or without proper
p.001994: authority using any mark, stamp (including tax stamp), tag, label, or other identification
p.001994: device upon any tobacco product or container or labeling thereof so as to render such
p.001994: tobacco product a counterfeit tobacco product.
p.001994: (2) Making, selling, disposing of, or keeping in possession, control, or custody, or
p.001994: concealing any punch, die, plate, stone, or other item that is designed to print, imprint, or
p.001994: reproduce the trademark, trade name, or other identifying mark, imprint, or device of
p.001994: another or any likeness of any of the foregoing upon any tobacco product or container or
p.001994: labeling thereof so as to render such tobacco product a counterfeit tobacco product.
p.001994: (3) The doing of any act that causes a tobacco product to be a counterfeit tobacco
p.001994: product, or the sale or dispensing, or the holding for sale or dispensing, of a counterfeit
p.001994: tobacco product.
p.001994: (rr) The charitable distribution of tobacco products.
p.001994: (ss) The failure of a manufacturer or distributor to notify the Attorney General and the
p.001994: Secretary of the Treasury of their knowledge of tobacco products used in illicit trade.
p.001994: (tt) Making any express or implied statement or representation directed to consumers
p.001994: with respect to a tobacco product, in a label or labeling or through the media or advertising,
p.001994: that either conveys, or misleads or would mislead consumers into believing, that—
p.001994: (1) the product is approved by the Food and Drug Administration;
p.001994: (2) the Food and Drug Administration deems the product to be safe for use by
p.001994: consumers;
p.001994: (3) the product is endorsed by the Food and Drug Administration for use by consumers;
p.001994: or
p.001994: (4) the product is safe or less harmful by virtue of—
p.001994: (A) its regulation or inspection by the Food and Drug Administration; or
p.001994: (B) its compliance with regulatory requirements set by the Food and Drug
p.001994: Administration;
p.001994:
p.001994: including any such statement or representation rendering the product misbranded under
p.001994: section 387c of this title.
p.001994: (uu) The operation of a facility that manufactures, processes, packs, or holds food for
p.001994: sale in the United States if the owner, operator, or agent in charge of such facility is not in
p.001994: compliance with section 350g of this title.
p.001994: (vv) The failure to comply with the requirements under section 350h of this title.
p.001994: (ww) The failure to comply with section 350i of this title.
p.001994: (xx) The refusal or failure to follow an order under section 350l of this title.
p.001994: (yy) The knowing and willful failure to comply with the notification requirement under
p.001994: section 350f(h) of this title.
p.001994: (zz) The importation or offering for importation of a food if the importer (as defined in
p.001994: section 384a of this title) does not have in place a foreign supplier verification program in
p.001994: compliance with such section 384a of this title.
p.001994: (June 25, 1938, ch. 675, §301, 52 Stat. 1042; Dec. 22, 1941, ch. 613, §1, 55 Stat. 851; July
p.001994: 6, 1945, ch. 281, §1, 59 Stat. 463; Mar. 10, 1947, ch. 16, §1, 61 Stat. 11; June 24, 1948, ch.
p.001994: 613, §1, 62 Stat. 582; Mar. 16, 1950, ch. 61, §3(b), 64 Stat. 20; Aug. 7, 1953, ch. 350, §2,
p.001994: 67 Stat. 477; Pub. L. 85–929, §5, Sept. 6, 1958, 72 Stat. 1788; Pub. L. 86–618, title I,
p.001994: §§104, 105(a), July 12, 1960, 74 Stat. 403; Pub. L. 87–781, title I, §§103(c), 104(e)(1),
p.001994: 106(c), 114(a), title III, §304, Oct. 10, 1962, 76 Stat. 784, 785, 788, 791, 795; Pub. L. 89–
p.001994: 74, §§5, 9(c), July 15, 1965, 79 Stat. 232, 235; Pub. L. 90–399, §103, July 13, 1968, 82
p.001994: Stat. 352; Pub. L. 90–639, §2(b), Oct. 24, 1968, 82 Stat. 1361; Pub. L. 91–513, title II,
...

p.001994: 2006—Par. (e). Pub. L. 109–462, §3(b), substituted “374(a), 379aa, or 379aa–1” for “374(a), or
p.001994: 379aa” and “360bbb–3, 379aa, or 379aa–1” for “360bbb–3, or 379aa”.
p.001994: Pub. L. 109–462, §2(c), substituted “, 374(a), or 379aa” for “, or 374(a)” and “, 360bbb–3, or
p.001994: 379aa” for “, or 360bbb–3”.
p.001994: Par. (ii). Pub. L. 109–462, §4(a), added par. (ii).
p.001994: 2005—Par. (e). Pub. L. 109–59, §7202(d), inserted “350e,” before “354,” in two places.
p.001994: Par. (hh). Pub. L. 109–59, §7202(e), added par. (hh).
p.001994: 2004—Par. (e). Pub. L. 108–282, §102(b)(5)(C), which directed the substitution of “360b(a)(4)
p.001994: (C), 360b (j), (l) or (m), 360ccc–1(i).” for “360b(a)(4)(C), 360b(j), (l) or (m)” was executed by
p.001994: making the substitution for “360b(a)(4)(C), 360b(j), (l), or (m)”, to reflect the probable intent of
p.001994: Congress.
p.001994: Par. (j). Pub. L. 108–282, §102(b)(5)(D), substituted “360j, 360ccc, 360ccc–1, 360ccc–2.” for
p.001994: “360j”.
p.001994: Par. (gg). Pub. L. 108–214 amended par. (gg) generally. Prior to amendment, text read as
p.001994: follows: “The knowing failure of a person accredited under paragraph (2) of section 374(g) of this
p.001994: title to comply with paragraph (7)(E) of such section; the knowing inclusion by such a person of
p.001994: false information in an inspection report under paragraph (7)(A) of such section; or the knowing
p.001994: failure of such a person to include material facts in such a report.”
p.001994: 2003—Par. (d). Pub. L. 108–136 substituted “section 344, 355, or 360bbb–3” for “section 344 or
p.001994: 355”.
p.001994: Par. (e). Pub. L. 108–136 inserted “360bbb–3,” after “350c, 354,” and substituted “360i, or
p.001994: 360bbb–3” for “or 360i”.
p.001994: Par. (aa). Pub. L. 108–173 substituted “prescription drug in violation of section 384” for “covered
p.001994: product in violation of section 384”.
p.001994: 2002—Par. (e). Pub. L. 107–188, §306(c)(1), substituted “by section 350a, 350c, 354, 373, or
p.001994: 374(a) of this title” for “by section 350a, 354, or 373 of this title” and “under section 350a, 350c(b)”
p.001994: for “under section 350a”.
p.001994: Par. (j). Pub. L. 107–188, §306(c)(2), inserted “350c,” after “350a,”.
p.001994: Par. (w). Pub. L. 107–188, §322(b), amended par. (w) generally. Prior to amendment, par. (w)
p.001994: read as follows: “The making of a knowingly false statement in any record or report required or
p.001994: requested under subparagraph (A) or (B) of section 381(d)(3) of this title, the failure to submit or
p.001994: maintain records as required by sections 381(d)(3)(A) and 381(d)(3)(B) of this title, the release into
p.001994: interstate commerce of any article imported into the United States under section 381(d)(3) of this
p.001994: title or any finished product made from such article (except for export in accordance with section
p.001994: 381(e) or 382 of this title or section 262(h) of title 42), or the failure to export or destroy any
p.001994: component, part or accessory not incorporated into a drug, biological product or device that will be
p.001994: exported in accordance with section 381(e) or 382 of this title or section 262(h) of title 42.”
p.001994: Par. (bb). Pub. L. 107–188, §303(b), added par. (bb).
p.001994: Par. (cc). Pub. L. 107–188, §304(d), added par. (cc).
p.001994: Par. (dd). Pub. L. 107–188, §305(b), added par. (dd).
p.001994: Par. (ee). Pub. L. 107–188, §307(b), added par. (ee).
p.001994: Par. (ff). Pub. L. 107–188, §321(b)(2), added par. (ff).
p.001994: Par. (gg). Pub. L. 107–250 added par. (gg).
p.001994: 2000—Par. (aa). Pub. L. 106–387 added par. (aa).
p.001994: 1997—Par. (e). Pub. L. 105–115, §125(b)(2)(B), struck out “357(d) or (g),” after “355(i) or (k),”.
p.001994: Par. (i)(1). Pub. L. 105–115, §125(a)(2)(C), struck out “, 356, 357,” before “or 379e of this title”.
p.001994: Par. (j). Pub. L. 105–115, §125(a)(2)(A), struck out “356, 357,” before “360,”.
p.001994: Par. (l). Pub. L. 105–115, §421, struck out par. (l) which read as follows: “The using, on the
p.001994: labeling of any drug or device or in any advertising relating to such drug or device, of any
p.001994: representation or suggestion that approval of an application with respect to such drug or device is
p.001994: in effect under section 355, 360e, or 360j(g) of this title, as the case may be, or that such drug or
p.001994: device complies with the provisions of such section.”
p.001994: Par. (x). Pub. L. 105–115, §204(b), added par. (x).
p.001994: Par. (y). Pub. L. 105–115, §210(c), added par. (y).
p.001994: Par. (z). Pub. L. 105–115, §401(b), temporarily added par. (z) which related to dissemination of
p.001994: information in violation of section 360aaa of this title. See Effective and Termination Dates of 1997
p.001994: Amendment note below.
p.001994: 1996—Par. (e). Pub. L. 104–250 inserted “, 354,” before “or 373 of this title” and “354,” before
p.001994: “355(i) or (k)”.
p.001994: Par. (j). Pub. L. 104–170 inserted before period at end of first sentence “; or the violating of
p.001994: section 346a(i)(2) of this title or any regulation issued under that section.”
p.001994: Pars. (u) to (w). Pub. L. 104–134 redesignated par. (u) relating to introduction into interstate
p.001994: commerce of unsafe dietary supplement as (v) and added par. (w).
p.001994: 1994—Par. (e). Pub. L. 103–396, §2(b)(1)(A), substituted “357(d) or (g), 360b(a)(4)(C),” for
p.001994: “357(d) or (g),”.
p.001994: Par. (u). Pub. L. 103–417 added par. (u) relating to introduction into interstate commerce of
p.001994: unsafe dietary supplement.
p.001994: Pub. L. 103–396, §2(b)(1)(B), added par. (u) relating to failure to comply with regulations or
p.001994: orders of Secretary.
p.001994: 1993—Par. (j). Pub. L. 103–80, §3(c)(1), substituted “379, or 379e” for “379e, or 379”.
p.001994: Par. (s). Pub. L. 103–80, §3(c)(2), substituted “350a(e)” for “350a(d)”.
p.001994: 1992—Pars. (i)(1), (j). Pub. L. 102–571 substituted “379e” for “376”.
p.001994: Par. (q)(1)(C). Pub. L. 102–300 added cl. (C).
p.001994: 1990—Par. (e). Pub. L. 101–502 substituted “or (k)” for “or (j)”.
p.001994: Par. (j). Pub. L. 101–508 inserted at end “This paragraph does not authorize the withholding of
p.001994: information from either House of Congress or from, to the extent of matter within its jurisdiction,
p.001994: any committee or subcommittee of such committee or any joint committee of Congress or any
p.001994: subcommittee of such joint committee.”
p.001994: 1988—Par. (t). Pub. L. 100–293 added par. (t).
p.001994: 1986—Par. (s). Pub. L. 99–570 amended par. (s) generally. Prior to amendment, par. (s) read
p.001994: as follows: “The failure to provide the notice required by section 350a(b) or 350a(c), the failure to
p.001994: make the reports required by section 350a(d)(1)(B), or the failure to meet the requirements
p.001994: prescribed under section 350a(d)(2).”
p.001994: 1980—Par. (e). Pub. L. 96–359, §5(b), inserted reference to section 350a of this title in two
p.001994: places.
p.001994: Par. (j). Pub. L. 96–359, §5(c), inserted reference to section 350a of this title.
p.001994: Par. (s). Pub. L. 96–359, §5(a), added par. (s).
p.001994: 1976—Par. (e). Pub. L. 94–295, §3(b)(2), inserted references to sections 360e(f) and 360i of
p.001994: this title.
