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

For the purposes of this chapter—

(a)

(1)

section 372(a) of this title The term “State”, except as used in the last sentence of , 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)

1 So in original. Probably should be “Pharmacopeia,”.

section 343(r) of this title section 343(r)(6) of this title 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 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 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 component, part, or accessory, which is—

(A)

recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,

(B)

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

(C)

intended to affect the structure or any function of the body of man or other animals, and

owhich 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() of this title.

(2)

The term “counterfeit device” means a device which, or the container, packaging, or labeling 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 manufacturer, processor, packer, or distributor other than the person or persons who in fact manufactured, processed, packed, or distributed such device and which thereby falsely purports or is represented to be the product of, or to have been packed or distributed by, such other device manufacturer, processor, packer, or distributor.

(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)

June 25, 1938June 30, 1906 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 , it was subject to the Food and Drugs Act of , 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)

7 U.S.C. 136 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 [ 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)

section 348(h)(6) of this title 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 , 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.

7 U.S.C. 136With respect to the definition of the term “pesticide” that is applicable to the Federal Insecticide, Fungicide, and Rodenticide Act [ 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)

January 1, 1958 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 , 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)

September 6, 195821 U.S.C. 451March 4, 190721 U.S.C. 601 any substance used in accordance with a sanction or approval granted prior to , pursuant to this chapter, the Poultry Products Inspection Act [ et seq.] or the Meat Inspection Act of , as amended and extended [ 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)

June 25, 1938June 30, 1906 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 , it was subject to the Food and Drug Act of , 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)

2 So in original. Probably should be paragraph “(v)”.

section 360b of this title The term “animal feed”, as used in paragraph (w)  of this section, in , and in provisions of this chapter referring to such paragraph or section, means an article which is intended for use for food for animals other than man and which is intended for use as a substantial source of nutrients in the diet of the animal, and is not limited to a mixture intended to be the sole ration of the animal.

(x)

The term “informal hearing” means a hearing which is not subject to section 554, 556, or 557 of title 5 and which provides for the following:

(1)

The presiding officer in the hearing shall be designated by the Secretary from officers and employees of the Department who have not participated in any action of the Secretary which is the subject of the hearing and who are not directly responsible to an officer or employee of the Department who has participated in any such action.

(2)

Each party to the hearing shall have the right at all times to be advised and accompanied by an attorney.

(3)

Before the hearing, each party to the hearing shall be given reasonable notice of the matters to be considered at the hearing, including a comprehensive statement of the basis for the action taken or proposed by the Secretary which is the subject of the hearing and a general summary of the information which will be presented by the Secretary at the hearing in support of such action.

(4)

At the hearing the parties to the hearing shall have the right to hear a full and complete statement of the action of the Secretary which is the subject of the hearing together with the information and reasons supporting such action, to conduct reasonable questioning, and to present any oral or written information relevant to such action.

(5)

The presiding officer in such hearing shall prepare a written report of the hearing to which shall be attached all written material presented at the hearing. The participants in the hearing shall be given the opportunity to review and correct or supplement the presiding officer’s report of the hearing.

(6)

The Secretary may require the hearing to be transcribed. A party to the hearing shall have the right to have the hearing transcribed at his expense. Any transcription of a hearing shall be included in the presiding officer’s report of the hearing.

(y)

The term “saccharin” includes calcium saccharin, sodium saccharin, and ammonium saccharin.

(z)

The term “infant formula” means a food which purports to be or is represented for special dietary use solely as a food for infants by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk.

(aa)

section 355(j) of this title The term “abbreviated drug application” means an application submitted under for the approval of a drug that relies on the approved application of another drug with the same active ingredient to establish safety and efficacy, and—

(1)

section 335a of this title in the case of , includes a supplement to such an application for a different or additional use of the drug but does not include a supplement to such an application for other than a different or additional use of the drug, and

(2)

in the case of sections 335b and 335c of this title, includes any supplement to such an application.

(bb)

The term “knowingly” or “knew” means that a person, with respect to information—

(1)

has actual knowledge of the information, or

(2)

acts in deliberate ignorance or reckless disregard of the truth or falsity of the information.

