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21 U.S.C. § 342 — Adulterated food

Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 342 — Adulterated food

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Stable record: federal_law:legal_authorities:record_usc_d2ec2b87c8b20f0ef719bd64
Source file: Laws/federal/codes/united-states-code/title-21/section-342-adulterated-food--53cb675938.md
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Source location: Title 21, Chapter 9, § 342; chapter-009-federal-food-drug-and-cosmetic-act.md

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A food shall be deemed to be adulterated— **(a) Poisonous, insanitary, etc., ingredients** (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.11 So in original. The period probably should be “; or”. (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 346 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section346&num=0&edition=prelim); or (B) if it bears or contains a pesticide chemical residue that is unsafe within the meaning of [section 346a(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section346a/a&num=0&edition=prelim); or (C) if it is or if it bears or contains (i) any food additive that is unsafe within the meaning of [section 348 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section348&num=0&edition=prelim); or (ii) a new animal drug (or conversion product thereof) that is unsafe within the meaning of [section 360b of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360b&num=0&edition=prelim); 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; or (7) if it has been intentionally subjected to radiation, unless the use of the radiation was in conformity with a regulation or exemption in effect pursuant to [section 348 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section348&num=0&edition=prelim). **(b) Absence, substitution, or addition of constituents** (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) Color additives** If it is, or it bears or contains, a color additive which is unsafe within the meaning of [section 379e(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section379e/a&num=0&edition=prelim). **(d) Confectionery containing alcohol or nonnutritive substance** If it is confectionery, and— (1) has partially or completely imbedded therein any nonnutritive object, except that this subparagraph shall not apply in the case of any nonnutritive object if, in the judgment of the Secretary as provided by regulations, such object is of practical functional value to the confectionery product and would not render the product injurious or hazardous to health; (2) bears or contains any alcohol other than alcohol not in excess of one-half of 1 per centum by volume derived solely from the use of flavoring extracts, 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; or (3) bears or contains any nonnutritive substance, except that this subparagraph shall not apply to a safe nonnutritive substance which is in or on confectionery by reason of its use for some practical functional purpose in the manufacture, packaging, or storage of such confectionery if the use of the substance does not promote deception of the consumer or otherwise result in adulteration or misbranding in violation of any provision of this chapter, except that the Secretary may, for the purpose of avoiding or resolving uncertainty as to the application of this subparagraph, issue regulations allowing or prohibiting the use of particular nonnutritive substances. **(e) Oleomargarine containing filthy, putrid, etc., matter** If it is oleomargarine or margarine or butter and any of the raw material used therein consisted in whole or in part of any filthy, putrid, or decomposed substance, or such oleomargarine or margarine or butter is otherwise unfit for food. **(f) Dietary supplement or ingredient: safety** (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 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 22 So in original. Probably should be “subparagraph”. (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. **(g) Dietary supplement: manufacturing practices** (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. **(h) Reoffer of food previously denied admission** 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 381(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section381/a&num=0&edition=prelim), 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 chapter, as determined by the Secretary. **(i) Noncompliance with sanitary transportation practices** 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 350e of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section350e&num=0&edition=prelim).

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 376 — Examination of sea food on request of packer; marking food with results; fees; penalties

The Secretary, upon application of any packer of any sea food for shipment or sale within the jurisdiction of this chapter, may, at his discretion, designate inspectors to examine and inspect such food and the production, packing, and labeling thereof. If on such examination and inspection compliance is found with the provisions of this chapter and regulations promulgated thereunder, the applicant shall be authorized or required to mark the food as provided by regulation to show such compliance. Services under this section shall be rendered only upon payment by the applicant of fees fixed by regulation in such amounts as may be necessary to provide, equip, and maintain an adequate and efficient inspection service. Receipts from such fees shall be covered into the Treasury and shall be available to the Secretary for expenditures incurred in carrying out the purposes of this section, including expenditures for salaries of additional inspectors when necessary to supplement the number of inspectors for whose salaries Congress has appropriated. The Secretary is authorized to promulgate regulations governing the sanitary and other conditions under which the service herein provided shall be granted and maintained, and for otherwise carrying out the purposes of this section. Any person who forges, counterfeits, simulates, or falsely represents, or without proper authority uses any mark, stamp, tag, label, or other identification devices authorized or required by the provisions of this section or regulations thereunder, shall be guilty of a misdemeanor, and shall on conviction thereof be subject to imprisonment for not more than one year or a fine of not less than $1,000 nor more than $5,000, or both such imprisonment and fine.

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 301 — Short title

This chapter may be cited as the Federal Food, Drug, and Cosmetic Act.