p.001994: Par. (j). Pub. L. 94–295, §3(b)(3), inserted references to sections 360, 360c, 360d, 360e, 360f,
p.001994: 360h, 360i, 360j, and 379 of this title.
p.001994: Par. (l). Pub. L. 94–295, §3(b)(4), substituted “drug or device” for “drug” wherever appearing,
p.001994: and inserted references to sections 360e and 360j(g) of this title.
p.001994: Par. (p). Pub. L. 94–295, §4(b)(1), substituted “section 360(j) or 360(k) of this title,” for “section
p.001994: 360(j) of this title,”.
p.001994: Par. (q). Pub. L. 94–295, §3(b)(1), added par. (q).
p.001994: Par. (r). Pub. L. 94–295, §7(b), added par. (r).
p.001994: 1972—Par. (p). Pub. L. 92–387 added failure to provide information required by section 360(j)
p.001994: of this title, and failure to provide notice required by section 360(j)(2) of this title as prohibited acts.
p.001994: 1970—Par. (q). Pub. L. 91–513 struck out par. (q) which set out penalties for illegal
p.001994: manufacture, sale, disposition, possession and other traffic in stimulant and depressant drugs.
p.001994: See section 801 et seq. of this title.
p.001994: 1968—Par. (e). Pub. L. 90–399, §103(1), struck out “or” before “357(d) or (g)” and inserted “, or
p.001994: 360b(j), (l), or (m)” after “357(d) or (g)”. Amendment striking out “or” was executed as described,
p.001994: notwithstanding directory language that “or” before “357,” be stricken out, to reflect the probable
p.001994: intent of Congress.
p.001994: Par. (j). Pub. L. 90–399, §103(2), inserted reference to section 360b of this title.
p.001994: Par. (q). Pub. L. 90–639 divided cl. (3), which referred simply to possession in violation of
p.001994: section 360a(c) of this title, into subcls. (A) and (B) which refer, respectively, to possession in
p.001994: violation of section 360a(c)(1) of this title and possession in violation of section 360a(c)(2) of this
p.001994: title.
p.001994: 1965—Par. (i). Pub. L. 89–74, §9(c), designated existing provisions as subpar. (1) and added
p.001994: subpars. (2) and (3).
p.001994: Par. (q). Pub. L. 89–74, §5, added par. (q).
...

p.001994: EFFECTIVE DATE OF 2011 AMENDMENT
p.001994: Amendment by section 103(e) of Pub. L. 111–353 effective 18 months after Jan. 4, 2011, and
p.001994: applicable to a small business (as defined in the regulations promulgated under section 350g(n) of
p.001994: this title) beginning on the date that is 6 months after the effective date of such regulations and to
p.001994: a very small business (as defined in such regulations) beginning on the date that is 18 months
p.001994: after the effective date of such regulations, see section 103(i) of Pub. L. 111–353, set out as an
p.001994: Effective Date note under section 350g of this title.
p.001994: Pub. L. 111–353, title III, §301(d), Jan. 4, 2011, 124 Stat. 3955, provided that: “The
p.001994: amendments made by this section [enacting section 384a of this title and amending this section
p.001994: and section 381 of this title] shall take effect 2 years after the date of enactment of this Act [Jan. 4,
p.001994: 2011].”
p.001994: EFFECTIVE DATE OF 2007 AMENDMENT
p.001994: Pub. L. 110–85, title IX, §909, Sept. 27, 2007, 121 Stat. 950, provided that:
p.001994: “(a) EFFECTIVE DATE.—This subtitle [subtitle A (§§901–909) of title IX of Pub. L. 110–85, enacting
p.001994: sections 353b and 355–1 of this title, amending this section, sections 333, 352, and 355 of this
p.001994: title, and section 262 of Title 42, The Public Health and Welfare, and enacting provisions set out
p.001994: as notes under sections 352, 355, and 355a of this title] takes effect 180 days after the date of the
p.001994: enactment of this Act [Sept. 27, 2007].
p.001994: “(b) DRUGS DEEMED TO HAVE RISK EVALUATION AND MITIGATION STRATEGIES.—
p.001994: “(1) IN GENERAL.—A drug that was approved before the effective date of this Act [probably
p.001994: means “this subtitle”, see above] is, in accordance with paragraph (2), deemed to have in effect
p.001994: an approved risk evaluation and mitigation strategy under section 505–1 of the Federal Food,
p.001994: Drug, and Cosmetic Act [21 U.S.C. 355–1] (as added by section 901) (referred to in this section
p.001994: as the ‘Act’) if there are in effect on the effective date of this Act elements to assure safe use—
p.001994: “(A) required under section 314.520 or section 601.42 of title 21, Code of Federal
p.001994: Regulations; or
p.001994: “(B) otherwise agreed to by the applicant and the Secretary for such drug.
p.001994: “(2) ELEMENTS OF STRATEGY; ENFORCEMENT.—The approved risk evaluation and mitigation
p.001994: strategy in effect for a drug under paragraph (1)—
p.001994: “(A) is deemed to consist of the timetable required under section 505–1(d) and any
p.001994: additional elements under subsections (e) and (f) of such section in effect for such drug on
p.001994: the effective date of this Act; and
p.001994: “(B) is subject to enforcement by the Secretary to the same extent as any other risk
p.001994: evaluation and mitigation strategy under section 505–1 of the Act, except that sections 303(f)
p.001994: (4) and 502(y) and (z) of the Act [21 U.S.C. 333(f)(4), 352(y), (z)] (as added by section 902)
p.001994: shall not apply to such strategy before the Secretary has completed review of, and acted on,
p.001994: the first assessment of such strategy under such section 505–1.
p.001994: “(3) SUBMISSION.—Not later than 180 days after the effective date of this Act, the holder of an
p.001994: approved application for which a risk evaluation and mitigation strategy is deemed to be in effect
p.001994: under paragraph (1) shall submit to the Secretary a proposed risk evaluation and mitigation
p.001994: strategy. Such proposed strategy is subject to section 505–1 of the Act as if included in such
p.001994: application at the time of submission of the application to the Secretary.”
p.001994: EFFECTIVE DATE OF 2006 AMENDMENT
p.001994: Amendment by section 2(c) of Pub. L. 109–462 effective 1 year after Dec. 22, 2006, see section
p.001994: 2(e)(1) of Pub. L. 109–462, set out as a note under section 352 of this title.
p.001994: Amendment by section 3(b) of Pub. L. 109–462 effective 1 year after Dec. 22, 2006, see section
p.001994: 3(d)(1) of Pub. L. 109–462, set out as a note under section 343 of this title.
p.001994: Pub. L. 109–462, §4(b), Dec. 22, 2006, 120 Stat. 3475, provided that: “The amendment made
p.001994: by this section [amending this section] shall take effect 1 year after the date of enactment of this
p.001994: Act [Dec. 22, 2006].”
p.001994: EFFECTIVE DATE OF 2005 AMENDMENT
...

p.001994: calendar month following Oct. 1962, and amendment by section 104(e)(1) of Pub. L. 87–781
p.001994: effective Oct. 10, 1962, see section 107 of Pub. L. 87–781, set out as a note under section 321 of
p.001994: this title.
p.001994: Section 114(b) of Pub. L. 87–781 provided that: “This section [amending this section] shall take
p.001994: effect on the first day of the seventh calendar month following the month in which this Act is
p.001994: enacted [October 1962].”
p.001994: EFFECTIVE DATE OF 1960 AMENDMENT
p.001994: Amendment by Pub. L. 86–618 effective July 12, 1960, subject to provisions of section 203 of
p.001994: Pub. L. 86–618, see section 202 of Pub. L. 86–618, set out as a note under section 379e of this
p.001994: title.
p.001994: EFFECTIVE DATE OF 1958 AMENDMENT
p.001994: Amendment by Pub. L. 85–929 effective Sept. 6, 1958, see section 6(a) of Pub. L. 85–929, set
p.001994: out as a note under section 342 of this title.
p.001994: EFFECTIVE DATE OF 1950 AMENDMENT
p.001994: Amendment by act Mar. 16, 1950, effective July 1, 1950, see section 7 of that act, set out as an
p.001994: Effective Date note under section 347 of this title.
p.001994: REGULATIONS
p.001994: Secretary of Health and Human Services to promulgate regulations to implement amendments
p.001994: made by section 401 of Pub. L. 105–115 not later than 1 year after Nov. 21, 1997, see section
p.001994: 401(c) of Pub. L. 105–115, set out as a note under section 360aaa of this title.
p.001994: SAVINGS PROVISION
p.001994: Amendment by Pub. L. 91–513 not to affect or abate any prosecutions for violation of law or any
p.001994: civil seizures or forfeitures and injunctive proceedings commenced prior to the effective date of
p.001994: such amendment, and all administrative proceedings pending before the Bureau of Narcotics and
p.001994: Dangerous Drugs [now the Drug Enforcement Administration] on Oct. 27, 1970, to be continued
p.001994: and brought to final determination in accord with laws and regulations in effect prior to Oct. 27,
p.001994: 1970, see section 702 of Pub. L. 91–513, set out as a note under section 321 of this title.
p.001994: CONSTRUCTION OF 2011 AMENDMENT
p.001994: Nothing in amendments by sections 103(e), 105(c), 106(d), 204(j)(1), 211(b), (c), and 301(b) of
p.001994: Pub. L. 111–353 to be construed to apply to certain alcohol-related facilities, see section 2206 of
p.001994: this title.
p.001994: Nothing in amendments by Pub. L. 111–353 to be construed to alter jurisdiction and authorities
p.001994: established under certain other Acts or in a manner inconsistent with international agreements to
p.001994: which the United States is a party, see sections 2251 and 2252 of this title.
p.001994: CONSTRUCTION OF 2009 AMENDMENTS
p.001994: Pub. L. 111–31, div. A, title I, §103(p), June 22, 2009, 123 Stat. 1838, provided that: “Nothing in
p.001994: this section [amending this section and sections 333, 334, 355, 360m, 372 to 374, 375, 379a, 381,
p.001994: 393, 399, and 679 of this title and enacting provisions set out as notes under sections 333 and
p.001994: 387c of this title] is intended or shall be construed to expand, contract, or otherwise modify or
p.001994: amend the existing limitations on State government authority over tribal restricted fee or trust
p.001994: lands.”
p.001994: CONSTRUCTION OF 2002 AMENDMENTS
p.001994: Pub. L. 107–188, title III, §315, June 12, 2002, 116 Stat. 675, provided that: “Nothing in this title
p.001994: [enacting sections 350c, 350d, 398, 399, and 679c of this title, sections 3353, 3354, 8319, and
p.001994: 8320 of Title 7, Agriculture, and section 247b–20 of Title 42, The Public Health and Welfare,
p.001994: amending this section, sections 334, 335a, 342, 343, 360, 372, 374, and 381 of this title, and
p.001994: section 43 of Title 18, Crimes and Criminal Procedure, and enacting provisions set out as notes
p.001994: under this section and sections 341, 350c, 350d, and 381 of this title], or an amendment made by
p.001994: this title, shall be construed to alter the jurisdiction between the Secretaries of Agriculture and of
p.001994: Health and Human Services, under applicable statutes and regulations.”
p.001994: TRANSFER OF FUNCTIONS
p.001994: For transfer of functions of Federal Security Administrator to Secretary of Health, Education,
p.001994: and Welfare [now Health and Human Services], and of Food and Drug Administration in the
p.001994: Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this
p.001994: title.
p.001994:
p.001994: 1 See References in Text note below.
p.001994:
p.001994: 2 So in original.
p.001994:
p.001994:
p.001994:
p.001994: §332. Injunction proceedings
p.001994: (a) Jurisdiction of courts
p.001994: The district courts of the United States and the United States courts of the Territories
p.001994: shall have jurisdiction, for cause shown 1 to restrain violations of section 331 of this title,
p.001994: except paragraphs (h), (i), and (j).
p.001994: (b) Violation of injunction
p.001994: In case of violation of an injunction or restraining order issued under this section, which
p.001994: also constitutes a violation of this chapter, trial shall be by the court, or, upon demand of the
p.001994: accused, by a jury.
p.001994: (June 25, 1938, ch. 675, §302, 52 Stat. 1043; Pub. L. 87–781, title I, §103(d), title II,
p.001994: §201(c), Oct. 10, 1962, 76 Stat. 784, 793; Pub. L. 103–80, §3(d), Aug. 13, 1993, 107 Stat.
