US Code

Public Law 119-73 (01/23/2026)

21 U.S.C. § 331

Prohibited acts

The following acts and the causing thereof are prohibited:
(a)
The introduction or delivery for introduction 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 delivery or proffered delivery thereof for pay or otherwise.
(d)
1
1 So in original.
The introduction or delivery for introduction into interstate commerce of any article in violation of section 344, 350d, 355,, 360bbb–3, or 364c of this title.
(e)
l2
2 See References in Text note below.
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, required under section 350a, 350c(b), 350f, 350e, 354, 355(i) or (k), 360b(a)(4)(C), 360b(j), () or (m), 360ccc–1(i), 360e(f), 360i, 360bbb–3, 364a, 364g, 379aa, 379aa–1, 387i, or 387t of this title or the refusal to permit access to or verification or copying of any such required record; or the violation of any recordkeeping requirement under section 2223  of this title (except when such violation is committed by a farm).
(f)
section 374 of this title The refusal to permit entry or inspection as authorized by .
(g)
The manufacture within any Territory of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded.
(h)
section 333(c)(2) of this titlesection 333(c)(3) of this title The giving of a guaranty or undertaking referred to in , which guaranty or undertaking is false, except by a person who relied upon a guaranty or undertaking to the same effect signed by, and containing the name and address of, the person residing in the United States from whom he received in good faith the food, drug, device, tobacco product, or cosmetic; or the giving of a guaranty or undertaking referred to in , which guaranty or undertaking is false.
(i)
(1)
Forging, counterfeiting, simulating, or falsely representing, or without proper authority using any mark, stamp, tag, label, or other 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 designed to print, imprint, or reproduce the trademark, 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 counterfeit drug.
(j)
section 346a(i)(2) of this title1 The using by any person to his own advantage, or revealing, other than to the Secretary or officers or employees of the Department, or to the courts when relevant in any judicial proceeding under this chapter, any information acquired 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 violating of or any regulation issued under that section..This paragraph does not authorize the withholding of information from either House of Congress or from, to the extent of matter within its jurisdiction, 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 commerce and results in such article being adulterated or misbranded.
(l)
Pub. L. 105–115, title IV, § 421111 Stat. 2380 Repealed. , , .
(m)
section 347 of this title The sale or offering for sale of colored oleomargarine or colored margarine, or the possession or serving of colored oleomargarine or colored margarine in violation of subsections (b) or (c) of .
(n)
section 374 of this title The using, in labeling, advertising or other sales promotion of any reference to any report or analysis furnished in compliance with .
(o)
In the case of a prescription drug distributed or offered for sale in interstate commerce, the failure of the manufacturer, packer, or distributor thereof to maintain for transmittal, or to transmit, to any practitioner licensed by applicable 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 section 360(j)(2) or 387e(i)(3) of this title.
(q)
(1)
The failure or refusal—
(A)
o to comply with any requirement prescribed under section 360h, 360j(g), 387c(b), 387g, 387h, or 387 of this title;
(B)
to furnish any notification or other material or information required by or under section 360i, 360j(g), 387d, 387i, or 387t of this title; or
(C)
l to comply with a requirement under section 360 or 387m of this title.
(2)
With respect to any device or tobacco product, the submission of any report that is required by or under this chapter that is false or misleading in any material respect.
(3)
section 360n–2(b)(2) of this title The failure to comply with any requirement under (relating to ensuring device cybersecurity).
(r)
section 334(g) of this title The movement of a device, drug, or tobacco product in violation of an order under 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)
section 350a(f)(1)(B) of this titlesection 350a(b)(4) of this titlesection 350a(f)(3) of this title The failure to provide the notice required by section 350a(c) or 350a(e) of this title, the failure to make the reports required by , the failure to retain the records required by , or the failure to meet the requirements prescribed under .
(t)
section 381(d)(1) of this titlesection 353(c) of this titlesection 353(c)(2) of this titlesection 353(d) of this titlesection 353(d) of this titlesection 353(e) of this titlesection 360eee–1 of this titlesection 360eee–3 of this titlesection 353(e) of this title The importation of a drug in violation of , 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 , the sale, purchase, or trade of a coupon, the offer to sell, purchase, or trade such a coupon, or the counterfeiting of such a coupon in violation of , the distribution of a drug sample in violation of or the failure to otherwise comply with the requirements of , the distribution of drugs in violation of , failure to comply with the requirements under , the failure to comply with the requirements under , as applicable, or the failure to otherwise comply with the requirements of .
