21 U.S.C. § 331 — Prohibited acts

Page 47 TITLE 21—FOOD AND DRUGS § 331 1 So in original. 2 See References in Text note below. § 321c. Nonfat dry milk; ‘‘milk’’ defined For the purposes of the Federal Food, Drug, and Cosmetic Act of June 26, 1938, (ch. 675, sec. 1, 52 Stat. 1040) [21 U.S.C. 301 et seq.] nonfat dry milk is the product resulting from the removal of fat and water from milk, and contains the lactose, milk proteins, and milk minerals in the same relative proportions as in the fresh milk from which made. It contains not over 5 per cen- tum by weight of moisture. The fat content is not over 11⁄2 per centum by weight unless other- wise indicated. The term ‘‘milk’’, when used herein, means sweet milk of cows. (Mar. 2, 1944, ch. 77, 58 Stat. 108; July 2, 1956, ch. 495, 70 Stat. 486.) Editorial Notes REFERENCES IN TEXT The Federal Food, Drug, and Cosmetic Act of June 26, 1938 (ch. 675, sec. 1, 52 Stat. 1040), referred to in text, probably means act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to this chapter (§ 301 et seq.). For complete classification of this Act to the Code, see section 301 of this title and Tables. CODIFICATION Section was not enacted as a part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter, but was made applicable thereto. AMENDMENTS 1956—Act July 2, 1956, substituted ‘‘nonfat dry milk’’ for ‘‘nonfat dry milk solids or defatted milk solids’’. § 321d. Market names for catfish and ginseng (a) Catfish labeling (1) In general Notwithstanding any other provision of law, for purposes of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.)— (A) the term ‘‘catfish’’ may only be consid- ered to be a common or usual name (or part thereof) for fish classified within the family Ictaluridae; and (B) only labeling or advertising for fish classified within that family may include the term ‘‘catfish’’. (2) Omitted (b) Ginseng labeling (1) In general Notwithstanding any other provision of law, for purposes of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.)— (A) the term ‘‘ginseng’’ may only be con- sidered to be a common or usual name (or part thereof) for any herb or herbal ingre- dient derived from a plant classified within the genus Panax; and (B) only labeling or advertising for herbs or herbal ingredients classified within that genus may include the term ‘‘ginseng’’. (2) Omitted (Pub. L. 107–171, title X, § 10806, May 13, 2002, 116 Stat. 526.) Editorial Notes REFERENCES IN TEXT The Federal Food, Drug, and Cosmetic Act, referred to in subsecs. (a)(1), (b)(1), is act June 25, 1938, ch. 675, 52 Stat. 1040, which is classified generally to this chap- ter. For complete classification of this Act to the Code, see section 301 of this title and Tables. CODIFICATION Section is comprised of section 10806 of Pub. L. 107–171. Subsecs. (a)(2) and (b)(2) of section 10806 of Pub. L. 107–171 amended section 343 of this title. Section was enacted as part of the Farm Security and Rural Investment Act of 2002, and not as part of Fed- eral Food, Drug, and Cosmetic Act which comprises this chapter. SUBCHAPTER III—PROHIBITED ACTS AND PENALTIES § 331. Prohibited acts The following acts and the causing thereof are prohibited: (a) The introduction or delivery for introduc- tion into interstate commerce of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded. (b) The adulteration or misbranding of any food, drug, device, tobacco product, or cosmetic in interstate commerce. (c) The receipt in interstate commerce of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded, and the deliv- ery or proffered delivery thereof for pay or oth- erwise. (d) The introduction or delivery for introduc- tion into interstate commerce of any article in violation of section 344, 350d, 355,,1 360bbb–3, or 364c of this title. (e) The refusal to permit access to or copying of any record as required by section 350a, 350c, 350f(j), 350e, 354, 360bbb–3, 364a, 373, 374(a), 379aa, or 379aa–1 of this title; or the failure to establish or maintain any record, or make any report, re- quired under section 350a, 350c(b), 350f, 350e, 354, 355(i) or (k), 360b(a)(4)(C), 360b(j), (l) or (m), 360ccc–1(i), 360e(f), 360i, 360bbb–3, 364a, 364g, 379aa, 379aa–1, 387i, or 387t of this title or the re- fusal to permit access to or verification or copy- ing of any such required record; or the violation of any recordkeeping requirement under section 2223 2 of this title (except when such violation is committed by a farm). (f) The refusal to permit entry or inspection as authorized by section 374 of this title. (g) The manufacture within any Territory of any food, drug, device, tobacco product, or cos- metic that is adulterated or misbranded. (h) The giving of a guaranty or undertaking referred to in section 333(c)(2) of this title, which guaranty or undertaking is false, except by a person who relied upon a guaranty or under- taking to the same effect signed by, and con- taining the name and address of, the person re- siding in the United States from whom he re- ceived in good faith the food, drug, device, to- bacco product, or cosmetic; or the giving of a guaranty or undertaking referred to in section 333(c)(3) of this title, which guaranty or under- taking is false. (i)(1) Forging, counterfeiting, simulating, or falsely representing, or without proper author- ity using any mark, stamp, tag, label, or other Page 48 TITLE 21—FOOD AND DRUGS § 331 identification device authorized or required by regulations promulgated under the provisions of section 344 or 379e of this title. (2) Making, selling, disposing of, or keeping in possession, control, or custody, or concealing any punch, die, plate, stone, or other thing de- signed to print, imprint, or reproduce the trade- mark, trade name, or other identifying mark, imprint, or device of another or any likeness of any of the foregoing upon any drug or container or labeling thereof so as to render such drug a counterfeit drug. (3) The doing of any act which causes a drug to be a counterfeit drug, or the sale or dispensing, or the holding for sale or dispensing, of a coun- terfeit drug. (j) The using by any person to his own advan- tage, or revealing, other than to the Secretary or officers or employees of the Department, or to the courts when relevant in any judicial pro- ceeding under this chapter, any information ac- quired under authority of section 344, 348, 350a, 350c, 355, 360, 360b, 360c, 360d, 360e, 360f, 360h, 360i, 360j, 360ccc, 360ccc–1, 360ccc–2, 374, 379, 379e, 387d, 387e, 387f, 387g, 387h, 387i, or 387t(b) of this title concerning any method or process which as a trade secret is entitled to protection; or the vio- lating of section 346a(i)(2) of this title or any regulation issued under that section..1This para- graph does not authorize the withholding of in- formation from either House of Congress or from, to the extent of matter within its jurisdic- tion, any committee or subcommittee of such committee or any joint committee of Congress or any subcommittee of such joint committee. (k) The alteration, mutilation, destruction, obliteration, or removal of the whole or any part of the labeling of, or the doing of any other act with respect to, a food, drug, device, tobacco product, or cosmetic, if such act is done while such article is held for sale (whether or not the first sale) after shipment in interstate com- merce and results in such article being adulter- ated or misbranded. (l) Repealed. Pub. L. 105–115, title IV, § 421, Nov. 21, 1997, 111 Stat. 2380. (m) The sale or offering for sale of colored ole- omargarine or colored margarine, or the posses- sion or serving of colored oleomargarine or col- ored margarine in violation of subsections (b) or (c) of section 347 of this title. (n) The using, in labeling, advertising or other sales promotion of any reference to any report or analysis furnished in compliance with section 374 of this title. (o) In the case of a prescription drug distrib- uted or offered for sale in interstate commerce, the failure of the manufacturer, packer, or dis- tributor thereof to maintain for transmittal, or to transmit, to any practitioner licensed by ap- plicable State law to administer such drug who makes written request for information as to such drug, true and correct copies of all printed matter which is required to be included in any package in which that drug is distributed or sold, or such other