p.001994: 775.)
p.001994: AMENDMENTS
p.001994: 1993—Subsec. (a). Pub. L. 103–80, §3(d)(1), struck out “, and subject to the provisions of
p.001994: section 17 (relating to notice to opposite party) of the Act entitled ‘An Act to supplement existing
p.001994: laws against unlawful restraints and monopolies, and for other purposes’, approved October 15,
p.001994: 1914, as amended (U.S.C., 1934 ed., title 28, sec. 381),” after “for cause shown”.
p.001994: Subsec. (b). Pub. L. 103–80, §3(d)(2), struck out at end “Such trial shall be conducted in
p.001994: accordance with the practice and procedure applicable in the case of proceedings subject to the
p.001994: provisions of section 22 of such Act of October 15, 1914, as amended (U.S.C., 1934 ed., title 28,
p.001994: sec. 387).”
p.001994: 1962—Subsec. (a). Pub. L. 87–781, §103(d), struck out “(e),” after “paragraphs”.
p.001994: Pub. L. 87–781, §201(c), struck out “(f),” after “paragraphs”.
p.001994: EFFECTIVE DATE OF 1962 AMENDMENT
p.001994: Amendment by section 103(c) of Pub. L. 87–781 effective on first day of seventh calendar
p.001994: month following October 1962, see section 107 of Pub. L. 87–781, set out as a note under section
p.001994: 321 of this title.
p.001994: Section 203 of title II of Pub. L. 87–781 provided that: “The amendments made by this title
p.001994: [amending this section and section 374 of this title and enacting provisions set out as notes under
p.001994: sections 321 and 374 of this title] shall take effect on the date of enactment of this Act [Oct. 10,
p.001994: 1962].”
p.001994:
p.001994: 1 So in original. Probably should be followed by a comma.
p.001994:
p.001994:
p.001994:
p.001994: §333. Penalties
p.001994: (a) Violation of section 331 of this title; second violation; intent to defraud or mislead
p.001994: (1) Any person who violates a provision of section 331 of this title shall be imprisoned for
p.001994: not more than one year or fined not more than $1,000, or both.
p.001994: (2) Notwithstanding the provisions of paragraph (1) of this section,1 if any person commits
p.001994: such a violation after a conviction of him under this section has become final, or commits
p.001994: such a violation with the intent to defraud or mislead, such person shall be imprisoned for
p.001994: not more than three years or fined not more than $10,000, or both.
p.001994: (b) Prescription drug marketing violations
p.001994: (1) Notwithstanding subsection (a) of this section, any person who violates section 331(t)
p.001994: of this title by—
p.001994: (A) knowingly importing a drug in violation of section 381(d)(1) of this title,
p.001994: (B) knowingly selling, purchasing, or trading a drug or drug sample or knowingly
p.001994: offering to sell, purchase, or trade a drug or drug sample, in violation of section 353(c)(1)
p.001994: of this title,
p.001994: (C) knowingly selling, purchasing, or trading a coupon, knowingly offering to sell,
p.001994: purchase, or trade such a coupon, or knowingly counterfeiting such a coupon, in violation
p.001994: of section 353(c)(2) of this title, or
p.001994: (D) knowingly distributing drugs in violation of section 353(e)(2)(A) of this title,
p.001994: shall be imprisoned for not more than 10 years or fined not more than $250,000, or both.
p.001994: (2) Any manufacturer or distributor who distributes drug samples by means other than the
p.001994: mail or common carrier whose representative, during the course of the representative's
p.001994: employment or association with that manufacturer or distributor, violated section 331(t) of
p.001994: this title because of a violation of section 353(c)(1) of this title or violated any State law
p.001994: prohibiting the sale, purchase, or trade of a drug sample subject to section 353(b) of this
p.001994: title or the offer to sell, purchase, or trade such a drug sample shall, upon conviction of the
p.001994: representative for such violation, be subject to the following civil penalties:
p.001994: (A) A civil penalty of not more than $50,000 for each of the first two such violations
p.001994: resulting in a conviction of any representative of the manufacturer or distributor in any 10-
p.001994: year period.
p.001994: (B) A civil penalty of not more than $1,000,000 for each violation resulting in a
p.001994: conviction of any representative after the second conviction in any 10-year period.
p.001994:
p.001994: For the purposes of this paragraph, multiple convictions of one or more persons arising
p.001994: out of the same event or transaction, or a related series of events or transactions, shall be
p.001994: considered as one violation.
p.001994: (3) Any manufacturer or distributor who violates section 331(t) of this title because of a
p.001994: failure to make a report required by section 353(d)(3)(E) of this title shall be subject to a civil
p.001994: penalty of not more than $100,000.
p.001994: (4)(A) If a manufacturer or distributor or any representative of such manufacturer or
p.001994: distributor provides information leading to the institution of a criminal proceeding against,
p.001994: and conviction of, any representative of that manufacturer or distributor for a violation of
p.001994: section 331(t) of this title because of a sale, purchase, or trade or offer to purchase, sell, or
p.001994: trade a drug sample in violation of section 353(c)(1) of this title or for a violation of State law
p.001994: prohibiting the sale, purchase, or trade or offer to sell, purchase, or trade a drug sample,
p.001994: the conviction of such representative shall not be considered as a violation for purposes of
p.001994: paragraph (2).
p.001994: (B) If, in an action brought under paragraph (2) against a manufacturer or distributor
p.001994: relating to the conviction of a representative of such manufacturer or distributor for the sale,
p.001994: purchase, or trade of a drug or the offer to sell, purchase, or trade a drug, it is shown, by
p.001994: clear and convincing evidence—
p.001994: (i) that the manufacturer or distributor conducted, before the institution of a criminal
p.001994: proceeding against such representative for the violation which resulted in such conviction,
p.001994: an investigation of events or transactions which would have led to the reporting of
p.001994: information leading to the institution of a criminal proceeding against, and conviction of,
p.001994: such representative for such purchase, sale, or trade or offer to purchase, sell, or trade,
p.001994: or
p.001994: (ii) that, except in the case of the conviction of a representative employed in a
p.001994: supervisory function, despite diligent implementation by the manufacturer or distributor of
p.001994: an independent audit and security system designed to detect such a violation, the
p.001994: manufacturer or distributor could not reasonably have been expected to have detected
p.001994: such violation,
p.001994:
p.001994: the conviction of such representative shall not be considered as a conviction for purposes
p.001994: of paragraph (2).
p.001994: (5) If a person provides information leading to the institution of a criminal proceeding
p.001994: against, and conviction of, a person for a violation of section 331(t) of this title because of
p.001994: the sale, purchase, or trade of a drug sample or the offer to sell, purchase, or trade a drug
p.001994: sample in violation of section 353(c)(1) of this title, such person shall be entitled to one-half
p.001994: of the criminal fine imposed and collected for such violation but not more than $125,000.
p.001994: (6) Notwithstanding subsection (a) of this section, any person who is a manufacturer or
p.001994: importer of a prescription drug under section 384(b) of this title and knowingly fails to
p.001994: comply with a requirement of section 384(e) of this title that is applicable to such
p.001994: manufacturer or importer, respectively, shall be imprisoned for not more than 10 years or
p.001994: fined not more than $250,000, or both.
p.001994: (c) Exceptions in certain cases of good faith, etc.
p.001994: No person shall be subject to the penalties of subsection (a)(1) of this section, (1) for
p.001994: having received in interstate commerce any article and delivered it or proffered delivery of it,
p.001994: if such delivery or proffer was made in good faith, unless he refuses to furnish on request of
p.001994: an officer or employee duly designated by the Secretary the name and address of the
p.001994: person from whom he purchased or received such article and copies of all documents, if
p.001994: any there be, pertaining to the delivery of the article to him; or (2) for having violated
p.001994: section 331(a) or (d) of this title, if he establishes a guaranty or undertaking signed by, and
p.001994: containing the name and address of, the person residing in the United States from whom he
p.001994: received in good faith the article, to the effect, in case of an alleged violation of section
p.001994: 331(a) of this title, that such article is not adulterated or misbranded, within the meaning of
p.001994: this chapter designating this chapter or to the effect, in case of an alleged violation of
p.001994: section 331(d) of this title, that such article is not an article which may not, under the
p.001994: provisions of section 344 or 355 of this title, be introduced into interstate commerce; or (3)
p.001994: for having violated section 331(a) of this title, where the violation exists because the article
p.001994: is adulterated by reason of containing a color additive not from a batch certified in
p.001994: accordance with regulations promulgated by the Secretary under this chapter, if such
p.001994: person establishes a guaranty or undertaking signed by, and containing the name and
p.001994: address of, the manufacturer of the color additive, to the effect that such color additive was
p.001994: from a batch certified in accordance with the applicable regulations promulgated by the
p.001994: Secretary under this chapter; or (4) for having violated section 331(b), (c) or (k) of this title
p.001994: by failure to comply with section 352(f) of this title in respect to an article received in
p.001994: interstate commerce to which neither section 353(a) nor 353(b)(1) of this title is applicable,
p.001994: if the delivery or proffered delivery was made in good faith and the labeling at the time
p.001994: thereof contained the same directions for use and warning statements as were contained in
p.001994: the labeling at the time of such receipt of such article; or (5) for having violated section
p.001994: 331(i)(2) of this title if such person acted in good faith and had no reason to believe that use
p.001994: of the punch, die, plate, stone, or other thing involved would result in a drug being a
p.001994: counterfeit drug, or for having violated section 331(i)(3) of this title if the person doing the
p.001994: act or causing it to be done acted in good faith and had no reason to believe that the drug
p.001994: was a counterfeit drug.
p.001994: (d) Exceptions involving misbranded food
p.001994: No person shall be subject to the penalties of subsection (a)(1) of this section for a
p.001994: violation of section 331 of this title involving misbranded food if the violation exists solely
p.001994: because the food is misbranded under section 343(a)(2) of this title because of its
p.001994: advertising.
p.001994: (e) Prohibited distribution of human growth hormone
p.001994: (1) Except as provided in paragraph (2), whoever knowingly distributes, or possesses
p.001994: with intent to distribute, human growth hormone for any use in humans other than the
p.001994: treatment of a disease or other recognized medical condition, where such use has been
p.001994: authorized by the Secretary of Health and Human Services under section 355 of this title
p.001994: and pursuant to the order of a physician, is guilty of an offense punishable by not more than
p.001994: 5 years in prison, such fines as are authorized by title 18, or both.
p.001994: (2) Whoever commits any offense set forth in paragraph (1) and such offense involves an
p.001994: individual under 18 years of age is punishable by not more than 10 years imprisonment,
p.001994: such fines as are authorized by title 18, or both.
p.001994: (3) Any conviction for a violation of paragraphs (1) and (2) of this subsection shall be
p.001994: considered a felony violation of the Controlled Substances Act [21 U.S.C. 801 et seq.] for
p.001994: the purposes of forfeiture under section 413 of such Act [21 U.S.C. 853].
p.001994: (4) As used in this subsection the term “human growth hormone” means somatrem,
p.001994: somatropin, or an analogue of either of them.
p.001994: (5) The Drug Enforcement Administration is authorized to investigate offenses punishable
p.001994: by this subsection.
p.001994: (f) Violations related to devices
p.001994: (1)(A) Except as provided in subparagraph (B), any person who violates a requirement of
p.001994: this chapter which relates to devices shall be liable to the United States for a civil penalty in
p.001994: an amount not to exceed $15,000 for each such violation, and not to exceed $1,000,000 for
p.001994: all such violations adjudicated in a single proceeding. For purposes of the preceding
p.001994: sentence, a person accredited under paragraph (2) of section 374(g) of this title who is
p.001994: substantially not in compliance with the standards of accreditation under such section, or
p.001994: who poses a threat to public health or fails to act in a manner that is consistent with the
p.001994: purposes of such section, shall be considered to have violated a requirement of this chapter
p.001994: that relates to devices.
p.001994: (B) Subparagraph (A) shall not apply—
p.001994: (i) to any person who violates the requirements of section 360i(a) or 360j(f) of this title
p.001994: unless such violation constitutes (I) a significant or knowing departure from such
p.001994: requirements, or (II) a risk to public health,
p.001994: (ii) to any person who commits minor violations of section 360i(e) or 360i(g) of this title
p.001994: (only with respect to correction reports) if such person demonstrates substantial
p.001994: compliance with such section, or
p.001994: (iii) to violations of section 351(a)(2)(A) of this title which involve one or more devices
p.001994: which are not defective.
p.001994:
...

