United States Code (Last Updated: May 24, 2014) |
Title 21. FOOD AND DRUGS |
Chapter 9. FEDERAL FOOD, DRUG, AND COSMETIC ACT |
SubChapter II. DEFINITIONS |
§ 321. Definitions; generally
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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 drug” 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 Homoeopathic 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 ofJune 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) (1) (A) Except as provided in clause (B), the term “pesticide chemical” means any substance that is a pesticide within the meaning of the Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 136 et seq.], including all active and inert ingredients of such pesticide. Notwithstanding any other provision of law, the term “pesticide” within such meaning includes ethylene oxide and propylene oxide when such substances are applied on food. (B) In the case of the use, with respect to food, of a substance described in clause (A) to prevent, destroy, repel, or mitigate microorganisms (including bacteria, viruses, fungi, protozoa, algae, and slime), the following applies for purposes of clause (A): (i) The definition in such clause for the term “pesticide chemical” does not include the substance if the substance is applied for such use on food, or the substance is included for such use in water that comes into contact with the food, in the preparing, packing, or holding of the food for commercial purposes. The substance is not excluded under this subclause from such definition if the substance is ethylene oxide or propylene oxide, and is applied for such use on food. The substance is not so excluded if the substance is applied for such use on a raw agricultural commodity, or the substance is included for such use in water that comes into contact with the commodity, as follows: (I) The substance is applied in the field. (II) The substance is applied at a treatment facility where raw agricultural commodities are the only food treated, and the treatment is in a manner that does not change the status of the food as a raw agricultural commodity (including treatment through washing, waxing, fumigating, and packing such commodities in such manner). (III) The substance is applied during the transportation of such commodity between the field and such a treatment facility. (ii) The definition in such clause for the term “pesticide chemical” does not include the substance if the substance is a food contact substance as defined in section 348(h)(6) of this title, and any of the following circumstances exist: The substance is included for such use in an object that has a food contact surface but is not intended to have an ongoing effect on any portion of the object; the substance is included for such use in an object that has a food contact surface and is intended to have an ongoing effect on a portion of the object but not on the food contact surface; or the substance is included for such use in or is applied for such use on food packaging (without regard to whether the substance is intended to have an ongoing effect on any portion of the packaging). The food contact substance is not excluded under this subclause from such definition if any of the following circumstances exist: The substance is applied for such use on a semipermanent or permanent food contact surface (other than being applied on food packaging); or the substance is included for such use in an object that has a semipermanent or permanent food contact surface (other than being included in food packaging) and the substance is intended to have an ongoing effect on the food contact surface. With respect to the definition of the term “pesticide” that is applicable to the Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 136 et seq.], this clause does not exclude any substance from such definition. (2) The term “pesticide chemical residue” means a residue in or on raw agricultural commodity or processed food of— (A) a pesticide chemical; or (B) any other added substance that is present on or in the commodity or food primarily as a result of the metabolism or other degradation of a pesticide chemical. (3) Notwithstanding subparagraphs (1) and (2), the Administrator may by regulation except a substance from the definition of “pesticide chemical” or “pesticide chemical residue” if— (A) its occurrence as a residue on or in a raw agricultural commodity or processed food is attributable primarily to natural causes or to human activities not involving the use of any substances for a pesticidal purpose in the production, storage, processing, or transportation of any raw agricultural commodity or processed food; and (B) the Administrator, after consultation with the Secretary, determines that the substance more appropriately should be regulated under one or more provisions of this chapter other than sections 342(a)(2)(B) and 346a of this title. (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 of 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 residue in or on a raw agricultural commodity or processed food; or (2) a pesticide chemical; 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 ofMarch 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, 360ccc, 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 ofJune 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. Provided