(u)
The failure to comply with any requirements 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)
section 350b of this title The introduction or delivery for introduction into interstate commerce of a dietary supplement that is unsafe under .
(w)
section 381(d)(3) of this titlesection 262(h) of title 42 The making of a knowingly false statement in any statement, certificate of analysis, record, or report required or requested under ; the failure to submit 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 United States under such section or any finished product made from such article or portion, except for export in accordance with section 381(e) or 382 of this title, or with ; or the failure to so export or to destroy such an article or portions thereof, or such a finished product.
(x)
section 360d(c) of this title The falsification of a declaration of conformity submitted under 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)
section 360m of this title the submission of a report or recommendation by a person accredited under that is false or misleading in any material respect;
(2)
section 360m of this title the disclosure by a person accredited under of confidential commercial information or any trade secret without the express written consent of the person who submitted such information or secret to such person; or
(3)
section 360m of this title the receipt by a person accredited under of a bribe in any form or the doing of any corrupt act by such person associated with a responsibility delegated to such person under this chapter.
(z)
Omitted.
(aa)
section 384 of this title The importation of a prescription drug in violation of , the falsification of any record required to be maintained or provided to the Secretary under such section, or any other violation of regulations under such section.
(bb)
section 334(h) of this title The transfer of an article of food in violation of an order under , or the removal or alteration of any mark or label required by the order to identify the article as detained.
(cc)
section 335a(b)(3) of this title 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 .
(dd)
section 350d of this title The failure to register in accordance with .
(ee)
section 381(m) of this title The importing or offering for import into the United States of an article of food in violation of the requirements under .
(ff)
o The importing or offering for import into the United States of a drug or device with respect to which there is a failure to comply with a request of the Secretary to submit to the Secretary a statement under section 381() of this title.
(gg)
section 374(g) of this title The knowing failure to comply with paragraph (7)(E) of ; the knowing inclusion by a person accredited under paragraph (2) of such section 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.
(hh)
section 350e of this title 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 practices prescribed by the Secretary under .
(ii)
section 364a(a) of this title 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 adverse event report (as defined under section 379aa or 379aa–1 of this title or required under ) submitted to the Secretary.
(jj)
(1)
section 282(j)(5)(B) of title 42 The failure to submit the certification required by , or knowingly submitting a false certification under such section.
(2)
section 282 of title 42 The failure to submit clinical trial information required under subsection (j) of .
(3)
section 282 of title 42 The submission of clinical trial information under subsection (j) of that is false or misleading in any particular under paragraph (5)(D) of such subsection (j).
(kk)
2 The dissemination of a television advertisement without complying with section 353c  of this title.
(ll)
section 355 of this titlesection 262 of title 42 The introduction or delivery for introduction into interstate commerce of any food to which has been added a drug approved under , a biological product licensed under , or a drug or a biological product for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, unless—
(1)
section 355 of this titlesection 262 of title 42 such drug or such biological product was marketed in food before any approval of the drug under , before licensure of the biological product under such , and before any substantial clinical investigations involving the drug or the biological product have been instituted;
(2)
the Secretary, in the Secretary’s discretion, 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 product in the food is to enhance the safety of the food to which the drug or the biological product is added or applied and not to have independent biological or therapeutic effects on humans, and the use is in conformity with—
(A)
