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

Page 36 TITLE 21—FOOD AND DRUGS § 321 1 So in original. Probably should be ‘‘Pharmacopeia,’’. of this title and section 210 of Title 42, The Public Health and Welfare, and enacting provisions set out as notes under sections 321, 342, and 451 of this title] may be cited as the ‘Food Additives Amendment of 1958’.’’ SEVERABILITY Pub. L. 113–54, title I, § 106(b), Nov. 27, 2013, 127 Stat. 598, provided that: ‘‘If any provision of this Act [see Short Title of 2013 Amendment note above] (including the amendments made by this Act) is declared uncon- stitutional, or the applicability of this Act (including the amendments made by this Act) to any person or circumstance is held invalid, the constitutionality of the remainder of this Act (including the amendments made by this Act) and the applicability thereof to other persons and circumstances shall not be affected.’’ Pub. L. 110–85, title XI, § 1105, Sept. 27, 2007, 121 Stat. 975, provided that: ‘‘If any provision of this Act [see Short Title of 2007 Amendment note above], an amend- ment made [by] this Act, or the application of such pro- vision or amendment to any person or circumstance is held to be unconstitutional, the remainder of this Act, the amendments made by this Act, and the application of the provisions of such to any person or cir- cumstances shall not be affected thereby.’’ HAZARDOUS SUBSTANCES Federal Hazardous Substances Act as not modifying this chapter, see Pub. L. 86–613, § 18, July 12, 1960, 74 Stat. 380, set out as an Effect Upon Federal and State Laws note under section 1261 of Title 15, Commerce and Trade. 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 Com- monwealth of Puerto Rico. (2) The term ‘‘Territory’’ means any Territory or possession of the United States, including the District of Columbia, and excluding the Com- monwealth 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 Depart- ment 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) chew- ing gum, and (3) articles used for components of any such article. (g)(1) The term ‘‘drug’’ means (A) articles rec- ognized in the official United States Pharma- copoeia,1 official Homoeopathic Pharmacopoeia of the United States, or official National For- mulary, 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 struc- ture 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 accord- ance 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, di- etary 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)(1) 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 compo- nent, part, or accessory, which is— (A) recognized in the official National For- mulary, or the United States Pharmacopeia, or any supplement to them, (B) intended for use in the diagnosis of dis- ease or other conditions, or in the cure, miti- gation, treatment, or prevention of disease, in man or other animals, or (C) 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. The term ‘‘device’’ does not include software functions excluded pursuant to section 360j(o) of this title. (2) The term ‘‘counterfeit device’’ means a de- vice which, or the container, packaging, or la- beling of which, without authorization, bears a trademark, trade name, or other identifying mark or imprint, or any likeness thereof, or is manufactured using a design, of a device manu- facturer, processor, packer, or distributor other than the person or persons who in fact manufac- tured, processed, packed, or distributed such de- vice and which thereby falsely purports or is represented to be the product of, or to have been packed or distributed by, such other device man- ufacturer, processor, packer, or distributor. (i) The term ‘‘cosmetic’’ means (1) articles in- tended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise ap- plied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and Page 37 TITLE 21—FOOD AND DRUGS § 321 (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 sup- plement to any of them. (k) The term ‘‘label’’ means a display of writ- ten, printed, or graphic matter upon the imme- diate container of any article; and a require- ment 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 re- tail 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 be- cause the labeling or advertising is misleading, then in determining whether the labeling or ad- vertising is misleading there shall be taken into account (among other things) not only represen- tations made or suggested by statement, word, design, device, or any combination thereof, but also the extent to which the labeling or adver- tising 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 adver- tising relates under the conditions of use pre- scribed 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 label- ing, 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 rep- resented 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 ani- mal 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 ef- fectiveness of drugs, as safe and effective for use under the conditions prescribed, rec- ommended, or suggested in the labeling there- of, 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 con- tained 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 ani- mal 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 recog- nized, but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such con- ditions. (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. Notwith- standing any other provision of law, the term ‘‘pesticide’’ within such meaning includes ethyl- ene oxide and propylene oxide when such sub- stances 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 (in- cluding 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 sub- stance 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 sub- stance is not excluded under this subclause from such definition if the substance is ethyl- ene oxide or propylene oxide, and is applied for such use on food. The substance is not so ex- cluded if the substance is applied for such use on a raw agricultural commodity, or the sub- stance 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 treat- ment facility where raw agricultural com- modities are the only food treated, and the treatment is in a manner that does not change the status of the food as a raw agri- cultural 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 con- tact substance as defined in section 348(h)(6) of this title, and any of the following cir- cumstances