that any drug intended for minor use or use in a minor species that is not the subject of a final regulation published by the Secretary through notice and comment rulemaking finding that the criteria of paragraphs (1) and (2) have not been met (or that the exception to the criterion in paragraph (1) has been met) is a new animal drug. (w) The term “animal feed”, as used in paragraph (w) Except for purposes of paragraph (g) and section 350f of this title, a dietary supplement shall be deemed to be a food within the meaning of this chapter. (gg) The term “processed food” means any food other than a raw agricultural commodity and includes any raw agricultural commodity that has been subject to processing, such as canning, cooking, freezing, dehydration, or milling. (hh) The term “Administrator” means the Administrator of the United States Environmental Protection Agency. (ii) The term “compounded positron emission tomography drug”— (1) means a drug that— (A) exhibits spontaneous disintegration of unstable nuclei by the emission of positrons and is used for the purpose of providing dual photon positron emission tomographic diagnostic images; and (B) has been compounded by or on the order of a practitioner who is licensed by a State to compound or order compounding for a drug described in subparagraph (A), and is compounded in accordance with that State’s law, for a patient or for research, teaching, or quality control; and (2) includes any nonradioactive reagent, reagent kit, ingredient, nuclide generator, accelerator, target material, electronic synthesizer, or other apparatus or computer program to be used in the preparation of such a drug. (jj) The term “antibiotic drug” means any drug (except drugs for use in animals other than humans) composed wholly or partly of any kind of penicillin, streptomycin, chlortetracycline, chloramphenicol, bacitracin, or any other drug intended for human use containing any quantity of any chemical substance which is produced by a micro-organism and which has the capacity to inhibit or destroy micro-organisms in dilute solution (including a chemically synthesized equivalent of any such substance) or any derivative thereof. (kk) Priority supplement.— The term “priority supplement” means a drug application referred to in section 101(4) of the Food and Drug Administration Modernization Act of 1997 (111 Stat. 2298). (ll) (1) The term “single-use device” means a device that is intended for one use, or on a single patient during a single procedure. (2) (A) The term “reprocessed”, with respect to a single-use device, means an original device that has previously been used on a patient and has been subjected to additional processing and manufacturing for the purpose of an additional single use on a patient. The subsequent processing and manufacture of a reprocessed single-use device shall result in a device that is reprocessed within the meaning of this definition. (B) A single-use device that meets the definition under clause (A) shall be considered a reprocessed device without regard to any description of the device used by the manufacturer of the device or other persons, including a description that uses the term “recycled” rather than the term “reprocessed”. (3) The term “original device” means a new, unused single-use device. (mm) (1) The term “critical reprocessed single-use device” means a reprocessed single-use device that is intended to contact normally sterile tissue or body spaces during use. (2) The term “semi-critical reprocessed single-use device” means a reprocessed single-use device that is intended to contact intact mucous membranes and not penetrate normally sterile areas of the body. (nn) The term “major species” means cattle, horses, swine, chickens, turkeys, dogs, and cats, except that the Secretary may add species to this definition by regulation. (oo) The term “minor species” means animals other than humans that are not major species. (pp) The term “minor use” means the intended use of a drug in a major species for an indication that occurs infrequently and in only a small number of animals or in limited geographical areas and in only a small number of animals annually. (qq) The term “major food allergen” means any of the following: (1) Milk, egg, fish (e.g., bass, flounder, or cod), Crustacean shellfish (e.g., crab, lobster, or shrimp), tree nuts (e.g., almonds, pecans, or walnuts), wheat, peanuts, and soybeans. (2) A food ingredient that contains protein derived from a food specified in paragraph (1), except the following: (A) Any highly refined oil derived from a food specified in paragraph (1) and any ingredient derived from such highly refined oil. (B) A food ingredient that is exempt under paragraph (6) or (7) of section 343(w) of this title. (rr) (1) The term “tobacco product” means any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product). (2) The term “tobacco product” does not mean an article that is a drug under subsection (g)(1), a device under subsection (h), or a combination product described in section 353(g) of this title. (3) The products described in paragraph (2) shall be subject to subchapter V of this chapter. (4) A tobacco product shall not be marketed in combination with any other article or product regulated under this chapter (including a drug, biologic, food, cosmetic, medical device, or a dietary supplement).