section 348 of this title a regulation issued under prescribing conditions of safe use in food;
(B)
a regulation listing or affirming conditions under which the use of the drug or the biological product in food is generally recognized as safe;
(C)
the conditions of use identified in a notification to the Secretary of a claim of exemption from the premarket approval requirements for food additives based on the notifier’s determination that the use of the drug or the biological product in food is generally recognized as safe, provided that the Secretary has not questioned the general recognition of safety determination in a letter to the notifier;
(D)
section 348(h) of this title a food contact substance notification that is effective under ; or
(E)
such drug or biological product had been marketed for smoking cessation prior to ; or
(4)
section 360b of this title the drug is a new animal drug whose use is not unsafe under .
(mm)
section 350f(d) of this title The failure to submit a report or provide a notification required under .
(nn)
section 350f(d) of this title The falsification of a report or notification required under .
(oo)
section 333(f) of this title The sale of tobacco products in violation of a no-tobacco-sale order issued under .
(pp)
section 387k of this title The introduction or delivery for introduction into interstate commerce of a tobacco product in violation of .
(qq)
(1)
Forging, counterfeiting, simulating, or falsely representing, or without proper authority using any mark, stamp (including tax stamp), tag, label, or other identification device upon any tobacco product or container or labeling 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 likeness of any of the foregoing upon any tobacco product or container or labeling thereof so as to render such tobacco product a counterfeit tobacco 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 distributor 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 respect to a tobacco product, in a label or labeling or through the media or advertising, that either conveys, or misleads or would mislead consumers 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 virtue of—
(A)
its regulation or inspection by the Food and Drug Administration; or
(B)
its compliance with regulatory requirements set by the Food and Drug Administration;
section 387c of this titleincluding any such statement or representation rendering the product misbranded under .
(uu)
section 350g of this title The operation of a facility that manufactures, 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 compliance with .
(vv)
section 350h of this title The failure to comply with the requirements under .
(ww)
section 350i of this title The failure to comply with .
(xx)
l The refusal or failure to follow an order under section 350 of this title.
(yy)
section 350f(h) of this title The knowing and willful failure to comply with the notification requirement under .
(zz)
section 384a of this titlesection 384a of this title The importation or offering for importation of a food if the importer (as defined in ) does not have in place a foreign supplier verification program in compliance with such .
(aaa)
section 381(s) of this title The failure to register in accordance with .
(bbb)
section 360bbb–7 of this title The failure to notify the Secretary in violation of .
(ccc)
(1)
section 353b of this title The resale of a compounded drug that is labeled “not for resale” in accordance with .
(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 applicable.
(3)
section 353b of this title The failure to report drugs or adverse events by an entity that is registered in accordance with subsection (b) of .
(ddd)
(1)
The manufacture or the introduction or delivery for introduction into interstate commerce of a rinse-off cosmetic that contains intentionally-added plastic microbeads.
(2)
In this paragraph—
(A)
the term “plastic microbead” means any solid plastic particle that is less than five millimeters 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)
section 360bbb–8d of this title The failure to comply with any order issued under .
(fff)
(1)
Forging, counterfeiting, simulating, or falsely representing, or without proper authority 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 designed to print, imprint, or reproduce the trademark, trade name, or other identifying mark or imprint of another or any likeness of any of the foregoing upon any device or container, packaging, 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 dispensing, or the holding for sale or dispensing, of a counterfeit device.
(ggg)
section 356(c) of this title The failure of a sponsor of a product approved under accelerated approval pursuant to —
(1)
section 356(c) of this title to conduct with due diligence any postapproval study required under with respect to such product; or
(2)
section 356b(a)(2) of this title to submit timely reports with respect to such product in accordance with .
(hhh)
section 364c of this title The failure to register or submit listing information in accordance with .
(iii)
section 364g of this title The refusal or failure to follow an order under .