(cc)

section 335a of this title For purposes of , the term “high managerial agent”—

(1)

means—

(A)

an officer or director of a corporation or an association,

(B)

a partner of a partnership, or

(C)

any employee or other agent of a corporation, association, or partnership,

having duties such that the conduct of such officer, director, partner, employee, or agent may fairly be assumed to represent the policy of the corporation, association, or partnership, and

(2)

includes persons having management responsibility for—

(A)

submissions to the Food and Drug Administration regarding the development or approval of any drug product,

(B)

production, quality assurance, or quality control of any drug product, or

(C)

research and development of any drug product.

(dd)

section 262 of title 42 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 .

(ee)

The term “Commissioner” means the Commissioner of Food and Drugs.

(ff)

The term “dietary supplement”—

(1)

means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients:

(A)

a vitamin;

(B)

a mineral;

(C)

an herb or other botanical;

(D)

an amino acid;

(E)

a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or

(F)

a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E);

(2)

means a product that—

(A)

(i)

section 350(c)(1)(B)(i) of this title is intended for ingestion in a form described in ; or

(ii)

section 350(c)(1)(B)(ii) of this title complies with ;

(B)

is not represented for use as a conventional food or as a sole item of a meal or the diet; and

(C)

is labeled as a dietary supplement; and

(3)

does—

(A)

section 355 of this title section 262 of title 42 section 342(f) of this title include an article that is approved as a new drug under or licensed as a biologic under and was, prior to such approval, certification, or license, marketed as a dietary supplement or as a food unless the Secretary has issued a regulation, after notice and comment, finding that the article, when used as or in a dietary supplement under the conditions of use and dosages set forth in the labeling for such dietary supplement, is unlawful under ; and

(B)

not include—

(i)

section 355 of this title section 357 of this title section 262 of title 42 an article that is approved as a new drug under , certified as an antibiotic under , or licensed as a biologic under , or

(ii)

an article authorized for investigation as a new drug, antibiotic, or biological for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public,

3 So in original. Provision probably should be set flush with subpar. (B).

which was not before such approval, certification, licensing, or authorization marketed as a dietary supplement or as a food unless the Secretary, in the Secretary’s discretion, has issued a regulation, after notice and comment, finding that the article would be lawful under this chapter.

section 350f of this titleExcept for purposes of paragraph (g) and , 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 .—

111 Stat. 2298The term “priority supplement” means a drug application referred to in section 101(4) of the Food and Drug Administration Modernization Act of 1997 ().

(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, soybeans, and sesame.

(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)

section 343(w) of this title A food ingredient that is exempt under paragraph (6) or (7) of .

(rr)

(1)

The term “tobacco product” means any product made or derived from tobacco, or containing nicotine from any source, 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)

section 353(g) of this title 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 .

(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).

(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 nicotine.

(ss)

The term “critical food” means a food that is—

(1)

an infant formula; or

(2)

section 360ee(b)(3) of this title a medical food, as defined in .