printed matter as is approved by the Secretary. Nothing in this paragraph shall be construed to exempt any person from any labeling requirement imposed by or under other provisions of this chapter. (p) The failure to register in accordance with section 360 or 387e of this title, the failure to provide any information required by section 360(j), 360(k), 387e(i), or 387e(j) of this title, or the failure to provide a notice required by sec- tion 360(j)(2) or 387e(i)(3) of this title. (q)(1) The failure or refusal— (A) to comply with any requirement pre- scribed under section 360h, 360j(g), 387c(b), 387g, 387h, or 387o of this title; (B) to furnish any notification or other ma- terial or information required by or under sec- tion 360i, 360j(g), 387d, 387i, or 387t of this title; or (C) to comply with a requirement under sec- tion 360l or 387m of this title. (2) With respect to any device or tobacco prod- uct, the submission of any report that is re- quired by or under this chapter that is false or misleading in any material respect. (3) The failure to comply with any require- ment under section 360n–2(b)(2) of this title (re- lating to ensuring device cybersecurity). (r) The movement of a device, drug, or tobacco product in violation of an order under section 334(g) of this title or the removal or alteration of any mark or label required by the order to identify the device, drug, or tobacco product as detained. (s) The failure to provide the notice required by section 350a(c) or 350a(e) of this title, the fail- ure to make the reports required by section 350a(f)(1)(B) of this title, the failure to retain the records required by section 350a(b)(4) of this title, or the failure to meet the requirements prescribed under section 350a(f)(3) of this title. (t) The importation of a drug in violation of section 381(d)(1) of this title, the sale, purchase, or trade of a drug or drug sample or the offer to sell, purchase, or trade a drug or drug sample in violation of section 353(c) of this title, the sale, purchase, or trade of a coupon, the offer to sell, purchase, or trade such a coupon, or the coun- terfeiting of such a coupon in violation of sec- tion 353(c)(2) of this title, the distribution of a drug sample in violation of section 353(d) of this title or the failure to otherwise comply with the requirements of section 353(d) of this title, the distribution of drugs in violation of section 353(e) of this title, failure to comply with the re- quirements under section 360eee–1 of this title, the failure to comply with the requirements under section 360eee–3 of this title, as applica- ble, or the failure to otherwise comply with the requirements of section 353(e) of this title. (u) The failure to comply with any require- ments of the provisions of, or any regulations or orders of the Secretary, under section 360b(a)(4)(A), 360b(a)(4)(D), or 360b(a)(5) of this title. (v) The introduction or delivery for introduc- tion into interstate commerce of a dietary sup- plement that is unsafe under section 350b of this title. (w) The making of a knowingly false state- ment in any statement, certificate of analysis, record, or report required or requested under section 381(d)(3) of this title; the failure to sub- mit a certificate of analysis as required under such section; the failure to maintain records or to submit records or reports as required by such section; the release into interstate commerce of any article or portion thereof imported into the Page 49 TITLE 21—FOOD AND DRUGS § 331 United States under such section or any finished product made from such article or portion, ex- cept for export in accordance with section 381(e) or 382 of this title, or with section 262(h) of title 42; or the failure to so export or to destroy such an article or portions thereof, or such a finished product. (x) The falsification of a declaration of con- formity submitted under section 360d(c) of this title or the failure or refusal to provide data or information requested by the Secretary under paragraph (3) of such section. (y) In the case of a drug, device, or food— (1) the submission of a report or rec- ommendation by a person accredited under section 360m of this title that is false or mis- leading in any material respect; (2) the disclosure by a person accredited under section 360m of this title of confidential commercial information or any trade secret without the express written consent of the person who submitted such information or se- cret to such person; or (3) the receipt by a person accredited under section 360m of this title of a bribe in any form or the doing of any corrupt act by such person associated with a responsibility dele- gated to such person under this chapter. (z) Omitted. (aa) The importation of a prescription drug in violation of section 384 of this title, the fal- sification of any record required to be main- tained or provided to the Secretary under such section, or any other violation of regulations under such section. (bb) The transfer of an article of food in viola- tion of an order under section 334(h) of this title, or the removal or alteration of any mark or label required by the order to identify the arti- cle as detained. (cc) The importing or offering for import into the United States of an article of food or a drug by, with the assistance of, or at the direction of, a person debarred from such activity under sec- tion 335a(b)(3) of this title. (dd) The failure to register in accordance with section 350d of this title. (ee) The importing or offering for import into the United States of an article of food in viola- tion of the requirements under section 381(m) of this title. (ff) The importing or offering for import into the United States of a drug or device with re- spect to which there is a failure to comply with a request of the Secretary to submit to the Sec- retary a statement under section 381(o) of this title. (gg) The knowing failure to comply with para- graph (7)(E) of section 374(g) of this title; the knowing inclusion by a person accredited under paragraph (2) of such section of false informa- tion in an inspection report under paragraph (7)(A) of such section; or the knowing failure of such a person to include material facts in such a report. (hh) The failure by a shipper, carrier by motor vehicle or rail vehicle, receiver, or any other person engaged in the transportation of food to comply with the sanitary transportation prac- tices prescribed by the Secretary under section 350e of this title. (ii) The falsification of a report of a serious adverse event submitted to a responsible person (as defined under section 364, 379aa, or 379aa–1 of this title) or the falsification of a serious ad- verse event report (as defined under section 379aa or 379aa–1 of this title or required under section 364a(a) of this title) submitted to the Secretary. (jj)(1) The failure to submit the certification required by section 282(j)(5)(B) of title 42, or knowingly submitting a false certification under such section. (2) The failure to submit clinical trial infor- mation required under subsection (j) of section 282 of title 42. (3) The submission of clinical trial informa- tion under subsection (j) of section 282 of title 42 that is false or misleading in any particular under paragraph (5)(D) of such subsection (j). (kk) The dissemination of a television adver- tisement without complying with section 353c 2 of this title. (ll) The introduction or delivery for introduc- tion into interstate commerce of any food to which has been added a drug approved under sec- tion 355 of this title, a biological product li- censed under section 262 of title 42, or a drug or a biological product for which substantial clin- ical investigations have been instituted and for which the existence of such investigations has been made public, unless— (1) such drug or such biological product was marketed in food before any approval of the drug under section 355 of this title, before li- censure of the biological product under such section 262 of title 42, and before any substan- tial clinical investigations involving the drug or the biological product have been instituted; (2) the Secretary, in the Secretary’s discre- tion, has issued a regulation, after notice and comment, approving the use of such drug or such biological product in the food; (3) the use of the drug or the biological