exist: The substance is included for such use in an object that has a food con- tact surface but is not intended to have an on- going 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 (with- out regard to whether the substance is in- tended to have an ongoing effect on any por- tion of the packaging). The food contact sub- stance is not excluded under this subclause from such definition if any of the following circumstances exist: The substance is applied Page 38 TITLE 21—FOOD AND DRUGS § 321 for such use on a semipermanent or permanent food contact surface (other than being applied on food packaging); or the substance is in- cluded 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 ‘‘pes- ticide’’ that is applicable to the Federal Insecti- cide, Fungicide, and Rodenticide Act [7 U.S.C. 136 et seq.], this clause does not exclude any sub- stance from such definition. (2) The term ‘‘pesticide chemical residue’’ means a residue in or on raw agricultural com- modity or processed food of— (A) a pesticide chemical; or (B) any other added substance that is present on or in the commodity or food pri- marily 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 pro- duction, storage, processing, or transportation of any raw agricultural commodity or proc- essed food; and (B) the Administrator, after consultation with the Secretary, determines that the sub- stance 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, in- cluding all fruits that are washed, colored, or otherwise treated in their unpeeled natural form prior to marketing. (s) The term ‘‘food additive’’ means any sub- stance the intended use of which results or may reasonably be expected to result, directly or in- directly, in its becoming a component or other- wise affecting the characteristics of any food (including any substance intended for use in pro- ducing, manufacturing, packing, processing, pre- paring, treating, packaging, transporting, or holding food; and including any source of radi- ation intended for any such use), if such sub- stance is not generally recognized, among ex- perts qualified by scientific training and experi- ence to evaluate its safety, as having been ade- quately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958, through either scientific proce- dures or experience based on common use in food) to be safe under the conditions of its in- tended use; except that such term does not in- clude— (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 Sep- tember 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 supple- ment. (t)(1) The term ‘‘color additive’’ means a mate- rial which— (A) is a dye, pigment, or other substance made by a process of synthesis or similar arti- fice, or extracted, isolated, or otherwise de- rived, 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 ma- terial which the Secretary, by regulation, deter- mines 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 para- graph shall be construed to apply to any pes- ticide chemical, soil or plant nutrient, or other agricultural chemical solely because of its effect in aiding, retarding, or otherwise affecting, di- rectly 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 ani- mal 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 ex- perience to evaluate the safety and effective- ness of animal drugs, as safe and effective for use under the conditions prescribed, rec- ommended, or suggested in the labeling there- of; 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 label- ing contained the same representations con- cerning the conditions of its use; or (2) the composition of which is such that such drug, as a result of investigations to de- termine its safety and effectiveness for use under such conditions, has become so recog- nized but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such con- ditions. Provided that any drug intended for minor use or use in a minor species that is not the subject Page 39 TITLE 21—FOOD AND DRUGS § 321 2 So in original. Probably should be paragraph ‘‘(v)’’. of a final regulation published by the Secretary through notice and comment rulemaking find- ing 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 para- graph (w) 2 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 in- tended to be the sole ration of the animal. (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 fol- lowing: (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 Sec- retary which is the subject of the hearing and who are not directly responsible to an officer or employee of the Department who has par- ticipated in any such action. (2) Each party to the hearing shall have the right at all times to be advised and accom- panied 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, in- cluding 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 com- plete 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 ques- tioning, and to present any oral or written in- formation 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 mate- rial presented at the hearing. The participants in the hearing shall be given the opportunity to review and correct or supplement the pre- siding 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 re- port 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 spe- cial 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) of this title for the approval of a drug that relies on the approved application of another drug with the same active ingredient to estab- lish safety and efficacy, and— (1) in the case of section 335a of this title, in- cludes a supplement to such an application for a different or additional use of the drug but does not include a supplement to such an ap- plication for other than a different or addi- tional 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 infor- mation. (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 cor- poration, association, or partnership, having duties such that the conduct of such of- ficer, 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 re- sponsibility for— (A) submissions to the Food and Drug Ad- ministration regarding the development or approval of any drug product, (B) production, quality assurance, or qual- ity 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, 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) in- tended 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 Page 40 TITLE 21—FOOD AND DRUGS § 321 3 So in original. Provision probably should be set flush