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 210 — Appointment of osteopaths as commissioned officers

Graduates of colleges of osteopathy whose graduates are eligible for licensure to practice medicine or osteopathy in a majority of the States of the United States, or approved by a body or bodies acceptable to the Secretary, shall be eligible, subject to the other provisions of this Act, for appointment as commissioned medical officers in the Public Health Service.

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 360b — New animal drugs

**(a) Unsafe new animal drugs and animal feed containing such drugs; conditions of safety; exemption of drugs for research; import tolerances** (1) A new animal drug shall, with respect to any particular use or intended use of such drug, be deemed unsafe for purposes of [section 351(a)(5) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section351/a/5&num=0&edition=prelim) and [section 342(a)(2)(C)(ii) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section342/a/2/C/ii&num=0&edition=prelim) unless— (A) there is in effect an approval of an application filed pursuant to subsection (b) with respect to such use or intended use of such drug, and such drug, its labeling, and such use conform to such approved application; (B) there is in effect a conditional approval of an application filed pursuant to [section 360ccc of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360ccc&num=0&edition=prelim) with respect to such use or intended use of such drug, and such drug, its labeling, and such use conform to such conditionally approved application; (C) there is in effect an index listing pursuant to [section 360ccc–1 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360ccc-1&num=0&edition=prelim) with respect to such use or intended use of such drug in a minor species, and such drug, its labeling, and such use conform to such index listing; or (D) there is in effect an authorization pursuant to [section 360bbb–3 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360bbb-3&num=0&edition=prelim) with respect to such use or intended use of such drug, and such drug, its labeling, and su

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 347 — Intrastate sales of colored oleomargarine

**(a) Law governing** Colored oleomargarine or colored margarine which is sold in the same State or Territory in which it is produced shall be subject in the same manner and to the same extent to the provisions of this chapter as if it had been introduced in interstate commerce. **(b) Labeling and packaging requirements** No person shall sell, or offer for sale, colored oleomargarine or colored margarine unless— (1) such oleomargarine or margarine is packaged, (2) the net weight of the contents of any package sold in a retail establishment is one pound or less, (3) there appears on the label of the package (A) the word “oleomargarine” or “margarine” in type or lettering at least as large as any other type or lettering on such label, and (B) a full and accurate statement of all the ingredients contained in such oleomargarine or margarine, and (4) each part of the contents of the package is contained in a wrapper which bears the word “oleomargarine” or “margarine” in type or lettering not smaller than 20-point type. The requirements of this subsection shall be in addition to and not in lieu of any of the other requirements of this chapter. **(c) Sales in public eating places** No person shall possess in a form ready for serving colored oleomargarine or colored margarine at a public eating place unless a notice that oleomargarine or margarine is served is displayed prominently and conspicuously in such place and in such manner as to render it likely to be read and understood by the ordinary individual being served in such eating place or is printed or is otherwise set forth on the menu in type or lettering not smaller than that normally used to designate the serving of other food items. No person shall serve colored oleomargarine or colored margarine at a public eati

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 348 — Food additives

**(a) Unsafe food additives; exception for conformity with exemption or regulation** A food additive shall, with respect to any particular use or intended use of such additives, be deemed to be unsafe for the purposes of the application of clause (2)(C) of [section 342(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section342/a&num=0&edition=prelim), unless— (1) it and its use or intended use conform to the terms of an exemption which is in effect pursuant to subsection (j) of this section; (2) there is in effect, and it and its use or intended use are in conformity with, a regulation issued under this section prescribing the conditions under which such additive may be safely used; or (3) in the case of a food additive as defined in this chapter that is a food contact substance, there is— (A) in effect, and such substance and the use of such substance are in conformity with, a regulation issued under this section prescribing the conditions under which such additive may be safely used; or (B) a notification submitted under subsection (h) that is effective. While such a regulation relating to a food additive, or such a notification under subsection (h)(1) relating to a food additive that is a food contact substance, is in effect, and has not been revoked pursuant to subsection (i), a food shall not, by reason of bearing or containing such a food additive in accordance with the regulation or notification, be considered adulterated under [section 342(a)(1) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section342/a/1&num=0&edition=prelim). **(b) Petition for regulation prescribing conditions of safe use; contents; description of production methods and controls; samples; notice of regulati

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21 U.S.C. § 346a — Tolerances and exemptions for pesticide chemical residues

