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Timestamp: 2019-07-21 02:50:41
Document Index: 475919100

Matched Legal Cases: ['§ 321', '§ 321', '§201', '§1', '§3', '§107', '§1', '§1002', '§902', '§1002', '§136', '§451', '§601']

Section 321 - Definitions; generally, 21 U.S.C. § 321 | Casetext
21 U.S.C. § 321
Section 321 - Definitions; generally
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Subchapter II - DEFINITIONS
(1) The term "State", except as used in the last sentence of section 372(a) of this title, means any State or Territory of the United States, the District of Columbia, and the Commonwealth of Puerto Rico.
(1) The term "drug" means (A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C). A food or dietary supplement for which a claim, subject to sections 343(r)(1)(B) and 343(r)(3) of this title or sections 343(r)(1)(B) and 343(r)(5)(D) of this title, is made in accordance with the requirements of section 343(r) of this title is not a drug solely because the label or the labeling contains such a claim. A food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is made in accordance with section 343(r)(6) of this title is not a drug under clause (C) solely because the label or the labeling contains such a statement.
(h) The term "device" (except when used in paragraph (n) of this section and in sections 331(i), 343(f), 352(c),and 362(c) of this title) means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is-
(A) Except as provided in clause (B), the term "pesticide chemical" means any substance that is a pesticide within the meaning of the Federal Insecticide, Fungicide, and Rodenticide Act [ 7 U.S.C. 136 et seq.], including all active and inert ingredients of such pesticide. Notwithstanding any other provision of law, the term "pesticide" within such meaning includes ethylene oxide and propylene oxide when such substances are applied on food.
With respect to the definition of the term "pesticide" that is applicable to the Federal Insecticide, Fungicide, and Rodenticide Act [ 7 U.S.C. 136 et seq.], this clause does not exclude any substance from such definition.
(4) any substance used in accordance with a sanction or approval granted prior to September 6, 1958, pursuant to this chapter, the Poultry Products Inspection Act [ 21 U.S.C. 451 et seq.] or the Meat Inspection Act of March 4, 1907, as amended and extended [ 21 U.S.C. 601 et seq.];
(1) The term "color additive" means a material which-
(w) The term "animal feed", as used in paragraph (w) 1 of this section, in section 360b of this title, and in provisions of this chapter referring to such paragraph or section, means an article which is intended for use for food for animals other than man and which is intended for use as a substantial source of nutrients in the diet of the animal, and is not limited to a mixture intended to be the sole ration of the animal.
(i) is intended for ingestion in a form described in section 350(c)(1)(B)(i) of this title; or
(1) The term "single-use device" means a device that is intended for one use, or on a single patient during a single procedure.
(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.
(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.
(1) The term "tobacco product" means any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product).
1 So in original. Probably should be paragraph "(v)".
2 So in original. Provision probably should be set flush with subpar. (B).
June 25, 1938, ch. 675, §201, 52 Stat. 1040; July 22, 1954, ch. 559, §1, 68 Stat. 511; Pub. L. 85-929Sept. 6, 1958, 72 Stat. 1784; Pub. L. 86-618July 12, 1960, 74 Stat. 397; Pub. L. 87-781Oct. 10, 1962, 76 Stat. 781, 796; Pub. L. 89-74July 15, 1965, 79 Stat. 227, 234; Pub. L. 90-399July 13, 1968, 82 Stat. 351; Pub. L. 90-639Oct. 24, 1968, 82 Stat. 1361, 1362; Pub. L. 91-513Oct. 27, 1970, 84 Stat. 1281, 1282; Pub. L. 92-516Oct. 21, 1972, 86 Stat. 998; Pub. L. 94-278Apr. 22, 1976, 90 Stat. 411; Pub. L. 94-295May 28, 1976, 90 Stat. 575; Pub. L. 95-203Nov. 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. 101-5351990; Pub. L. 101-6291990; Pub. L. 102-2821992; Pub. L. 102-3001992; Pub. L. 102-5711992; Pub. L. 103-801993; Pub. L. 103-4171994; Pub. L. 104-1701996; Pub. L. 105-1151997; Pub. L. 105-3241998; Pub. L. 107-1092002; Pub. L. 107-2502002; Pub. L. 108-2822004; Pub. L. 110-852007; Pub. L. 111-312009; Pub. L. 114-255Dec. 13, 2016, 130 Stat. 1133.