June 25, 1938, ch. 675, § 201 52 Stat. 1040 July 22, 1954, ch. 559, § 1 68 Stat. 511 Pub. L. 85–929, § 2Sept. 6, 195872 Stat. 1784 Pub. L. 86–618, title I, § 101July 12, 196074 Stat. 397 Pub. L. 87–781, title I, § 102(a)Oct. 10, 196276 Stat. 781 Pub. L. 89–74July 15, 196579 Stat. 227 Pub. L. 90–399, § 102July 13, 196882 Stat. 351 Pub. L. 90–639Oct. 24, 196882 Stat. 1361 Pub. L. 91–513, title II, § 701(a)Oct. 27, 197084 Stat. 1281 Pub. L. 92–516, § 3(3)Oct. 21, 197286 Stat. 998 Pub. L. 94–278, title V, § 502(a)(2)(A)Apr. 22, 197690 Stat. 411 Pub. L. 94–295, § 3(a)(1)(A)May 28, 197690 Stat. 575 Pub. L. 95–203, § 4(b)(3)Nov. 23, 197791 Stat. 1453 Pub. L. 96–359, § 3Sept. 26, 198094 Stat. 1193 Pub. L. 100–670, title I, § 107(a)(1)Nov. 16, 1988102 Stat. 3984 Pub. L. 101–535, § 5(b)Nov. 8, 1990104 Stat. 2362 Pub. L. 101–629, § 16(b)Nov. 28, 1990104 Stat. 4526 Pub. L. 102–282, § 6May 13, 1992106 Stat. 161 Pub. L. 102–300, § 6(a)June 16, 1992106 Stat. 240 Pub. L. 102–571, title I, § 107(1)Oct. 29, 1992106 Stat. 4499 Pub. L. 103–80Aug. 13, 1993107 Stat. 775 Pub. L. 103–417Oct. 25, 1994108 Stat. 4327 Pub. L. 104–170, title IV, § 402Aug. 3, 1996110 Stat. 1513 Pub. L. 105–115, title INov. 21, 1997111 Stat. 2320 Pub. L. 105–324, § 2(a)Oct. 30, 1998112 Stat. 3035 Pub. L. 107–109, § 5(b)(1)Jan. 4, 2002115 Stat. 1413 Pub. L. 107–250, title III, § 302(d)Oct. 26, 2002116 Stat. 1619 Pub. L. 108–282, title I, § 102(b)(1)Aug. 2, 2004118 Stat. 891 Pub. L. 110–85, title X, § 1005(c)Sept. 27, 2007121 Stat. 968 Pub. L. 111–31, div. A, title I, § 101(a)June 22, 2009123 Stat. 1783 Pub. L. 114–255, div. A, title III, § 3060(d)Dec. 13, 2016130 Stat. 1133 Pub. L. 116–304, § 2(b)Jan. 5, 2021134 Stat. 4916 Pub. L. 117–11, § 2(a)Apr. 23, 2021135 Stat. 262 Pub. L. 117–103, div. P, title I, § 111(a)Mar. 15, 2022136 Stat. 789 Pub. L. 117–328, div. FF, title III, § 3401(a)(2)Dec. 29, 2022136 Stat. 5838(, ; , ; , , ; , , ; , title III, § 307(a), , , 796; , §§ 3(a), 9(b), , , 234; , , ; , §§ 1, 4(a), , , 1362; , (g), , , 1282; , , ; , , ; , (2), , ; , , ; , , ; , , ; , , ; , , ; , , ; , (b), , ; , , ; , §§ 3(b), (dd)(1), 4(b), , , 779; , §§ 3(a), (b), 10(a), , , 4332; , , ; , §§ 121(a), 125(b)(2)(A), (e), , , 2325, 2327; , (c), , , 3037; , , ; , , ; , (5)(A), (B), title II, § 203(c)(1), , , 902, 908; , , ; , , ; , , ; , , ; , , ; , , ; , , .)

Editorial Notes

References in Text

June 30, 1906June 30, 1906act June 30, 1906, ch. 3915 34 Stat. 768 section 376 of this title act June 25, 1938, ch. 675, § 1002(a)52 Stat. 1059 Pub. L. 111–31, div. A, title I, § 101(b)(2)June 22, 2009123 Stat. 1784The Food and Drugs Act of , as amended, referred to in par. (p)(1), and the Food and Drug Act of , as amended, referred to in par. (v)(1), is , , 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 ) by , formerly § 902(a), ; renumbered § 1002(a), , , , and is covered by this chapter.

act June 25, 1947, ch. 125 Pub. L. 92–516Oct. 21, 197286 Stat. 973 section 136 of Title 7The Federal Insecticide, Fungicide, and Rodenticide Act, referred to in par. (q)(1), is , as amended generally by , , , which is classified generally to subchapter II (§ 136 et seq.) of chapter 6 of Title 7, Agriculture. For complete classification of this Act to the Code, see Short Title note set out under and Tables.

Pub. L. 85–172Aug. 28, 195771 Stat. 441 section 451 of this titleThe Poultry Products Inspection Act, referred to in par. (s)(4), is , , , 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 and Tables.

March 4, 1907act Mar. 4, 1907, ch. 2907Dec. 15, 1967Pub. L. 90–201 81 Stat. 584 section 601 of this titleThe Meat Inspection Act of , as amended and extended, referred to in par. (s)(4), is , titles I to IV, as added , , , 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 and Tables.

section 101(4) of Pub. L. 105–115 section 379g of this titleSection 101(4) of the Food and Drug Administration Modernization Act of 1997, referred to in par. (kk), is , which is set out as a note under .

