§ 342. Adulterated food

Footnotes

1. 1 So in original. The period probably should be “; or”.
2. 2 So in original. Probably should be “subparagraph”.

Legislative history

Reconstructed from this section’s Code source credit and amendment notes, resolved against the local Statutes at Large. Editorial notes are evidence, not the law that made the change.

1. 1938

   Pub. L. 75–675 § 402 · 52 Stat. 1040

   Enacted · 21 U.S.C. § 342

   June 25, 1938, ch. 675, § 402, 52 Stat. 1046

   Source evidence

   Code source credit
   June 25, 1938, ch. 675, § 402, 52 Stat. 1046

   Enacted provision · exact public law section
   Sec. 402. adulterated food A food shall be deemed to be adulterated— (a) (1) If it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance such food shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health; or (2) if it bears or Post, p. 1049. contains any added poisonous or added deleterious substance which is unsafe within the meaning of section 406; or (3) if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food; or (4) if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health; or (5) if it is, in whole or in part, the product of a diseased animal or of an animal which has died otherwise than by slaughter; or (6) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health. (b) (1) If any valuable constituent has been in whole or in part omitted or abstracted therefrom; or (2) if any substance has been substituted wholly or in part therefor; or (3) if damage or inferiority has been concealed in any manner; or (4) if any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is. (c) If it bears or contains a coal-tar color other than one from a Coal-tar color other than in accordance with regulations. Post, p. 1049. Proviso. Citrus fruits. batch that has been certified in accordance with regulations as provided by section 406: Provided, That this paragraph shall not apply to citrus fruit bearing or containing a coal-tar color if application for listing of such color has been made under this Act and such application has not been acted on by the Secretary, if such color was commonly used prior to the enactment of this Act for the purpose of coloring citrus fruit. (d) If it is confectionery, and it bears or contains any alcohol or Confectionery, containing alcohol, etc. nonnutritive article or substance except harmless coloring, harmless flavoring, harmless resinous glaze not in excess of four-tenths of 1 per centum, natural gum, and pectin: Provided, That this paragraph shall Proviso. Exemptions. not apply to any confectionery by reason of its containing less than one-half of 1 per centum by volume of alcohol derived solely from the use of flavoring extracts, or to any chewing gum by reason of its containing harmless nonnutritive masticatory substances.

2. 1950

   Public Law not identified

   Added · 21 U.S.C. § 342(e)

   Par. (e). Act Mar. 16, 1950, added par. (e)

   Unresolved: No Public Law or Statutes at Large citation in the Code source.

   Source evidence

   Code amendment note
   Par. (e). Act Mar. 16, 1950, added par. (e).

3. 1954

   Public Law not identified

   Changed · 21 U.S.C. § 342(a)(2)

   Par. (a)(2). Act July 22, 1954, provided in the case of any raw agricultural commodity bearing or containing a pesticide chemical, that such commodity shall be deemed to be adulterated if such pesticide chemical is unsafe within the meaning of section 346a of this title

   Unresolved: No Public Law or Statutes at Large citation in the Code source.

   Source evidence

   Code amendment note
   Par. (a)(2). Act July 22, 1954, provided in the case of any raw agricultural commodity bearing or containing a pesticide chemical, that such commodity shall be deemed to be adulterated if such pesticide chemical is unsafe within the meaning of section 346a of this title.

4. 1956

   Public Law not identified

   Inserted · 21 U.S.C. § 342(c)

   Par. (c). Act July 9, 1956, inserted second proviso relating to coloring of oranges

   Unresolved: No Public Law or Statutes at Large citation in the Code source.

   Source evidence

   Code amendment note
   Par. (c). Act July 9, 1956, inserted second proviso relating to coloring of oranges.

5. 1958

   Food Additives Amendment of 1958

   Pub. L. 85–929 § 3(a) · 72 Stat. 1784

   1. Inserted · 21 U.S.C. § 342(a)

      Pub. L. 85–929, among other changes, inserted cl. (2)(C) relating to food additive unsafe within the meaning of section 348 of this title, and to pesticide chemical

   2. Added · 21 U.S.C. § 342(a)

      Pub. L. 85–929, among other changes, added cl. (7) relating to radiated food

   Source evidence

   Code amendment note
   Par. (a). Pub. L. 85–929, among other changes, inserted cl. (2)(C) relating to food additive unsafe within the meaning of section 348 of this title, and to pesticide chemical, and added cl. (7) relating to radiated food.

