§ 301. Short title.

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

SUBCHAPTER II - DEFINITIONS

§ 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, 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, 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 specified in clause (A), (B), or (C). A food or dietary supplement for which a claim, subject to sections 343(r)(1)(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 accordance with the requirements of section 343(r) of this title is not a drug solely because the label or the labeling contains such a claim. A food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is made in accordance with section 343(r)(6) of this title is not a drug under clause (C) solely because the label or the labeling contains such a statement.
  • (2) The term ''counterfeit drugs'' means a drug which, or the container or labeling of which, without authorization, bears the trademark, trade name, or other identifying mark, imprint, or device, or any likeness thereof, of a drug manufacturer, processor, packer, or distributor other than the person or persons who in fact manufactured, processed, packed, or distributed such drug and which thereby falsely purports or is represented to be the product of, or to have been packed or distributed by, such other drug manufacturer, processor, packer, or distributor.
• (h) The term ''device'' (except when used in paragraph (n) of this section and in sections 331(i), 343(f), 352(c), and 362(c) of this title) means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is -
  • (1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,
  • (2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
  • (3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.
• (i) The term ''cosmetic'' means (1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap.
• (j) The term ''official compendium'' means the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, official National Formulary, or any supplement to any of them.
• (k) The term ''label'' means a display of written, printed, or graphic matter upon the immediate container of any article; and a requirement made by or under authority of this chapter that any word, statement, or other information appear on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such article, or is easily legible through the outside container or wrapper.
• (l) The term ''immediate container'' does not include package liners.
• (m) 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.
• (n) If an article is alleged to be misbranded because the labeling or advertising is misleading, then in determining whether the labeling or advertising is misleading there shall be taken into account (among other things) not only representations made or suggested by statement, word, design, device, or any combination thereof, but also the extent to which the labeling or advertising fails to reveal facts material in the light of such representations or material with respect to consequences which may result from the use of the article to which the labeling or advertising relates under the conditions of use prescribed in the labeling or advertising thereof or under such conditions of use as are customary or usual.
• (o) The representation of a drug, in its labeling, as an antiseptic shall be considered to be a representation that it is a germicide, except in the case of a drug purporting to be, or represented as, an antiseptic for inhibitory use as a wet dressing, ointment, dusting powder, or such other use as involves prolonged contact with the body.
• (p) The term ''new drug'' means -
  • (1) Any drug (except a new animal drug or an animal feed bearing or containing a new animal drug) the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof, except that such a drug not so recognized shall not be deemed to be a ''new drug'' if at any time prior to June 25, 1938, it was subject to the Food and Drugs Act of June 30, 1906, as amended, and if at such time its labeling contained the same representations concerning the conditions of its use; or
  • (2) Any drug (except a new animal drug or an animal feed bearing or containing a new animal drug) the composition of which is such that such drug, as a result of investigations to determine its safety and effectiveness for use under such conditions, has become so recognized, but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions.
• (q) The term ''pesticide chemical'' means any substance which, alone, in chemical combination or in formulation with one or more other substances, is ''a pesticide'' within the meaning of the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.) as now in force or as hereafter amended, and which is used in the production, storage, or transportation of raw agricultural commodities.
• (r) The term ''raw agricultural commodity'' means any food in its raw or natural state, including all fruits that are washed, colored, or otherwise treated in their unpeeled natural form prior to marketing.
• (s) The term ''food additive'' means any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; and including any source of radiation intended for any such use), if such substance is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case as a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use; except that such term does not include -
  • (1) a pesticide chemical in or on a raw agricultural commodity; or
  • (2) a pesticide chemical to the extent that it is intended for use or is used in the production, storage, or transportation of any raw agricultural commodity; or
  • (3) a color additive; or
  • (4) any substance used in accordance with a sanction or approval granted prior to September 6, 1958, pursuant to this chapter, the Poultry Products Inspection Act (21 U.S.C. 451 et seq.) or the Meat Inspection Act of March 4, 1907, as amended and extended (21 U.S.C. 601 et seq.);
  • (5) a new animal drug; or
  • (6) an ingredient described in paragraph (ff) in, or intended for use in, a dietary supplement.
• (t)
  • (1) The term ''color additive'' means a material which -
    • (A) is a dye, pigment, or other substance made by a process of synthesis or similar artifice, or extracted, isolated, or otherwise derived, with or without intermediate or final change of identity, from a vegetable, animal, mineral, or other source, and
    • (B) when added or applied to a food, drug, or cosmetic, or to the human body or any part thereof, is capable (alone or through reaction with other substance) of imparting color thereto; except that such term does not include any material which the Secretary, by regulation, determines is used (or intended to be used) solely for a purpose or purposes other than coloring.
  • (2) The term ''color'' includes black, white, and intermediate grays.
  • (3) Nothing in subparagraph (1) of this paragraph shall be construed to apply to any pesticide chemical, soil or plant nutrient, or other agricultural chemical solely because of its effect in aiding, retarding, or otherwise affecting, directly or indirectly, the growth or other natural physiological processes of produce of the soil and thereby affecting its color, whether before or after harvest.
• (u) The term ''safe'' as used in paragraph (s) of this section and in sections 348, 360b, and 379e of this title, has reference to the health of man or animal.
• (v) The term ''new animal drug'' means any drug intended for use for animals other than man, including any drug intended for use in animal feed but not including such animal feed, -