Amendments

Pub. L. 117–103, § 111(a)(1)2022—Par. (rr)(1). , inserted “, or containing nicotine from any source,” after “from tobacco”.

Pub. L. 117–103, § 111(a)(2)Par. (rr)(5). , added subpar. (5).

Pub. L. 117–328Par. (ss). added par. (ss).

Pub. L. 116–3042021—Par. (h). redesignated introductory provisions as subpar. (1) and former subpars. (1) to (3) as cls. (A) to (C), respectively, of subpar. (1) and added subpar. (2).

Pub. L. 117–11Par. (qq)(1). substituted “soybeans, and sesame” for “and soybeans”.

Pub. L. 114–255o2016—Par. (h). inserted at end of concluding provisions “The term ‘device’ does not include software functions excluded pursuant to section 360j() of this title.”

Pub. L. 111–312009—Par. (rr). added par. (rr).

Pub. L. 110–85 section 350f of this title2007—Par. (ff). substituted “paragraph (g) and ” for “paragraph (g)” in concluding provisions.

Pub. L. 108–282, § 102(b)(5)(A)2004–Par. (u). , substituted “360b, 360ccc” for “360b”.

Pub. L. 108–282, § 102(b)(5)(B)Par. (v). , inserted concluding provisions.

Pub. L. 108–282, § 102(b)(1)Pars. (nn) to (pp). , added pars. (nn) to (pp).

Pub. L. 108–282, § 203(c)(1)Par. (qq). , added par. (qq).

Pub. L. 107–1092002—Par. (kk). added par. (kk).

llPub. L. 107–250llPars. (), (mm). added pars. () and (mm).

Pub. L. 105–324, § 2(a)1998—Par. (q)(1). , 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.”

Pub. L. 105–324, § 2(c)Par. (q)(3). , substituted “subparagraphs (1) and (2)” for “paragraphs (1) and (2)” in introductory provisions.

Pub. L. 105–115, § 125(b)(2)(A)1997—Par. (aa). , struck out “or 357” after “section 355(j)”.

Pub. L. 105–115, § 125(b)(2)(A)Par. (dd). , struck out “357,” after “section 355,”.

Pub. L. 105–115, § 125(b)(2)(A)section 357 of this titlePar. (ff)(3)(A). , struck out “, certified as an antibiotic under ,” before “or licensed as a biologic”.

Pub. L. 105–115, § 121(a)Par. (ii). , added par. (ii).

Pub. L. 105–115, § 125(e)Par. (jj). , added par. (jj).

Pub. L. 104–170, § 402(a)1996—Par. (q). , 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.”

Pub. L. 104–170, § 402(b)Par. (s)(1), (2). , 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”.

Pub. L. 104–170, § 402(c)Pars. (gg), (hh). , added pars. (gg) and (hh).

Pub. L. 103–417, § 10(a)section 343(r) of this title1994—Par. (g)(1). , 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 is not a drug under clause (B) solely because the label or labeling contains such a claim.”

Pub. L. 103–417, § 3(b)Par. (s)(6). , added subpar. (6).

Pub. L. 103–417, § 3(a)Par. (ff). , added par. (ff).

Pub. L. 103–80, § 3(dd)(1)1993—Pars. (c), (d). , substituted “Health and Human Services” for “Agriculture”.

Pub. L. 103–80, § 4(b)Pub. L. 102–300, § 6(a)(1)Par. (h). , amended directory language of . See 1992 amendment note below.

Pub. L. 103–80, § 3(b)Pars. (v) to (ff). , redesignated pars. (w) to (ff) as (v) to (ee), respectively.

Pub. L. 102–300, § 6(b)(1)1992—Pars. (c), (d). , 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.

Pub. L. 102–300, § 6(a)(1)Pub. L. 103–80, § 4(b)Par. (h). , as amended by , substituted “its primary” for “any of its principal” in two places in concluding provisions.

Pub. L. 102–571Par. (u). substituted “379e” for “376”.

Pub. L. 102–300, § 6(b)(2)Par. (y)(1). , struck out “of Health, Education, and Welfare” after “employees of the Department”.