p.001994: for the District of Columbia Circuit or for any other circuit in which such person resides or
p.001994: transacts business. Such a petition may only be filed within the 60-day period beginning on
p.001994: the date the order making such assessment was issued, or on which the no-tobacco-sale
p.001994: order was imposed, as the case may be.
p.001994: (7) If any person fails to pay an assessment of a civil penalty—
p.001994: (A) after the order making the assessment becomes final, and if such person does not
p.001994: file a petition for judicial review of the order in accordance with paragraph (6), or
p.001994: (B) after a court in an action brought under paragraph (6) has entered a final judgment
p.001994: in favor of the Secretary,
p.001994:
p.001994: the Attorney General shall recover the amount assessed (plus interest at currently
p.001994: prevailing rates from the date of the expiration of the 60-day period referred to in paragraph
p.001994: (6) or the date of such final judgment, as the case may be) in an action brought in any
p.001994: appropriate district court of the United States. In such an action, the validity, amount, and
p.001994: appropriateness of such penalty shall not be subject to review.
p.001994: (8) If the Secretary finds that a person has committed repeated violations of restrictions
p.001994: promulgated under section 387f(d) of this title at a particular retail outlet then the Secretary
p.001994: may impose a no-tobacco-sale order on that person prohibiting the sale of tobacco products
p.001994: in that outlet. A no-tobacco-sale order may be imposed with a civil penalty under paragraph
p.001994: (1). Prior to the entry of a no-sale order under this paragraph, a person shall be entitled to a
p.001994: hearing pursuant to the procedures established through regulations of the Food and Drug
p.001994: Administration for assessing civil money penalties, including at a retailer's request a hearing
p.001994: by telephone, or at the nearest regional or field office of the Food and Drug Administration,
p.001994: or at a Federal, State, or county facility within 100 miles from the location of the retail outlet,
p.001994: if such a facility is available.
p.001994: (9) CIVIL MONETARY PENALTIES FOR VIOLATION OF TOBACCO PRODUCT REQUIREMENTS.—
p.001994: (A) IN GENERAL.—Subject to subparagraph (B), any person who violates a requirement of
p.001994: this chapter which relates to tobacco products shall be liable to the United States for a
p.001994: civil penalty in an amount not to exceed $15,000 for each such violation, and not to
p.001994: exceed $1,000,000 for all such violations adjudicated in a single proceeding.
p.001994: (B) ENHANCED PENALTIES.—
p.001994: (i) Any person who intentionally violates a requirement of section 387b(5), 387b(6),
p.001994: 387d, 387h(c), or 387k(a) of this title, shall be subject to a civil monetary penalty of—
p.001994: (I) not to exceed $250,000 per violation, and not to exceed $1,000,000 for all such
p.001994: violations adjudicated in a single proceeding; or
p.001994: (II) in the case of a violation that continues after the Secretary provides written
p.001994: notice to such person, $250,000 for the first 30-day period (or any portion thereof)
p.001994: that the person continues to be in violation, and such amount shall double for every
p.001994: 30-day period thereafter that the violation continues, not to exceed $1,000,000 for
p.001994: any 30-day period, and not to exceed $10,000,000 for all such violations adjudicated
p.001994: in a single proceeding.
p.001994:
p.001994: (ii) Any person who violates a requirement of section 387k(g)(2)(C)(ii) or 387k(i)(1) of
p.001994: this title, shall be subject to a civil monetary penalty of—
p.001994: (I) not to exceed $250,000 per violation, and not to exceed $1,000,000 for all such
p.001994: violations adjudicated in a single proceeding; or
p.001994: (II) in the case of a violation that continues after the Secretary provides written
p.001994: notice to such person, $250,000 for the first 30-day period (or any portion thereof)
p.001994: that the person continues to be in violation, and such amount shall double for every
p.001994: 30-day period thereafter that the violation continues, not to exceed $1,000,000 for
p.001994: any 30-day period, and not to exceed $10,000,000 for all such violations adjudicated
p.001994: in a single proceeding.
p.001994:
p.001994: (iii) In determining the amount of a civil penalty under clause (i)(II) or (ii)(II), the
p.001994: Secretary shall take into consideration whether the person is making efforts toward
p.001994: correcting the violation of the requirements of the section for which such person is
p.001994: subject to such civil penalty.
p.001994: (g) Violations regarding direct-to-consumer advertising
p.001994: (1) With respect to a person who is a holder of an approved application under section 355
p.001994: of this title for a drug subject to section 353(b) of this title or under section 262 of title 42,
p.001994: any such person who disseminates or causes another party to disseminate a direct-to-
p.001994: consumer advertisement that is false or misleading shall be liable to the United States for a
p.001994: civil penalty in an amount not to exceed $250,000 for the first such violation in any 3-year
p.001994: period, and not to exceed $500,000 for each subsequent violation in any 3-year period. No
p.001994: other civil monetary penalties in this chapter (including the civil penalty in subsection (f)(4))
p.001994: shall apply to a violation regarding direct-to-consumer advertising. For purposes of this
p.001994: paragraph: (A) Repeated dissemination of the same or similar advertisement prior to the
p.001994: receipt of the written notice referred to in paragraph (2) for such advertisements shall be
p.001994: considered one violation. (B) On and after the date of the receipt of such a notice, all
p.001994: violations under this paragraph occurring in a single day shall be considered one violation.
p.001994: With respect to advertisements that appear in magazines or other publications that are
p.001994: published less frequently than daily, each issue date (whether weekly or monthly) shall be
p.001994: treated as a single day for the purpose of calculating the number of violations under this
p.001994: paragraph.
p.001994: (2) A civil penalty under paragraph (1) shall be assessed by the Secretary by an order
p.001994: made on the record after providing written notice to the person to be assessed a civil
p.001994: penalty and an opportunity for a hearing in accordance with this paragraph and section 554
...

p.001994: 1976, 90 Stat. 411; Pub. L. 100–293, §7(b), Apr. 22, 1988, 102 Stat. 99; Pub. L. 100–690,
p.001994: title II, §2403, Nov. 18, 1988, 102 Stat. 4230; Pub. L. 101–629, §17(a), Nov. 28, 1990, 104
p.001994: Stat. 4526; Pub. L. 101–647, title XIX, §1904, Nov. 29, 1990, 104 Stat. 4853; Pub. L. 102–
p.001994: 353, §3, Aug. 26, 1992, 106 Stat. 941; Pub. L. 103–80, §3(e), Aug. 13, 1993, 107 Stat. 775;
p.001994: Pub. L. 103–322, title XXXIII, §330015, Sept. 13, 1994, 108 Stat. 2146; Pub. L. 104–170,
p.001994: title IV, §407, Aug. 3, 1996, 110 Stat. 1535; Pub. L. 106–387, §1(a) [title VII, §745(d)(2)],
p.001994: Oct. 28, 2000, 114 Stat. 1549, 1549A–40; Pub. L. 107–250, title II, §201(c), Oct. 26, 2002,
p.001994: 116 Stat. 1609; Pub. L. 108–173, title XI, §1121(b)(2), Dec. 8, 2003, 117 Stat. 2469; Pub. L.
p.001994: 110–85, title II, §226(b), title VIII, §801(b)(2), title IX, §§901(d)(4), 902(b), Sept. 27, 2007,
p.001994: 121 Stat. 854, 920, 940, 943; Pub. L. 111–31, div. A, title I, §103(c), June 22, 2009, 123
p.001994: Stat. 1835; Pub. L. 111–353, title II, §206(c), Jan. 4, 2011, 124 Stat. 3943.)
p.001994: REFERENCES IN TEXT
p.001994: The Controlled Substances Act, referred to in subsec. (e)(3), is title II of Pub. L. 91–513, Oct.
p.001994: 27, 1970, 84 Stat. 1242, which is classified principally to subchapter I (§801 et seq.) of chapter 13
p.001994: of this title. For complete classification of this Act to the Code, see Short Title note set out under
p.001994: section 801 of this title and Tables.
p.001994: Section 282(j)(5)(C)(ii) of title 42, referred to in subsec. (f)(3)(B), was in the original “section
p.001994: 402(j)(5)(C)(ii)”, and was translated as meaning section 402(j)(5)(C)(ii) of the Public Health
p.001994: Service Act to reflect the probable intent of Congress because there is no subsec. (j) of section
p.001994: 402 of the Federal Food, Drug, and Cosmetic Act and section 402(j)(5)(C)(ii) of the Public Health
p.001994: Service Act relates to notification of noncompliance with clinical trial information requirements.
p.001994: AMENDMENTS
p.001994: 2011—Subsec. (f)(2)(A). Pub. L. 111–353 inserted “or any person who does not comply with a
p.001994: recall order under section 350l of this title” after “section 342(a)(2)(B) of this title”.
p.001994: 2009—Subsec. (f)(5)(A). Pub. L. 111–31, §103(c)(1)(A), (B), substituted “paragraph (1), (2), (3),
p.001994: (4), or (9)” for “paragraph (1), (2), (3), or (4)”, “shall be assessed, or a no-tobacco-sale order may
p.001994: be imposed,” for “shall be assessed”, and “assessed a civil penalty, or upon whom a no-tobacco-
p.001994: sale order is to be imposed,” for “assessed a civil penalty”.
p.001994: Subsec. (f)(5)(B). Pub. L. 111–31, §103(c)(1)(C), inserted “or the period to be covered by a no-
p.001994: tobacco-sale order,” after “penalty,” and inserted at end “A no-tobacco-sale order permanently
p.001994: prohibiting an individual retail outlet from selling tobacco products shall include provisions that
p.001994: allow the outlet, after a specified period of time, to request that the Secretary compromise, modify,
p.001994: or terminate the order.”
p.001994: Subsec. (f)(5)(C). Pub. L. 111–31, §103(c)(1)(A), substituted “paragraph (1), (2), (3), (4), or (9)”
p.001994: for “paragraph (1), (2), (3), or (4)”.
p.001994: Subsec. (f)(5)(D). Pub. L. 111–31, §103(c)(1)(D), added subpar. (D).
p.001994: Subsec. (f)(6). Pub. L. 111–31, §103(c)(2), inserted “or the imposition of a no-tobacco-sale
p.001994: order” after “penalty” in two places and substituted “issued, or on which the no-tobacco-sale order
p.001994: was imposed, as the case may be.” for “issued.”
p.001994: Subsec. (f)(8), (9). Pub. L. 111–31, §103(c)(3), added pars. (8) and (9).
p.001994: 2007—Subsec. (f). Pub. L. 110–85, §226(b)(1), redesignated subsec. (g) as (f).
p.001994: Subsec. (f)(1)(B)(ii). Pub. L. 110–85, §226(b)(2), substituted “360i(g)” for “360i(f)”.
p.001994: Subsec. (f)(2)(C). Pub. L. 110–85, §801(b)(2)(C), substituted “paragraph (5)(A)” for “paragraph
p.001994: (3)(A)”.
p.001994: Subsec. (f)(3). Pub. L. 110–85, §801(b)(2)(B), added par. (3). Former par. (3) redesignated (5).
p.001994: Subsec. (f)(4). Pub. L. 110–85, §902(b)(1), added par. (4).
p.001994: Pub. L. 110–85, §801(b)(2)(A), redesignated par. (4) as (6).
p.001994: Subsec. (f)(5). Pub. L. 110–85, §801(b)(2)(A), redesignated par. (3) as (5). Former par. (5)
p.001994: redesignated (7).
p.001994: Subsec. (f)(5)(A), (C). Pub. L. 110–85, §902(b)(2), substituted “paragraph (1), (2), (3), or (4)” for
p.001994: “paragraph (1), (2), or (3)”.
p.001994: Pub. L. 110–85, §801(b)(2)(D), substituted “paragraph (1), (2), or (3)” for “paragraph (1) or (2)”.
p.001994: Subsec. (f)(6). Pub. L. 110–85, §801(b)(2)(A), (E), redesignated par. (4) as (6) and substituted
p.001994: “paragraph (5)(A)” for “paragraph (3)(A)”.