   Enacted provision · exact public law section
   (a) Clause (2) of section 402 (a), as amended, of such Act Insanitary ingredients. 21 USC 342. is amended to read as follows: “(2) (A) if it bears or contains any added poisonous or added deleterious substance (except a pesticide chemical in or on a raw agricultural commodity and except a food additive) which is unsafe within the meaning of section 406, or (B) if it is a raw agricultural commodity and it bears or contains a pesticide chemical which is unsafe within the meaning of section 408 (a), or (C) if it is, or it bears or contains, any food additive which is unsafe within the meaning of section 409: Provided, That where a pesticide chemical has been used in or on a raw agricultural commodity in conformity with an exemption granted or a tolerance prescribed under section 408 and such raw agricultural commodity has been subjected to processing such as canning, cooking, freezing, dehydrating, or milling, the residue of such pesticide chemical remaining in or on such processed food shall, notwithstanding the provisions of sections 406 and 409, not be deemed unsafe if such residue in or on the raw agricultural commodity has been removed to the extent possible in good manufacturing practice and the concentration of such residue in the processed food when ready to eat is not greater than the tolerance prescribed for the raw agricultural commodity;”.

6. 1959

   Pub. L. 86–2 · 73 Stat. 3

   Inserted · 21 U.S.C. § 342(c)

   Pub. L. 86–2 extended from Mar. 1, 1959, to May 1, 1959, the period during which par. is inapplicable to oranges which have been colored with F.D. & C. Red 32, and inserted proviso requiring Secretary to establish regulations prescribing the conditions under which Citrus Red No. 2 may be safely used in coloring certain mature oranges, and providing for separately listing and for certification of batches of such color

   Source evidence

   Code amendment note
   Par. (c). Pub. L. 86–2 extended from Mar. 1, 1959, to May 1, 1959, the period during which par. is inapplicable to oranges which have been colored with F.D. & C. Red 32, and inserted proviso requiring Secretary to establish regulations prescribing the conditions under which Citrus Red No. 2 may be safely used in coloring certain mature oranges, and providing for separately listing and for certification of batches of such color.

7. 1960

   Color Additive Amendments of 1960

   Pub. L. 86–618 § 102(a)(1) · 74 Stat. 397

   Substituted · 21 U.S.C. § 342(a)

   Pub. L. 86–618, § 102(a)(1), substituted “other than one which is (i) a pesticide chemical in or on a raw agricultural commodity; (ii) a food additive; or (iii) a color additive” for “(except a pesticide chemical in or on a raw agricultural commodity and except a food additive)” in cl. (2)(A)

   Source evidence

   Code amendment note
   Par. (a). Pub. L. 86–618, § 102(a)(1), substituted “other than one which is (i) a pesticide chemical in or on a raw agricultural commodity; (ii) a food additive; or (iii) a color additive” for “(except a pesticide chemical in or on a raw agricultural commodity and except a food additive)” in cl. (2)(A).

   Enacted provision · exact public law section
   (1) Clause (2)(A) of section 402(a), as amended, 52 Stat. 1040. 21 USC 342. of such Act (relating to food deemed adulterated by reason of unsafe additives) is further amended by striking out the matter within the parentheses and inserting in lieu thereof the following: “other than one which is (i) a pesticide chemical in or on a raw agricultural commodity; (ii) a food additive; or (iii) a color additive”.

8. 1960

   Color Additive Amendments of 1960

   Pub. L. 86–618 § 102(a)(2) · 74 Stat. 397

   1. Amended · 21 U.S.C. § 342(c)

      Pub. L. 86–618, § 102(a)(2), amended par. (c) generally

   2. Substituted · 21 U.S.C. § 342(c)

      Pub. L. 86–618, § 102(a)(2), substituting provisions deeming a food adulterated if it is, or it bears or contains, a color additive which is unsafe within the meaning of section 376 of this title for provisions which related to food that bears or contains a coal-tar color other than one from a batch that has been certified in accordance with regulations as provided by section 346 of this title

   3. Struck · 21 U.S.C. § 342(c)

      Pub. L. 86–618, § 102(a)(2), struck out provisos which related to the use of color on oranges

   Source evidence

   Code amendment note
   Par. (c). Pub. L. 86–618, § 102(a)(2), amended par. (c) generally, substituting provisions deeming a food adulterated if it is, or it bears or contains, a color additive which is unsafe within the meaning of section 376 of this title for provisions which related to food that bears or contains a coal-tar color other than one from a batch that has been certified in accordance with regulations as provided by section 346 of this title, and struck out provisos which related to the use of color on oranges.