References In Text
The Food and Drugs Act of
The Federal Insecticide, Fungicide, and Rodenticide Act, referred to in par. (q)(1), is act June 25, 1947, ch. 125, as amended generally by Pub. L. 92–516,
The Poultry Products Inspection Act, referred to in par. (s)(4), is Pub. L. 85–172,
The Meat Inspection Act of
Section 101(4) of the Food and Drug Administration Modernization Act of 1997, referred to in par. (kk), is section 101(4) of Pub. L. 105–115, which is set out as a note under section 379g of this title.
Amendments
2009—Par. (rr). Pub. L. 111–31 added par. (rr).
2007—Par. (ff). Pub. L. 110–85 substituted “paragraph (g) and section 350f of this title” for “paragraph (g)” in concluding provisions.
2004–Par. (u). Pub. L. 108–282, § 102(b)(5)(A), substituted “360b, 360ccc” for “360b”.
Par. (v). Pub. L. 108–282, § 102(b)(5)(B), inserted concluding provisions.
Pars. (nn) to (pp). Pub. L. 108–282, § 102(b)(1), added pars. (nn) to (pp).
Par. (qq). Pub. L. 108–282, § 203(c)(1), added par. (qq).
2002—Par. (kk). Pub. L. 107–109 added par. (kk).
Pars. (ll), (mm). Pub. L. 107–250 added pars. (ll) and (mm).
1998—Par. (q)(1). Pub. L. 105–324, § 2(a), added subpar. (1) and struck out former subpar. (1) which read as follows: “The term ‘pesticide chemical’ means any substance that is a pesticide within the meaning of the Federal Insecticide, Fungicide, and Rodenticide Act, including all active and inert ingredients of such pesticide.”
Par. (q)(3). Pub. L. 105–324, § 2(c), substituted “subparagraphs (1) and (2)” for “paragraphs (1) and (2)” in introductory provisions.
1997—Par. (aa). Pub. L. 105–115, § 125(b)(2)(A), struck out “or 357” after “section 355(j)”.
Par. (dd). Pub. L. 105–115, § 125(b)(2)(A), struck out “357,” after “section 355,”.
Par. (ff)(3)(A). Pub. L. 105–115, § 125(b)(2)(A), struck out “, certified as an antibiotic under section 357 of this title,” before “or licensed as a biologic”.
Par. (ii). Pub. L. 105–115, § 121(a), added par. (ii).
Par. (jj). Pub. L. 105–115, § 125(e), added par. (jj).
1996—Par. (q). Pub. L. 104–170, § 402(a), amended par. (q) generally. Prior to amendment, par. (q) read as follows: “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 as now in force or as hereafter amended, and which is used in the production, storage, or transportation of raw agricultural commodities.”
Par. (s)(1), (2). Pub. L. 104–170, § 402(b), amended subpars. (1) and (2) generally. Prior to amendment, subpars. (1) and (2) read as follows:
“(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”.
Pars. (gg), (hh). Pub. L. 104–170, § 402(c), added pars. (gg) and (hh).
1994—Par. (g)(1). Pub. L. 103–417, § 10(a), amended last sentence generally. Prior to amendment, last sentence read as follows: “A food 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 under clause (B) solely because the label or labeling contains such a claim.”
Par. (s)(6). Pub. L. 103–417, § 3(b), added subpar. (6).
Par. (ff). Pub. L. 103–417, § 3(a), added par. (ff).
1993—Pars. (c), (d). Pub. L. 103–80, § 3(dd)(1), substituted “Health and Human Services” for “Agriculture”.
Par. (h). Pub. L. 103–80, § 4(b), amended directory language of Pub. L. 102–300, § 6(a)(1). See 1992 amendment note below.
Pars. (v) to (ff). Pub. L. 103–80, § 3(b), redesignated pars. (w) to (ff) as (v) to (ee), respectively.
1992—Pars. (c), (d). Pub. L. 102–300, § 6(b)(1), which directed the substitution of “Health and Human Services” for “Health, Education, and Welfare”, could not be executed because such words did not appear in the original statutory text. See 1993 Amendment note above and Transfer of Functions notes below.
Par. (h). Pub. L. 102–300, § 6(a)(1), as amended by Pub. L. 103–80, § 4(b), substituted “its primary” for “any of its principal” in two places in concluding provisions.
Par. (u). Pub. L. 102–571 substituted “379e” for “376”.