p.001994: Subsec. (f)(7). Pub. L. 110–85, §801(b)(2)(A), (F), redesignated par. (5) as (7) and substituted
p.001994: “paragraph (6)” for “paragraph (4)” wherever appearing.
p.001994: Subsec. (g). Pub. L. 110–85, §901(d)(4), added subsec. (g).
p.001994: Pub. L. 110–85, §226(b)(1), redesignated subsec. (g) as (f).
p.001994: 2003—Subsec. (b)(6). Pub. L. 108–173, which directed amendment of subsec. (a)(6) by
p.001994: substituting “prescription drug under section 384(b)” for “covered product pursuant to section
p.001994: 384(a)”, was executed by making the substitution in subsec. (b)(6), to reflect the probable intent of
p.001994: Congress.
p.001994: 2002—Subsec. (g)(1)(A). Pub. L. 107–250 inserted at end “For purposes of the preceding
p.001994: sentence, a person accredited under paragraph (2) of section 374(g) of this title who is
p.001994: substantially not in compliance with the standards of accreditation under such section, or who
p.001994: poses a threat to public health or fails to act in a manner that is consistent with the purposes of
p.001994: such section, shall be considered to have violated a requirement of this chapter that relates to
p.001994: devices.”
p.001994: 2000—Subsec. (b)(6). Pub. L. 106–387 added par. (6).
p.001994: 1996—Subsec. (g)(2). Pub. L. 104–170, §407(1), (2), added par. (2). Former par. (2)
p.001994: redesignated (3).
p.001994: Subsec. (g)(3). Pub. L. 104–170, §407(1), (3), redesignated par. (2) as (3) and substituted
p.001994: “paragraph (1) or (2)” for “paragraph (1)” in subpars. (A) and (C). Former par. (3) redesignated (4).
p.001994: Subsec. (g)(4). Pub. L. 104–170, §407(1), (4), redesignated par. (3) as (4) and substituted
p.001994: “paragraph (3)(A)” for “paragraph (2)(A)”. Former par. (4) redesignated (5).
p.001994: Subsec. (g)(5). Pub. L. 104–170, §407(1), (5), redesignated par. (4) as (5) and substituted
p.001994: “paragraph (4)” for “paragraph (3)” wherever appearing.
p.001994: 1994—Subsec. (e). Pub. L. 103–322 amended directory language of Pub. L. 101–647. See
p.001994: 1990 Amendment note below.
p.001994: 1993—Subsecs. (e) to (g). Pub. L. 103–80, which directed the amendment of this section by
p.001994: redesignating the second subsec. (e) and subsec. (f) as subsecs. (f) and (g), respectively, could
p.001994: only be executed by designating subsec. (f) as (g) because this section did not contain a second
p.001994: subsec. (e) subsequent to amendment of Pub. L. 101–647 by Pub. L. 103–322. See 1990 and
p.001994: 1994 amendment notes for subsec. (e) under this section.
p.001994: 1992—Subsec. (b)(1). Pub. L. 102–353, §3(a), amended par. (1) generally. Prior to amendment,
p.001994: par. (1) read as follows: “Notwithstanding subsection (a) of this section, any person who violates
p.001994: section 331(t) of this title because of an importation of a drug in violation of section 381(d)(1) of
p.001994: this title, because of a sale, purchase, or trade of a drug or drug sample or the offer to sell,
p.001994: purchase, or trade a drug or drug sample in violation of section 353(c) of this title, because of the
p.001994: sale, purchase, or trade of a coupon, the offer to sell, purchase, or trade such a coupon, or the
p.001994: counterfeiting of such a coupon in violation of section 353(c)(2) of this title, or the distribution of
p.001994: drugs in violation of section 353(e)(2)(A) of this title shall be imprisoned for not more than 10 years
p.001994: or fined not more than $250,000, or both.”
p.001994: Subsec. (b)(4)(A). Pub. L. 102–353, §3(b)(1), substituted “the institution of a criminal proceeding
p.001994: against, and conviction of,” for “the arrest and conviction of”.
p.001994: Subsec. (b)(4)(B)(i). Pub. L. 102–353, §3(b)(1), (2), substituted “before the institution of a
p.001994: criminal proceeding against” for “before the arrest of” and “the institution of a criminal proceeding
p.001994: against, and conviction of,” for “the arrest and conviction of”.
p.001994: Subsec. (b)(5). Pub. L. 102–353, §3(b)(3), substituted “the institution of a criminal proceeding
p.001994: against, and conviction of,” for “the arrest and conviction of”.
p.001994: Subsec. (c). Pub. L. 102–353, §3(b)(4), substituted “subsection (a)(1) of this section” for
p.001994: “subsection (a) of this section”.
p.001994: Subsec. (d). Pub. L. 102–353, §3(b)(4), (5), substituted “subsection (a)(1) of this section” for
...

p.001994: under title 18, or both.
p.001994: “(2) Any person who distributes or possesses with the intent to distribute to an individual under
p.001994: 18 years of age, any anabolic steroid for any use in humans other than the treatment of disease
p.001994: pursuant to the order of a physician shall be imprisoned for not more than six years or fined under
p.001994: title 18, or both.”
p.001994: Subsec. (f). Pub. L. 101–629 added subsec. (f).
p.001994: 1988—Subsecs. (a), (b). Pub. L. 100–293 designated existing subsecs. (a) and (b) as pars. (1)
p.001994: and (2) of subsec. (a), substituted “paragraph (1)” for “subsection (a)” in par. (2), and added
p.001994: subsec. (b).
p.001994: Subsec. (e). Pub. L. 100–690 added subsec. (e).
p.001994: 1976—Subsec. (d). Pub. L. 94–278 added subsec. (d).
p.001994: 1970—Subsec. (a). Pub. L. 91–513 struck out reference to subsec. (b) and transferred to
p.001994: subsec. (b) provisions covering second offenses and offenses committed with intent to defraud or
p.001994: mislead.
p.001994: Subsec. (b). Pub. L. 91–513 inserted provisions covering second offenses and offenses
p.001994: committed with intent to defraud or mislead formerly set out in subsec. (a) and struck out
p.001994: provisions covering violations involving depressant and stimulant drugs. See section 801 et seq.
p.001994: of this title.
p.001994: 1968—Subsecs. (a), (b). Pub. L. 90–639 made a general revision in the penalties prescribed for
p.001994: offenses involving depressant or stimulant drugs, set a fine of not to exceed $10,000 or
p.001994: imprisonment of not more than 5 years for offenses involving the unlawful manufacturing of, sale,
p.001994: or disposal of, or possession with intent to sell, a depressant or stimulant drug or involving
p.001994: counterfeit depressant or stimulant drugs, stiffened the penalties for unlawful sales or other
p.001994: disposals by persons over 18 to persons under 21, and set new penalties for possession of a
p.001994: depressant or stimulant drug for purposes other than sale or other disposal.
p.001994: 1965—Subsec. (a). Pub. L. 89–74, §7(a), inserted proviso limiting the penalties for depressant
p.001994: or stimulant drug violations to two years imprisonment or $5,000 fine or both for first offense and
p.001994: to two years imprisonment or $15,000 fine or both for subsequent offenses.
p.001994: Subsec. (b). Pub. L. 89–74, §7(b), inserted parenthetical exception provision.
p.001994: Subsec. (c)(5). Pub. L. 89–74, §9(d), added cl. (5).
p.001994: 1960—Subsec. (c)(3). Pub. L. 86–618 substituted “a color additive” for “a coal-tar color”, “the
p.001994: color additive” for “the coal-tar color” and “such color additive was” for “such color was”.
p.001994: 1951—Subsec. (c)(4). Act Oct. 26, 1951, added cl. (4).
p.001994: EFFECTIVE DATE OF 2009 AMENDMENT
p.001994: Pub. L. 111–31, div. A, title I, §103(q)(3), (4), June 22, 2009, 123 Stat. 1840, provided that:
p.001994: “(3) GENERAL EFFECTIVE DATE.—The amendments made by paragraphs (2) [amending this
p.001994: section], (3) [amending this section], and (4) [no par. (4) has been enacted] of subsection (c) shall
p.001994: take effect upon the issuance of guidance described in paragraph (1) of this subsection [set out as
p.001994: a Guidance note below].
p.001994: “(4) SPECIAL EFFECTIVE DATE.—The amendment made by subsection (c)(1) [amending this section]
p.001994: shall take effect on the date of enactment of this Act [June 22, 2009].”
p.001994: EFFECTIVE DATE OF 2007 AMENDMENT
p.001994: Amendment by sections 901(d)(4) and 902(b) of Pub. L. 110–85 effective 180 days after Sept.
p.001994: 27, 2007, see section 909 of Pub. L. 110–85, set out as a note under section 331 of this title.
p.001994: EFFECTIVE DATE OF 1994 AMENDMENT
p.001994: Section 330015 of Pub. L. 103–322 provided that the amendment made by that section is
p.001994: effective as of the date on which section 1904 of Pub. L. 101–647, which amended this section,
p.001994: took effect.
p.001994: EFFECTIVE DATE OF 1990 AMENDMENT
p.001994: Section 17(b) of Pub. L. 101–629 provided that:
p.001994: “(b) EFFECTIVE DATE OF APPLICATION TO DEVICE USER FACILITIES.—
p.001994: “(1) The Secretary of Health and Human Services shall conduct a study to determine
p.001994: whether there has been substantial compliance with the requirements of section 519(b) of the
p.001994: Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360i(b)] by device user facilities (as defined in
p.001994: section 519(b)(5)(A) of such Act). The Secretary shall report the results of the study to the
p.001994: Congress after the expiration of 45 months after the date of the enactment of this Act [Nov. 28,
p.001994: 1990].
p.001994: “(2)(A) If upon the expiration of 48 months after the date of the enactment of this Act [Nov.
p.001994: 28, 1990] the Secretary has not made the report required by paragraph (1), section 303(f) of the
p.001994: Federal Food, Drug, and Cosmetic Act [21 U.S.C. 333(f)], as added by the amendment made
p.001994: by subsection (a), shall take effect with respect to device user facilities (as defined in section
p.001994: 519(b)(5)(A) of such Act). [Secretary of Health and Human Services had not made the report
p.001994: required by par. (1) on the expiration of 48 months after Nov. 28, 1990.]
p.001994: “(B) If in the report under paragraph (1) the Secretary reports that there has been
p.001994: substantial compliance with the requirements of such section 519(b) by a type of device user
p.001994: facility and if the Secretary does not make a determination under subparagraph (C) with respect
p.001994: to such type of facility, such section 303(f) shall not take effect with respect to such type of
p.001994: facility.
p.001994: “(C) If the Secretary determines in the report under paragraph (1) that there is not
p.001994: substantial compliance with the requirements of such section 519(b) by a type of device user
p.001994: facility or if the Secretary makes such a determination after making the report under paragraph
p.001994: (1), such section 303(f) shall take effect with respect to such type of facility upon the effective
p.001994: date of the report.”
p.001994: EFFECTIVE DATE OF 1988 AMENDMENT
p.001994: Amendment by Pub. L. 100–293 effective upon expiration of 90 days after Apr. 22, 1988, see
p.001994: section 8(a) of Pub. L. 100–293, set out as a note under section 353 of this title.
p.001994: EFFECTIVE DATE OF 1976 AMENDMENT
p.001994: Amendment by Pub. L. 94–278 effective 180 days after Apr. 22, 1976, see section 502(c) of
p.001994: Pub. L. 94–278, set out as a note under section 334 of this title.
p.001994: EFFECTIVE DATE OF 1970 AMENDMENT
p.001994: Amendment by Pub. L. 91–513 effective on first day of seventh calendar month that begins
p.001994: after Oct. 26, 1970, see section 704 of Pub. L. 91–513, set out as an Effective Date note under
p.001994: section 801 of this title.
p.001994: EFFECTIVE DATE OF 1968 AMENDMENT
p.001994: Amendment by Pub. L. 90–639 applicable only with respect to violations of this chapter
p.001994: committed after Oct. 24, 1968, see section 6 of Pub. L. 90–639, set out as an Effective Date of
p.001994: 1968 Amendments; Transitional Provisions note under section 321 of this title.
p.001994: EFFECTIVE DATE OF 1965 AMENDMENT
p.001994: Amendment by Pub. L. 89–74 effective Feb. 1, 1966, see section 11 of Pub. L. 89–74, set out
p.001994: as a note under section 321 of this title.