   Enacted provision · exact public law section
   (2) Section 402(c), as amended, of such Act (relating to food deemed adulterated by reason of uncertified coaltar color) is amended to read as follows: “(c) If it is, or it bears or contains, a color additive which is unsafe within the meaning of section 706(a).”

9. 1960

   Color Additive Amendments of 1960

   Pub. L. 86–618 § 105(c) · 74 Stat. 397

   Substituted · 21 U.S.C. § 342(d)

   Pub. L. 86–618, § 105(c), substituted “authorized coloring” for “harmless coloring”

   Source evidence

   Code amendment note
   Par. (d). Pub. L. 86–618, § 105(c), substituted “authorized coloring” for “harmless coloring”.

   Enacted provision · exact public law section
   (c) striking out “harmless coloring” in section 402(d) (relating to nonnutritive substances in confectionery) and inserting in lieu thereof “authorized coloring”.

10. 1966

    Pub. L. 89–477 · 80 Stat. 231

    Added · 21 U.S.C. § 342(d)

    Pub. L. 89–477 permitted the imbedding of nonnutritive objects in confectionery foods if in the judgment of the Secretary of Health, Education, and Welfare, as provided by regulation, the imbedding of the object is of practical functional value to the confectionery product and would not render it injurious or hazardous to health, raised to one-half of 1 per centum by volume the upper limit for the allowable use of alcohol derived solely from the use of flavoring extracts, allowed the use of safe nonnutritive substances in and on confectionery foods by reason of their use for some practical and functional purpose in the manufacture, packaging, or storage of the confectionery foods if the use of the substances does not promote deception of the consumer or otherwise result in adulteration or misbranding, authorized the Secretary to issue regulations on the use of particular nonnutritive substances, and removed reference to nonnutritive masticatory substances added to chewing gum and harmless flavoring, harmless resinous glaze not in excess of four-tenths of 1 per centum, natural gum, authorized coloring, and pectin

    Source evidence

    Code amendment note
    Par. (d). Pub. L. 89–477 permitted the imbedding of nonnutritive objects in confectionery foods if in the judgment of the Secretary of Health, Education, and Welfare, as provided by regulation, the imbedding of the object is of practical functional value to the confectionery product and would not render it injurious or hazardous to health, raised to one-half of 1 per centum by volume the upper limit for the allowable use of alcohol derived solely from the use of flavoring extracts, allowed the use of safe nonnutritive substances in and on confectionery foods by reason of their use for some practical and functional purpose in the manufacture, packaging, or storage of the confectionery foods if the use of the substances does not promote deception of the consumer or otherwise result in adulteration or misbranding, authorized the Secretary to issue regulations on the use of particular nonnutritive substances, and removed reference to nonnutritive masticatory substances added to chewing gum and harmless flavoring, harmless resinous glaze not in excess of four-tenths of 1 per centum, natural gum, authorized coloring, and pectin.

11. 1968

    Animal Drug Amendments of 1968

    Pub. L. 90–399 § 104 · 82 Stat. 342

    Added · 21 U.S.C. § 342(a)(2)

    Pub. L. 90–399 added cls. (A)(iv) and (D)

    Source evidence

    Code amendment note
    Par. (a)(2). Pub. L. 90–399 added cls. (A)(iv) and (D).

    Enacted provision · exact public law section
    Sec. 104. animal dregs in feeds and residues thereof in other food Section 402 of the Federal Food, Drug, and Cosmetic Act, as amended, is amended by— (1) striking out the word “or” before “(iii)” in clause (A) of subparagraph (2) of paragraph (a) and inserting “; or (iv) a new animal drug” after the words “color additive” therein; and (2) adding before the semicolon following “commodity” at the end of the proviso to clause (Cl of subparagraph (2) of paragraph (a) the following: “; or (D) if it is, or it rears or contains, a new animal drug (or conversion product thereof) which is unsafe within the meaning of section 512”.

12. 1986

    Comprehensive Smokeless Tobacco Health Education Act of 1986

    Pub. L. 99–252 § 10 · 100 Stat. 30

    Inserted · 21 U.S.C. § 342(d)(2)

    Pub. L. 99–252 inserted provision that this clause not apply to confectionery introduced or delivered for introduction into or received or held for sale in, interstate commerce if the sale is permitted under the laws of the State in which the confectionery is intended to be offered for sale

    Source evidence

    Code amendment note
    Par. (d)(2). Pub. L. 99–252 inserted provision that this clause not apply to confectionery introduced or delivered for introduction into or received or held for sale in, interstate commerce if the sale is permitted under the laws of the State in which the confectionery is intended to be offered for sale.