Pub. L. 102–282Pars. (bb) to (ee). added pars. (bb) to (ee).

Pub. L. 102–300, § 6(a)(2)Par. (ff). , added par. (ff).

Pub. L. 101–629, § 16(b)(1)1990—Par. (g)(1). , struck out “; but does not include devices or their components, parts, or accessories” after “clause (A), (B), or (C)”.

Pub. L. 101–535 section 343(r) of this title 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 is not a drug under clause (B) solely because the label or labeling contains such a claim.”

Pub. L. 101–629, § 16(b)(2)Par. (h)(3). , 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).

Pub. L. 100–670 section 360b(n) of this title1988—Par. (w)(3). 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 , 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.”

Pub. L. 96–3591980—Par. (aa). added par. (aa).

Pub. L. 95–2031977—Par. (z). added par. (z).

Pub. L. 94–295, § 3(a)(1)(A)1976—Par. (h). , 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.

Pub. L. 94–278Par. (n). inserted “or advertising” after “labeling” wherever appearing.

Pub. L. 94–295, § 3(a)(2)Par. (y). , added par. (y).

Pub. L. 92–5161972—Par. (q). substituted reference to pesticide for reference to economic poison.

Pub. L. 91–513, § 701(g)1970—Par. (a)(2). , 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.

Pub. L. 91–513, § 701(a)Par. (v). , struck out par. (v) which defined “depressant or stimulant drug”.

Pub. L. 90–639, § 4(a)1968—Par. (a)(2). , 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.

Pub. L. 90–399, § 102(a)Par. (p). , (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.

Pub. L. 90–399, § 102(c)Par. (s)(5). , added subpar. (5).

Pub. L. 90–399, § 102(d)section 360b of this titlePar. (u). , inserted reference to .

Pub. L. 90–639, § 1Par. (v)(3). , inserted reference to lysergic acid diethylamide.

Pub. L. 90–399, § 102(e)Pars. (w), (x). , added pars. (w) and (x).

Pub. L. 89–74, § 9(b)1965—Par. (g). , 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).

Pub. L. 89–74, § 3(a)Par. (v). , added par. (v).

Pub. L. 87–781, § 307(a)1962—Par. (a). , designated existing provisions as subpar. (2), inserted “Commonwealth of Puerto Rico and the”, and added subpar. (1).

Pub. L. 87–781, § 102(a)(1)Par. (p)(1). , inserted “and effectiveness” after “to evaluate the safety”, and “and effective” after “as safe”.

Pub. L. 87–781, § 102(a)(2)Par. (p)(2). , inserted “and effectiveness” after “safety”.

Pub. L. 86–618, § 101(a)1960—Par. (s). , excluded color additives from definition of “food additive”.

Pub. L. 86–618, § 101(c)Par. (t). , added par. (t). Former par. (t) redesignated (u).

Pub. L. 86–618, § 101(b)section 376 of this titlePar. (u). , redesignated par. (t) as (u) and inserted reference to .

Pub. L. 85–9291958—Pars. (s), (t). added pars. (s) and (t).

July 22, 19541954—Pars. (q), (r). Act , 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, 2022136 Stat. 789

section 387a of this titleMar. 15, 2022“The amendments made by subsections (a) and (b) [amending this section and ] shall take effect 30 days after the date of enactment of this Act [].”

, , , provided that:

Effective Date of 2021 Amendment

Pub. L. 117–11, § 2(b)Apr. 23, 2021135 Stat. 262

January 1, 2023“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 .”

, , , provided that:

Effective Date of 2004 Amendment

Pub. L. 108–282, title II, § 203(d)Aug. 2, 2004118 Stat. 908

January 1, 2006“The amendments made by this section [amending this section and sections 343 and 343–1 of this title] shall apply to any food that is labeled on or after .”

, , , provided that:

Effective Date of 1997 Amendment

Pub. L. 105–115, title V, § 501Nov. 21, 1997111 Stat. 2380

section 301 of this title section 355a of this title section 45C of Title 26 section 156 of Title 35 section 8126 of Title 38Nov. 21, 1997“Except as otherwise provided in this Act [see Short Title of 1997 Amendment note set out under ], this Act and the amendments made by this Act, other than the provisions of and the amendments made by sections 111, 121, 125, and 307 [enacting , amending this section and sections 331, 335a, 351, 352, 360, 360j, 360aa to 360cc, 360ee, 374, 379g, 381, and 382 of this title, , Internal Revenue Code, , Patents, and , Veterans’ 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 [].”