p.001994: EFFECTIVE DATE OF 1960 AMENDMENT
p.001994: Amendment by Pub. L. 86–618 effective July 12, 1960, subject to the provisions of section 203
p.001994: of Pub. L. 86–618, see section 202 of Pub. L. 86–618, set out as a note under section 379e of this
p.001994: title.
p.001994: EFFECTIVE DATE OF 1951 AMENDMENT
p.001994: Section 3 of act Oct. 26, 1951, provided that: “The provisions of this Act [amending this section
p.001994: and section 353 of this title] shall take effect six months after the date of its enactment [Oct. 26,
p.001994: 1951].”
p.001994: SAVINGS PROVISION
p.001994: Amendment by Pub. L. 91–513 not to affect or abate any prosecutions for violation of law or any
p.001994: civil seizures or forfeitures and injunctive proceedings commenced prior to the effective date of
p.001994: such amendment, and all administrative proceedings pending before the Bureau of Narcotics and
p.001994: Dangerous Drugs [now the Drug Enforcement Administration] on Oct. 27, 1970, to be continued
p.001994: and brought to final determination in accord with laws and regulations in effect prior to Oct. 27,
p.001994: 1970, see section 702 of Pub. L. 91–513, set out as a note under section 321 of this title.
p.001994: TRANSFER OF FUNCTIONS
p.001994: For transfer of functions of Federal Security Administrator to Secretary of Health, Education,
p.001994: and Welfare [now Health and Human Services], and of Food and Drug Administration in the
p.001994: Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this
p.001994: title.
p.001994: GUIDANCE
p.001994: Pub. L. 111–31, div. A, title I, §103(q)(1), (2), June 22, 2009, 123 Stat. 1838, 1839, provided
p.001994: that:
p.001994: “(1) IN GENERAL.—The Secretary of Health and Human Services shall issue guidance [see 76
p.001994: F.R. 22905, effective Apr. 15, 2011]—
p.001994: “(A) defining the term ‘repeated violation’, as used in section 303(f)(8) of the Federal Food,
p.001994: Drug, and Cosmetic Act (21 U.S.C. 333(f)(8)) as amended by subsection (c), as including at
p.001994: least 5 violations of particular requirements over a 36-month period at a particular retail outlet
p.001994: that constitute a repeated violation and providing for civil penalties in accordance with
p.001994: paragraph (2);
p.001994: “(B) providing for timely and effective notice by certified or registered mail or personal
p.001994: delivery to the retailer of each alleged violation at a particular retail outlet prior to conducting a
p.001994: followup compliance check, such notice to be sent to the location specified on the retailer's
p.001994: registration or to the retailer's registered agent if the retailer has provider [sic] such agent
p.001994: information to the Food and Drug Administration prior to the violation;
p.001994: “(C) providing for a hearing pursuant to the procedures established through regulations of
p.001994: the Food and Drug Administration for assessing civil money penalties, including at a retailer's
p.001994: request a hearing by telephone or at the nearest regional or field office of the Food and Drug
p.001994: Administration, and providing for an expedited procedure for the administrative appeal of an
p.001994: alleged violation;
p.001994: “(D) providing that a person may not be charged with a violation at a particular retail outlet
p.001994: unless the Secretary has provided notice to the retailer of all previous violations at that outlet;
p.001994: “(E) establishing that civil money penalties for multiple violations shall increase from one
p.001994: violation to the next violation pursuant to paragraph (2) within the time periods provided for in
p.001994: such paragraph;
p.001994: “(F) providing that good faith reliance on the presentation of a false government-issued
p.001994: photographic identification that contains a date of birth does not constitute a violation of any
p.001994: minimum age requirement for the sale of tobacco products if the retailer has taken effective
p.001994: steps to prevent such violations, including—
p.001994: “(i) adopting and enforcing a written policy against sales to minors;
p.001994: “(ii) informing its employees of all applicable laws;
p.001994: “(iii) establishing disciplinary sanctions for employee noncompliance; and
p.001994: “(iv) requiring its employees to verify age by way of photographic identification or
p.001994: electronic scanning device; and
p.001994: “(G) providing for the Secretary, in determining whether to impose a no-tobacco-sale order
p.001994: and in determining whether to compromise, modify, or terminate such an order, to consider
p.001994: whether the retailer has taken effective steps to prevent violations of the minimum age
p.001994: requirements for the sale of tobacco products, including the steps listed in subparagraph (F).
p.001994: “(2) PENALTIES FOR VIOLATIONS.—
p.001994: “(A) IN GENERAL.—The amount of the civil penalty to be applied for violations of restrictions
p.001994: promulgated under section 906(d) [probably means section 906(d) of the Federal Food, Drug,
p.001994: and Cosmetic Act, 21 U.S.C. 387f(d)], as described in paragraph (1), shall be as follows:
p.001994: “(i) With respect to a retailer with an approved training program, the amount of the civil
p.001994: penalty shall not exceed—
p.001994: “(I) in the case of the first violation, $0.00 together with the issuance of a warning
p.001994: letter to the retailer;
p.001994: “(II) in the case of a second violation within a 12-month period, $250;
p.001994: “(III) in the case of a third violation within a 24-month period, $500;
p.001994: “(IV) in the case of a fourth violation within a 24-month period, $2,000;
p.001994: “(V) in the case of a fifth violation within a 36-month period, $5,000; and
p.001994: “(VI) in the case of a sixth or subsequent violation within a 48-month period,
p.001994: $10,000 as determined by the Secretary on a case-by-case basis.
p.001994: “(ii) With respect to a retailer that does not have an approved training program, the
p.001994: amount of the civil penalty shall not exceed—
p.001994: “(I) in the case of the first violation, $250;
p.001994: “(II) in the case of a second violation within a 12-month period, $500;
p.001994: “(III) in the case of a third violation within a 24-month period, $1,000;
p.001994: “(IV) in the case of a fourth violation within a 24-month period, $2,000;
p.001994: “(V) in the case of a fifth violation within a 36-month period, $5,000; and
p.001994: “(VI) in the case of a sixth or subsequent violation within a 48-month period,
p.001994: $10,000 as determined by the Secretary on a case-by-case basis.
p.001994: “(B) TRAINING PROGRAM.—For purposes of subparagraph (A), the term ‘approved training
p.001994: program’ means a training program that complies with standards developed by the Food and
p.001994: Drug Administration for such programs.
p.001994: “(C) CONSIDERATION OF STATE PENALTIES.—The Secretary shall coordinate with the States in
p.001994: enforcing the provisions of this Act [probably means div. A of Pub. L. 111–31, see Short Title of
p.001994: 2009 Amendment note set out under section 301 of this title and Tables for classifications] and,
p.001994: for purposes of mitigating a civil penalty to be applied for a violation by a retailer of any
p.001994: restriction promulgated under section 906(d) [21 U.S.C. 387f(d)], shall consider the amount of
p.001994: any penalties paid by the retailer to a State for the same violation.”
p.001994: CONSTRUCTION OF 2011 AMENDMENT
p.001994: Nothing in amendment by Pub. L. 111–353 to be construed to alter jurisdiction and authorities
p.001994: established under certain other Acts or in a manner inconsistent with international agreements to
p.001994: which the United States is a party, see sections 2251 and 2252 of this title.
p.001994: ENFORCEMENT
p.001994: Pub. L. 99–660, title I, §103, Nov. 14, 1986, 100 Stat. 3751, provided that: “For the fines
p.001994: authorized to be imposed under section 303 of the Federal Food, Drug, and Cosmetic Act [21
p.001994: U.S.C. 333], see section 3623 of title 18, United States Code, for the period ending October 31,
p.001994: 1986 [probably should be October 31, 1987], and sections 3559 and 3571 of such title for the
p.001994: period beginning November 1, 1986 [probably should be November 1, 1987].”
p.001994:
p.001994: 1 So in original. Words “of this section” probably should not appear.
p.001994:
p.001994: 2 See References in Text note below.
p.001994:
p.001994:
p.001994:
p.001994: §333a. Repealed. Pub. L. 101–647, title XIX, §1905, Nov. 29, 1990, 104
p.001994: Stat. 4853
p.001994: Section, Pub. L. 100–690, title II, §2401, Nov. 18, 1988, 102 Stat. 4230, related to forfeiture and
p.001994: illegal trafficking in steroids or human growth hormones.
p.001994:
p.001994:
p.001994: §334. Seizure
p.001994: (a) Grounds and jurisdiction
p.001994: (1) Any article of food, drug, or cosmetic that is adulterated or misbranded when
p.001994: introduced into or while in interstate commerce or while held for sale (whether or not the
p.001994: first sale) after shipment in interstate commerce, or which may not, under the provisions of
p.001994: section 331(ll), 344, or 355 of this title, be introduced into interstate commerce, shall be
p.001994: liable to be proceeded against while in interstate commerce, or at any time thereafter, on
p.001994: libel of information and condemned in any district court of the United States or United
p.001994: States court of a Territory within the jurisdiction of which the article is found. No libel for
p.001994: condemnation shall be instituted under this chapter, for any alleged misbranding if there is
p.001994: pending in any court a libel for condemnation proceeding under this chapter based upon the
p.001994: same alleged misbranding, and not more than one such proceeding shall be instituted if no
p.001994: such proceeding is so pending, except that such limitations shall not apply (A) when such
p.001994: misbranding has been the basis of a prior judgment in favor of the United States, in a
p.001994: criminal, injunction, or libel for condemnation proceeding under this chapter, or (B) when the
p.001994: Secretary has probable cause to believe from facts found, without hearing, by him or any
p.001994: officer or employee of the Department that the misbranded article is dangerous to health, or
p.001994: that the labeling of the misbranded article is fraudulent, or would be in a material respect
p.001994: misleading to the injury or damage of the purchaser or consumer. In any case where the
p.001994: number of libel for condemnation proceedings is limited as above provided the proceeding
p.001994: pending or instituted shall, on application of the claimant, seasonably made, be removed for
p.001994: trial to any district agreed upon by stipulation between the parties, or, in case of failure to so
p.001994: stipulate within a reasonable time, the claimant may apply to the court of the district in
p.001994: which the seizure has been made, and such court (after giving the United States attorney
p.001994: for such district reasonable notice and opportunity to be heard) shall by order, unless good
p.001994: cause to the contrary is shown, specify a district of reasonable proximity to the claimant's
p.001994: principal place of business, to which the case shall be removed for trial.
p.001994: (2) The following shall be liable to be proceeded against at any time on libel of
p.001994: information and condemned in any district court of the United States or United States court
p.001994: of a Territory within the jurisdiction of which they are found: (A) Any drug that is a counterfeit
p.001994: drug, (B) Any container of a counterfeit drug, (C) Any punch, die, plate, stone, labeling,
p.001994: container, or other thing used or designed for use in making a counterfeit drug or drugs, (D)
p.001994: Any adulterated or misbranded device, and (E) Any adulterated or misbranded tobacco
p.001994: product.
p.001994: (3)(A) Except as provided in subparagraph (B), no libel for condemnation may be
p.001994: instituted under paragraph (1) or (2) against any food which—
p.001994: (i) is misbranded under section 343(a)(2) of this title because of its advertising, and
p.001994: (ii) is being held for sale to the ultimate consumer in an establishment other than an
p.001994: establishment owned or operated by a manufacturer, packer, or distributor of the food.
p.001994:
p.001994: (B) A libel for condemnation may be instituted under paragraph (1) or (2) against a food
p.001994: described in subparagraph (A) if—
p.001994: (i)(I) the food's advertising which resulted in the food being misbranded under section
p.001994: 343(a)(2) of this title was disseminated in the establishment in which the food is being
p.001994: held for sale to the ultimate consumer,
p.001994: (II) such advertising was disseminated by, or under the direction of, the owner or
p.001994: operator of such establishment, or
p.001994: (III) all or part of the cost of such advertising was paid by such owner or operator; and
p.001994: (ii) the owner or operator of such establishment used such advertising in the
p.001994: establishment to promote the sale of the food.
p.001994: (b) Procedure; multiplicity of pending proceedings
p.001994: The article, equipment, or other thing proceeded against shall be liable to seizure by
p.001994: process pursuant to the libel, and the procedure in cases under this section shall conform,
p.001994: as nearly as may be, to the procedure in admiralty; except that on demand of either party
p.001994: any issue of fact joined in any such case shall be tried by jury. When libel for condemnation
...