prod- uct in the food is to enhance the safety of the food to which the drug or the biological prod- uct is added or applied and not to have inde- pendent biological or therapeutic effects on humans, and the use is in conformity with— (A) a regulation issued under section 348 of this title prescribing conditions of safe use in food; (B) a regulation listing or affirming condi- tions under which the use of the drug or the biological product in food is generally recog- nized as safe; (C) the conditions of use identified in a no- tification to the Secretary of a claim of ex- emption from the premarket approval re- quirements for food additives based on the notifier’s determination that the use of the drug or the biological product in food is gen- erally recognized as safe, provided that the Secretary has not questioned the general recognition of safety determination in a let- ter to the notifier; (D) a food contact substance notification that is effective under section 348(h) of this title; or (E) such drug or biological product had been marketed for smoking cessation prior to September 27, 2007; or Page 50 TITLE 21—FOOD AND DRUGS § 331 (4) the drug is a new animal drug whose use is not unsafe under section 360b of this title. (mm) The failure to submit a report or provide a notification required under section 350f(d) of this title. (nn) The falsification of a report or notifica- tion required under section 350f(d) of this title. (oo) The sale of tobacco products in violation of a no-tobacco-sale order issued under section 333(f) of this title. (pp) The introduction or delivery for introduc- tion into interstate commerce of a tobacco prod- uct in violation of section 387k of this title. (qq)(1) Forging, counterfeiting, simulating, or falsely representing, or without proper author- ity using any mark, stamp (including tax stamp), tag, label, or other identification device upon any tobacco product or container or label- ing thereof so as to render such tobacco product a counterfeit tobacco product. (2) Making, selling, disposing of, or keeping in possession, control, or custody, or concealing any punch, die, plate, stone, or other item that is designed to print, imprint, or reproduce the trademark, trade name, or other identifying mark, imprint, or device of another or any like- ness of any of the foregoing upon any tobacco product or container or labeling thereof so as to render such tobacco product a counterfeit to- bacco product. (3) The doing of any act that causes a tobacco product to be a counterfeit tobacco product, or the sale or dispensing, or the holding for sale or dispensing, of a counterfeit tobacco product. (rr) The charitable distribution of tobacco products. (ss) The failure of a manufacturer or dis- tributor to notify the Attorney General and the Secretary of the Treasury of their knowledge of tobacco products used in illicit trade. (tt) Making any express or implied statement or representation directed to consumers with re- spect to a tobacco product, in a label or labeling or through the media or advertising, that either conveys, or misleads or would mislead con- sumers into believing, that— (1) the product is approved by the Food and Drug Administration; (2) the Food and Drug Administration deems the product to be safe for use by consumers; (3) the product is endorsed by the Food and Drug Administration for use by consumers; or (4) the product is safe or less harmful by vir- tue of— (A) its regulation or inspection by the Food and Drug Administration; or (B) its compliance with regulatory require- ments set by the Food and Drug Administra- tion; including any such statement or representation rendering the product misbranded under section 387c of this title. (uu) The operation of a facility that manufac- tures, processes, packs, or holds food for sale in the United States if the owner, operator, or agent in charge of such facility is not in compli- ance with section 350g of this title. (vv) The failure to comply with the require- ments under section 350h of this title. (ww) The failure to comply with section 350i of this title. (xx) The refusal or failure to follow an order under section 350l of this title. (yy) The knowing and willful failure to comply with the notification requirement under section 350f(h) of this title. (zz) The importation or offering for importa- tion of a food if the importer (as defined in sec- tion 384a of this title) does not have in place a foreign supplier verification program in compli- ance with such section 384a of this title. (aaa) The failure to register in accordance with section 381(s) of this title. (bbb) The failure to notify the Secretary in violation of section 360bbb–7 of this title. (ccc)(1) The resale of a compounded drug that is labeled ‘‘not for resale’’ in accordance with section 353b of this title. (2) With respect to a drug to be compounded pursuant to section 353a or 353b of this title, the intentional falsification of a prescription, as ap- plicable. (3) The failure to report drugs or adverse events by an entity that is registered in accord- ance with subsection (b) of section 353b of this title. (ddd)(1) The manufacture or the introduction or delivery for introduction into interstate com- merce of a rinse-off cosmetic that contains in- tentionally-added plastic microbeads. (2) In this paragraph— (A) the term ‘‘plastic microbead’’ means any solid plastic particle that is less than five mil- limeters in size and is intended to be used to exfoliate or cleanse the human body or any part thereof; and (B) the term ‘‘rinse-off cosmetic’’ includes toothpaste. (eee) The failure to comply with any order issued under section 360bbb–8d of this title. (fff)(1) Forging, counterfeiting, simulating, or falsely representing, or without proper author- ity using any mark, stamp, tag, label, or other identification upon any device or container, packaging, or labeling thereof so as to render such device a counterfeit device. (2) Making, selling, disposing of, or keeping in possession, control, or custody, or concealing any punch, die, plate, stone, or other thing de- signed to print, imprint, or reproduce the trade- mark, trade name, or other identifying mark or imprint of another or any likeness of any of the foregoing upon any device or container, pack- aging, or labeling thereof so as to render such device a counterfeit device. (3) The doing of any act which causes a device to be a counterfeit device, or the sale or dis- pensing, or the holding for sale or dispensing, of a counterfeit device. (ggg) The failure of a sponsor of a product ap- proved under accelerated approval pursuant to section 356(c) of this title— (1) to conduct with due diligence any post- approval study required under section 356(c) of this title with respect to such product; or (2) to submit timely reports with respect to such product in accordance with section 356b(a)(2) of this title. (hhh) The failure to register or submit listing information in accordance with section 364c of this title. (iii) The refusal or failure to follow an order under section 364g of this title. Page 51 TITLE 21—FOOD AND DRUGS § 331 (June 25, 1938, ch. 675, § 301, 52 Stat. 1042; Dec. 22, 1941, ch. 613, § 1, 55 Stat. 851; July 6, 1945, ch. 281, § 1, 59 Stat. 463; Mar. 10, 1947, ch. 16, § 1, 61 Stat. 11; June 24, 1948, ch. 613, § 1, 62 Stat. 582; Mar. 16, 1950, ch. 61, § 3(b), 64 Stat. 20; Aug. 7, 1953, ch. 350, § 2, 67 Stat. 477; Pub. L. 85–929, § 5, Sept. 6, 1958, 72 Stat. 1788; Pub. L. 86–618, title I, §§ 104, 105(a), July 12, 1960, 74 Stat. 403; Pub. L. 87–781, title I, §§ 103(c), 104(e)(1), 106(c), 114(a), title III, § 304, Oct. 10, 1962, 76 Stat. 784, 785, 788, 791, 795; Pub. L. 89–74, §§ 5, 9(c), July 15, 1965, 79 Stat. 232, 235; Pub. L. 90–399, § 103, July 13, 1968, 82 Stat. 352; Pub. L. 90–639, § 2(b), Oct. 24, 1968, 82 Stat. 1361; Pub. L. 91–513, title II, § 701(a), Oct. 27, 1970, 84 Stat. 1281; Pub. L. 92–387, § 4(e), Aug. 16, 1972, 86 Stat. 562; Pub. L. 94–295, §§ 3(b), 4(b)(1), 7(b), May 28, 1976, 90 Stat. 576, 580, 582; Pub. L. 96–359, § 5, Sept. 26, 1980, 94 Stat. 1193; Pub. L. 99–570, title IV, § 4014(b)(2), Oct. 27, 1986, 100 Stat. 3207–120; Pub. L. 100–293, § 7(a), Apr. 22, 1988, 102 Stat. 99; Pub. L. 101–502, § 5(j), Nov. 3, 1990, 104 Stat. 1289; Pub. L. 101–508, title IV, § 4755(c)(2), Nov. 5, 1990, 104 Stat. 1388–210; Pub. L. 102–300, § 3(a)(1), June 