, , , provided that:

Effective Date of 1990 Amendment

Pub. L. 101–535 section 343(r) of this titleNov. 8, 1992section 343(r)(2)(A)(i) of this title section 10(a) of Pub. L. 101–535 section 343 of this titleAmendment by effective six months after the date of the promulgation of final regulations to implement , or if such regulations are not promulgated, the date proposed regulations are to be considered as such final regulations (), with exception for persons marketing food the brand name of which contains a term defined by the Secretary under , see , set out as a note under .

Effective Date of 1976 Amendment

Pub. L. 94–278Apr. 22, 1976section 502(c) of Pub. L. 94–278 section 334 of this titleAmendment by effective 180 days after , see , set out as a note under .

Effective Date of 1972 Amendment

Pub. L. 92–516Oct. 21, 1972Oct. 21, 1972Oct. 21, 1972Pub. L. 92–516 section 4 of Pub. L. 92–516 section 136 of Title 7Amendment by effective at the close of , except if regulations are necessary for the implementation of any provision that becomes effective on , and continuation in effect of subchapter I of chapter 6 of Title 7, and regulations thereunder, relating to the control of economic poisons, as in existence prior to , until superseded by provisions of , and regulations thereunder, see , set out as an Effective Date note under , Agriculture.

Effective Date of 1970 Amendment

Pub. L. 91–513Oct. 26, 1970section 704 of Pub. L. 91–513 section 801 of this titleAmendment by effective on first day of seventh calendar month that begins after , see , set out as an Effective Date note under .

Effective Date of 1968 Amendments; Transitional Provisions

Pub. L. 90–639, § 6Oct. 24, 196882 Stat. 1362

section 289a of Title 42Oct. 24, 1968“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 , 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 [].”

, , , provided that:

Pub. L. 90–399July 13, 1968section 360b(n) of this titleOct. 9, 1962section 355 of this title Pub. L. 90–399 section 360b of this titleAmendment by effective on first day of thirteenth calendar month after , except that in the case of a drug (other than one subject to ) intended for use in animals other than man which, on , was commercially 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 , the words “effectiveness” and “effective” contained in par. (v) of this section not applicable to such drug when intended solely for use under conditions prescribed, recommended, or suggested in labeling with respect to such drug on that day, see section 108(a), (b)(3) of , as amended, set out as an Effective Date and Transitional Provisions note under .

Effective Date of 1965 Amendment

Pub. L. 89–74, § 11July 15, 196579 Stat. 235

section 301 of this titleFeb. 1, 1966July 15, 1965section 360 of this title section 360a of this title section 372 of this title section 1114 of Title 18July 15, 1965“The foregoing provisions of this Act [see Short Title of 1965 Amendment note set out under ] shall take effect on the first day of the seventh calendar month [] following the month in which this Act is enacted []; except that (1) the Secretary shall permit persons, owning or operating any establishment engaged in manufacturing, preparing, propagating, compounding, processing, wholesaling, jobbing, or distributing any depressant or stimulant drug, as referred to in the amendments made by section 4 of this Act to section 510 of the Federal Food, Drug, and Cosmetic Act [], 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 ], and the provisions of sections 8 [amending and , 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 [].”

, , , provided that:

Effective Date of 1962 Amendment

Pub. L. 87–781, title I, § 107Oct. 10, 196276 Stat. 788

“(a)

section 355 of this titleOct. 10, 1962 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 provisions set out as a note under ] shall take effect on the date of enactment of this Act [].

“(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 calendar month following the month in which this Act is enacted [Oct. 1962].

“(c)

(1)

As used in this subsection, the term ‘enactment date’ means the date of enactment of this Act; and the term ‘basic Act’ means the Federal Food, Drug, and Cosmetic Act [this chapter].