p.001994: jurisdiction, shall be consolidated for trial by order of such court, and tried in (1) any district
p.001994: selected by the claimant where one of such proceedings is pending; or (2) a district agreed
p.001994: upon by stipulation between the parties. If no order for consolidation is so made within a
p.001994: reasonable time, the claimant may apply to the court of one such jurisdiction and such court
p.001994: (after giving the United States attorney for such district reasonable notice and opportunity to
p.001994: be heard) shall by order, unless good cause to the contrary is shown, specify a district of
p.001994: reasonable proximity to the claimant's principal place of business, in which all such pending
p.001994: proceedings shall be consolidated for trial and tried. Such order of consolidation shall not
p.001994: apply so as to require the removal of any case the date for trial of which has been fixed. The
p.001994: court granting such order shall give prompt notification thereof to the other courts having
p.001994: jurisdiction of the cases covered thereby.
p.001994: (c) Availability of samples of seized goods prior to trial
p.001994: The court at any time after seizure up to a reasonable time before trial shall by order
p.001994: allow any party to a condemnation proceeding, his attorney or agent, to obtain a
p.001994: representative sample of the article seized and a true copy of the analysis, if any, on which
p.001994: the proceeding is based and the identifying marks or numbers, if any, of the packages from
p.001994: which the samples analyzed were obtained.
p.001994: (d) Disposition of goods after decree of condemnation; claims for remission or
p.001994: mitigation of forfeitures
p.001994: (1) Any food, drug, device, tobacco product, or cosmetic condemned under this section
p.001994: shall, after entry of the decree, be disposed of by destruction or sale as the court may, in
p.001994: accordance with the provisions of this section, direct and the proceeds thereof, if sold, less
p.001994: the legal costs and charges, shall be paid into the Treasury of the United States; but such
p.001994: article shall not be sold under such decree contrary to the provisions of this chapter or the
p.001994: laws of the jurisdiction in which sold. After entry of the decree and upon the payment of the
p.001994: costs of such proceedings and the execution of a good and sufficient bond conditioned that
p.001994: such article shall not be sold or disposed of contrary to the provisions of this chapter or the
p.001994: laws of any State or Territory in which sold, the court may by order direct that such article
p.001994: be delivered to the owner thereof to be destroyed or brought into compliance with the
p.001994: provisions of this chapter, under the supervision of an officer or employee duly designated
p.001994: by the Secretary, and the expenses of such supervision shall be paid by the person
p.001994: obtaining release of the article under bond. If the article was imported into the United States
p.001994: and the person seeking its release establishes (A) that the adulteration, misbranding, or
p.001994: violation did not occur after the article was imported, and (B) that he had no cause for
p.001994: believing that it was adulterated, misbranded, or in violation before it was released from
p.001994: customs custody, the court may permit the article to be delivered to the owner for
p.001994: exportation in lieu of destruction upon a showing by the owner that all of the conditions of
p.001994: section 381(e) of this title can and will be met. The provisions of this sentence shall not
p.001994: apply where condemnation is based upon violation of section 342(a)(1), (2), or (6), section
p.001994: 351(a)(3), section 352(j), or section 361(a) or (d) of this title. Where such exportation is
p.001994: made to the original foreign supplier, then subparagraphs (A) and (B) of section 381(e)(1)
p.001994: of this title and the preceding sentence shall not be applicable; and in all cases of
p.001994: exportation the bond shall be conditioned that the article shall not be sold or disposed of
p.001994: until the applicable conditions of section 381(e) of this title have been met. Any person
p.001994: seeking to export an imported article pursuant to any of the provisions of this subsection
p.001994: shall establish that the article was intended for export at the time the article entered
p.001994: commerce. Any article condemned by reason of its being an article which may not, under
p.001994: section 344 or 355 of this title, be introduced into interstate commerce, shall be disposed of
p.001994: by destruction.
p.001994: (2) The provisions of paragraph (1) of this subsection shall, to the extent deemed
p.001994: appropriate by the court, apply to any equipment or other thing which is not otherwise within
p.001994: the scope of such paragraph and which is referred to in paragraph (2) of subsection (a) of
p.001994: this section.
p.001994: (3) Whenever in any proceeding under this section, involving paragraph (2) of subsection
p.001994: (a) of this section, the condemnation of any equipment or thing (other than a drug) is
p.001994: decreed, the court shall allow the claim of any claimant, to the extent of such claimant's
p.001994: interest, for remission or mitigation of such forfeiture if such claimant proves to the
p.001994: satisfaction of the court (i) that he has not committed or caused to be committed any
p.001994: prohibited act referred to in such paragraph (2) and has no interest in any drug referred to
p.001994: therein, (ii) that he has an interest in such equipment or other thing as owner or lienor or
p.001994: otherwise, acquired by him in good faith, and (iii) that he at no time had any knowledge or
p.001994: reason to believe that such equipment or other thing was being or would be used in, or to
p.001994: facilitate, the violation of laws of the United States relating to counterfeit drugs.
p.001994: (e) Costs
p.001994: When a decree of condemnation is entered against the article, court costs and fees, and
p.001994: storage and other proper expenses, shall be awarded against the person, if any, intervening
p.001994: as claimant of the article.
p.001994: (f) Removal of case for trial
p.001994: In the case of removal for trial of any case as provided by subsection (a) or (b) of this
p.001994: section—
p.001994: (1) The clerk of the court from which removal is made shall promptly transmit to the
p.001994: court in which the case is to be tried all records in the case necessary in order that such
p.001994: court may exercise jurisdiction.
p.001994: (2) The court to which such case was removed shall have the powers and be subject to
p.001994: the duties, for purposes of such case, which the court from which removal was made
p.001994: would have had, or to which such court would have been subject, if such case had not
p.001994: been removed.
p.001994: (g) Administrative restraint; detention orders
p.001994: (1) If during an inspection conducted under section 374 of this title of a facility or a
p.001994: vehicle, a device or tobacco product which the officer or employee making the inspection
p.001994: has reason to believe is adulterated or misbranded is found in such facility or vehicle, such
...

p.001994: under this paragraph may require the labeling or marking of a device or tobacco product
p.001994: during the period of its detention for the purpose of identifying the device or tobacco product
p.001994: as detained. Any person who would be entitled to claim a device or tobacco product if it
p.001994: were seized under subsection (a) of this section may appeal to the Secretary a detention of
p.001994: such device or tobacco product under this paragraph. Within five days of the date an appeal
p.001994: of a detention is filed with the Secretary, the Secretary shall after affording opportunity for
p.001994: an informal hearing by order confirm the detention or revoke it.
p.001994: (2)(A) Except as authorized by subparagraph (B), a device or tobacco product subject to
p.001994: a detention order issued under paragraph (1) shall not be moved by any person from the
p.001994: place at which it is ordered detained until—
p.001994: (i) released by the Secretary, or
p.001994: (ii) the expiration of the detention period applicable to such order,
p.001994:
p.001994: whichever occurs first.
p.001994: (B) A device subject to a detention order under paragraph (1) may be moved—
p.001994: (i) in accordance with regulations prescribed by the Secretary, and
p.001994: (ii) if not in final form for shipment, at the discretion of the manufacturer of the device
p.001994: for the purpose of completing the work required to put it in such form.
p.001994: (h) Administrative detention of foods
p.001994: (1) Detention authority
p.001994: (A) In general
p.001994: An officer or qualified employee of the Food and Drug Administration may order the
p.001994: detention, in accordance with this subsection, of any article of food that is found during
p.001994: an inspection, examination, or investigation under this chapter conducted by such
p.001994: officer or qualified employee, if the officer or qualified employee has reason to believe
p.001994: that such article is adulterated or misbranded.
p.001994: (B) Secretary's approval
p.001994: An article of food may be ordered detained under subparagraph (A) only if the
p.001994: Secretary or an official designated by the Secretary approves the order. An official may
p.001994: not be so designated unless the official is the director of the district under this chapter
p.001994: in which the article involved is located, or is an official senior to such director.
p.001994: (2) Period of detention
p.001994: An article of food may be detained under paragraph (1) for a reasonable period, not to
p.001994: exceed 20 days, unless a greater period, not to exceed 30 days, is necessary, to enable
p.001994: the Secretary to institute an action under subsection (a) of this section or section 332 of
p.001994: this title. The Secretary shall by regulation provide for procedures for instituting such
p.001994: action on an expedited basis with respect to perishable foods.
p.001994: (3) Security of detained article
p.001994: An order under paragraph (1) with respect to an article of food may require that such
p.001994: article be labeled or marked as detained, and shall require that the article be removed to
p.001994: a secure facility, as appropriate. An article subject to such an order shall not be
p.001994: transferred by any person from the place at which the article is ordered detained, or from
...

p.001994: sentence.
p.001994: Subsec. (g)(1). Pub. L. 111–31, §103(d)(3), inserted “or tobacco product” after “device”
p.001994: wherever appearing.
p.001994: Subsec. (g)(2)(A). Pub. L. 111–31, §103(d)(4), inserted “or tobacco product” after “device” in
p.001994: introductory provisions.
p.001994: 2007—Subsec. (a)(1). Pub. L. 110–85 substituted “section 331(ll), 344, or 355” for “section 344
p.001994: or 355”.
p.001994: 2002—Subsec. (h). Pub. L. 107–188 added subsec. (h).
p.001994: 1997—Subsec. (d)(1). Pub. L. 105–115 substituted “subparagraphs (A) and (B) of section
p.001994: 381(e)(1) of this title” for “paragraphs (1) and (2) of section 381(e) of this title” and inserted “Any
p.001994: person seeking to export an imported article pursuant to any of the provisions of this subsection
p.001994: shall establish that the article was intended for export at the time the article entered commerce.”
p.001994: before “Any article condemned by reason”.
p.001994: 1993—Subsec. (a)(1). Pub. L. 103–80, §3(f)(1), substituted “found. No libel” for “found:
p.001994: Provided, however, That no libel”.
p.001994: Subsec. (d)(1). Pub. L. 103–80, §3(f)(2), substituted “sold. After entry” for “sold: Provided, That
p.001994: after entry”, “met. The provisions of this sentence” for “met: Provided, however, That the
p.001994: provisions of this sentence”, “title. Where such exportation” for “title: And provided further, That
p.001994: where such exportation”, and “the preceding sentence shall not be applicable” for “the foregoing
p.001994: proviso shall not be applicable”.
p.001994: 1992—Subsec. (d)(1). Pub. L. 102–300 substituted “381(e)” for “381(d)” in three places and
p.001994: “paragraphs” for “clauses” before “(1) and (2) of section 381(e)”.
p.001994: 1976—Subsec. (a)(1). Pub. L. 94–295, §3(c)(1), struck out “device,” after “Any article of food,
p.001994: drug,”.
p.001994: Subsec. (a)(2). Pub. L. 94–295, §3(c)(2), (3), added cl. (D) covering adulterated or misbranded
p.001994: devices.
p.001994: Subsec. (a)(3). Pub. L. 94–278 added par. (3).
p.001994: Subsec. (g). Pub. L. 94–295, §7(a), added subsec. (g).
p.001994: 1970—Subsec. (a)(2). Pub. L. 91–513, §701(c), struck out cls. (A) and (D) which dealt with
p.001994: depressant or stimulant drugs, struck out reference to depressant or stimulant drugs in cl. (C), and
p.001994: redesignated cls. (B), (C), and (E) as cls. (A), (B), and (C), respectively.
p.001994: Subsec. (d)(3)(iii). Pub. L. 91–513, §701(d), struck out reference to depressant or stimulant
p.001994: drugs.
p.001994: 1968—Subsec. (a). Pub. L. 90–639 inserted references to the United States courts of
p.001994: Territories.
p.001994: 1965—Subsec. (a). Pub. L. 89–74, §6(a), designated existing provisions as par. (1),
p.001994: redesignated cls. (1) and (2) of proviso as (A) and (B), and added par. (2).
p.001994: Subsec. (b). Pub. L. 89–74, §6(b)(1), inserted “equipment, or other thing proceeded against”
p.001994: after “article” in first sentence.
p.001994: Subsec. (d). Pub. L. 89–74, §6(b)(2), designated existing provisions as par. (1), redesignated
p.001994: cls. (1) and (2) of the second sentence thereof as (A) and (B), and added pars. (2) and (3).
p.001994: 1957—Subsec. (d). Pub. L. 85–250 permitted, under certain circumstances, reexportation of
p.001994: articles condemned at places other than original port of entry.
p.001994: 1953—Subsec. (c). Act Aug. 7, 1953, provided that a true copy of the analysis in any case shall
p.001994: be furnished the owner.
p.001994: 1948—Subsec. (a). Act June 24, 1948, inserted “or while held for sale (whether or not the first
p.001994: sale) after shipment in interstate commerce” to make this subsection coextensive with section
p.001994: 331(k) of this title.
p.001994: EFFECTIVE DATE OF 2011 AMENDMENT
...