with subpar. (B). (ii) complies with section 350(c)(1)(B)(ii) of this title; (B) is not represented for use as a conven- tional 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 or li- censed as a biologic under section 262 of title 42 and was, prior to such approval, certifi- cation, 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 un- lawful 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, cer- tified 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 investiga- tion as a new drug, antibiotic, or biologi- cal for which substantial clinical inves- tigations have been instituted and for which the existence of such investigations has been made public, which was not before such approval, certifi- cation, 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.3 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 can- ning, cooking, freezing, dehydration, or milling. (hh) The term ‘‘Administrator’’ means the Ad- ministrator 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 diag- nostic 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, rea- gent kit, ingredient, nuclide generator, accel- erator, 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 so- lution (including a chemically synthesized equivalent of any such substance) or any deriva- tive thereof. (kk) PRIORITY SUPPLEMENT.—The term ‘‘pri- ority supplement’’ means a drug application re- ferred 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 sin- gle 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 proc- essing and manufacture of a reprocessed single- use device shall result in a device that is reproc- essed within the meaning of this definition. (B) A single-use device that meets the defini- tion under clause (A) shall be considered a re- processed device without regard to any descrip- tion of the device used by the manufacturer of the device or other persons, including a descrip- tion 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 de- vice 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 de- vice 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 an- nually. (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, soybeans, and ses- ame. (2) A food ingredient that contains protein derived from a food specified in paragraph (1), except the following: Page 41 TITLE 21—FOOD AND DRUGS § 321 (A) Any highly refined oil derived from a food specified in paragraph (1) and any ingre- dient 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, or con- taining nicotine from any source, that is in- tended for human consumption, including any component, part, or accessory of a tobacco prod- uct (except for raw materials other than tobacco used in manufacturing a component, part, or ac- cessory 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 di- etary supplement). (5) The term ‘‘tobacco product’’ does not mean an article that is a food under paragraph (f), if such article contains no nicotine, or no more than trace amounts of naturally occurring nico- tine. (ss) The term ‘‘critical food’’ means a food that is— (1) an infant formula; or (2) a medical food, as defined in section 360ee(b)(3) of this title. (June 25, 1938, ch. 675, § 201, 52 Stat. 1040; July 22, 1954, ch. 559, § 1, 68 Stat. 511; Pub. L. 85–929, § 2, Sept. 6, 1958, 72 Stat. 1784; Pub. L. 86–618, title I, § 101, July 12, 1960, 74 Stat. 397; Pub. L. 87–781, title I, § 102(a), title III, § 307(a), Oct. 10, 1962, 76 Stat. 781, 796; Pub. L. 89–74, §§ 3(a), 9(b), July 15, 1965, 79 Stat. 227, 234; Pub. L. 90–399, § 102, July 13, 1968, 82 Stat. 351; Pub. L. 90–639, §§ 1, 4(a), Oct. 24, 1968, 82 Stat. 1361, 1362; Pub. L. 91–513, title II, § 701(a), (g), Oct. 27, 1970, 84 Stat. 1281, 1282; Pub. L. 92–516, § 3(3), Oct. 21, 1972, 86 Stat. 998; Pub. L. 94–278, title V, § 502(a)(2)(A), Apr. 22, 1976, 90 Stat. 411; Pub. L. 94–295, § 3(a)(1)(A), (2), May 28, 1976, 90 Stat. 575; Pub. L. 95–203, § 4(b)(3), Nov. 23, 1977, 91 Stat. 1453; Pub. L. 96–359, § 3, Sept. 26, 1980, 94 Stat. 1193; Pub. L. 100–670, title I, § 107(a)(1), Nov. 16, 1988, 102 Stat. 3984; Pub. L. 101–535, § 5(b), Nov. 8, 1990, 104 Stat. 2362; Pub. L. 101–629, § 16(b), Nov. 28, 1990, 104 Stat. 4526; Pub. L. 102–282, § 6, May 13, 1992, 106 Stat. 161; Pub. L. 102–300, § 6(a), (b), June 16, 1992, 106 Stat. 240; Pub. L. 102–571, title I, § 107(1), Oct. 29, 1992, 106 Stat. 4499; Pub. L. 103–80, §§ 3(b), (dd)(1), 4(b), Aug. 13, 1993, 107 Stat. 775, 779; Pub. L. 103–417, §§ 3(a), (b), 10(a), Oct. 25, 1994, 108 Stat. 4327, 4332; Pub. L. 104–170, title IV, § 402, Aug. 3, 1996, 110 Stat. 1513; Pub. L. 105–115, title I, §§ 121(a), 125(b)(2)(A), (e), Nov. 21, 1997, 111 Stat. 2320, 2325, 2327; Pub. L. 105–324, § 2(a), (c), Oct. 30, 1998, 112 Stat. 3035, 3037; Pub. L. 107–109, § 5(b)(1), Jan. 4, 2002, 115 Stat. 1413; Pub. L. 107–250, title III, § 302(d), Oct. 26, 2002, 116 Stat. 1619; Pub. L. 108–282, title I, § 102(b)(1), (5)(A), (B), title II, § 203(c)(1), Aug. 2, 2004, 118 Stat. 891, 902, 908; Pub. L. 110–85, title X, § 1005(c), Sept. 27, 2007, 121 Stat. 968; Pub. L. 111–31, div. A, title I, § 101(a), June 22, 2009, 123 Stat. 1783; Pub. L. 114–255, div. A, title III, § 3060(d), Dec. 13, 2016, 130 Stat. 1133; Pub. L. 116–304, § 2(b), Jan. 5, 2021, 134 Stat. 4916; Pub. L. 117–11, § 2(a), Apr. 23, 2021, 135 Stat. 262; Pub. L. 117–103, div. P, title I, § 111(a), Mar. 15, 2022, 136 Stat. 789; Pub. L. 117–328, div. FF, title III, § 3401(a)(2), Dec. 29, 2022, 136 Stat. 5838.) Editorial Notes REFERENCES IN TEXT The Food and Drugs Act of June 30, 1906, as amended, referred to in par. (p)(1), and the Food and Drug Act of June 30, 1906, as amended, referred to in par. (v)(1), is act June 30, 1906, ch. 3915, 34 Stat. 768, which was classi- fied to subchapter I (§ 1 et seq.) of chapter 1 of this title, was repealed (except for section 14a which was trans- ferred to section 376 of this title) by act June 25, 1938, ch. 675, § 1002(a), formerly § 902(a), 52 Stat. 1059; renum- bered § 1002(a), Pub. L. 111–31, div. A, title I, § 101(b)(2), June 22, 2009, 123 Stat. 1784, and is covered by this chap- ter. 