  • (1) the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof; except that such a drug not so recognized shall not be deemed to be a ''new animal drug'' if at any time prior to June 25, 1938, it was subject to the Food and Drug Act of June 30, 1906, as amended, and if at such time its labeling contained the same representations concerning the conditions of its use; or
  • (2) the composition of which is such that such drug, as a result of investigations to determine its safety and effectiveness for use under such conditions, has become so recognized but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions.
• (w) The term ''animal feed'', as used in paragraph (w) (FOOTNOTE 1) of this section, in section 360b of this title, and in provisions of this chapter referring to such paragraph or section, means an article which is intended for use for food for animals other than man and which is intended for use as a substantial source of nutrients in the diet of the animal, and is not limited to a mixture intended to be the sole ration of the animal. (FOOTNOTE 1) So in original. Probably should be paragraph ''(v)''.
• (x) The term ''informal hearing'' means a hearing which is not subject to section 554, 556, or 557 of title 5 and which provides for the following:
  • (1) The presiding officer in the hearing shall be designated by the Secretary from officers and employees of the Department who have not participated in any action of the Secretary which is the subject of the hearing and who are not directly responsible to an officer or employee of the Department who has participated in any such action.
  • (2) Each party to the hearing shall have the right at all times to be advised and accompanied by an attorney.
  • (3) Before the hearing, each party to the hearing shall be given reasonable notice of the matters to be considered at the hearing, including a comprehensive statement of the basis for the action taken or proposed by the Secretary which is the subject of the hearing and a general summary of the information which will be presented by the Secretary at the hearing in support of such action.
  • (4) At the hearing the parties to the hearing shall have the right to hear a full and complete statement of the action of the Secretary which is the subject of the hearing together with the information and reasons supporting such action, to conduct reasonable questioning, and to present any oral or written information relevant to such action.
  • (5) The presiding officer in such hearing shall prepare a written report of the hearing to which shall be attached all written material presented at the hearing. The participants in the hearing shall be given the opportunity to review and correct or supplement the presiding officer's report of the hearing.
  • (6) The Secretary may require the hearing to be transcribed. A party to the hearing shall have the right to have the hearing transcribed at his expense. Any transcription of a hearing shall be included in the presiding officer's report of the hearing.
• (y) The term ''saccharin'' includes calcium saccharin, sodium saccharin, and ammonium saccharin.
• (z) The term ''infant formula'' means a food which purports to be or is represented for special dietary use solely as a food for infants by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk.
• (aa) The term ''abbreviated drug application'' means an application submitted under section 355(j) or 357 of this title for the approval of a drug that relies on the approved application of another drug with the same active ingredient to establish safety and efficacy, and -
  • (1) in the case of section 335a of this title, includes a supplement to such an application for a different or additional use of the drug but does not include a supplement to such an application for other than a different or additional use of the drug, and
  • (2) in the case of sections 335b and 335c of this title, includes any supplement to such an application.
• (bb) The term ''knowingly'' or ''knew'' means that a person, with respect to information -
  • (1) has actual knowledge of the information, or
  • (2) acts in deliberate ignorance or reckless disregard of the truth or falsity of the information.
• (cc) For purposes of section 335a of this title, the term ''high managerial agent'' -
  • (1) means -
    • (A) an officer or director of a corporation or an association,
    • (B) a partner of a partnership, or
    • (C) any employee or other agent of a corporation, association, or partnership, having duties such that the conduct of such officer, director, partner, employee, or agent may fairly be assumed to represent the policy of the corporation, association, or partnership, and
  • (2) includes persons having management responsibility for -
    • (A) submissions to the Food and Drug Administration regarding the development or approval of any drug product,
    • (B) production, quality assurance, or quality control of any drug product, or
    • (C) research and development of any drug product.
• (dd) For purposes of sections 335a and 335b of this title, the term ''drug product'' means a drug subject to regulation under section 355, 357, 360b, or 382 of this title or under section 262 of title 42.
• (ee) The term ''Commissioner'' means the Commissioner of Food and Drugs.
• (ff) The term ''dietary supplement'' -
  • (1) means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients:
    • (A) a vitamin;
    • (B) a mineral;
    • (C) an herb or other botanical;
    • (D) an amino acid;
    • (E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or
    • (F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E);
  • (2) means a product that -
    • (A)
      • (i) is intended for ingestion in a form described in section 350(c)(1)(B)(i) of this title; or
      • (ii) complies with section 350(c)(1)(B)(ii) of this title;
    • (B) is not represented for use as a conventional food or as a sole item of a meal or the diet; and
    • (C) is labeled as a dietary supplement; and
  • (3) does -
    • (A) include an article that is approved as a new drug under section 355 of this title, certified as an antibiotic under section 357 of this title, or licensed as a biologic under section 262 of title 42 and was, prior to such approval, certification, or license, marketed as a dietary supplement or as a food unless the Secretary has issued a regulation, after notice and comment, finding that the article, when used as or in a dietary supplement under the conditions of use and dosages set forth in the labeling for such dietary supplement, is unlawful under section 342(f) of this title; and
    • (B) not include -
      • (i) an article that is approved as a new drug under section 355 of this title, certified as an antibiotic under section 357 of this title, or licensed as a biologic under section 262 of title 42, or
      • (ii) an article authorized for investigation as a new drug, antibiotic, or biological for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, which was not before such approval, certification, licensing, or authorization marketed as a dietary supplement or as a food unless the Secretary, in the Secretary's discretion, has issued a regulation, after notice and comment, finding that the article would be lawful under this chapter.

Except for purposes of paragraph (g), a dietary supplement shall be deemed to be a food within the meaning of this chapter.