p.001994: [amending this section and sections 321, 333, and 343 of this title] shall take effect 180 days after
p.001994: the date of the enactment of this Act [Apr. 22, 1976].”
p.001994: EFFECTIVE DATE OF 1970 AMENDMENT
p.001994: Amendment by Pub. L. 91–513 effective on first day of seventh calendar month that begins
p.001994: after Oct. 26, 1970, see section 704 of Pub. L. 91–513, set out as an Effective Date note under
p.001994: section 801 of this title.
p.001994: EFFECTIVE DATE OF 1968 AMENDMENT
p.001994: Amendment by Pub. L. 90–639 applicable only with respect to violations of this chapter
p.001994: committed after Oct. 24, 1968, see section 6 of Pub. L. 90–639, set out as an Effective Date of
p.001994: 1968 Amendments; Transitional Provisions note under section 321 of this title.
p.001994: EFFECTIVE DATE OF 1965 AMENDMENT
p.001994: Amendment by Pub. L. 89–74 effective Feb. 1, 1966, see section 11 of Pub. L. 89–74, set out
p.001994: as a note under section 321 of this title.
p.001994: REGULATIONS
p.001994: Pub. L. 111–353, title II, §207(b), Jan. 4, 2011, 124 Stat. 3944, provided that: “Not later than
p.001994: 120 days after the date of enactment of this Act [Jan. 4, 2011], the Secretary shall issue an
p.001994: interim final rule amending subpart K of part 1 of title 21, Code of Federal Regulations, to
p.001994: implement the amendment made by this section [amending this section].”
p.001994: SAVINGS PROVISION
p.001994: Amendment by Pub. L. 91–513 not to affect or abate any prosecutions for any violation of law or
p.001994: any civil seizures or forfeitures and injunctive proceedings commenced prior to the effective date
p.001994: of such amendment, and all administrative proceedings pending before the Bureau of Narcotics
p.001994: and Dangerous Drugs [now the Drug Enforcement Administration] on Oct. 27, 1970, to be
p.001994: continued and brought to final determination in accord with laws and regulations in effect prior to
p.001994: Oct. 27, 1970, see section 702 of Pub. L. 91–513, set out as a note under section 321 of this title.
p.001994: CONSTRUCTION OF 2011 AMENDMENT
p.001994: Nothing in amendment by Pub. L. 111–353 to be construed to alter jurisdiction and authorities
p.001994: established under certain other Acts or in a manner inconsistent with international agreements to
p.001994: which the United States is a party, see sections 2251 and 2252 of this title.
p.001994: TRANSFER OF FUNCTIONS
p.001994: For transfer of functions of Federal Security Administrator to Secretary of Health, Education,
p.001994: and Welfare [now Health and Human Services], and of Food and Drug Administration in the
p.001994: Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this
p.001994: title.
p.001994:
p.001994:
p.001994: §335. Hearing before report of criminal violation
p.001994: Before any violation of this chapter is reported by the Secretary to any United States
p.001994: attorney for institution of a criminal proceeding, the person against whom such proceeding
p.001994: is contemplated shall be given appropriate notice and an opportunity to present his views,
p.001994: either orally or in writing, with regard to such contemplated proceeding.
p.001994: (June 25, 1938, ch. 675, §305, 52 Stat. 1045.)
p.001994: TRANSFER OF FUNCTIONS
p.001994: For transfer of functions of Federal Security Administrator to Secretary of Health, Education,
p.001994: and Welfare [now Health and Human Services], and of Food and Drug Administration in the
p.001994: Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this
p.001994: title.
p.001994:
p.001994:
p.001994: §335a. Debarment, temporary denial of approval, and suspension
p.001994: (a) Mandatory debarment; certain drug applications
p.001994: (1) Corporations, partnerships, and associations
p.001994: If the Secretary finds that a person other than an individual has been convicted, after
p.001994: May 13, 1992, of a felony under Federal law for conduct relating to the development or
p.001994: approval, including the process for development or approval, of any abbreviated drug
p.001994: application, the Secretary shall debar such person from submitting, or assisting in the
p.001994: submission of, any such application.
p.001994: (2) Individuals
p.001994: If the Secretary finds that an individual has been convicted of a felony under Federal
p.001994: law for conduct—
p.001994: (A) relating to the development or approval, including the process for development or
p.001994: approval, of any drug product, or
p.001994: (B) otherwise relating to the regulation of any drug product under this chapter,
p.001994:
p.001994: the Secretary shall debar such individual from providing services in any capacity to a
p.001994: person that has an approved or pending drug product application.
p.001994: (b) Permissive debarment; certain drug applications; food imports
p.001994: (1) In general
p.001994: The Secretary, on the Secretary's own initiative or in response to a petition, may, in
p.001994: accordance with paragraph (2), debar—
p.001994: (A) a person other than an individual from submitting or assisting in the submission of
p.001994: any abbreviated drug application,
p.001994: (B) an individual from providing services in any capacity to a person that has an
p.001994: approved or pending drug product application, or
p.001994: (C) a person from importing an article of food or offering such an article for import
p.001994: into the United States.
p.001994: (2) Persons subject to permissive debarment; certain drug applications
p.001994: The following persons are subject to debarment under subparagraph (A) or (B) of
p.001994: paragraph (1):
p.001994: (A) Corporations, partnerships, and associations
p.001994: Any person other than an individual that the Secretary finds has been convicted—
p.001994: (i) for conduct that—
p.001994: (I) relates to the development or approval, including the process for the
p.001994: development or approval, of any abbreviated drug application; and
p.001994: (II) is a felony under Federal law (if the person was convicted before May 13,
p.001994: 1992), a misdemeanor under Federal law, or a felony under State law, or
p.001994:
p.001994: (ii) of a conspiracy to commit, or aiding or abetting, a criminal offense described in
p.001994: clause (i) or a felony described in subsection (a)(1) of this section,
p.001994:
p.001994: if the Secretary finds that the type of conduct which served as the basis for such
p.001994: conviction undermines the process for the regulation of drugs.
p.001994: (B) Individuals
p.001994: (i) Any individual whom the Secretary finds has been convicted of—
p.001994: (I) a misdemeanor under Federal law or a felony under State law for conduct
p.001994: relating to the development or approval, including the process for development or
p.001994: approval, of any drug product or otherwise relating to the regulation of drug products
p.001994: under this chapter, or
p.001994: (II) a conspiracy to commit, or aiding or abetting, such criminal offense or a felony
p.001994: described in subsection (a)(2) of this section,
p.001994:
p.001994: if the Secretary finds that the type of conduct which served as the basis for such
p.001994: conviction undermines the process for the regulation of drugs.
p.001994: (ii) Any individual whom the Secretary finds has been convicted of—
p.001994: (I) a felony which is not described in subsection (a)(2) of this section or clause (i)
p.001994: of this subparagraph and which involves bribery, payment of illegal gratuities, fraud,
p.001994: perjury, false statement, racketeering, blackmail, extortion, falsification or destruction
p.001994: of records, or interference with, obstruction of an investigation into, or prosecution of,
p.001994: any criminal offense, or
p.001994: (II) a conspiracy to commit, or aiding or abetting, such felony,
p.001994:
p.001994: if the Secretary finds, on the basis of the conviction of such individual and other
p.001994: information, that such individual has demonstrated a pattern of conduct sufficient to find that
p.001994: there is reason to believe that such individual may violate requirements under this chapter
p.001994: relating to drug products.
p.001994: (iii) Any individual whom the Secretary finds materially participated in acts that were
p.001994: the basis for a conviction for an offense described in subsection (a) of this section or in
p.001994: clause (i) or (ii) for which a conviction was obtained, if the Secretary finds, on the basis
p.001994: of such participation and other information, that such individual has demonstrated a
p.001994: pattern of conduct sufficient to find that there is reason to believe that such individual
p.001994: may violate requirements under this chapter relating to drug products.
p.001994: (iv) Any high managerial agent whom the Secretary finds—
p.001994: (I) worked for, or worked as a consultant for, the same person as another
p.001994: individual during the period in which such other individual took actions for which a
p.001994: felony conviction was obtained and which resulted in the debarment under
p.001994: subsection (a)(2) of this section, or clause (i), of such other individual,
p.001994: (II) had actual knowledge of the actions described in subclause (I) of such other
p.001994: individual, or took action to avoid such actual knowledge, or failed to take action for
p.001994: the purpose of avoiding such actual knowledge,
p.001994: (III) knew that the actions described in subclause (I) were violative of law, and
p.001994: (IV) did not report such actions, or did not cause such actions to be reported, to an
p.001994: officer, employee, or agent of the Department or to an appropriate law enforcement
p.001994: officer, or failed to take other appropriate action that would have ensured that the
p.001994: process for the regulation of drugs was not undermined, within a reasonable time
p.001994: after such agent first knew of such actions,
p.001994:
p.001994: if the Secretary finds that the type of conduct which served as the basis for such other
p.001994: individual's conviction undermines the process for the regulation of drugs.
p.001994: (3) Persons subject to permissive debarment; food importation
p.001994: A person is subject to debarment under paragraph (1)(C) if—
p.001994: (A) the person has been convicted of a felony for conduct relating to the importation
p.001994: into the United States of any food; or
p.001994: (B) the person has engaged in a pattern of importing or offering for import
p.001994: adulterated food that presents a threat of serious adverse health consequences or
p.001994: death to humans or animals.
p.001994: (4) Stay of certain orders
p.001994: An order of the Secretary under clause (iii) or (iv) of paragraph (2)(B) shall not take
p.001994: effect until 30 days after the order has been issued.
p.001994: (c) Debarment period and considerations
p.001994: (1) Effect of debarment
p.001994: The Secretary—
p.001994: (A) shall not accept or review (other than in connection with an audit under this
p.001994: section) any abbreviated drug application submitted by or with the assistance of a
p.001994: person debarred under subsection (a)(1) or (b)(2)(A) of this section during the period
p.001994: such person is debarred,
p.001994: (B) shall, during the period of a debarment under subsection (a)(2) or (b)(2)(B) of this
p.001994: section, debar an individual from providing services in any capacity to a person that has
p.001994: an approved or pending drug product application and shall not accept or review (other
p.001994: than in connection with an audit under this section) an abbreviated drug application
p.001994: from such individual, and
p.001994: (C) shall, if the Secretary makes the finding described in paragraph (6) or (7) of
p.001994: section 335b(a) of this title, assess a civil penalty in accordance with section 335b of
p.001994: this title.
p.001994: (2) Debarment periods
p.001994: (A) In general
p.001994: The Secretary shall debar a person under subsection (a) or (b) of this section for the
p.001994: following periods:
p.001994: (i) The period of debarment of a person (other than an individual) under subsection
p.001994: (a)(1) of this section shall not be less than 1 year or more than 10 years, but if an act
p.001994: leading to a subsequent debarment under subsection (a) of this section occurs within
p.001994: 10 years after such person has been debarred under subsection (a)(1) of this
p.001994: section, the period of debarment shall be permanent.
p.001994: (ii) The debarment of an individual under subsection (a)(2) of this section shall be
p.001994: permanent.
p.001994: (iii) The period of debarment of any person under paragraph (2) or (3) of
p.001994: subsection (b) of this section shall not be more than 5 years.
p.001994:
p.001994: The Secretary may determine whether debarment periods shall run concurrently or
p.001994: consecutively in the case of a person debarred for multiple offenses.
p.001994: (B) Notification
p.001994: Upon a conviction for an offense described in subsection (a) or (b) of this section or
p.001994: upon execution of an agreement with the United States to plead guilty to such an
p.001994: offense, the person involved may notify the Secretary that the person acquie