    Enacted provision · exact public law section
    SEC. 10. TECHNICAL AMENDMENT. Section 402(d)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(d)(2)) is amended by inserting before the semicolon a comma and the following: “except that this clause shall not apply to confectionery which is introduced or delivered for introduction into, or received or held for sale in, interstate commerce if the sale of such confectionery is permitted under the laws of the State in which such confectionery is intended to be offered for sale”.

13. 1992

    Prescription Drug User Fee Act of 1992

    Pub. L. 102–571 title I § 107(4) · 106 Stat. 4491

    Substituted · 21 U.S.C. § 342(c)

    Pub. L. 102–571 substituted “379e(a)” for “376(a)”

    Source evidence

    Code amendment note
    Par. (c). Pub. L. 102–571 substituted “379e(a)” for “376(a)”.

    Enacted provision · exact public law section
    (4) Section 402(c) (21 U.S.C. 342(c)) is amended by striking out “706” and inserting in lieu thereof “721”.

14. 1993

    Nutrition Labeling and Education Act Amendments of 1993

    Pub. L. 103–80 § 3(i)(1) · 107 Stat. 773

    Substituted · 21 U.S.C. § 342(a)

    Pub. L. 103–80, § 3(i)(1), substituted a period for “; or” at end of subpar. (1) and “If it” for “if it” at beginning of par. (3). That part of Pub. L. 103–80, § 3(i)(1), which directed the substitution of a period for “; or” at end of subpar. (2) could not be executed because “; or” did not appear

    Source evidence

    Code amendment note
    Par. (a). Pub. L. 103–80, § 3(i)(1), substituted a period for “; or” at end of subpar. (1) and “If it” for “if it” at beginning of par. (3). That part of Pub. L. 103–80, § 3(i)(1), which directed the substitution of a period for “; or” at end of subpar. (2) could not be executed because “; or” did not appear.

    Enacted provision · exact public law section
    (1) by striking out “; or” at the end of subparagraphs (1) and (2) of paragraph (a) and inserting in lieu thereof a period and by striking out “if it” at the beginning of subparagraph (3) of such paragraph and inserting in lieu thereof “If it”,

15. 1993

    Nutrition Labeling and Education Act Amendments of 1993

    Pub. L. 103–80 § 3(i)(2) · 107 Stat. 773

    Substituted · 21 U.S.C. § 342(d)(1)

    Pub. L. 103–80, § 3(i)(2), substituted “, except that this subparagraph” for “: Provided, That this clause”

    Source evidence

    Code amendment note
    Par. (d)(1). Pub. L. 103–80, § 3(i)(2), substituted “, except that this subparagraph” for “: Provided, That this clause”.

    Enacted provision · exact public law section
    (2) in paragraph (d)(1), by striking out “: Provided, That this clause” and inserting in lieu thereof “, except that this subparagraph”, and

16. 1993

    Nutrition Labeling and Education Act Amendments of 1993

    Pub. L. 103–80 § 3(i)(3) · 107 Stat. 773

    1. Substituted · 21 U.S.C. § 342(d)(3)

       Pub. L. 103–80, § 3(i)(3), substituted “, except that this subparagraph shall not apply” for “: Provided, That this clause shall not apply”

    2. Substituted · 21 U.S.C. § 342(d)(3)

       Pub. L. 103–80, § 3(i)(3), substituted “, except that the Secretary may, for the purpose of avoiding or resolving uncertainty as to the application of this subparagraph” for “: And provided further, That the Secretary may, for the purpose of avoiding or resolving uncertainty as to the application of this clause”

    Source evidence

    Code amendment note
    Par. (d)(3). Pub. L. 103–80, § 3(i)(3), substituted “, except that this subparagraph shall not apply” for “: Provided, That this clause shall not apply” and “, except that the Secretary may, for the purpose of avoiding or resolving uncertainty as to the application of this subparagraph” for “: And provided further, That the Secretary may, for the purpose of avoiding or resolving uncertainty as to the application of this clause”.

    Enacted provision · exact public law section
    (3) in paragraph (d)(3), by striking out “: Provided, That this clause” and inserting in lieu thereof “, except that this subparagraph” and by striking out “: And provided further, That the Secretary may, for the purpose of avoiding or resolving uncertainty as to the application of this clause” and inserting in lieu thereof “, except that the Secretary may, for the purpose of avoiding or resolving uncertainty as to the application of this subparagraph”.