REFERENCES IN TEXTThe 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 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. 111-312009, and is covered by this chapter.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 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 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, as amended, 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 2016-Par. (h). Pub. L. 114-255 inserted at end of concluding 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. 108-2822004substituted "360b, 360ccc" for "360b".Par. (v). Pub. L. 108-282inserted concluding provisions. Pars. (nn) to (pp). Pub. L. 108-282added pars. (nn) to (pp). Par. (qq). Pub. L. 108-282added par. (qq). 2002-Par. (kk). Pub. L. 107-109 added par. (kk).Pars. (ll), (mm). Pub. L. 107-250 added pars. (ll) and (mm).1998-Par. (q)(1). Pub. L. 105-324added subpar. (1) and struck out former subpar. (1) which read as follows: "The term 'pesticide chemical' means any substance that is a pesticide within the meaning of the Federal Insecticide, Fungicide, and Rodenticide Act, including all active and inert ingredients of such pesticide."Par. (q)(3). Pub. L. 105-324substituted "subparagraphs (1) and (2)" for "paragraphs (1) and (2)" in introductory provisions. 1997-Par. (aa). Pub. L. 105-115struck out "or 357" after "section 355(j)".Par. (dd). Pub. L. 105-115struck out "357," after "section 355,".Par. (ff)(3)(A). Pub. L. 105-115struck out ", certified as an antibiotic under section 357 of this title," before "or licensed as a biologic".Par. (ii). Pub. L. 105-115added par. (ii).Par. (jj). Pub. L. 105-115added par. (jj). 1996-Par. (q). Pub. L. 104-170amended par. (q) generally. Prior to amendment, par. (q) read as follows: "The term 'pesticide chemical' means any substance which, alone, in chemical combination or in formulation with one or more other substances, is 'a pesticide' within the meaning of the Federal Insecticide, Fungicide, and Rodenticide Act as now in force or as hereafter amended, and which is used in the production, storage, or transportation of raw agricultural commodities."Par. (s)(1), (2). Pub. L. 104-170amended subpars. (1) and (2) generally. Prior to amendment, subpars. (1) and (2) read as follows: "(1) a pesticide chemical in or on a raw agricultural commodity; or"(2) a pesticide chemical to the extent that it is intended for use or is used in the production, storage, or transportation of any raw agricultural commodity; or".Pars. (gg), (hh). Pub. L. 104-170added pars. (gg) and (hh). 1994-Par. (g)(1). Pub. L. 103-417amended last sentence generally. Prior to amendment, last sentence read as follows: "A food for which a claim, subject to sections 343(r)(1)(B) and 343(r)(3) of this title or sections 343(r)(1)(B) and 343(r)(5)(D) of this title, is made in accordance with the requirements of section 343(r) of this title is not a drug under clause (B) solely because the label or labeling contains such a claim."Par. (s)(6). Pub. L. 103-417added subpar. (6).Par. (ff). Pub. L. 103-417added par. (ff). 1993-Pars. (c), (d). Pub. L. 103-80substituted "Health and Human Services" for "Agriculture".Par. (h). Pub. L. 103-80amended directory language of Pub. L. 102-300. See 1992 amendment note below. Pars. (v) to (ff). Pub. L. 103-80redesignated pars. (w) to (ff) as (v) to (ee), respectively.1992-Pars. (c), (d). Pub. L. 102-300which directed the substitution of "Health and Human Services" for "Health, Education, and Welfare", could not be executed because such words did not appear in the original statutory text. See 1993 Amendment note above and Transfer of Functions notes below. Par. (h). Pub. L. 102-300as amended by Pub. L. 103-80substituted "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. 102-300struck 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. 102-300added par. (ff). 1990-Par. (g)(1). Pub. L. 101-629struck 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. 101-629which directed the amendment of subpar. (3) by substituting "its primary" for "any of its principal", could not be executed because "any of its principal" did not appear in subpar. (3). 