June 25, 1938, ch. 675, § 30152 Stat. 1042Dec. 22, 1941, ch. 613, § 155 Stat. 851July 6, 1945, ch. 281, § 159 Stat. 463Mar. 10, 1947, ch. 16, § 161 Stat. 11June 24, 1948, ch. 613, § 162 Stat. 582Mar. 16, 1950, ch. 61, § 3(b)64 Stat. 20Aug. 7, 1953, ch. 350, § 267 Stat. 477Pub. L. 85–929, § 572 Stat. 1788Pub. L. 86–618, title I74 Stat. 403Pub. L. 87–781, title I76 Stat. 784Pub. L. 89–7479 Stat. 232Pub. L. 90–399, § 10382 Stat. 352Pub. L. 90–639, § 2(b)82 Stat. 1361Pub. L. 91–513, title II, § 701(a)84 Stat. 1281Pub. L. 92–387, § 4(e)86 Stat. 562Pub. L. 94–29590 Stat. 576Pub. L. 96–359, § 594 Stat. 1193Pub. L. 99–570, title IV, § 4014(b)(2)100 Stat. 3207–120Pub. L. 100–293, § 7(a)102 Stat. 99Pub. L. 101–502, § 5(j)104 Stat. 1289Pub. L. 101–508, title IV, § 4755(c)(2)104 Stat. 1388–210Pub. L. 102–300, § 3(a)(1)106 Stat. 238Pub. L. 102–571, title I, § 107(2)106 Stat. 4499Pub. L. 103–80, § 3(c)107 Stat. 775Pub. L. 103–396, § 2(b)(1)108 Stat. 4154Pub. L. 103–417, § 10(b)108 Stat. 4332Pub. L. 104–134, title II, § 2103110 Stat. 1321–319Pub. L. 104–170, title IV, § 403110 Stat. 1514Pub. L. 104–250, § 5(d)110 Stat. 3156Pub. L. 105–115, title I, § 125(a)(2)(A)111 Stat. 2325Pub. L. 106–387, § 1(a) [title VII, § 745(d)(1)]114 Stat. 1549Pub. L. 107–188, title III116 Stat. 664Pub. L. 107–250, title II, § 201(d)116 Stat. 1609Pub. L. 108–136, div. A, title XVI, § 1603(c)117 Stat. 1690Pub. L. 108–173, title XI, § 1121(b)(1)117 Stat. 2469Pub. L. 108–214, § 2(b)(2)(A)118 Stat. 575Pub. L. 108–282, title I, § 102(b)(5)(C)118 Stat. 902Pub. L. 109–59, title VII, § 7202(d)119 Stat. 1913Pub. L. 109–462120 Stat. 3472Pub. L. 110–85, title VIII, § 801(b)(1)121 Stat. 920Pub. L. 111–31, div. A, title I, § 103(b)123 Stat. 1833Pub. L. 111–353, title I124 Stat. 3889Pub. L. 112–144, title VII126 Stat. 1073Pub. L. 113–54, title I, § 103(a)127 Stat. 597Pub. L. 114–114, § 2(a)129 Stat. 3129Pub. L. 114–255, div. A, title III, § 3101(a)(2)(A)130 Stat. 1152Pub. L. 115–271, title III132 Stat. 3935Pub. L. 117–328, div. FF, title II, § 2513(a)136 Stat. 5805(, ; , ; , ; , ; , ; , ; , ; , , ; , §§ 104, 105(a), , ; , §§ 103(c), 104(e)(1), 106(c), 114(a), title III, § 304, , , 785, 788, 791, 795; , §§ 5, 9(c), , , 235; , , ; , , ; , , ; , , ; , §§ 3(b), 4(b)(1), 7(b), , , 580, 582; , , ; , , ; , , ; , , ; , , ; , , ; , (3), , ; , , ; , , ; , , ; , , ; , , ; , , ; , (C), (b)(2)(B), title II, §§ 204(b), 210(c), title IV, §§ 401(b), 421, , , 2336, 2345, 2364, 2380; , , , 1549A–39; , §§ 303(b), 304(d), 305(b), 306(c), 307(b), 321(b)(2), 322(b), , , 666, 668, 670, 672, 676, 677; , , ; , , ; , , ; , , ; , (D), , ; , (e), , ; , §§ 2(c), 3(b), 4(a), , , 3475; , title IX, §§ 901(d)(1), 912(a), title X, § 1005(d), , , 939, 951, 968; , , ; , §§ 102(d)(1), 103(e), 105(c), 106(d), title II, §§ 204(j)(1), 206(d), 211(b), (c), title III, § 301(b), , , 3898, 3904, 3906, 3937, 3943, 3953, 3954; , §§ 714(a), 715(a), , , 1075; , title II, § 206(a), , , 639; , , ; , , ; , §§ 3012(a), 3022(b)(1), , , 3938; , title III, §§ 3210(c), 3305(b), 3503(a)(1), (4)(A), (B), , , 5824, 5833, 5858.)