16, 1992, 106 Stat. 238; Pub. L. 102–571, title I, § 107(2), (3), Oct. 29, 1992, 106 Stat. 4499; Pub. L. 103–80, § 3(c), Aug. 13, 1993, 107 Stat. 775; Pub. L. 103–396, § 2(b)(1), Oct. 22, 1994, 108 Stat. 4154; Pub. L. 103–417, § 10(b), Oct. 25, 1994, 108 Stat. 4332; Pub. L. 104–134, title II, § 2103, Apr. 26, 1996, 110 Stat. 1321–319; Pub. L. 104–170, title IV, § 403, Aug. 3, 1996, 110 Stat. 1514; Pub. L. 104–250, § 5(d), Oct. 9, 1996, 110 Stat. 3156; Pub. L. 105–115, title I, § 125(a)(2)(A), (C), (b)(2)(B), title II, §§ 204(b), 210(c), title IV, §§ 401(b), 421, Nov. 21, 1997, 111 Stat. 2325, 2336, 2345, 2364, 2380; Pub. L. 106–387, § 1(a) [title VII, § 745(d)(1)], Oct. 28, 2000, 114 Stat. 1549, 1549A–39; Pub. L. 107–188, title III, §§ 303(b), 304(d), 305(b), 306(c), 307(b), 321(b)(2), 322(b), June 12, 2002, 116 Stat. 664, 666, 668, 670, 672, 676, 677; Pub. L. 107–250, title II, § 201(d), Oct. 26, 2002, 116 Stat. 1609; Pub. L. 108–136, div. A, title XVI, § 1603(c), Nov. 24, 2003, 117 Stat. 1690; Pub. L. 108–173, title XI, § 1121(b)(1), Dec. 8, 2003, 117 Stat. 2469; Pub. L. 108–214, § 2(b)(2)(A), Apr. 1, 2004, 118 Stat. 575; Pub. L. 108–282, title I, § 102(b)(5)(C), (D), Aug. 2, 2004, 118 Stat. 902; Pub. L. 109–59, title VII, § 7202(d), (e), Aug. 10, 2005, 119 Stat. 1913; Pub. L. 109–462, §§ 2(c), 3(b), 4(a), Dec. 22, 2006, 120 Stat. 3472, 3475; Pub. L. 110–85, title VIII, § 801(b)(1), title IX, §§ 901(d)(1), 912(a), title X, § 1005(d), Sept. 27, 2007, 121 Stat. 920, 939, 951, 968; Pub. L. 111–31, div. A, title I, § 103(b), June 22, 2009, 123 Stat. 1833; Pub. L. 111–353, title I, §§ 102(d)(1), 103(e), 105(c), 106(d), title II, §§ 204(j)(1), 206(d), 211(b), (c), title III, § 301(b), Jan. 4, 2011, 124 Stat. 3889, 3898, 3904, 3906, 3937, 3943, 3953, 3954; Pub. L. 112–144, title VII, §§ 714(a), 715(a), July 9, 2012, 126 Stat. 1073, 1075; Pub. L. 113–54, title I, § 103(a), title II, § 206(a), Nov. 27, 2013, 127 Stat. 597, 639; Pub. L. 114–114, § 2(a), Dec. 28, 2015, 129 Stat. 3129; Pub. L. 114–255, div. A, title III, § 3101(a)(2)(A), Dec. 13, 2016, 130 Stat. 1152; Pub. L. 115–271, title III, §§ 3012(a), 3022(b)(1), Oct. 24, 2018, 132 Stat. 3935, 3938; Pub. L. 117–328, div. FF, title II, § 2513(a), title III, §§ 3210(c), 3305(b), 3503(a)(1), (4)(A), (B), Dec. 29, 2022, 136 Stat. 5805, 5824, 5833, 5858.) Editorial Notes REFERENCES IN TEXT Section 2223 of this title, referred to in par. (e), was in the original ‘‘section 204 of the FDA Food Safety Modernization Act’’, meaning section 204 of Pub. L. 111–353, which enacted section 2223 of this title and amended this section and section 381 of this title. Section 353c of this title, referred to in par. (kk), was in the original a reference to section 503B of act June 25, 1938, and was translated as if it referred to section 503C of that Act, to reflect the probable intent of Con- gress and the renumbering of section 503B as 503C by Pub. L. 113–54, title I, § 102(a)(1), Nov. 27, 2013, 127 Stat. 587, and its transfer to section 353c of this title. A new section 503B, which was enacted by section 102(a)(2) of Pub. L. 113–54, is classified to section 353b of this title and does not relate to television advertisements. AMENDMENTS 2022—Subsec. (d). Pub. L. 117–328, § 3503(a)(1)(B), which directed the substitution of ‘‘, 360bbb–3, or 364c’’ for ‘‘or 360bbb–3’’ in par. (d), was executed by making the sub- stitution in subsec. (d) to reflect the probable intent of Congress. Subsec. (e). Pub. L. 117–328, § 3503(a)(4)(A), substituted ‘‘360bbb–3, 364a, 373’’ for ‘‘360bbb–3, 373’’ and ‘‘360bbb–3, 364a, 364g, 379aa’’ for ‘‘360bbb–3, 379aa’’. Subsec. (q)(3). Pub. L. 117–328, § 3305(b), added par. (3). Subsec. (ii). Pub. L. 117–328, § 3503(a)(4)(B)(ii), inserted ‘‘or required under section 364a(a) of this title’’ after ‘‘report (as defined under section 379aa or 379aa–1 of this title’’. Pub. L. 117–328, § 3503(a)(4)(B)(i), substituted ‘‘364, 379aa, or 379aa–1 of this title) or’’ for ‘‘379aa or 379aa–1 of this title) or’’. Subsec. (fff). Pub. L. 117–328, § 2513(a), added subsec. (fff). Subsec. (ggg). Pub. L. 117–328, § 3210(c), added subsec. (ggg). Subsecs. (hhh), (iii). Pub. L. 117–328, § 3503(a)(1)(A), added subsecs. (hhh) and (iii). 2018—Par. (cc). Pub. L. 115–271, § 3022(b)(1), inserted ‘‘or a drug’’ after ‘‘food’’ and ‘‘from such activity’’ after ‘‘person debarred’’. Par. (eee). Pub. L. 115–271, § 3012(a), added par. (eee). 2016—Subsec. (r). Pub. L. 114–255 inserted ‘‘, drug,’’ after ‘‘device’’ in two places. 2015—Par. (ddd). Pub. L. 114–114 added par. (ddd). 2013—Par. (t). Pub. L. 113–54, § 206(a), struck out ‘‘or’’ after ‘‘the requirements of section 353(d) of this title,’’ and inserted ‘‘, failure to comply with the require- ments under section 360eee–1 of this title, the failure to comply with the requirements under section 360eee–3 of this title, as applicable,’’ after ‘‘in violation of section 353(e) of this title’’. Par. (ccc). Pub. L. 113–54, § 103(a), added par. (ccc). 2012—Par. (aaa). Pub. L. 112–144, § 714(a), added par. (aaa). Par. (bbb). Pub. L. 112–144, § 715(a), added par. (bbb). 2011—Par. (d). Pub. L. 111–353, § 102(d)(1), inserted ‘‘350d,’’ after ‘‘344,’’. Par. (e). Pub. L. 111–353, §§ 204(j)(1), 211(c), substituted ‘‘350f(j)’’ for ‘‘350f(g)’’ and inserted before period at end ‘‘; or the violation of any recordkeeping requirement under section 2223 of this title (except when such viola- tion is committed by a farm)’’. Par. (uu). Pub. L. 111–353, § 103(e), added par. (uu). Par. (vv). Pub. L. 111–353, § 105(c), added par. (vv). Par. (ww). Pub. L. 111–353, § 106(d), added par. (ww). Par. (xx). Pub. L. 111–353, § 206(d), added par. (xx). Par. (yy). Pub. L. 111–353, § 211(b), added par. (yy). Par. (zz). Pub. L. 111–353, § 301(b), added par. (zz). 2009—Pars. (a) to (c). Pub. L. 111–31, § 103(b)(1)–(3), in- serted ‘‘tobacco product,’’ after ‘‘device,’’. Par. (e). Pub. L. 111–31, § 103(b)(4)(B), which directed substitution of ‘‘379aa–1, 387i, or 387t of this title or the refusal to permit access to’’ for ‘‘or 379aa–1 of this title or the refusal to permit access to’’, was executed by Page 52 TITLE 21—FOOD AND DRUGS § 331 making the substitution for ‘‘or 379aa–1 of this title, or the refusal to permit access to’’, to reflect the probable intent of Congress. Pub. L. 111–31, § 103(b)(4)(A), struck out period after ‘‘360ccc–1(i)’’. Pars. (g), (h). Pub. L. 111–31, § 103(b)(5), (6), inserted ‘‘tobacco product,’’ after ‘‘device,’’. Par. (j). Pub. L. 111–31, § 103(b)(7), struck out period after ‘‘360ccc–2’’ and substituted ‘‘379, 379e, 387d, 387e, 387f, 387g, 387h, 387i, or 387t(b)’’ for ‘‘379, or 379e’’. Par. (k). Pub. L. 111–31, § 103(b)(8), inserted ‘‘tobacco product,’’ after ‘‘device,’’. Par. (p). Pub. L. 111–31, § 103(b)(9), added par. (p) and struck out former par. (p) which read as follows: ‘‘The failure to register in accordance with section 360 of this title, the failure to provide any information required by section 360(j) or 360(k) of this title, or the failure to provide a notice required by section 360(j)(2) of this title.’’ Par. (q)(1). Pub. L. 111–31, § 103(b)(10), added subpar. (1) and struck out former subpar. (1) which read as follows: ‘‘The failure or refusal to (A) comply with any require- ment prescribed under section 360h or 360j(g) of this title, (B) furnish any notification or other material or information required by or under section 360i or 360j(g) of this title, or (C) comply with a requirement under section 360l of this title.’’ Par. (q)(2). Pub. L. 111–31, § 103(b)(11), substituted ‘‘de- vice or tobacco product,’’ for ‘‘device,’’. Par. (r). Pub. L. 111–31, § 103(b)(12), inserted ‘‘or to- bacco product’’ after ‘‘device’’ in two places. Pars. (oo) to (tt). Pub. L. 111–31, § 103(b)(13), added pars. (oo) to (tt). 2007—Par. (e). Pub. L. 110–85, § 1005(d)(1), substituted ‘‘350c, 350f(g),’’ for ‘‘350c,’’ and ‘‘350c(b), 350f’’ for ‘‘350c(b)’’. Par. (jj). Pub. L. 110–85, § 801(b)(1), added par. (jj). Par. (kk). Pub. L. 110–85, § 901(d)(1), added par. (kk). Par. (ll). Pub. L. 110–85, § 912(a), added par. (ll). Pars. (mm), (nn). Pub. L. 110–85, § 1005(d)(2), added pars. (mm) and (nn). 2006—Par. (e). Pub. L. 109–462, § 3(b), substituted ‘‘374(a), 379aa, or 379aa–1’’ for ‘‘374(a), or 379aa’’ and ‘‘360bbb–3, 379aa, or 379aa–1’’ for ‘‘360bbb–3, or 379aa’’. Pub. L. 109–462, § 2(c), substituted ‘‘, 374(a), or 379aa’’ for ‘‘, or 374(a)’’ and ‘‘, 360bbb–3, or 379aa’’ for ‘‘, or 360bbb–3’’. Par. (ii). Pub. L. 109–462, § 4(a), added par. (ii). 