Par. (y)(1). Pub. L. 102–300, § 6(b)(2), struck out “of Health, Education, and Welfare” after “employees of the Department”.
Pars. (bb) to (ee). Pub. L. 102–282 added pars. (bb) to (ee).
Par. (ff). Pub. L. 102–300, § 6(a)(2), added par. (ff).
1990—Par. (g)(1). Pub. L. 101–629, § 16(b)(1), struck out “; but does not include devices or their components, parts, or accessories” after “clause (A), (B), or (C)”.
Pub. L. 101–535 inserted at end “A food 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 under clause (B) solely because the label or labeling contains such a claim.”
Par. (h)(3). Pub. L. 101–629, § 16(b)(2), which directed the amendment of subpar. (3) by substituting “its primary” for “any of its principal”, could not be executed because “any of its principal” did not appear in subpar. (3).
1988—Par. (w)(3). Pub. L. 100–670 struck out subpar. (3) which read as follows: “which drug is composed wholly or partly of any kind of penicillin, streptomycin, chlortetracycline, chloramphenicol, or bacitracin, or any derivative thereof, except when there is in effect a published order of the Secretary declaring such drug not to be a new animal drug on the grounds that (A) the requirement of certification of batches of such drug, as provided for in section 360b(n) of this title, is not necessary to insure that the objectives specified in paragraph (3) thereof are achieved and (B) that neither subparagraph (1) nor (2) of this paragraph (w) applies to such drug.”
1980—Par. (aa). Pub. L. 96–359 added par. (aa).
1977—Par. (z). Pub. L. 95–203 added par. (z).
1976—Par. (h). Pub. L. 94–295, § 3(a)(1)(A), expanded definition of “device” to include implements, machines, implants, in vitro reagents, and other similar or related articles, added recognition in the National Formulary or the United States Pharmacopeia, or any supplement to the Formulary or Pharmacopeia, to the enumeration of conditions under which a device may qualify for inclusion under this chapter, and inserted requirements that a device be one which does not achieve any of its principal 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 any of its principal intended purposes.
Par. (n). Pub. L. 94–278 inserted “or advertising” after “labeling” wherever appearing.
Par. (y). Pub. L. 94–295, § 3(a)(2), added par. (y).
1972—Par. (q). Pub. L. 92–516 substituted reference to pesticide for reference to economic poison.
1970—Par. (a)(2). Pub. L. 91–513, § 701(g), struck out reference to sections 321, 331(i), 331(p), 331(q), 332, 333, 334, 337, 360, 360a, 372, 373, 374, and 375 of this title as they apply to depressant or stimulant drugs.
Par. (v). Pub. L. 91–513, § 701(a), struck out par. (v) which defined “depressant or stimulant drug”.
1968—Par. (a)(2). Pub. L. 90–639, § 4(a), extended provisions to cover depressant and stimulant drugs, the containers thereof, and equipment used in manufacturing, compounding, or processing such drugs, to the Canal Zone.
Par. (p). Pub. L. 90–399, § 102(a), (b), inserted “(except a new animal drug or an animal feed bearing or containing a new animal drug)” after “Any drug” in subpars. (1) and (2), respectively.
Par. (s)(5). Pub. L. 90–399, § 102(c), added subpar. (5).
Par. (u). Pub. L. 90–399, § 102(d), inserted reference to section 360b of this title.
Par. (v)(3). Pub. L. 90–639, § 1, inserted reference to lysergic acid diethylamide.
Pars. (w), (x). Pub. L. 90–399, § 102(e), added pars. (w) and (x).
1965—Par. (g). Pub. L. 89–74, § 9(b), designated existing provisions as subpar. (1), redesignated cls. (1) to (4) thereof as (A) to (D), substituted “(A), (B), or (C)” for “(1), (2), or (3)” and added subpar. (2).
Par. (v). Pub. L. 89–74, § 3(a), added par. (v).
1962—Par. (a). Pub. L. 87–781, § 307(a), designated existing provisions as subpar. (2), inserted “Commonwealth of Puerto Rico and the”, and added subpar. (1).