Editorial Notes

References in Text

Section 2223 of this titlesection 204 of Pub. L. 111–353section 2223 of this titlesection 381 of this title, referred to in par. (e), was in the original “section 204 of the FDA Food Safety Modernization Act”, meaning , which enacted and amended this section and .

Section 353c of this titlePub. L. 113–54, title I, § 102(a)(1)127 Stat. 587section 353c of this titlesection 102(a)(2) of Pub. L. 113–54section 353b of this title, referred to in par. (kk), was in the original a reference to section 503B of act , and was translated as if it referred to section 503C of that Act, to reflect the probable intent of Congress and the renumbering of section 503B as 503C by , , , and its transfer to . A new section 503B, which was enacted by , is classified to and does not relate to television advertisements.

Amendments

Pub. L. 117–328, § 3503(a)(1)(B)2022—Subsec. (d). , which directed the substitution of “, 360bbb–3, or 364c” for “or 360bbb–3” in par. (d), was executed by making the substitution in subsec. (d) to reflect the probable intent of Congress.

Pub. L. 117–328, § 3503(a)(4)(A)Subsec. (e). , substituted “360bbb–3, 364a, 373” for “360bbb–3, 373” and “360bbb–3, 364a, 364g, 379aa” for “360bbb–3, 379aa”.

Pub. L. 117–328, § 3305(b)Subsec. (q)(3). , added par. (3).

Pub. L. 117–328, § 3503(a)(4)(B)(ii)section 364a(a) of this titleSubsec. (ii). , inserted “or required under ” 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”.

Pub. L. 117–328, § 2513(a)Subsec. (fff). , added subsec. (fff).

Pub. L. 117–328, § 3210(c)Subsec. (ggg). , added subsec. (ggg).

Pub. L. 117–328, § 3503(a)(1)(A)Subsecs. (hhh), (iii). , added subsecs. (hhh) and (iii).

Pub. L. 115–271, § 3022(b)(1)2018—Par. (cc). , inserted “or a drug” after “food” and “from such activity” after “person debarred”.

Pub. L. 115–271, § 3012(a)Par. (eee). , added par. (eee).

Pub. L. 114–2552016—Subsec. (r). inserted “, drug,” after “device” in two places.

Pub. L. 114–1142015—Par. (ddd). added par. (ddd).

Pub. L. 113–54, § 206(a)section 353(d) of this titlesection 360eee–1 of this titlesection 360eee–3 of this titlesection 353(e) of this title2013—Par. (t). , struck out “or” after “the requirements of ,” and inserted “, failure to comply with the requirements under , the failure to comply with the requirements under , as applicable,” after “in violation of ”.

Pub. L. 113–54, § 103(a)Par. (ccc). , added par. (ccc).

Pub. L. 112–144, § 714(a)2012—Par. (aaa). , added par. (aaa).

Pub. L. 112–144, § 715(a)Par. (bbb). , added par. (bbb).

Pub. L. 111–353, § 102(d)(1)2011—Par. (d). , inserted “350d,” after “344,”.

Pub. L. 111–353section 2223 of this titlePar. (e). , §§ 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 (except when such violation is committed by a farm)”.

Pub. L. 111–353, § 103(e)Par. (uu). , added par. (uu).