2005—Par. (e). Pub. L. 109–59, § 7202(d), inserted ‘‘350e,’’ before ‘‘354,’’ in two places. Par. (hh). Pub. L. 109–59, § 7202(e), added par. (hh). 2004—Par. (e). Pub. L. 108–282, § 102(b)(5)(C), which di- rected the substitution of ‘‘360b(a)(4)(C), 360b (j), (l) or (m), 360ccc–1(i).’’ for ‘‘360b(a)(4)(C), 360b(j), (l) or (m)’’ was executed by making the substitution for ‘‘360b(a)(4)(C), 360b(j), (l), or (m)’’, to reflect the prob- able intent of Congress. Par. (j). Pub. L. 108–282, § 102(b)(5)(D), substituted ‘‘360j, 360ccc, 360ccc–1, 360ccc–2.’’ for ‘‘360j’’. Par. (gg). Pub. L. 108–214 amended par. (gg) generally. Prior to amendment, text read as follows: ‘‘The know- ing failure of a person accredited under paragraph (2) of section 374(g) of this title to comply with paragraph (7)(E) of such section; the knowing inclusion by such a person of false information in an inspection report under paragraph (7)(A) of such section; or the knowing failure of such a person to include material facts in such a report.’’ 2003—Par. (d). Pub. L. 108–136 substituted ‘‘section 344, 355, or 360bbb–3’’ for ‘‘section 344 or 355’’. Par. (e). Pub. L. 108–136 inserted ‘‘360bbb–3,’’ after ‘‘350c, 354,’’ and substituted ‘‘360i, or 360bbb–3’’ for ‘‘or 360i’’. Par. (aa). Pub. L. 108–173 substituted ‘‘prescription drug in violation of section 384’’ for ‘‘covered product in violation of section 384’’. 2002—Par. (e). Pub. L. 107–188, § 306(c)(1), substituted ‘‘by section 350a, 350c, 354, 373, or 374(a) of this title’’ for ‘‘by section 350a, 354, or 373 of this title’’ and ‘‘under section 350a, 350c(b)’’ for ‘‘under section 350a’’. Par. (j). Pub. L. 107–188, § 306(c)(2), inserted ‘‘350c,’’ after ‘‘350a,’’. Par. (w). Pub. L. 107–188, § 322(b), amended par. (w) generally. Prior to amendment, par. (w) read as follows: ‘‘The making of a knowingly false statement in any record or report required or requested under subpara- graph (A) or (B) of section 381(d)(3) of this title, the failure to submit or maintain records as required by sections 381(d)(3)(A) and 381(d)(3)(B) of this title, the re- lease into interstate commerce of any article imported into the United States under section 381(d)(3) of this title or any finished product made from such article (except for export in accordance with section 381(e) or 382 of this title or section 262(h) of title 42), or the fail- ure to export or destroy any component, part or acces- sory not incorporated into a drug, biological product or device that will be exported in accordance with section 381(e) or 382 of this title or section 262(h) of title 42.’’ Par. (bb). Pub. L. 107–188, § 303(b), added par. (bb). Par. (cc). Pub. L. 107–188, § 304(d), added par. (cc). Par. (dd). Pub. L. 107–188, § 305(b), added par. (dd). Par. (ee). Pub. L. 107–188, § 307(b), added par. (ee). Par. (ff). Pub. L. 107–188, § 321(b)(2), added par. (ff). Par. (gg). Pub. L. 107–250 added par. (gg). 2000—Par. (aa). Pub. L. 106–387 added par. (aa). 1997—Par. (e). Pub. L. 105–115, § 125(b)(2)(B), struck out ‘‘357(d) or (g),’’ after ‘‘355(i) or (k),’’. Par. (i)(1). Pub. L. 105–115, § 125(a)(2)(C), struck out ‘‘, 356, 357,’’ before ‘‘or 379e of this title’’. Par. (j). Pub. L. 105–115, § 125(a)(2)(A), struck out ‘‘356, 357,’’ before ‘‘360,’’. Par. (l). Pub. L. 105–115, § 421, struck out par. (l) which read as follows: ‘‘The using, on the labeling of any drug or device or in any advertising relating to such drug or device, of any representation or suggestion that ap- proval of an application with respect to such drug or device is in effect under section 355, 360e, or 360j(g) of this title, as the case may be, or that such drug or de- vice complies with the provisions of such section.’’ Par. (x). Pub. L. 105–115, § 204(b), added par. (x). Par. (y). Pub. L. 105–115, § 210(c), added par. (y). Par. (z). Pub. L. 105–115, § 401(b), temporarily added par. (z) which related to dissemination of information in violation of section 360aaa of this title. See Effective and Termination Dates of 1997 Amendment note below. 1996—Par. (e). Pub. L. 104–250 inserted ‘‘, 354,’’ before ‘‘or 373 of this title’’ and ‘‘354,’’ before ‘‘355(i) or (k)’’. Par. (j). Pub. L. 104–170 inserted before period at end of first sentence ‘‘; or the violating of section 346a(i)(2) of this title or any regulation issued under that sec- tion.’’ Pars. (u) to (w). Pub. L. 104–134 redesignated par. (u) relating to introduction into interstate commerce of unsafe dietary supplement as (v) and added par. (w). 1994—Par. (e). Pub. L. 103–396, § 2(b)(1)(A), substituted ‘‘357(d) or (g), 360b(a)(4)(C),’’ for ‘‘357(d) or (g),’’. Par. (u). Pub. L. 103–417 added par. (u) relating to in- troduction into interstate commerce of unsafe dietary supplement. Pub. L. 103–396, § 2(b)(1)(B), added par. (u) relating to failure to comply with regulations or orders of Sec- retary. 1993—Par. (j). Pub. L. 103–80, § 3(c)(1), substituted ‘‘379, or 379e’’ for ‘‘379e, or 379’’. Par. (s). Pub. L. 103–80, § 3(c)(2), substituted ‘‘350a(e)’’ for ‘‘350a(d)’’. 1992—Pars. (i)(1), (j). Pub. L. 102–571 substituted ‘‘379e’’ for ‘‘376’’. Par. (q)(1)(C). Pub. L. 102–300 added cl. (C). 1990—Par. (e). Pub. L. 101–502 substituted ‘‘or (k)’’ for ‘‘or (j)’’. Par. (j). Pub. L. 101–508 inserted at end ‘‘This para- graph does not authorize the withholding of informa- tion from either House of Congress or from, to the ex- tent of matter within its jurisdiction, any committee or subcommittee of such committee or any joint com- mittee of Congress or any subcommittee of such joint committee.’’ 1988—Par. (t). Pub. L. 100–293 added par. (t). 1986—Par. (s). Pub. L. 99–570 amended par. (s) gen- erally. Prior to amendment, par. (s) read as follows: Page 53 TITLE 21—FOOD AND DRUGS § 331 ‘‘The failure to provide the notice required by section 350a(b) or 350a(c), the failure to make the reports re- quired by section 350a(d)(1)(B), or the failure to meet the requirements prescribed under section 350a(d)(2).’’ 1980—Par. (e). Pub. L. 96–359, § 5(b), inserted reference to section 350a of this title in two places. Par. (j). Pub. L. 96–359, § 5(c), inserted reference to section 350a of this title. Par. (s). Pub. L. 96–359, § 5(a), added par. (s). 1976—Par. (e). Pub. L. 94–295, § 3(b)(2), inserted ref- erences to sections 360e(f) and 360i of this title. Par. (j). Pub. L. 94–295, § 3(b)(3), inserted references to sections 360, 360c, 360d, 360e, 360f, 360h, 360i, 360j, and 379 of this title. Par. (l). Pub. L. 94–295, § 3(b)(4), substituted ‘‘drug or device’’ for ‘‘drug’’ wherever appearing, and inserted references to sections 360e and 360j(g) of this title. Par. (p). Pub. L. 94–295, § 4(b)(1), substituted ‘‘section 360(j) or 360(k) of this title,’’ for ‘‘section 360(j) of this title,’’. Par. (q). Pub. L. 94–295, § 3(b)(1), added par. (q). Par. (r). Pub. L. 94–295, § 7(b), added par. (r). 1972—Par. (p). Pub. L. 92–387 added failure to provide information required by section 360(j) of this title, and failure to provide notice required by section 360(j)(2) of this title as prohibited acts. 1970—Par. (q). Pub. L. 91–513 struck out par. (q) which set out penalties for illegal manufacture, sale, disposi- tion, possession and other traffic in stimulant and de- pressant drugs. See section 801 et seq. of this title. 1968—Par. (e). Pub. L. 90–399, § 103(1), struck out ‘‘or’’ before ‘‘357(d) or (g)’’ and inserted ‘‘, or 360b(j), (l), or (m)’’ after ‘‘357(d) or (g)’’. Amendment striking out ‘‘or’’ was executed as described, notwithstanding direc- tory language that ‘‘or’’ before ‘‘357,’’ be stricken out, to reflect the probable intent of Congress. Par. (j). Pub. L. 90–399, § 103(2), inserted reference to section 360b of this title. Par. (q). Pub. L. 90–639 divided cl. (3), which referred simply to possession in violation of section 360a(c) of this title, into subcls. (A) and (B) which refer, respec- tively, to possession in violation of section 360a(c)(1) of this title and possession in violation of section 360a(c)(2) of this title. 1965—Par. (i). Pub. L. 89–74, § 9(c), designated existing provisions as subpar. (1) and added subpars. (2) and (3). Par. (q). Pub. L. 89–74, § 5, added par. (q). 