1988-Par. (w)(3). Pub. L. 100-670 struck out subpar. (3) which read as follows: "which drug is composed wholly or partly of any kind of penicillin, streptomycin, chlortetracycline, chloramphenicol, or bacitracin, or any derivative thereof, except when there is in effect a published order of the Secretary declaring such drug not to be a new animal drug on the grounds that (A) the requirement of certification of batches of such drug, as provided for in section 360b(n) of this title, is not necessary to insure that the objectives specified in paragraph (3) thereof are achieved and (B) that neither subparagraph (1) nor (2) of this paragraph (w) applies to such drug."1980-Par. (aa). Pub. L. 96-359 added par. (aa).1977-Par. (z). Pub. L. 95-203 added par. (z).1976-Par. (h). Pub. L. 94-295expanded definition of "device" to include implements, machines, implants, in vitro reagents, and other similar or related articles, added recognition in the National Formulary or the United States Pharmacopeia, or any supplement to the Formulary or Pharmacopeia, to the enumeration of conditions under which a device may qualify for inclusion under this chapter, and inserted requirements that a device be one which does not achieve any of its principal intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its principal intended purposes. Par. (n). Pub. L. 94-278 inserted "or advertising" after "labeling" wherever appearing.Par. (y). Pub. L. 94-295added par. (y).1972-Par. (q). Pub. L. 92-516 substituted reference to pesticide for reference to economic poison. 1970-Par. (a)(2). Pub. L. 91-513struck 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. 91-513struck out par. (v) which defined "depressant or stimulant drug". 1968-Par. (a)(2). Pub. L. 90-639extended provisions to cover depressant and stimulant drugs, the containers thereof, and equipment used in manufacturing, compounding, or processing such drugs, to the Canal Zone.Par. (p). Pub. L. 90-399inserted "(except a new animal drug or an animal feed bearing or containing a new animal drug)" after "Any drug" in subpars. (1) and (2), respectively.Par. (s)(5). Pub. L. 90-399added subpar. (5).Par. (u). Pub. L. 90-399inserted reference to section 360b of this title. Par. (v)(3). Pub. L. 90-639inserted reference to lysergic acid diethylamide.Pars. (w), (x). Pub. L. 90-399added pars. (w) and (x).1965-Par. (g). Pub. L. 89-74designated 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. 89-74added par. (v). 1962-Par. (a). Pub. L. 87-781designated existing provisions as subpar. (2), inserted "Commonwealth of Puerto Rico and the", and added subpar. (1).Par. (p)(1). Pub. L. 87-781inserted "and effectiveness" after "to evaluate the safety", and "and effective" after "as safe".Par. (p)(2). Pub. L. 87-781inserted "and effectiveness" after "safety".1960-Par. (s). Pub. L. 86-618excluded color additives from definition of "food additive".Par. (t). Pub. L. 86-618added par. (t). Former par. (t) redesignated (u).Par. (u). Pub. L. 86-618redesignated 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).
EFFECTIVE DATE OF 2004 AMENDMENT Pub. L. 108-2822004, provided that: "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 January 1, 2006."
EFFECTIVE DATE OF 1997 AMENDMENT Pub. L. 105-1151997, 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 provisions of and the amendments made by sections 111, 121, 125, and 307 [enacting section 355a of this title, amending 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, 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 [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 regulations are not promulgated, the date proposed regulations 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 effective on Oct. 21, 1972, 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 Oct. 21, 1972, until superseded by provisions of Pub. L. 92-516, and regulations thereunder, see section 4 of Pub. L. 92-516, set out as an Effective Date note under section 136 of Title 7, Agriculture.