Pub. L. 111–353, § 105(c)Par. (vv). , added par. (vv).

Pub. L. 111–353, § 106(d)Par. (ww). , added par. (ww).

Pub. L. 111–353, § 206(d)Par. (xx). , added par. (xx).

Pub. L. 111–353, § 211(b)Par. (yy). , added par. (yy).

Pub. L. 111–353, § 301(b)Par. (zz). , added par. (zz).

Pub. L. 111–31, § 103(b)(1)2009—Pars. (a) to (c). –(3), inserted “tobacco product,” after “device,”.

Pub. L. 111–31, § 103(b)(4)(B)Par. (e). , 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 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)”.

Pub. L. 111–31, § 103(b)(5)Pars. (g), (h). , (6), inserted “tobacco product,” after “device,”.

Pub. L. 111–31, § 103(b)(7)Par. (j). , struck out period after “360ccc–2” and substituted “379, 379e, 387d, 387e, 387f, 387g, 387h, 387i, or 387t(b)” for “379, or 379e”.

Pub. L. 111–31, § 103(b)(8)Par. (k). , inserted “tobacco product,” after “device,”.

Pub. L. 111–31, § 103(b)(9)section 360 of this titlesection 360(j)(2) of this titlePar. (p). , added par. (p) and struck out former par. (p) which read as follows: “The failure to register in accordance with , 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 .”

Pub. L. 111–31, § 103(b)(10)lPar. (q)(1). , added subpar. (1) and struck out former subpar. (1) which read as follows: “The failure or refusal to (A) comply with any requirement 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 360 of this title.”

Pub. L. 111–31, § 103(b)(11)Par. (q)(2). , substituted “device or tobacco product,” for “device,”.

Pub. L. 111–31, § 103(b)(12)Par. (r). , inserted “or tobacco product” after “device” in two places.

ooPub. L. 111–31, § 103(b)(13)ooPars. () to (tt). , added pars. () to (tt).

Pub. L. 110–85, § 1005(d)(1)2007—Par. (e). , substituted “350c, 350f(g),” for “350c,” and “350c(b), 350f” for “350c(b)”.

Pub. L. 110–85, § 801(b)(1)Par. (jj). , added par. (jj).

Pub. L. 110–85, § 901(d)(1)Par. (kk). , added par. (kk).

llPub. L. 110–85, § 912(a)llPar. (). , added par. ().

Pub. L. 110–85, § 1005(d)(2)Pars. (mm), (nn). , added pars. (mm) and (nn).

Pub. L. 109–462, § 3(b)2006—Par. (e). , 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”.

Pub. L. 109–462, § 4(a)Par. (ii). , added par. (ii).

Pub. L. 109–59, § 7202(d)2005—Par. (e). , inserted “350e,” before “354,” in two places.

Pub. L. 109–59, § 7202(e)Par. (hh). , added par. (hh).

Pub. L. 108–282, § 102(b)(5)(C)lll2004—Par. (e). , which directed the substitution of “360b(a)(4)(C), 360b (j), () or (m), 360ccc–1(i).” for “360b(a)(4)(C), 360b(j), () or (m)” was executed by making the substitution for “360b(a)(4)(C), 360b(j), (), or (m)”, to reflect the probable intent of Congress.

Pub. L. 108–282, § 102(b)(5)(D)Par. (j). , substituted “360j, 360ccc, 360ccc–1, 360ccc–2.” for “360j”.

Pub. L. 108–214section 374(g) of this titlePar. (gg). amended par. (gg) generally. Prior to amendment, text read as follows: “The knowing failure of a person accredited under paragraph (2) of 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.”

Pub. L. 108–1362003—Par. (d). substituted “section 344, 355, or 360bbb–3” for “section 344 or 355”.

Pub. L. 108–136Par. (e). inserted “360bbb–3,” after “350c, 354,” and substituted “360i, or 360bbb–3” for “or 360i”.

Pub. L. 108–173Par. (aa). substituted “prescription drug in violation of section 384” for “covered product in violation of section 384”.

