21 U.S.C. § 453 (FOOD AND DRUGS)
§ 453. Definitions
For purposes of this chapter—
(a) The term “commerce” means commerce between any State, any territory, or the District of Columbia, and any place outside thereof; or within any territory not organized with a legislative body, or the District of Columbia.
(b) Except as otherwise provided in this chapter, the term “State” means any State of the United States and the Commonwealth of Puerto Rico.
(c) The term “territory” means Guam, the Virgin Islands of the United States, American Samoa, and any other territory or possession of the United States, excluding the Canal Zone.
(d) The term “United States” means the States, the District of Columbia, and the territories of the United States.
(e) The term “poultry” means any domesticated bird, whether live or dead.
(f) The term “poultry product” means any poultry carcass, or part thereof; or any product which is made wholly or in part from any poultry carcass or part thereof, excepting products which contain poultry ingredients only in a relatively small proportion or historically have not been considered by consumers as products of the poultry food industry, and which are exempted by the Secretary from definition as a poultry product under such conditions as the Secretary may prescribe to assure that the poultry ingredients in such products are not adulterated and that such products are not represented as poultry products.
(g) The term “adulterated” shall apply to any poultry product under one or more of the following circumstances:
(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 article shall not be considered adulterated under this clause if the quantity of such substance in or on such article does not ordinarily render it injurious to health;
(2)
(A) if it bears or contains (by reason of administration of any substance to the live poultry or otherwise) 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; or (iii) a color additive) which may, in the judgment of the Secretary, make such article unfit for human food;
(B) if it is, in whole or in part, a raw agricultural commodity and such commodity bears or contains a pesticide chemical which is unsafe within the meaning of section 346a of this title;
(C) if it bears or contains any food additive which is unsafe within the meaning of section 348 of this title;
(D) if it bears or contains any color additive which is unsafe within the meaning of section 379e of this title: Provided, That an article which is not otherwise deemed adulterated under clause (B), (C), or (D) shall nevertheless be deemed adulterated if use of the pesticide chemical, food additive, or color additive in or on such article is prohibited by regulations of the Secretary in official establishments;
(3) if it consists in whole or in part of any filthy, putrid, or decomposed substance or is for any other reason unsound, unhealthful, unwholesome, or otherwise unfit for human food;
(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;
(5) if it is, in whole or in part, the product of any poultry which has died otherwise than by slaughter;
(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;
(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;
(8) if any valuable constituent has been in whole or in part omitted or abstracted therefrom; or if any substance has been substituted, wholly or in part therefor; or if damage or inferiority has been concealed in any manner; or 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.
(h) The term “misbranded” shall apply to any poultry product under one or more of the following circumstances:
(1) if its labeling is false or misleading in any particular;
(2) if it is offered for sale under the name of another food;
(3) if it is an imitation of another food, unless its label bears, in type of uniform size and prominence, the word “imitation” and immediately thereafter, the name of the food imitated;
(4) if its container is so made, formed, or filled as to be misleading;
(5) unless it bears a label showing (A) the name and the place of business of the manufacturer, packer, or distributor; and (B) an accurate statement of the quantity of the product in terms of weight, measure, or numerical count: Provided, That under clause (B) of this subparagraph (5), reasonable variations may be permitted, and exemptions as to small packages or articles not in packages or other containers may be established by regulations prescribed by the Secretary;
(6) if any word, statement, or other information required by or under authority of this chapter to appear on the label or other labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use;
(7) if it purports to be or is represented as a food for which a definition and standard of identity or composition has been prescribed by regulations of the Secretary under section 457 of this title unless (A) it conforms to such definition and standard, and (B) its label bears the name of the food specified in the definition and standard and, insofar as may be required by such regulations, the common names of optional ingredients (other than spices, flavoring, and coloring) present in such food;
(8) if it purports to be or is represented as a food for which a standard or standards of fill of container have been prescribed by regulations of the Secretary under section 457 of this title, and it falls below the standard of fill of container applicable thereto, unless its label bears, in such manner and form as such regulations specify, a statement that it falls below such standard;
(9) if it is not subject to the provisions of subparagraph (7), unless its label bears (A) the common or usual name of the food, if any there be, and (B) in case it is fabricated from two or more ingredients, the common or usual name of each such ingredient; except that spices, flavorings, and colorings may, when authorized by the Secretary, be designated as spices, flavorings, and colorings without naming each: Provided, That to the extent that compliance with the requirements of clause (B) of this subparagraph (9) is impracticable or results in deception or unfair competition, exemptions shall be established by regulations promulgated by the Secretary;
(10) if it purports to be or is represented for special dietary uses unless its label bears such information concerning its vitamin, mineral, and other dietary properties as the Secretary, after consultation with the Secretary of Health and Human Services, determines to be, and by regulations prescribes as, necessary in order fully to inform purchasers as to its value for such uses;
(11) if it bears or contains any artificial flavoring, artificial coloring, or chemical preservative unless it bears labeling stating that fact: Provided, That, to the extent that compliance with the requirements of this subparagraph (11) is impracticable, exemptions shall be established by regulations promulgated by the Secretary; or
(12) if it fails to bear on its containers, and in the case of nonconsumer packaged carcasses (if the Secretary so requires) directly thereon, as the Secretary may by regulations prescribe, the official inspection legend and official establishment number of the establishment where the article was processed, and, unrestricted by any of the foregoing, such other information as the Secretary may require in such regulations to assure that it will not have false or misleading labeling and that the public will be informed of the manner of handling required to maintain the article in a wholesome condition.