“(2)

section 355(b) of this title An application filed pursuant to section 505(b) of the basic Act [] which was ‘effective’ within the meaning of that Act on the day immediately 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)

section 355 of this title section 355(e) of this title 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 ], 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 [], apply to such drug when intended solely for use under conditions prescribed, recommended, or suggested in labeling covered by such approved application, but shall apply to any changed use, or conditions of use, prescribed, recommended, or suggested in its labeling, including such conditions of use as are the subject of an amendment or supplement to such application pending on, or filed after, the enactment date; and

“(B)

section 355(e) of this title section 355 of this title section 355(e) of this title section 355(e) of this title clause (3) of the first sentence of section 505(e) of the basic Act, as amended by this Act [], 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 application, which amendment or supplement has been approved after the enactment date under section 505 of the basic Act as amended by this Act []) until whichever of the following first occurs: (i) the expiration of the two-year period beginning with the enactment date; (ii) the effective date of an order under section 505(e) of the basic Act [], other than clause (3) of the first sentence of such section 505(e) [], withdrawing or suspending the approval of such application.

“(4)

section 355 of this title In the case of any drug which, on the day immediately preceding the enactment date, (A) was commercially 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 [], the amendments 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, recommended, or suggested in labeling with respect to such drug on that day.”

, , , provided that:

Effective Date of 1960 Amendment

Pub. L. 86–618July 12, 1960section 203 of Pub. L. 86–618 section 202 of Pub. L. 86–618 section 379e of this titleAmendment by effective , subject to provisions of , see , set out as a note under .

Effective Date of 1958 Amendment

Pub. L. 85–929Sept. 6, 1958section 6(a) of Pub. L. 85–929 section 342 of this titleAmendment by effective , see , set out as a note under .

Effective Date of 1954 Amendment

July 22, 1954section 342 of this titleFor effective date of amendment by act , see section 5 of that act, set out as a note under .

Pub. L. 102–282Construction of Amendments by

Pub. L. 102–282 Pub. L. 102–282 section 7 of Pub. L. 102–282 section 335a of this titleAmendment by 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 , see , set out as a note under .

Pub. L. 101–535Construction of Amendments by

Pub. L. 101–535 21 U.S.C. 301 21 U.S.C. 601 21 U.S.C. 451 21 U.S.C. 1031 section 9 of Pub. L. 101–535 section 343 of this titleAmendments by 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 ( et seq.), the Federal Meat Inspection Act ( et seq.), the Poultry Products Inspection Act ( et seq.), and the Egg Products Inspection Act ( et seq.), see , set out as a note under .

Savings Provision

Pub. L. 91–513, title II, § 702Oct. 27, 197084 Stat. 1283 Pub. L. 93–481, § 2Oct. 26, 197488 Stat. 1455

“(a)

section 360a of this title section 242 of Title 42 Prosecutions for any violation of law occurring prior to the effective date [see Effective Date of 1970 Amendment note above] of section 701 [repealing , 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 , 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 proceedings commenced prior to the effective date of section 701 shall not be affected by the repeals or amendments made by such section, or abated by reason thereof.

“(c)

Oct. 27, 1970section 812 of this title All administrative proceedings pending before the Bureau of Narcotics and Dangerous Drugs [now the Drug Enforcement Administration] on the date of enactment of this Act [] shall be continued and brought to final determination in accord with laws and regulations in effect prior to such date of enactment. Where a drug is finally determined under such proceedings to be a depressant or stimulant drug, as defined 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 [subchapter 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 recommendation 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 [] 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)

Pub. L. 91–513 section 4202 of title 18 Notwithstanding subsection (a) of this section or section 1103 [of , set out as a note under sections 171 to 174 of this title], , United States Code, shall apply to any individual convicted 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.”

, , , as amended by , , , provided that:

Transfer of Functions

Pub. L. 96–88, title V, § 509(b)Oct. 17, 197993 Stat. 695 section 3508(b) of Title 20Secretary and Department of Health, Education, and Welfare redesignated Secretary and Department of Health and Human Services by , , , which is classified to , Education.

15 U.S.C. 1471 section 2079 of Title 15Functions 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 ( et seq.), transferred to Consumer Product Safety Commission by , Commerce and Trade.

Regulation of Tobacco

Pub. L. 117–103, div. P, title I, § 111(e)Mar. 15, 2022136 Stat. 790

Mar. 15, 202221 U.S.C. 301 21 U.S.C. 321(rr)“Effective 30 days after the date of enactment of this Act [], with respect to any regulation promulgated or related guidance issued, in whole or part, under the Federal Food, Drug, and Cosmetic Act ( 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 (), 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.”