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 PROVISIONSPub. L. 90-639Oct. 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 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 section 355 of this title, 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 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 AMENDMENTPub. L. 89-74July 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]; 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 [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 AMENDMENTPub. L. 87-781Oct. 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 provisions 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 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) An application filed pursuant to section 505(b) of the basic Act [section 355(b) of this title] 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) 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 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) 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 application, which amendment or supplement has been approved 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 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 [section 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 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 [section 355 of this title], 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."
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 section 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 AMENDMENTFor 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. 102-282Amendment by Pub. L. 102-282 not to preclude any other civil, criminal, or administrative remedy provided under Federal or State law, including any private right of action against any person for the same action subject to any action or civil penalty under an amendment made by Pub. L. 102-282, see section 7 of Pub. L. 102-282, set out as a note under section 335a of this title.
CONSTRUCTION OF AMENDMENTS BY PUB. L. 101-535Amendments by Pub. L. 101-535 not to be construed to alter authority of Secretary of Health and Human Services and Secretary of Agriculture under the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq.), the Federal Meat Inspection Act ( 21 U.S.C. 601 et seq.), the Poultry Products Inspection Act ( 21 U.S.C. 451 et seq.), and the Egg Products Inspection Act ( 21 U.S.C. 1031 et seq.), see section 9 of Pub. L. 101-535, set out as a note under section 343 of this title.
SAVINGS PROVISIONPub. L. 91-513Oct. 27, 1970, 84 Stat. 1283, as amended by Pub. L. 93-481Oct. 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 section 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 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) 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 [Oct. 27, 1970] 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 [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 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."
TRANSFER OF FUNCTIONSSecretary and Department of Health, Education, and Welfare redesignated Secretary and Department of Health and Human Services by Pub. L. 96-88Oct. 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 Federal Food, Drug, and Cosmetic Act, to the extent such functions related to administration and enforcement of the Poison Prevention Packaging Act of 1970 ( 15 U.S.C. 1471 et seq.), transferred to Consumer Product Safety Commission by section 2079 of Title 15, Commerce and Trade.Functions of Secretary of Health, Education, and Welfare [now Health and Human Services] under Drug Abuse Control Amendments of 1965 [see Short Title of 1965 Amendment note set out under section 301 of this title] transferred to Attorney General except function of regulating counterfeiting of those drugs which are not "depressant or stimulant" drugs, see section 2 of Reorg. Plan No. 1 of 1968, set out in the Appendix to Title 5, Government Organization and Employees.Functions of Federal Security Administrator transferred to Secretary of Health, Education, and Welfare and all agencies of Federal Security Agency transferred to Department of Health, Education, and Welfare by section 5 of Reorg. Plan No. 1 of 1953, set out in the Appendix to Title 5, Government Organization and Employees. Federal Security Agency and office of Administrator abolished by section 8 of Reorg. Plan No. 1 of 1953.Food and Drug Administration in Department of Agriculture and its functions, except those functions relating to administration of Insecticide Act of 1910 and Naval Stores Act, transferred to Federal Security Agency, to be administered under direction and supervision of Federal Security Administrator, by Reorg. Plan No. IV of 1940, set out in the Appendix to Title 5.
REGULATION OF TOBACCOPub. L. 105-1151997, 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 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 [ 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. 103-417Pub. L. 103-4171994, provided 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 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."
DISSEMINATION OF INFORMATION REGARDING THE DANGERS OF DRUG ABUSEPub. L. 90-639Oct. 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 POLICYPub. L. 89-74July 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 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 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 LAWSPub. L. 89-74July 15, 1965, 79 Stat. 235, provided that:"(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 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."
EFFECT OF DRUG AMENDMENTS OF 1962 ON STATE LAWSPub. L. 87-781Oct. 10, 1962, 76 Stat. 793, provided that: "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."
DEFINITIONSPub. L. 105-1151997, provided that: "In this Act [see Short Title of 1997 Amendment 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 )."
Section 321a - "Butter" defined