17. 1994

    Dietary Supplement Health and Education Act of 1994

    Pub. L. 103–417 § 4 · 108 Stat. 4325

    Added · 21 U.S.C. § 342(f)

    Pub. L. 103–417, § 4, added par. (f)

    Source evidence

    Code amendment note
    Par. (f). Pub. L. 103–417, § 4, added par. (f).

    Enacted provision · exact public law section
    SEC. 4. SAFETY OF DIETARY SUPPLEMENTS AND BURDEN OF PROOF ON FDA. Section 402 (21 U.S.C. 342) is amended by adding at the end the following: “(f) (1) If it is a dietary supplement or contains a dietary ingredient that— “(A) presents a significant or unreasonable risk of illness or injury under— “(i) conditions of use recommended or suggested in labeling, or “(ii) if no conditions of use are suggested or recommended in the labeling, under ordinary conditions of use; “(B) is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury; “(C) the Secretary declares to pose an imminent hazard to public health or safety, except that the authority to make such declaration shall not be delegated and the Secretary shall promptly after such a declaration initiate a proceeding in accordance with sections 554 and 556 of title 5, United States Code, to affirm or withdraw the declaration; or “(D) is or contains a dietary ingredient that renders it adulterated under paragraph (a)(1) under the conditions of use recommended or suggested in the labeling of such dietary supplement. In any proceeding under this subparagraph, the United States shall bear the burden of proof on each element to show that a dietary supplement is adulterated. The court shall decide any issue under this paragraph on a de novo basis. “(2) Before the Secretary may report to a United States attorney a violation of paragraph (1)(A) for a civil proceeding, the person against whom such proceeding would be initiated shall be given appropriate notice and the opportunity to present views, orally and in writing, at least 10 days before such notice, with regard to such proceeding.”.

18. 1994

    Dietary Supplement Health and Education Act of 1994

    Pub. L. 103–417 § 9 · 108 Stat. 4325

    Added · 21 U.S.C. § 342(g)

    Pub. L. 103–417, § 9, added par. (g)

    Source evidence

    Code amendment note
    Par. (g). Pub. L. 103–417, § 9, added par. (g).

    Enacted provision · exact public law section
    SEC. 9. GOOD MANUFACTURING PRACTICES. Section 402 (21 U.S.C. 342), as amended by section 4, is amended by adding at the end the following: “(g) (1) If it is a dietary supplement and it has been prepared, packed, or held under conditions that do not meet current good manufacturing practice regulations, including regulations requiring, when necessary, expiration date labeling, issued by the Secretary under subparagraph (2). “(2) The Secretary may by regulation prescribe good manufacturing practices for dietary supplements. Such regulations shall be modeled after current good manufacturing practice regulations for food and may not impose standards for which there is no current and generally available analytical methodology. No standard of current good manufacturing practice may be imposed unless such standard is included in a regulation promulgated after notice and opportunity for comment in accordance with chapter 5 of title 5, United States Code.”.

19. 1996

    Food Quality Protection Act of 1996

    Pub. L. 104–170 title IV § 404 · 110 Stat. 1489

    1. Added · 21 U.S.C. § 342(a)

       Pub. L. 104–170 added subpar. (2)

    2. Substituted · 21 U.S.C. § 342(a)

       Pub. L. 104–170 struck out former subpar. (2) which read as follows: “(2)(A) if it bears or contains any added poisonous or added deleterious substance (other than one which is (i) a pesticide chemical in or on a raw agricultural commodity; (ii) a food additive; (iii) a color additive; or (iv) a new animal drug) which is unsafe within the meaning of section 346 of this title, or (B) if it is a raw agricultural commodity and it bears or contains a pesticide chemical which is unsafe within the meaning of section 346a(a) of this title, or (C) if it is, or if it bears or contains, any food additive which is unsafe within the meaning of section 348 of this title: Provided, That where a pesticide chemical has been used in or on a raw agricultural commodity in conformity with an exemption granted or a tolerance prescribed under section 346a of this title and such raw agricultural commodity has been subjected to processing such as canning, cooking, freezing, dehydrating, or milling, the residue of such pesticide chemical remaining in or on such processed food shall, notwithstanding the provisions of sections 346 and 348 of this title, not be deemed unsafe if such residue in or on the raw agricultural commodity has been removed to the extent possible in good manufacturing practice and the concentration of such residue in the processed food when ready to eat is not greater than the tolerance prescribed for the raw agricultural commodity, or (D) if it is, or it bears or contains, a new animal drug (or conversion product thereof) which is unsafe within the meaning of section 360b of this title;”. That part of Pub. L. 104–170 which directed the substitution of “or (3) if it consists” for “(3) if it consists” was executed by making the substitution for “(3) If it consists” to reflect the probable intent of Congress