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, Oct. 21, 1972, 86 Stat. 973, which is classified generally to sub- chapter II (§ 136 et seq.) of chapter 6 of Title 7, Agri- culture. For complete classification of this Act to the Code, see Short Title note set out under section 136 of Title 7 and Tables. The Poultry Products Inspection Act, referred to in par. (s)(4), is Pub. L. 85–172, Aug. 28, 1957, 71 Stat. 441, which is classified generally to chapter 10 (§ 451 et seq.) of this title. For complete classification of this Act to the Code, see Short Title note set out under section 451 of this title and Tables. The Meat Inspection Act of March 4, 1907, as amended and extended, referred to in par. (s)(4), is act Mar. 4, 1907, ch. 2907, titles I to IV, as added Dec. 15, 1967, Pub. L. 90–201, 81 Stat. 584, which are classified generally to subchapters I to IV (§ 601 et seq.) of chapter 12 of this title. For complete classification of this Act to the Code, see Short Title note set out under section 601 of this title and Tables. 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 2022—Par. (rr)(1). Pub. L. 117–103, § 111(a)(1), inserted ‘‘, or containing nicotine from any source,’’ after ‘‘from tobacco’’. Par. (rr)(5). Pub. L. 117–103, § 111(a)(2), added subpar. (5). Par. (ss). Pub. L. 117–328 added par. (ss). 2021—Par. (h). Pub. L. 116–304 redesignated introduc- tory provisions as subpar. (1) and former subpars. (1) to (3) as cls. (A) to (C), respectively, of subpar. (1) and added subpar. (2). Par. (qq)(1). Pub. L. 117–11 substituted ‘‘soybeans, and sesame’’ for ‘‘and soybeans’’. 2016—Par. (h). Pub. L. 114–255 inserted at end of con- cluding provisions ‘‘The term ‘device’ does not include software functions excluded pursuant to section 360j(o) of this title.’’ 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), sub- stituted ‘‘360b, 360ccc’’ for ‘‘360b’’. Par. (v). Pub. L. 108–282, § 102(b)(5)(B), inserted con- cluding 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). Page 42 TITLE 21—FOOD AND DRUGS § 321 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 fol- lows: ‘‘The term ‘pesticide chemical’ means any sub- stance that is a pesticide within the meaning of the Federal Insecticide, Fungicide, and Rodenticide Act, including all active and inert ingredients of such pes- ticide.’’ Par. (q)(3). Pub. L. 105–324, § 2(c), substituted ‘‘sub- paragraphs (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 fol- lows: ‘‘The term ‘pesticide chemical’ means any sub- stance which, alone, in chemical combination or in for- mulation with one or more other substances, is ‘a pes- ticide’ 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 produc- tion, storage, or transportation of raw agricultural commodities.’’ Par. (s)(1), (2). Pub. L. 104–170, § 402(b), amended sub- pars. (1) and (2) generally. Prior to amendment, sub- pars. (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 in- tended 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 ac- cordance 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), sub- stituted ‘‘Health and Human Services’’ for ‘‘Agri- culture’’. Par. (h). Pub. L. 103–80, § 4(b), amended directory lan- guage 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 di- rected the substitution of ‘‘Health and Human Serv- ices’’ 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 pri- mary’’ 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, chlor- tetracycline, chloramphenicol, or bacitracin, or any de- rivative thereof, except when there is in effect a pub- lished order of the Secretary declaring such drug not to be a new animal drug on the grounds that (A) the re- quirement of certification of batches of such drug, as provided for in section 360b(n) of this title, is not nec- essary to insure that the objectives specified in para- graph (3) thereof are achieved and (B) that neither sub- paragraph (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, ma- chines, implants, in vitro reagents, and other similar or related articles, added recognition in the National For- mulary or the United States Pharmacopeia, or any sup- plement 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 metab- olized for the achievement of any of its principal in- tended 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 provi- sions to cover depressant and stimulant drugs, the con- tainers 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 con- taining a new animal drug)’’ after ‘‘Any drug’’ in sub- pars. (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 ly- sergic 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 ex- isting provisions as subpar. (2), inserted ‘‘Common- wealth of Puerto Rico and the’’, and added subpar. (1). Par. (p)(1). Pub. L. 87–781, § 102(a)(1), inserted ‘‘and ef- fectiveness’’ after ‘‘to evaluate the safety’’, and ‘‘and effective’’ after ‘‘as safe’’. Par. (p)(2). Pub. L. 87–781, § 102(a)(2), inserted ‘‘and ef- fectiveness’’ after ‘‘safety’’. 1960—Par. (s). Pub. L. 86–618, § 101(a), excluded color additives from definition of ‘‘food additive’’. Page 43 TITLE 21—FOOD AND DRUGS § 321 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 July 22, 1954, added pars. (q) and (r). Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 2022 AMENDMENT Pub. L. 117–103, div. P, title I, § 111(c), Mar. 15, 2022, 136 Stat. 789, provided that: ‘‘The amendments made by subsections (a) and (b) [amending this section and sec- tion 387a of this title] shall take effect 30 days after the date of enactment of this Act [Mar. 15, 2022].’’ EFFECTIVE DATE OF 2021 AMENDMENT Pub. L. 117–11, § 2(b), Apr. 23, 2021, 135 Stat. 262, pro- vided that: ‘‘The amendment made by subsection (a) [amending this section] shall apply to any food that is introduced or delivered for introduction into interstate commerce on or after January 1, 2023.’’ EFFECTIVE DATE OF 2004 AMENDMENT Pub. L. 108–282, title II, § 203(d), Aug. 2, 2004, 118 Stat. 908, provided that: ‘‘The amendments made by this sec- tion [amending this section and sections 343 and 343–1 of this title] shall apply to any food that is labeled on or after January 1, 2006.’’ EFFECTIVE DATE OF 1997 AMENDMENT Pub. L. 105–115, title V, § 501, Nov. 21, 1997, 111 Stat. 2380, provided that: ‘‘Except as otherwise provided in this Act [see Short Title of 1997 Amendment note set out under section 301 of this title], this Act and the amendments made by this Act, other than the provi- sions of and the amendments made by sections 111, 121, 125, and 307 [enacting section 355a of this title, amend- ing this section and sections 331, 335a, 351, 352, 360, 360j, 360aa to 360cc, 360ee, 374, 379g, 381, and 382 of this title, section 45C of Title 26, Internal Revenue Code, section 156 of Title 35, Patents, and section 8126 of Title 38, Vet- erans’ Benefits, repealing sections 356 and 357 of this title, and enacting provisions set out as notes under sections 351 and 355 of this title], shall take effect 90 days after the date of enactment of this Act [Nov. 21, 1997].’’ EFFECTIVE DATE OF 1990 AMENDMENT 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 regu- lations are not promulgated, the date proposed regula- tions are to be considered as such final regulations (Nov. 8, 1992), with exception for persons marketing food the brand name of which contains a term defined by the Secretary under section 343(r)(2)(A)(i) of this title, see section 10(a) of Pub. L. 101–535, set out as a note under section 343 of this title. EFFECTIVE DATE OF 1976 AMENDMENT Amendment by Pub. L. 94–278 effective 180 days after Apr. 22, 1976, see section 502(c) of Pub. L. 94–278, set out as a note under section 334 of this title. EFFECTIVE DATE OF 1972 AMENDMENT Amendment by Pub. L. 92–516 effective at the close of Oct. 21, 1972, except if regulations are necessary for the implementation of any provision that becomes effec- tive on Oct. 21, 1972, and continuation in effect of sub- chapter I of chapter 6 of Title 7, and regulations there- under, relating to the control of economic poisons, as in existence prior to Oct. 21, 1972, until superseded by provisions of Pub. L. 92–516, and regulations there- under, see section 4 of Pub. L. 92–516, set out as an Ef- fective Date note under section 136 of Title 7, Agri- culture. EFFECTIVE DATE OF 1970 AMENDMENT Amendment by Pub. L. 91–513 effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of Pub. L. 91–513, set out as an Effective Date note under section 801 of this title. EFFECTIVE DATE OF 1968 AMENDMENTS; TRANSITIONAL PROVISIONS Pub. L. 90–639, § 6, Oct. 24, 1968, 82 Stat. 1362, provided that: ‘‘The amendments made by this Act [amending this section, sections 331, 333, 334, and 360a of this title, and provisions set out as a note under section 289a of Title 42, The Public Health and Welfare] shall apply only with respect to violations of the Federal Food, Drug, and Cosmetic Act [this chapter] committed after the date of the enactment of this Act [Oct. 24, 1968].’’ Amendment by Pub. L. 90–399 effective on first day of thirteenth calendar month after July 13, 1968, except that in the case of a drug (other than one subject to section 360b(n) of this title) intended for use in animals other than man which, on Oct. 9, 1962, was commer- cially used or sold in the United States, was not a new drug as defined in par. (p) of this section then in force, and was not covered by an effective application under section 355 of this title, the words ‘‘effectiveness’’ and ‘‘effective’’ contained in par. (v) of this section not ap- plicable to such drug when intended solely for use under conditions prescribed, recommended, or sug- gested in labeling with respect to such drug on that day, see section 108(a), (b)(3) of Pub. L. 90–399, as amended, set out as an Effective Date and Transitional Provisions note under section 360b of this title. EFFECTIVE DATE OF 1965 AMENDMENT Pub. L. 89–74, § 11, July 15, 1965, 79 Stat. 235, provided that: ‘‘The foregoing provisions of this Act [see Short Title of 1965 Amendment note set out under section 301 of this title] shall take effect on the first day of the seventh calendar month [Feb. 1, 1966] following the month in which this Act is enacted [July 15, 1965]; ex- cept that (1) the Secretary shall permit persons, own- ing or operating any establishment engaged in manu- facturing, preparing, propagating, compounding, proc- essing, wholesaling, jobbing, or distributing any depres- sant or stimulant drug, as referred to in the amend- ments made by section 4 of this Act to section 510 of the Federal Food, Drug, and Cosmetic Act [section 360 of this title], to register their name, places of business, and establishments, and other information prescribed by such amendments, with the Secretary prior to such effective date, and (2) sections 201(v) and 511(g) of the Federal Food, Drug, and Cosmetic Act, as added by this act [par. (v) of this section and par. (g) of section 360a of this title], and the provisions of sections 8 [amending section 372 of this title and section 1114 of Title 18, Crimes and Criminal Procedure] and 10 [set out as a note under this section] shall take effect upon the date of enactment of this Act [July 15, 1965].’’ EFFECTIVE DATE OF 1962 AMENDMENT Pub. L. 87–781, title I, § 107, Oct. 10, 1962, 76 Stat. 788, provided that: ‘‘(a) Except as otherwise provided in this section, the amendments made by the foregoing sections of this part A [amending this section and sections 331, 332, 348, 351 to 353, 355, 357, 379e of this title, and enacting provi- sions set out as a note under section 355 of this title] shall take effect on the date of enactment of this Act [Oct. 10, 1962]. ‘‘(b) The amendments made by sections 101, 103, 105, and 106 of this part A [amending sections 331, 332, 351, 352, 355, and 357 of this title] shall, with respect to any drug, take effect on the first day of the seventh cal- endar month following the month in which this Act is enacted [Oct. 1962]. ‘‘(c)(1) As used in this subsection, the term ‘enact- ment date’ means the date of enactment of this Act; and the term ‘basic Act’ means the Federal Food, Drug, and Cosmetic Act [this chapter]. Page 44 TITLE 21—FOOD AND DRUGS § 321 ‘‘(2) An application filed pursuant to section 505(b) of the basic Act [section 355(b) of this title] which was ‘ef- fective’ within the meaning of that Act on the day im- mediately preceding the enactment date shall be deemed as of the enactment date, to be an application ‘approved’ by the Secretary within the meaning of the basic Act as amended by this Act. ‘‘(3) In the case of any drug with respect to which an application filed under section 505(b) of the basic Act is deemed to be an approved application on the enactment date by virtue of paragraph (2) of this subsection— ‘‘(A) the amendments made by this Act to section 201(p), and to subsections (b) and (d) of section 505, of the basic Act [par. (p) of this section, and subsecs. (b) and (d) of section 355 of this title], insofar as such amendments relate to the effectiveness of drugs, shall not, so long as approval of such application is not withdrawn or suspended pursuant to section 505(e) of that Act [section 355(e) of this title], apply to such drug when intended solely for use under con- ditions prescribed, recommended, or suggested in la- beling covered by such approved