Pub. L. 107–188, § 306(c)(1)2002—Par. (e). , 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”.

Pub. L. 107–188, § 306(c)(2)Par. (j). , inserted “350c,” after “350a,”.

Pub. L. 107–188, § 322(b)section 381(d)(3) of this titlesection 381(d)(3) of this titlesection 262(h) of title 42section 262(h) of title 42Par. (w). , 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 subparagraph (A) or (B) of , the failure to submit or maintain records as required by sections 381(d)(3)(A) and 381(d)(3)(B) of this title, the release into interstate commerce of any article imported into the United States under or any finished product made from such article (except for export in accordance with section 381(e) or 382 of this title or ), or the failure to export or destroy any component, part or accessory 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 .”

Pub. L. 107–188, § 303(b)Par. (bb). , added par. (bb).

Pub. L. 107–188, § 304(d)Par. (cc). , added par. (cc).

Pub. L. 107–188, § 305(b)Par. (dd). , added par. (dd).

Pub. L. 107–188, § 307(b)Par. (ee). , added par. (ee).

Pub. L. 107–188, § 321(b)(2)Par. (ff). , added par. (ff).

Pub. L. 107–250Par. (gg). added par. (gg).

Pub. L. 106–3872000—Par. (aa). added par. (aa).

Pub. L. 105–115, § 125(b)(2)(B)1997—Par. (e). , struck out “357(d) or (g),” after “355(i) or (k),”.

Pub. L. 105–115, § 125(a)(2)(C)Par. (i)(1). , struck out “, 356, 357,” before “or 379e of this title”.

Pub. L. 105–115, § 125(a)(2)(A)Par. (j). , struck out “356, 357,” before “360,”.

lPub. L. 105–115, § 421lPar. (). , struck out par. () 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 approval 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 device complies with the provisions of such section.”

Pub. L. 105–115, § 204(b)Par. (x). , added par. (x).

Pub. L. 105–115, § 210(c)Par. (y). , added par. (y).

Pub. L. 105–115, § 401(b)section 360aaa of this titlePar. (z). , temporarily added par. (z) which related to dissemination of information in violation of . See Effective and Termination Dates of 1997 Amendment note below.

Pub. L. 104–2501996—Par. (e). inserted “, 354,” before “or 373 of this title” and “354,” before “355(i) or (k)”.

Pub. L. 104–170section 346a(i)(2) of this titlePar. (j). inserted before period at end of first sentence “; or the violating of or any regulation issued under that section.”

Pub. L. 104–134Pars. (u) to (w). redesignated par. (u) relating to introduction into interstate commerce of unsafe dietary supplement as (v) and added par. (w).

Pub. L. 103–396, § 2(b)(1)(A)1994—Par. (e). , substituted “357(d) or (g), 360b(a)(4)(C),” for “357(d) or (g),”.

Pub. L. 103–417Par. (u). added par. (u) relating to introduction 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 Secretary.

Pub. L. 103–80, § 3(c)(1)1993—Par. (j). , substituted “379, or 379e” for “379e, or 379”.

Pub. L. 103–80, § 3(c)(2)Par. (s). , substituted “350a(e)” for “350a(d)”.

Pub. L. 102–5711992—Pars. (i)(1), (j). substituted “379e” for “376”.

Pub. L. 102–300Par. (q)(1)(C). added cl. (C).

Pub. L. 101–5021990—Par. (e). substituted “or (k)” for “or (j)”.

Pub. L. 101–508Par. (j). inserted at end “This paragraph does not authorize the withholding of information from either House of Congress or from, to the extent of matter within its jurisdiction, any committee or subcommittee of such committee or any joint committee of Congress or any subcommittee of such joint committee.”

Pub. L. 100–2931988—Par. (t). added par. (t).

Pub. L. 99–5701986—Par. (s). amended par. (s) generally. Prior to amendment, par. (s) read as follows: “The failure to provide the notice required by section 350a(b) or 350a(c), the failure to make the reports required by section 350a(d)(1)(B), or the failure to meet the requirements prescribed under section 350a(d)(2).”