**(a) Requirement for tolerance or exemption** (1) **General rule** — Except as provided in paragraph (2) or (3), any pesticide chemical residue in or on a food shall be deemed unsafe for the purpose of [section 342(a)(2)(B) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section342/a/2/B&num=0&edition=prelim) unless— (A) a tolerance for such pesticide chemical residue in or on such food is in effect under this section and the quantity of the residue is within the limits of the tolerance; or (B) an exemption from the requirement of a tolerance is in effect under this section for the pesticide chemical residue. For the purposes of this section, the term “food”, when used as a noun without modification, shall mean a raw agricultural commodity or processed food. (2) **Processed food** — Notwithstanding paragraph (1)— (A) if a tolerance is in effect under this section for a pesticide chemical residue in or on a raw agricultural commodity, a pesticide chemical residue that is present in or on a processed food because the food is made from that raw agricultural commodity shall not be considered unsafe within the meaning of [section 342(a)(2)(B) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section342/a/2/B&num=0&edition=prelim) despite the lack of a tolerance for the pesticide chemical residue in or on the processed food if the pesticide chemical has been used in or on the raw agricultural commodity in conformity with a tolerance under this section, such residue in or on the raw agricultural commodity has been removed to the extent possible in good manufacturing practice, and the concentration of the pesticide chemical residue in the processed food is not greater than the tolerance prescrib

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 321 — Definitions; generally

For the purposes of this chapter— **(a)** (1) The term “State”, except as used in the last sentence of [section 372(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section372/a&num=0&edition=prelim), means any State or Territory of the United States, the District of Columbia, and the Commonwealth of Puerto Rico. (2) The term “Territory” means any Territory or possession of the United States, including the District of Columbia, and excluding the Commonwealth of Puerto Rico and the Canal Zone. **(b)** The term “interstate commerce” means (1) commerce between any State or Territory and any place outside thereof, and (2) commerce within the District of Columbia or within any other Territory not organized with a legislative body. **(c)** The term “Department” means Department of Health and Human Services. **(d)** The term “Secretary” means the Secretary of Health and Human Services. **(e)** The term “person” includes individual, partnership, corporation, and association. **(f)** The term “food” means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article. **(g)** (1) The term “drug” means (A) articles recognized in the official United States Pharmacopoeia,11 So in original. Probably should be “Pharmacopeia,”. official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specif

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 379e — Listing and certification of color additives for foods, drugs, devices, and cosmetics

**(a) Unsafe color additives** A color additive shall, with respect to any particular use (for which it is being used or intended to be used or is represented as suitable) in or on food or drugs or devices or cosmetics, be deemed unsafe for the purposes of the application of section 342(c), 351(a)(4), or 361(e) of this title, as the case may be, unless— (1) (A) there is in effect, and such additive and such use are in conformity with, a regulation issued under subsection (b) of this section listing such additive for such use, including any provision of such regulation prescribing the conditions under which such additive may be safely used, and (B) such additive either (i) is from a batch certified, in accordance with regulations issued pursuant to subsection (c), for such use, or (ii) has, with respect to such use, been exempted by the Secretary from the requirement of certification; or (2) such additive and such use thereof conform to the terms of an exemption which is in effect pursuant to subsection (f) of this section. While there are in effect regulations under subsections (b) and (c) of this section relating to a color additive or an exemption pursuant to subsection (f) with respect to such additive, an article shall not, by reason of bearing or containing such additive in all respects in accordance with such regulations or such exemption, be considered adulterated within the meaning of clause (1) of [section 342(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section342/a&num=0&edition=prelim) if such article is a food, or within the meaning of [section 361(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section361/a&num=0&edition=prelim) if such article is a cosmetic other than a

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 346 — Tolerances for poisonous or deleterious substances in food; regulations

Any poisonous or deleterious substance added to any food, except where such substance is required in the production thereof or cannot be avoided by good manufacturing practice shall be deemed to be unsafe for purposes of the application of clause (2)(A) of [section 342(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section342/a&num=0&edition=prelim); but when such substance is so required or cannot be so avoided, the Secretary shall promulgate regulations limiting the quantity therein or thereon to such extent as he finds necessary for the protection of public health, and any quantity exceeding the limits so fixed shall also be deemed to be unsafe for purposes of the application of clause (2)(A) of [section 342(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section342/a&num=0&edition=prelim). While such a regulation is in effect limiting the quantity of any such substance in the case of any food, such food shall not, by reason of bearing or containing any added amount of such substance, be considered to be adulterated within the meaning of clause (1) of [section 342(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section342/a&num=0&edition=prelim). In determining the quantity of such added substance to be tolerated in or on different articles of food the Secretary shall take into account the extent to which the use of such substance is required or cannot be avoided in the production of each such article, and the other ways in which the consumer may be affected by the same or other poisonous or deleterious substances.

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