Par. (p)(1). Pub. L. 87–781, § 102(a)(1), inserted “and effectiveness” after “to evaluate the safety”, and “and effective” after “as safe”.
Par. (p)(2). Pub. L. 87–781, § 102(a)(2), inserted “and effectiveness” after “safety”.
1960—Par. (s). Pub. L. 86–618, § 101(a), excluded color additives from definition of “food additive”.
Par. (t). Pub. L. 86–618, § 101(c), added par. (t). Former par. (t) redesignated (u).
Par. (u). Pub. L. 86–618, § 101(b), redesignated par. (t) as (u) and inserted reference to section 376 of this title.
1958—Pars. (s), (t). Pub. L. 85–929 added pars. (s) and (t).
1954—Pars. (q), (r). Act
Effective Date Of Amendment
Pub. L. 108–282, title II, § 203(d),
Pub. L. 105–115, title V, § 501,
Amendment by Pub. L. 101–535 effective six months after the date of the promulgation of final regulations to implement section 343(r) of this title, or if such regulations are not promulgated, the date proposed regulations are to be considered as such final regulations (
Amendment by Pub. L. 94–278 effective 180 days after
Amendment by Pub. L. 92–516 effective at the close of
Amendment by Pub. L. 91–513 effective on first day of seventh calendar month that begins after
Pub. L. 90–639, § 6,
Amendment by Pub. L. 90–399 effective on first day of thirteenth calendar month after
Pub. L. 89–74, § 11,
Pub. L. 87–781, title I, § 107,
Amendment by Pub. L. 86–618 effective
Amendment by Pub. L. 85–929 effective
For effective date of amendment by act
Miscellaneous
Amendment by Pub. L. 102–282 not to preclude any other civil, criminal, or administrative remedy provided under Federal or State law, including any private right of action against any person for the same action subject to any action or civil penalty under an amendment made by Pub. L. 102–282, see section 7 of Pub. L. 102–282, set out as a note under section 335a of this title.
Amendments by Pub. L. 101–535 not to be construed to alter authority of Secretary of Health and Human Services and Secretary of Agriculture under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), and the Egg Products Inspection Act (21 U.S.C. 1031 et seq.), see section 9 of Pub. L. 101–535, set out as a note under section 343 of this title.
Savings
Pub. L. 91–513, title II, § 702,
Transfer Of Functions
Secretary and Department of Health, Education, and Welfare redesignated Secretary and Department of Health and Human Services by Pub. L. 96–88, title V, § 509(b),
Functions of Secretary of Health, Education, and Welfare [now Health and Human Services] under Federal Food, Drug, and Cosmetic Act, to the extent such functions related to administration and enforcement of the Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 et seq.), transferred to Consumer Product Safety Commission by section 2079 of Title 15, Commerce and Trade.
Functions of Secretary of Health, Education, and Welfare [now Health and Human Services] under Drug Abuse Control Amendments of 1965 [see Short Title of 1965 Amendment note set out under section 301 of this title] transferred to Attorney General except function of regulating counterfeiting of those drugs which are not “depressant or stimulant” drugs, see section 2 of Reorg. Plan No. 1 of 1968, set out in the Appendix to Title 5, Government Organization and Employees.
Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare and all agencies of Federal Security Agency transferred to Department of Health, Education, and Welfare by section 5 of Reorg. Plan No. 1 of 1953, set out in the Appendix to Title 5, Government Organization and Employees. Federal Security Agency and office of Administrator abolished by section 8 of Reorg. Plan No. 1 of 1953.
Food and Drug Administration in Department of Agriculture and its functions, except those functions relating to administration of Insecticide Act of 1910 and Naval Stores Act, transferred to Federal Security Agency, to be administered under direction and supervision of Federal Security Administrator, by Reorg. Plan No. IV of 1940, set out in the Appendix to Title 5.
Miscellaneous
Pub. L. 105–115, title IV, § 422,
Pub. L. 103–417, § 2,
Pub. L. 90–639, § 5,
Pub. L. 89–74, § 2,
Pub. L. 89–74, § 10,
Pub. L. 87–781, title II, § 202,
Definitions
Pub. L. 105–115, § 2,