(i) The term “Secretary” means the Secretary of Agriculture or his delegate.
(j) The term “person” means any individual, partnership, corporation, association, or other business unit.
(k) The term “inspector” means: (1) an employee or official of the United States Government authorized by the Secretary to inspect poultry and poultry products under the authority of this chapter, or (2) any employee or official of the government of any State or territory or the District of Columbia authorized by the Secretary to inspect poultry and poultry products under authority of this chapter, under an agreement entered into between the Secretary and the appropriate State or other agency.
(l) The term “official mark” means the official inspection legend or any other symbol prescribed by regulation of the Secretary to identify the status of any article or poultry under this chapter.
(m) The term “official inspection legend” means any symbol prescribed by regulations of the Secretary showing that an article was inspected for wholesomeness in accordance with this chapter.
(n) The term “official certificate” means any certificate prescribed by regulations of the Secretary for issuance by an inspector or other person performing official functions under this chapter.
(o) The term “official device” means any device prescribed or authorized by the Secretary for use in applying any official mark.
(p) The term “official establishment” means any establishment as determined by the Secretary at which inspection of the slaughter of poultry, or the processing of poultry products, is maintained under the authority of this chapter.
(q) The term “inspection service” means the official Government service within the Department of Agriculture designated by the Secretary as having the responsibility for carrying out the provisions of this chapter.
(r) The term “container” or “package” includes any box, can, tin, cloth, plastic, or other receptacle, wrapper, or cover.
(s) The term “label” means a display of written, printed, or graphic matter upon any article or the immediate container (not including packaged liners) of any article; and the term “labeling” means all labels and other written, printed, or graphic matter (1) upon any article or any of its containers or wrappers, or (2) accompanying such article.
(t) The term “shipping container” means any container used or intended for use in packaging the product packed in an immediate container.
(u) The term “immediate container” includes any consumer package; or any other container in which poultry products, not consumer packaged, are packed.
(v) The term “capable of use as human food” shall apply to any carcass, or part or product of a carcass, of any poultry, unless it is denatured or otherwise identified as required by regulations prescribed by the Secretary to deter its use as human food, or it is naturally inedible by humans.
(w) The term “processed” means slaughtered, canned, salted, stuffed, rendered, boned, cut up, or otherwise manufactured or processed.
(x) The term “Federal Food, Drug, and Cosmetic Act” means the Act so entitled, approved June 25, 1938 (52 Stat. 1040) [21 U.S.C. 301 et seq.], and Acts amendatory thereof or supplementary thereto.
(y) The terms “pesticide chemical”, “food additive”, “color additive”, and “raw agricultural commodity” shall have the same meanings for purposes of this chapter as under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.].
(z) The term “poultry products broker” means any person engaged in the business of buying or selling poultry products on commission, or otherwise negotiating purchases or sales of such articles other than for his own account or as an employee of another person.
(aa) The term “renderer” means any person engaged in the business of rendering carcasses, or parts or products of the carcasses, of poultry, except rendering conducted under inspection or exemption under this chapter.
(bb) The term “animal food manufacturer” means any person engaged in the business of manufacturing or processing animal food derived wholly or in part from carcasses, or parts or products of the carcasses, of poultry.
(Pub. L. 85–172, § 4, Aug. 28, 1957, 71 Stat. 441; Pub. L. 87–498, June 25, 1962, 76 Stat. 110; Pub. L. 90–492, § 4, Aug. 18, 1968, 82 Stat. 792; Pub. L. 96–88, title V, § 509(b), Oct. 17, 1979, 93 Stat. 695; Pub. L. 102–571, title I, § 107(13), Oct. 29, 1992, 106 Stat. 4499.)
heading: Editorial Notes
heading: References in Text
text: The Federal Food, Drug, and Cosmetic Act, referred to in pars. (x) and (y), is act June 25, 1938, ch. 675, 52 Stat. 1040, as amended, which is classified generally to chapter 9 (§ 301 et seq.) of this title. For complete classification of this Act to the Code, see section 301 of this title and Tables.
heading: Amendments
text: 1992—Subsec. (g)(2)(D). Pub. L. 102–571 substituted “379e” for “376”.
1968—Pub. L. 90–492 inserted definitions of “State”, “territory”, “United States”, “misbranded”, “official mark”, “official inspection legend”, “official certificate”, “official device”, “capable of use as human food”, “processed”, “Federal Food, Drug, and Cosmetic Act”, “pesticide chemical”, “poultry products broker”, “renderer”, and “animal food manufacturer”, revised definitions of “commerce”, “poultry”, “poultry product”, “adulterated”, “Secretary”, “inspector”, “container” or “package”, “label”, and “immediate container”, reenacted without change definitions of “person”, “official establishment”, “inspection service”, and “shipping container”, and deleted definition of “wholesome”, “unwholesome”, and “official inspection mark”.
1962—Par. (a). Pub. L. 87–498 struck out references to Territories or possessions, and inserted definition of “State”.
heading: Statutory Notes and Related Subsidiaries
heading: Change of Name
text: “Secretary of Health and Human Services” substituted for “Secretary of Health, Education, and Welfare” in par. (h)(10) pursuant to section 509(b) of Pub. L. 96–88, which is classified to section 3508(b) of Title 20, Education.
heading: Effective Date of 1968 Amendment
text: Amendment by Pub. L. 90–492 effective Aug. 18, 1968, see section 20 of Pub. L. 90–492, set out as a note under section 451 of this title.