    Source evidence

    Code amendment note
    Par. (a). Pub. L. 104–170 added subpar. (2) and struck out former subpar. (2) which read as follows: “(2)(A) if it bears or contains any added poisonous or added deleterious substance (other than one which is (i) a pesticide chemical in or on a raw agricultural commodity; (ii) a food additive; (iii) a color additive; or (iv) a new animal drug) which is unsafe within the meaning of section 346 of this title, or (B) if it is a raw agricultural commodity and it bears or contains a pesticide chemical which is unsafe within the meaning of section 346a(a) of this title, or (C) if it is, or if it bears or contains, any food additive which is unsafe within the meaning of section 348 of this title: Provided, That where a pesticide chemical has been used in or on a raw agricultural commodity in conformity with an exemption granted or a tolerance prescribed under section 346a of this title and such raw agricultural commodity has been subjected to processing such as canning, cooking, freezing, dehydrating, or milling, the residue of such pesticide chemical remaining in or on such processed food shall, notwithstanding the provisions of sections 346 and 348 of this title, not be deemed unsafe if such residue in or on the raw agricultural commodity has been removed to the extent possible in good manufacturing practice and the concentration of such residue in the processed food when ready to eat is not greater than the tolerance prescribed for the raw agricultural commodity, or (D) if it is, or it bears or contains, a new animal drug (or conversion product thereof) which is unsafe within the meaning of section 360b of this title;”. That part of Pub. L. 104–170 which directed the substitution of “or (3) if it consists” for “(3) if it consists” was executed by making the substitution for “(3) If it consists” to reflect the probable intent of Congress.

    Enacted provision · exact public law section
    SEC. 404. ADULTERATED FOOD. Section 402(a) (21 U.S.C. 342(a)) is amended by striking “(2)(A) if it bears” and all that follows through “(3) if it consists” and inserting the following: “(2)(A) if it bears or contains any added poisonous or added deleterious substance (other than a substance that is a pesticide chemical residue in or on a raw agricultural commodity or processed food, a food additive, a color additive, or a new animal drug) that is unsafe within the meaning of section 406; or (B) if it bears or contains a pesticide chemical residue that is unsafe within the meaning of section 408(a); or (C) if it is or if it bears or contains (i) any food additive that is unsafe within the meaning of section 409; or (ii) a new animal drug (or conversion product thereof) that is unsafe within the meaning of section 512; or (3) if it consists”.

20. 2002

    Public Health Security and Bioterrorism Preparedness and Response Act of 2002”

    Pub. L. 107–188 title III § 309 · 116 Stat. 594

    Added · 21 U.S.C. § 342(h)

    Pub. L. 107–188 added par. (h)

    Source evidence

    Code amendment note
    Par. (h). Pub. L. 107–188 added par. (h).

    Enacted provision · exact public law section
    SEC. 309. PROHIBITION AGAINST PORT SHOPPING. Section 402 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342) is amended by adding at the end the following: “(h) If it is an article of food imported or offered for import into the United States and the article of food has previously been refused admission under section 801(a), unless the person reoffering the article affirmatively establishes, at the expense of the owner or consignee of the article, that the article complies with the applicable requirements of this Act, as determined by the Secretary.”

21. 2005

    Sanitary Food Transportation Act of 2005

    Pub. L. 109–59 title VII § 7202(a) · 119 Stat. 1144

    Added · 21 U.S.C. § 342(i)

    Pub. L. 109–59 added par. (i)

    Source evidence

    Code amendment note
    Par. (i). Pub. L. 109–59 added par. (i).

    Enacted provision · exact public law section
    (a) Unsanitary Transport Deemed Adulteration.— Section 402 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342) is amended by adding at the end the following: “(i) If it is transported or offered for transport by a shipper, carrier by motor vehicle or rail vehicle, receiver, or any other person engaged in the transportation of food under conditions that are not in compliance with regulations promulgated under section 416.” .

    Effective date note
    Amendment by Pub. L. 109–59 effective Oct. 1, 2005, see section 7204 of Pub. L. 109–59, set out as a note under section 331 of this title.

21 of 26 references resolved to an enrolled provision · 2 partial · 3 unresolved