application, but shall apply to any changed use, or conditions of use, prescribed, recommended, or suggested in its label- ing, including such conditions of use as are the sub- ject of an amendment or supplement to such applica- tion pending on, or filed after, the enactment date; and ‘‘(B) clause (3) of the first sentence of section 505(e) of the basic Act, as amended by this Act [section 355(e) of this title], shall not apply to such drug when intended solely for use under conditions prescribed, recommended, or suggested in labeling covered by such approved application (except with respect to such use, or conditions of use, as are the subject of an amendment or supplement to such approved applica- tion, which amendment or supplement has been ap- proved after the enactment date under section 505 of the basic Act as amended by this Act [section 355 of this title]) until whichever of the following first oc- curs: (i) the expiration of the two-year period begin- ning with the enactment date; (ii) the effective date of an order under section 505(e) of the basic Act [sec- tion 355(e) of this title], other than clause (3) of the first sentence of such section 505(e) [section 355(e) of this title], withdrawing or suspending the approval of such application. ‘‘(4) In the case of any drug which, on the day imme- diately preceding the enactment date, (A) was commer- cially used or sold in the United States, (B) was not a new drug as defined by section 201(p) of the basic Act as then in force [par. (p) of this section], and (C) was not covered by an effective application under section 505 of that Act [section 355 of this title], the amend- ments to section 201(p) [par. (p) of this section] made by this Act shall not apply to such drug when intended solely for use under conditions prescribed, rec- ommended, or suggested in labeling with respect to such drug on that day.’’ EFFECTIVE DATE OF 1960 AMENDMENT Amendment by Pub. L. 86–618 effective July 12, 1960, subject to provisions of section 203 of Pub. L. 86–618, see section 202 of Pub. L. 86–618, set out as a note under sec- tion 379e of this title. EFFECTIVE DATE OF 1958 AMENDMENT Amendment by Pub. L. 85–929 effective Sept. 6, 1958, see section 6(a) of Pub. L. 85–929, set out as a note under section 342 of this title. EFFECTIVE DATE OF 1954 AMENDMENT For effective date of amendment by act July 22, 1954, see section 5 of that act, set out as a note under section 342 of this title. CONSTRUCTION OF AMENDMENTS BY PUB. L. 102–282 Amendment by Pub. L. 102–282 not to preclude any other civil, criminal, or administrative remedy pro- vided 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 amend- ment 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. CONSTRUCTION OF AMENDMENTS BY PUB. L. 101–535 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 Fed- eral 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 PROVISION Pub. L. 91–513, title II, § 702, Oct. 27, 1970, 84 Stat. 1283, as amended by Pub. L. 93–481, § 2, Oct. 26, 1974, 88 Stat. 1455, provided that: ‘‘(a) Prosecutions for any violation of law occurring prior to the effective date [see Effective Date of 1970 Amendment note above] of section 701 [repealing sec- tion 360a of this title, and amending sections 321, 331, 333, 334, 360, 372, and 381 of this title, sections 1114 and 1952 of Title 18, Crimes and Criminal Procedure, and section 242 of Title 42, The Public Health and Welfare] shall not be affected by the repeals or amendments made by such section, or abated by reason thereof. ‘‘(b) Civil seizures or forfeitures and injunctive pro- ceedings commenced prior to the effective date of sec- tion 701 shall not be affected by the repeals or amend- ments made by such section, or abated by reason there- of. ‘‘(c) All administrative proceedings pending before the Bureau of Narcotics and Dangerous Drugs [now the Drug Enforcement Administration] on the date of en- actment of this Act [Oct. 27, 1970] shall be continued and brought to final determination in accord with laws and regulations in effect prior to such date of enact- ment. Where a drug is finally determined under such proceedings to be a depressant or stimulant drug, as de- fined in section 201(v) of the Federal Food, Drug, and Cosmetic Act [par. (v) of this section], such drug shall automatically be controlled under this title [sub- chapter I of chapter 13 of this title] by the Attorney General without further proceedings and listed in the appropriate schedule after he has obtained the rec- ommendation of the Secretary. Any drug with respect to which such a final determination has been made prior to the date of enactment of this Act which is not listed in section 202 [section 812 of this title] within schedules I through V shall automatically be controlled under this title [subchapter I of chapter 13 of this title] by the Attorney General without further proceedings, and be listed in the appropriate schedule, after he has obtained the recommendations of the Secretary. ‘‘(d) Notwithstanding subsection (a) of this section or section 1103 [of Pub. L. 91–513, set out as a note under sections 171 to 174 of this title], section 4202 of title 18, United States Code, shall apply to any individual con- victed under any of the laws repealed by this title or title III [subchapter I or subchapter II of chapter 13 of this title] without regard to the terms of any sentence imposed on such individual under such law.’’ 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), Oct. 17, 1979, 93 Stat. 695, which is classified to section 3508(b) of Title 20, Education. Functions of Secretary of Health, Education, and Welfare [now Health and Human Services] under Fed- eral 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 Page 45 TITLE 21—FOOD AND DRUGS § 321 Commission by section 2079 of Title 15, Commerce and Trade. REGULATION OF TOBACCO Pub. L. 117–103, div. P, title I, § 111(e), Mar. 15, 2022, 136 Stat. 790, provided that: ‘‘Effective 30 days after the date of enactment of this Act [Mar. 15, 2022], with re- spect to any regulation promulgated or related guid- ance issued, in whole or part, under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) before the date that is 30 days after such date of enactment, the term ‘tobacco product’ shall have the meaning of, and shall be deemed amended to reflect the meaning of, such term as defined in section 201(rr) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(rr)), as amended by subsection (a). Products that are tobacco products under such section 201(rr), as so amended, shall be subject to all requirements of regulations for tobacco products. The Secretary of Health and Human Services shall publish a notice in the Federal Register to update the Code of Federal Regulations to reflect such deemed amendment to existing regulations and guidance.’’ Pub. L. 105–115, title IV, § 422, Nov. 21, 1997, 111 Stat. 2380, provided that: ‘‘Nothing in this Act [see Short Title of 1997 Amendment note set out under section 301 of this title] or the amendments made by this Act shall be construed to affect the question of whether the Sec- retary of Health and Human Services has any authority to regulate any tobacco product, tobacco ingredient, or tobacco additive. Such authority, if any, shall be exer- cised under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] as in effect on the day before the date of the enactment of this Act [Nov. 21, 1997].’’ CONGRESSIONAL FINDINGS RELATING TO PUB. L. 103–417 Pub. L. 103–417, § 2, Oct. 25, 1994, 108 Stat. 4325, pro- vided that: ‘‘Congress finds that— ‘‘(1) improving the health status of United States citizens ranks at the top of the national priorities of the Federal Government; ‘‘(2) the importance of nutrition and the benefits of dietary supplements to health promotion and disease prevention have been documented increasingly in sci- entific studies; ‘‘(3)(A) there is a link between the ingestion of cer- tain nutrients or dietary supplements and the preven- tion of chronic diseases such as cancer, heart disease, and osteoporosis; and ‘‘(B) clinical research has shown that several chron- ic diseases can be prevented simply with a healthful diet, such as a diet that is low in fat, saturated fat, cholesterol, and sodium, with a high proportion of plant-based foods; ‘‘(4) healthful diets may mitigate the need for ex- pensive medical procedures, such as coronary bypass surgery or angioplasty; ‘‘(5) preventive health measures, including edu- cation, good nutrition, and appropriate use of safe nutritional supplements will limit the incidence of chronic diseases, and reduce long-term health care expenditures; ‘‘(6)(A) promotion of good health and healthy life- styles improves and extends lives while reducing health care expenditures; and ‘‘(B) reduction in health care expenditures is of paramount importance to the future of the country and the economic well-being of the country; ‘‘(7) there is a growing need for emphasis on the dis- semination of information linking nutrition and long-term good health; ‘‘(8) consumers should be empowered to make choices about preventive health care programs based on data from scientific studies of health benefits re- lated to particular dietary supplements; ‘‘(9) national surveys have revealed that almost 50 percent of the 260,000,000 Americans regularly con- sume dietary supplements of vitamins, minerals, or herbs as a means of improving their nutrition; ‘‘(10) studies indicate that consumers are placing increased reliance on the use of nontraditional health care providers to avoid the excessive costs of tradi- tional medical services and to obtain more holistic consideration of their needs; ‘‘(11) the United States will spend over $1,000,000,000,000 on health care in 1994, which is about 12 percent of the Gross National Product of the United States, and this amount and percentage will continue to increase unless significant efforts are un- dertaken to reverse the increase; ‘‘(12)(A) the nutritional supplement industry is an integral part of the economy of the United States; ‘‘(B) the industry consistently projects a positive trade balance; and ‘‘(C) the estimated 600 dietary supplement manufac- turers in the United States produce approximately 4,000 products, with total annual sales of such prod- ucts alone reaching at least $4,000,000,000; ‘‘(13) although the Federal Government should take swift action against products that are unsafe or adul- terated, the Federal Government should not take any actions to impose unreasonable regulatory barriers limiting or slowing the flow of safe products and ac- curate information to consumers; ‘‘(14) dietary supplements are safe within a broad range of intake, and safety problems with the supple- ments are relatively rare; and ‘‘(15)(A) legislative action that protects the right of access of consumers to safe dietary supplements is necessary in order to promote wellness; and ‘‘(B) a rational Federal framework must be estab- lished to supersede the current ad hoc, patchwork regulatory policy on dietary supplements.’’ DISSEMINATION OF INFORMATION REGARDING THE DANGERS OF DRUG ABUSE Pub. L. 90–639, § 5, Oct. 24, 1968, 82 Stat. 1362, provided that: ‘‘It is the sense of the Congress that, because of the inadequate knowledge on the part of the people of the United States of the substantial adverse effects of misuse of depressant and stimulant drugs, and of other drugs liable to abuse, on the individual, his family, and the community, the highest priority should be given to Federal programs to disseminate information which may be used to educate the public, particularly young persons, regarding the dangers of drug abuse.’’ CONGRESSIONAL FINDINGS AND DECLARATION OF POLICY Pub. L. 89–74, § 2, July 15, 1965, 79 Stat. 226, provided that: ‘‘The Congress hereby finds and declares that there is a widespread illicit traffic in depressant and stimulant drugs moving in or otherwise affecting inter- state commerce; that the use of such drugs, when not under the supervision of a licensed practitioner, often endangers safety on the highways (without distinction of interstate and intrastate traffic thereon) and other- wise has become a threat to the public health and safe- ty, making additional regulation of such drugs nec- essary regardless of the intrastate or interstate origin of such drugs; that in order to make regulation and protection of interstate commerce in such drugs effec- tive, regulation of intrastate commerce is also nec- essary because, among other things, such drugs, when held for illicit sale, often do not bear labeling showing their place of origin and because in the form in which they are so held or in which they are consumed a deter- mination of their place of origin is often extremely dif- ficult or impossible; and that regulation of interstate commerce without the regulation of intrastate com- merce in such drugs, as provided in this Act [see Short Title of 1965 Amendment note set out under section 301 of this title], would discriminate against and adversely affect interstate commerce in such drugs.’’ EFFECT OF DRUG ABUSE CONTROL AMENDMENTS OF 1965 ON STATE LAWS Pub. L. 89–74, § 10, July 15, 1965, 79 Stat. 235, provided that: Page 46 TITLE 21—FOOD AND DRUGS § 321a ‘‘(a) Nothing in this Act [enacting section 360a of this title, amending sections 321, 331, 333, 334, 360, and 372 of this title and section 1114 of Title 18, Crimes and Crimi- nal Procedure, and enacting provisions set out as notes under sections 321, 352, and 360a of this title] shall be construed as authorizing the manufacture, compounding, processing, possession, sale, delivery, or other disposal of any drug in any State in contraven- tion of the laws of such State. ‘‘(b) No provision of this Act nor any amendment made by it shall be construed as indicating an intent on the part of the Congress to occupy the field in which such provision or amendment operates to the exclusion of any State law on the same subject matter, unless there is a direct and positive conflict between such pro- vision or amendment and such State law so that the two cannot be reconciled or consistently stand to- gether. ‘‘(c) No amendment made by this Act shall be con- strued to prevent the enforcement in the courts of any State of any statute of such State prescribing any criminal penalty for any act made criminal by any such amendment.’’ EFFECT OF DRUG AMENDMENTS OF 1962 ON STATE LAWS Pub. L. 87–781, title II, § 202, Oct. 10, 1962, 76 Stat. 793, provided that: ‘‘Nothing in the amendments made by this Act [enacting sections 358 to 360, amending sec- tions 321, 331, 332, 348, 351 to 353, 355, 357, 372, 374, 379e, and 381 of this title, and enacting provisions set out as notes under sections 321, 331, 332, 352, 355, 360, and 374 of this title] to the Federal Food, Drug, and Cosmetic Act [this chapter] shall be construed as invalidating any provision of State law which would be valid in the ab- sence of such amendments unless there is a direct and positive conflict between such amendments and such provision of State law.’’ DEFINITIONS Pub. L. 105–115, § 2, Nov. 21, 1997, 111 Stat. 2297, pro- vided that: ‘‘In this Act [see Short Title of 1997 Amend- ment note set out under section 301 of this title], the terms ‘drug’, ‘device’, ‘food’, and ‘dietary supplement’ have the meaning given such terms in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).’’ Executive Documents TRANSFER OF FUNCTIONS 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 trans- ferred 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 Ap- pendix to Title 5, Government Organization and Em- ployees. Federal Security Agency and office of Admin- istrator abolished by section 8 of Reorg. Plan No. 1 of 1953. Food and Drug Administration in Department of Ag- riculture and its functions, except those functions re- lating to administration of Insecticide Act of 1910 and Naval Stores Act, transferred to Federal Security Agency, to be administered under direction and super- vision of Federal Security Administrator, by Reorg. Plan No. IV of 1940, set out in the Appendix to Title 5. § 321a. ‘‘Butter’’ defined For the purposes of the Food and Drug Act of June 30, 1906 (Thirty-fourth Statutes at Large, page 768) ‘‘butter’’ shall be understood to mean the food product usually known as butter, and which is made exclusively from milk or cream, or both, with or without common salt, and with or without additional coloring matter, and con- taining not less than 80 per centum by weight of milk fat, all tolerances having been allowed for. (Mar. 4, 1923, ch. 268, 42 Stat. 1500.) Editorial Notes REFERENCES IN TEXT The Food and Drug Act of June 30, 1906, referred to in text, is act June 30, 1906, ch. 3915, 34 Stat. 768, which was classified to subchapter I (§ 1 et seq.) of chapter 1 of this title, was repealed (except for section 14a which was transferred to section 376 of this title) by act June 25, 1938, ch. 675, § 1002(a), formerly § 902(a), 52 Stat. 1059; renumbered § 1002(a), Pub. L. 111–31, div. A, title I, § 101(b)(2), June 22, 2009, 123 Stat. 1784, and is covered by this chapter. CODIFICATION Section, which was not enacted as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter, was formerly classified to section 6 of this title. Section 1002(a) of act June 25, 1938, set out as an Effective Date note under section 301 of this title, pro- vided that this section should remain in force and ef- fect and be applicable to the provisions of this chapter. § 321b. ‘‘Package’’ defined The word ‘‘package’’ where it occurs the sec- ond and last time in the act entitled ‘‘An act to amend section 8 of an act entitled, ‘An act for preventing the manufacture, sale, or transpor- tation of adulterated or misbranded or poi- sonous deleterious foods, drugs, medicines, and liquors, and for regulating traffic therein, and for other purposes,’ ’’ approved March 3, 1913, shall include and shall be construed to include wrapped meats inclosed in papers or other mate- rials as prepared by the manufacturers thereof for sale. (July 24, 1919, ch. 26, 41 Stat. 271.) Editorial Notes REFERENCES IN TEXT An act approved March 3, 1913, referred to in text, is act Mar. 3, 1913, ch. 117, 37 Stat. 732, which amended section 10 of this title. For complete classification of this Act to the Code, see Tables. ‘‘An act for preventing the manufacture, sale, or transportation of adulterated or misbranded or poi- sonous deleterious foods, drugs, medicines, and liquors, and for regulating traffic therein, and for other pur- poses’’, referred to in text, is act June 30, 1906, ch. 3915, 34 Stat. 768, which was classified to subchapter I (§ 1 et seq.) of chapter 1 of this title, was repealed (except for section 14a which was transferred to section 376 of this title) by act June 25, 1938, ch. 675, § 1002(a), formerly § 902(a), 52 Stat. 1059; renumbered § 1002(a), Pub. L. 111–31, div. A, title I, § 101(b)(2), June 22, 2009, 123 Stat. 1784, and is covered by this chapter. CODIFICATION Section, which was not enacted as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter, was formerly classified to the last sentence of paragraph third of section 10 of this title. Section 1002(a) of act June 25, 1938, set out as an Effective Date note under section 301 of this title, provided that this section should remain in force and effect and be appli- cable to the provisions of this chapter.