1962—Par. (e). Pub. L. 87–781, §§ 103(c), 106(c), prohib- ited the failure to establish or maintain any record, or make any report, required under sections 355(i) or (j) and 507(d) or (g) of this title, or the refusal to permit access to, or verification or copying of, any such re- quired record. Par. (l). Pub. L. 87–781, § 104(e)(1), inserted ‘‘approval of’’ before ‘‘an application’’, and substituted ‘‘in effect’’ for ‘‘effective’’. Par. (o). Pub. L. 87–781, § 114(a), added par. (o). Par. (p). Pub. L. 87–781, § 304, added par. (p). 1960—Par. (i). Pub. L. 86–618, § 105(a), struck out ref- erences to sections 346(b), 354, and 364 of this title and inserted reference to section 376 of this title. Par. (j). Pub. L. 86–618, § 104, inserted reference to sec- tion 376 of this title. 1958—Par. (j). Pub. L. 85–929, inserted reference to sec- tion 348 of this title. 1953—Par. (n). Act Aug. 7, 1953, added par. (n). 1950—Par. (m). Act Mar. 16, 1950, added par. (m). 1948—Par. (k). Act June 24, 1948, inserted ‘‘(whether or not the first sale)’’ so as to make it clear that this subsection is not limited to the case where the act oc- curs while the article is held for the first sale after interstate shipment, and extended coverage of sub- section to acts which result in adulteration. 1947—Par. (j). Act Mar. 10, 1947, inserted reference to sections 356 and 357 of this title. 1945—Par. (i). Act July 6, 1945, inserted reference to section 357 of this title. 1941—Par. (i). Act Dec. 22, 1941, inserted reference to section 356 of this title. Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 2022 AMENDMENT Pub. L. 117–328, div. FF, title III, § 3305(d), Dec. 29, 2022, 136 Stat. 5833, provided that: ‘‘The amendments made by subsections (a) and (b) [enacting section 360n–2 of this title and amending this section] shall take ef- fect 90 days after the date of enactment of this Act [Dec. 29, 2022]. An application or submission submitted before such effective date shall not be subject to the re- quirements under subsection (a) or (b) of section 524B of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360n–2(a), (b)], as added by this section.’’ Pub. L. 117–328, div. FF, title III, § 3503(b)(1), Dec. 29, 2022, 136 Stat. 5859, provided that: ‘‘The amendments made by subsection (a) [amending this section and sec- tions 361, 362, and 381 of this title] shall take effect on the date that is 1 year after the date of enactment of this Act [Dec. 29, 2022].’’ EFFECTIVE DATE OF 2018 AMENDMENT Pub. L. 115–271, title III, § 3012(d), Oct. 24, 2018, 132 Stat. 3936, provided that: ‘‘Sections 301(eee) [21 U.S.C. 331(eee)] and 569D [21 U.S.C. 360bbb–8d] of the Federal Food, Drug, and Cosmetic Act, as added by subsections (a) and (b), shall be effective beginning on the date of enactment of this Act [Oct. 24, 2018].’’ EFFECTIVE DATE OF 2015 AMENDMENT Pub. L. 114–114, § 2(b), Dec. 28, 2015, 129 Stat. 3129, pro- vided that: ‘‘(1) IN GENERAL.—The amendment made by sub- section (a) [amending this section] applies— ‘‘(A) with respect to manufacturing, beginning on July 1, 2017, and with respect to introduction or deliv- ery for introduction into interstate commerce, begin- ning on July 1, 2018; and ‘‘(B) notwithstanding subparagraph (A), in the case of a rinse-off cosmetic that is a nonprescription drug, with respect to manufacturing, beginning on July 1, 2018, and with respect to the introduction or delivery for introduction into interstate commerce, beginning on July 1, 2019. ‘‘(2) NONPRESCRIPTION DRUG.—For purposes of this subsection, the term ‘nonprescription drug’ means a drug not subject to section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(b)(1)).’’ EFFECTIVE DATE OF 2011 AMENDMENT Amendment by section 103(e) of Pub. L. 111–353 effec- tive 18 months after Jan. 4, 2011, and applicable to a small business (as defined in the regulations promul- gated under section 350g(n) of this title) beginning on the date that is 6 months after the effective date of such regulations and to a very small business (as de- fined in such regulations) beginning on the date that is 18 months after the effective date of such regulations, see section 103(i) of Pub. L. 111–353, set out as an Effec- tive Date note under section 350g of this title. Pub. L. 111–353, title III, § 301(d), Jan. 4, 2011, 124 Stat. 3955, provided that: ‘‘The amendments made by this section [enacting section 384a of this title and amend- ing this section and section 381 of this title] shall take effect 2 years after the date of enactment of this Act [Jan. 4, 2011].’’ EFFECTIVE DATE OF 2007 AMENDMENT Pub. L. 110–85, title IX, § 909, Sept. 27, 2007, 121 Stat. 950, provided that: ‘‘(a) EFFECTIVE DATE.—This subtitle [subtitle A (§§ 901–909) of title IX of Pub. L. 110–85, enacting sec- tions 353b and 355–1 of this title, amending this section, sections 333, 352, and 355 of this title, and section 262 of Title 42, The Public Health and Welfare, and enacting provisions set out as notes under sections 352, 355, and 355a of this title] takes effect 180 days after the date of the enactment of this Act [Sept. 27, 2007]. ‘‘(b) DRUGS DEEMED TO HAVE RISK EVALUATION AND MITIGATION STRATEGIES.— Page 54 TITLE 21—FOOD AND DRUGS § 331 ‘‘(1) IN GENERAL.—A drug that was approved before the effective date of this Act [probably means ‘‘this subtitle’’, see above] is, in accordance with paragraph (2), deemed to have in effect an approved risk evalua- tion and mitigation strategy under section 505–1 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 355–1] (as added by section 901) (referred to in this sec- tion as the ‘Act’) if there are in effect on the effective date of this Act elements to assure safe use— ‘‘(A) required under section 314.520 or section 601.42 of title 21, Code of Federal Regulations; or ‘‘(B) otherwise agreed to by the applicant and the Secretary for such drug. ‘‘(2) ELEMENTS OF STRATEGY; ENFORCEMENT.—The approved risk evaluation and mitigation strategy in effect for a drug under paragraph (1)— ‘‘(A) is deemed to consist of the timetable re- quired under section 505–1(d) and any additional ele- ments under subsections (e) and (f) of such section in effect for such drug on the effective date of this Act; and ‘‘(B) is subject to enforcement by the Secretary to the same extent as any other risk evaluation and mitigation strategy under section 505–1 of the Act, except that sections 303(f)(4) and 502(y) and (z) of the Act [21 U.S.C. 333(f)(4), 352(y), (z)] (as added by section 902) shall not apply to such strategy before the Secretary has completed review of, and acted on, the first assessment of such strategy under such section 505–1. ‘‘(3) SUBMISSION.—Not later than 180 days after the effective date of this Act, the holder of an approved application for which a risk evaluation and mitiga- tion strategy is deemed to be in effect under para- graph (1) shall submit to the Secretary a proposed risk evaluation and mitigation strategy. Such pro- posed strategy is subject to section 505–1 of the Act as if included in such application at the time of submis- sion of the application to the Secretary.’’ EFFECTIVE DATE OF 2006 AMENDMENT Amendment by section 2(c) of Pub. L. 109–462 effective 1 year after Dec. 22, 2006, see section 2(e)(1) of Pub. L. 109–462, set out as a note under section 352 of this title. Amendment by section 3(b) of Pub. L. 109–462 effec- tive 1 year after Dec. 22, 2006, see section 3(d)(1) of Pub. L. 109–462, set out as a note under section 343 of this title. Pub. L. 109–462, § 4(b), Dec. 22, 2006, 120 Stat. 3475, pro- vided that: ‘‘The amendment made by this section [amending this section] shall take effect 1 year after the date of enactment of this Act [Dec. 22, 2006].’’ EFFECTIVE DATE OF 2005 AMENDMENT Pub. L. 109–59, title VII, § 7204, Aug. 10, 2005, 119 Stat. 1914, provided that: ‘‘This subtitle [subtitle B (§§ 7201–7204) of title VII of Pub. L. 109–59, enacting sec- tion 350e of this title, amending this section, sections 342 and 373 of this title, and section 5701 of Title 49, Transportation, omitting sections 5702 to 5714 of Title 49, and enacting provisions set out as a note under sec- tion 301 of this title] takes effect on October 1, 2005.’’ EFFECTIVE DATE OF 2002 AMENDMENT Pub. L. 107–188, title III, § 321(c), June 12, 2002, 116 Stat. 676, provided that: ‘‘The amendments made by this section [amending this section and sections 360 and 381 of this title] take effect upon the expiration of the 180-day period beginning on the date of the enactment of this Act [June 12, 2002].’’ Pub. L. 107–188, title III, § 322(c), June 12, 2002, 116 Stat. 678, provided that: ‘‘The amendments made by this section [amending this section and section 381 of this title] take effect upon the expiration of the 90-day period beginning on the date of the enactment of this Act [June 12, 2002].’’ EFFECTIVE AND TERMINATION DATES OF 1997 AMENDMENT Amendment by sections 204, 210, and 421 of Pub. L. 105–115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as a note under section 321 of this title. Amendment by section 401(b) of Pub. L. 105–115 effec- tive 1 year after Nov. 21, 1997, or upon Secretary’s issuance of final regulations pursuant to section 401(c) of Pub. L. 105–115, whichever is sooner, and ceases to be effective Sept. 30, 2006, see section 401(d), (e) of Pub. L. 105–115, set out as an Effective and Termination Dates note under former section 360aaa of this title. EFFECTIVE DATE OF 1994 AMENDMENT Amendment by Pub. L. 103–396 effective upon adop- tion of final regulations under section 2(c) of Pub. L. 103–396, set out as a Regulations note under section 360b of this title, see section 2(d) of Pub. L. 103–396, set out as a note under section 360b of this title. EFFECTIVE DATE OF 1990 AMENDMENT Pub. L. 101–508, title IV, § 4755(c)(2), Nov. 5, 1990, 104 Stat. 1388–210, provided that the amendment made by section 4755(c)(2) is effective as if included in subtitle D of title VI of the Omnibus Budget Reconciliation Act of 1989, Pub. L. 101–239, title VI, §§ 6601, 6602, Dec. 19, 1989, 103 Stat. 2285, see 42 U.S.C. 300aa–1 note, 300aa–10 note. EFFECTIVE DATE OF 1988 AMENDMENT Amendment by Pub. L. 100–293 effective upon expira- tion of 90 days after Apr. 22, 1988, see section 8(a) of Pub. L. 100–293, set out as a note under section 353 of this title. EFFECTIVE DATE OF 1972 AMENDMENT Amendment by Pub. L. 92–387 effective on first day of sixth month beginning after Aug. 16, 1972, see section 5 of Pub. L. 92–387, set out as a note under section 360 of this title. 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 Amendment by Pub. L. 90–399 effective on first day of thirteenth calendar month after July 13, 1968, see sec- tion 108(a) of Pub. L. 90–399, set out as an Effective Date and Transitional Provisions note under section 360b of this title. Amendment by Pub. L. 90–639 applicable only with re- spect to violations of this chapter committed after Oct. 24, 1968, see section 6 of Pub. L. 90–639, set out as an Ef- fective Date of 1968 Amendments; Transitional Provi- sions note under section 321 of this title. EFFECTIVE DATE OF 1965 AMENDMENT Amendment by Pub. L. 89–74 effective Feb. 1, 1966, see section 11 of Pub. L. 89–74, set out as a note under sec- tion 321 of this title. EFFECTIVE DATE OF 1962 AMENDMENT Amendment by sections 103(c) and 106(c) of Pub. L. 87–781 effective on first day of seventh calendar month following Oct. 1962, and amendment by section 104(e)(1) of Pub. L. 87–781 effective Oct. 10, 1962, see section 107 of Pub. L. 87–781, set out as a note under section 321 of this title. Pub. L. 87–781, title I, § 114(b), Oct. 10, 1962, 76 Stat. 791, provided that: ‘‘This section [amending this sec- tion] shall take effect on the first day of the seventh calendar month following the month in which this Act is enacted [October 1962].’’ EFFECTIVE DATE OF 1960 AMENDMENT Amendment by Pub. L. 86–618 effective July 12, 1960, subject to provisions of section 203 of Pub. L. 86–618, see section 202 of Pub. L. 86–618, set out as a note under sec- tion 379e of this title. Page 55 TITLE 21—FOOD AND DRUGS § 331 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 1950 AMENDMENT Amendment by act Mar. 16, 1950, effective July 1, 1950, see section 7 of that act, set out as an Effective Date note under section 347 of this title. REGULATIONS Pub. L. 113–54, title I, § 104, Nov. 27, 2013, 127 Stat. 597, provided that: ‘‘In promulgating any regulations to im- plement this title [enacting subpart 9 of part C of sub- chapter VII of this chapter and sections 353a–1 and 353b of this title, amending this section and sections 352, 353a, 352b, and 353c of this title, and enacting provisions set out as notes under section 301 of this title] (and the amendments made by this title), the Secretary of Health and Human Services shall— ‘‘(1) issue a notice of proposed rulemaking that in- cludes the proposed regulation; ‘‘(2) provide a period of not less than 60 calendar days for comments on the proposed regulation; and ‘‘(3) publish the final regulation not more than 18 months following publication of the proposed rule and not less than 30 calendar days before the effective date of such final regulation.’’ Secretary of Health and Human Services to promul- gate regulations to implement amendments made by section 401 of Pub. L. 105–115 not later than 1 year after Nov. 21, 1997, see section 401(c) of Pub. L. 105–115, set out as a note under section 360aaa of this title. SAVINGS PROVISIONS Pub. L. 113–54, title II, § 208, Nov. 27, 2013, 127 Stat. 640, provided that: ‘‘Except as provided in the amendments made by paragraphs (1), (2), and (3) of section 204(a) [amending section 353 of this title] and by section 206(a) [amending this section], nothing in this title [enacting part H of subchapter V of this chapter, amending this section and sections 333, 352, 353, and 360eee–1 of this title, and enacting provisions set out as notes under sections 301, 333, and 353 of this title] (including the amendments made by this title) shall be construed as altering any authority of the Secretary of Health and Human Services with respect to a drug subject to sec- tion 503(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(b)(1)) under any other provision of such Act [21 U.S.C. 301 et seq.] or the Public Health Service Act (42 U.S.C. 201 et seq.).’’ Amendment by Pub. L. 91–513 not to affect or abate any prosecutions for violation of law or any civil sei- zures or forfeitures and injunctive proceedings com- menced prior to the effective date of such amendment, and all administrative proceedings pending before the Bureau of Narcotics and Dangerous Drugs [now the Drug Enforcement Administration] on Oct. 27, 1970, to be continued and brought to final determination in ac- cord with laws and regulations in effect prior to Oct. 27, 1970, see section 702 of Pub. L. 91–513, set out as a note under section 321 of this title. CONSTRUCTION OF 2022 AMENDMENT Nothing in amendment made by section 3210(c) of Pub. L. 117–328 to be construed to affect ongoing with- drawal proceedings for products approved pursuant to section 356(c) of this title for which a notice of proposed withdrawal has been published in the Federal Register prior to Dec. 29, 2022, see section 3210(f) of Pub. L. 117–328, set out as a note under section 356 of this title. Pub. L. 117–328, div. FF, title III, § 3305(c), Dec. 29, 2022, 136 Stat. 5833, provided that: ‘‘Nothing in this sec- tion [enacting section 360n–2 of this title, amending this section, and enacting provisions set out as notes under this section and section 360n–2 of this title], in- cluding the amendments made by this section, shall be construed to affect the Secretary’s [of Health and Human Services] authority related to ensuring that there is a reasonable assurance of the safety and effec- tiveness of devices, which may include ensuring that there is a reasonable assurance of the cybersecurity of certain cyber devices, including for devices approved or cleared prior to the date of enactment of this Act [Dec. 29, 2022].’’ [For definition of ‘‘device’’ as used in section 3305(c) of Pub. L. 117–328, set out above, see section 321(h) of this title, as made applicable by section 3305(h) of Pub. L. 117–328, which is set out as a note under section 360n–2 of this title.] Nothing in amendment made by section 3503(a)(1), (4)(A), (B) of Pub. L. 117–328, to be construed to author- ize the disclosure of information that is prohibited from disclosure under section 331(j) of this title or sec- tion 1905 of title 18 or that is subject to withholding under section 552(b)(4) of title 5, see section 3503(c)(2) of Pub. L. 117–328, set out as a Construction; Confiden- tiality note under section 364 of this title. CONSTRUCTION OF 2015 AMENDMENT Pub. L. 114–114, § 2(d), Dec. 28, 2015, 129 Stat. 3130, pro- vided that: ‘‘Nothing in this Act [amending this section and enacting provisions set out as notes under this sec- tion and section 301 of this title] (or the amendments made by this Act) shall be construed to apply with re- spect to drugs that are not also cosmetics (as such terms are defined in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321)).’’ CONSTRUCTION OF 2011 AMENDMENT Nothing in amendments by sections 103(e), 105(c), 106(d), 204(j)(1), 211(b), (c), and 301(b) of Pub. L. 111–353 to be construed to apply to certain alcohol-related fa- cilities, see section 2206 of this title. Nothing in amendments by Pub. L. 111–353 to be con- strued to alter jurisdiction and authorities established under certain other Acts or in a manner inconsistent with international agreements to which the United States is a party, see sections 2251 and 2252 of this title. CONSTRUCTION OF 2009 AMENDMENTS Pub. L. 111–31, div. A, title I, § 103(p), June 22, 2009, 123 Stat. 1838, provided that: ‘‘Nothing in this section [amending this section and sections 333, 334, 355, 360m, 372 to 374, 375, 379a, 381, 393, 399, and 679 of this title and enacting provisions set out as notes under sections 333 and 387c of this title] is intended or shall be construed to expand, contract, or otherwise modify or amend the existing limitations on State government authority over tribal restricted fee or trust lands.’’ CONSTRUCTION OF 2002 AMENDMENTS Pub. L. 107–188, title III, § 315, June 12, 2002, 116 Stat. 675, provided that: ‘‘Nothing in this title [enacting sec- tions 350c, 350d, 398, 399, and 679c of this title, sections 3353, 3354, 8319, and 8320 of Title 7, Agriculture, and sec- tion 247b–20 of Title 42, The Public Health and Welfare, amending this section, sections 334, 335a, 342, 343, 360, 372, 374, and 381 of this title, and section 43 of Title 18, Crimes and Criminal Procedure, and enacting provi- sions set out as notes under this section and sections 341, 350c, 350d, and 381 of this title], or an amendment made by this title, shall be construed to alter the juris- diction between the Secretaries of Agriculture and of Health and Human Services, under applicable statutes and regulations.’’ PREEMPTION OF STATE LAWS Pub. L. 114–114, § 2(c), Dec. 28, 2015, 129 Stat. 3129, pro- vided that: ‘‘No State or political subdivision of a State may directly or indirectly establish under any author- ity or continue in effect restrictions with respect to the manufacture or introduction or delivery for introduc- tion into interstate commerce of rinse-off cosmetics containing plastic microbeads (as defined in section 301(ddd) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a)) that are not identical to the Page 56 TITLE 21—FOOD AND DRUGS § 332 1 So in original. Probably should be followed by a comma. 1 So in original. Words ‘‘of this section’’ probably should not appear. restrictions under such section 301(ddd) that have begun to apply under subsection (b) [set out as a note above].’’ Executive Documents TRANSFER OF FUNCTIONS For transfer of functions of Federal Security Admin- istrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title. § 332. Injunction proceedings (a) Jurisdiction of courts The district courts of the United States and the United States courts of the Territories shall have jurisdiction, for cause shown 1 to restrain violations of section 331 of this title, except paragraphs (h), (i), and (j). (b) Violation of injunction In case of violation of an injunction or re- straining order issued under this section, which also constitutes a violation of this chapter, trial shall be by the court, or, upon demand of the ac- cused, by a jury. (June 25, 1938, ch. 675, § 302, 52 Stat. 1043; Pub. L. 87–781, title I, § 103(d), title II, § 201(c), Oct. 10, 1962, 76 Stat. 784, 793; Pub. L. 103–80, § 3(d), Aug. 13, 1993, 107 Stat. 775.) Editorial Notes AMENDMENTS 1993—Subsec. (a). Pub. L. 103–80, § 3(d)(1), struck out ‘‘, and subject to the provisions of section 17 (relating to notice to opposite party) of the Act entitled ‘An Act to supplement existing laws against unlawful restraints and monopolies, and for other purposes’, approved Oc- tober 15, 1914, as amended (U.S.C., 1934 ed., title 28, sec. 381),’’ after ‘‘for cause shown’’. Subsec. (b). Pub. L. 103–80, § 3(d)(2), struck out at end ‘‘Such trial shall be conducted in accordance with the practice and procedure applicable in the case of pro- ceedings subject to the provisions of section 22 of such Act of October 15, 1914, as amended (U.S.C., 1934 ed., title 28, sec. 387).’’ 1962—Subsec. (a). Pub. L. 87–781, § 103(d), struck out ‘‘(e),’’ after ‘‘paragraphs’’. Pub. L. 87–781, § 201(c), struck out ‘‘(f),’’ after ‘‘para- graphs’’. Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 1962 AMENDMENT Amendment by section 103(c) of Pub. L. 87–781 effec- tive on first day of seventh calendar month following October 1962, see section 107 of Pub. L. 87–781, set out as a note under section 321 of this title. Pub. L. 87–781, title II, § 203, Oct. 10, 1962, 76 Stat. 793, provided that: ‘‘The amendments made by this title [amending this section and section 374 of this title and enacting provisions set out as notes under sections 321 and 374 of this title] shall take effect on the date of en- actment of this Act [Oct. 10, 1962].’’ § 333. Penalties (a) Violation of section 331 of this title; second violation; intent to defraud or mislead (1) Any person who violates a provision of sec- tion 331 of this title shall be imprisoned for not more than one year or fined not more than $1,000, or both. (2) Notwithstanding the provisions of para- graph (1) of this section,1 if any person commits such a violation after a conviction of him under this section has become final, or commits such a violation with the intent to defraud or mis- lead, such person shall be imprisoned for not more than three years or fined not more than $10,000, or both. (b) Prescription drug marketing violations (1) Notwithstanding subsection (a), any person who violates section 331(t) of this title by— (A) knowingly importing a drug in violation of section 381(d)(1) of this title, (B) knowingly selling, purchasing, or trading a drug or drug sample or knowingly offering to sell, purchase, or trade a drug or drug sample, in violation of section 353(c)(1) of this title, (C) knowingly selling, purchasing, or trading a coupon, knowingly offering to sell, purchase, or trade such a coupon, or knowingly counter- feiting such a coupon, in violation of section 353(c)(2) of this title, or (D) knowingly distributing drugs in viola- tion of section 353(e)(1) of this title, shall be imprisoned for not more than 10 years or fined not more than $250,000, or both. (2) Any manufacturer or distributor who dis- tributes drug samples by means other than the mail or common carrier whose representative, during the course of the representative’s em- ployment or association with that manufacturer or distributor, violated section 331(t) of this title because of a violation of section 353(c)(1) of this title or violated any State law prohibiting the sale, purchase, or trade of a drug sample subject to section 353(b) of this title or the offer to sell, purchase, or trade such a drug sample shall, upon conviction of the representative for such violation, be subject to the following civil penalties: (A) A civil penalty of not more than $50,000 for each of the first two such violations result- ing in a conviction of any representative of the manufacturer or distributor in any 10-year period. (B) A civil penalty of not more than $1,000,000 for each violation resulting in a con- viction of any representative after the second conviction in any 10-year period. For the purposes of this paragraph, multiple convictions of one or more persons arising out of the same event or transaction, or a related se- ries of events or transactions, shall be consid- ered as one violation. (3) Any manufacturer or distributor who vio- lates section 331(t) of this title because of a fail- ure to make a report required by section 353(d)(3)(E) of this title shall be subject to a civil penalty of not more than $100,000. (4)(A) If a manufacturer or distributor or any representative of such manufacturer or dis- tributor provides information leading to the in- stitution of a criminal proceeding against, and conviction of, any representative of that manu- facturer or distributor for a violation of section