, , , provided that:

Pub. L. 105–115, title IV, § 422Nov. 21, 1997111 Stat. 2380

section 301 of this title 21 U.S.C. 301Nov. 21, 1997“Nothing in this Act [see Short Title of 1997 Amendment note set out under ] or the amendments made by this Act shall be construed to affect the question of whether the Secretary of Health and Human Services has any authority to regulate any tobacco product, tobacco ingredient, or tobacco additive. Such authority, if any, shall be exercised under the Federal Food, Drug, and Cosmetic Act [ et seq.] as in effect on the day before the date of the enactment of this Act [].”

, , , provided that:

Pub. L. 103–417Congressional Findings Relating to

Pub. L. 103–417, § 2Oct. 25, 1994108 Stat. 4325

“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 scientific studies;

“(3)

(A)

there is a link between the ingestion of certain nutrients or dietary supplements and the prevention of chronic diseases such as cancer, heart disease, and osteoporosis; and

“(B)

clinical research has shown that several chronic 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 expensive medical procedures, such as coronary bypass surgery or angioplasty;

“(5)

preventive health measures, including education, 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 lifestyles 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 dissemination 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 related to particular dietary supplements;

“(9)

national surveys have revealed that almost 50 percent of the 260,000,000 Americans regularly consume 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 traditional 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 undertaken 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 manufacturers in the United States produce approximately 4,000 products, with total annual sales of such products alone reaching at least $4,000,000,000;

“(13)

although the Federal Government should take swift action against products that are unsafe or adulterated, the Federal Government should not take any actions to impose unreasonable regulatory barriers limiting or slowing the flow of safe products and accurate information to consumers;

“(14)

dietary supplements are safe within a broad range of intake, and safety problems with the supplements 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 established to supersede the current ad hoc, patchwork regulatory policy on dietary supplements.”

, , , provided that:

Dissemination of Information Regarding the Dangers of Drug Abuse

Pub. L. 90–639, § 5Oct. 24, 196882 Stat. 1362

“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.”

, , , provided that:

Congressional Findings and Declaration of Policy

Pub. L. 89–74, § 2July 15, 196579 Stat. 226

section 301 of this title“The Congress hereby finds and declares that there is a widespread illicit traffic in depressant and stimulant drugs moving in or otherwise affecting interstate 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 otherwise has become a threat to the public health and safety, making additional regulation of such drugs necessary regardless of the intrastate or interstate origin of such drugs; that in order to make regulation and protection of interstate commerce in such drugs effective, regulation of intrastate commerce is also necessary 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 determination of their place of origin is often extremely difficult or impossible; and that regulation of interstate commerce without the regulation of intrastate commerce in such drugs, as provided in this Act [see Short Title of 1965 Amendment note set out under ], would discriminate against and adversely affect interstate commerce in such drugs.”

, , , provided that:

Effect of Drug Abuse Control Amendments of 1965 on State Laws

Pub. L. 89–74, § 10July 15, 196579 Stat. 235

“(a)

section 360a of this title section 1114 of Title 18 Nothing in this Act [enacting , amending sections 321, 331, 333, 334, 360, and 372 of this title and , Crimes and Criminal 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 contravention 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 provision or amendment and such State law so that the two cannot be reconciled or consistently stand together.

“(c)

No amendment made by this Act shall be construed 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.”

, , , provided that:

Effect of Drug Amendments of 1962 on State Laws

Pub. L. 87–781, title II, § 202Oct. 10, 196276 Stat. 793

“Nothing in the amendments made by this Act [enacting sections 358 to 360, amending sections 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 absence of such amendments unless there is a direct and positive conflict between such amendments and such provision of State law.”

, , , provided that:

Definitions

Pub. L. 105–115, § 2Nov. 21, 1997111 Stat. 2297

section 301 of this title 21 U.S.C. 321“In this Act [see Short Title of 1997 Amendment note set out under ], 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 ().”

, , , provided that:

Executive Documents

Transfer of Functions

section 301 of this titleFunctions 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 ] 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.