Pub. L. 96–359, § 5(b)section 350a of this title1980—Par. (e). , inserted reference to in two places.

Pub. L. 96–359, § 5(c)section 350a of this titlePar. (j). , inserted reference to .

Pub. L. 96–359, § 5(a)Par. (s). , added par. (s).

Pub. L. 94–295, § 3(b)(2)1976—Par. (e). , inserted references to sections 360e(f) and 360i of this title.

Pub. L. 94–295, § 3(b)(3)Par. (j). , inserted references to sections 360, 360c, 360d, 360e, 360f, 360h, 360i, 360j, and 379 of this title.

lPub. L. 94–295, § 3(b)(4)Par. (). , substituted “drug or device” for “drug” wherever appearing, and inserted references to sections 360e and 360j(g) of this title.

Pub. L. 94–295, § 4(b)(1)section 360(j) of this titlePar. (p). , substituted “section 360(j) or 360(k) of this title,” for “,”.

Pub. L. 94–295, § 3(b)(1)Par. (q). , added par. (q).

Pub. L. 94–295, § 7(b)Par. (r). , added par. (r).

Pub. L. 92–387section 360(j) of this titlesection 360(j)(2) of this title1972—Par. (p). added failure to provide information required by , and failure to provide notice required by as prohibited acts.

Pub. L. 91–5131970—Par. (q). struck out par. (q) which set out penalties for illegal manufacture, sale, disposition, possession and other traffic in stimulant and depressant drugs. See section 801 et seq. of this title.

Pub. L. 90–399, § 103(1)l1968—Par. (e). , struck out “or” before “357(d) or (g)” and inserted “, or 360b(j), (), or (m)” after “357(d) or (g)”. Amendment striking out “or” was executed as described, notwithstanding directory language that “or” before “357,” be stricken out, to reflect the probable intent of Congress.

Pub. L. 90–399, § 103(2)section 360b of this titlePar. (j). , inserted reference to .

Pub. L. 90–639section 360a(c) of this titlesection 360a(c)(1) of this titlesection 360a(c)(2) of this titlePar. (q). divided cl. (3), which referred simply to possession in violation of , into subcls. (A) and (B) which refer, respectively, to possession in violation of and possession in violation of .

Pub. L. 89–74, § 9(c)1965—Par. (i). , designated existing provisions as subpar. (1) and added subpars. (2) and (3).

Pub. L. 89–74, § 5Par. (q). , added par. (q).

Pub. L. 87–7811962—Par. (e). , §§ 103(c), 106(c), prohibited 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 required record.

lPub. L. 87–781, § 104(e)(1)Par. (). , inserted “approval of” before “an application”, and substituted “in effect” for “effective”.

oPub. L. 87–781, § 114(a)oPar. (). , added par. ().

Pub. L. 87–781, § 304Par. (p). , added par. (p).

Pub. L. 86–618, § 105(a)section 376 of this title1960—Par. (i). , struck out references to sections 346(b), 354, and 364 of this title and inserted reference to .

Pub. L. 86–618, § 104section 376 of this titlePar. (j). , inserted reference to .

Pub. L. 85–929section 348 of this title1958—Par. (j). , inserted reference to .

1953—Par. (n). Act , added par. (n).

1950—Par. (m). Act , added par. (m).

1948—Par. (k). Act , 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 occurs while the article is held for the first sale after interstate shipment, and extended coverage of subsection to acts which result in adulteration.

1947—Par. (j). Act , inserted reference to sections 356 and 357 of this title.

section 357 of this title1945—Par. (i). Act , inserted reference to .

section 356 of this title1941—Par. (i). Act , inserted reference to .

Statutory Notes and Related Subsidiaries

Effective Date of 2022 Amendment

Pub. L. 117–328, div. FF, title III, § 3305(d)136 Stat. 5833

section 360n–2 of this title21 U.S.C. 360n–2(a)“The amendments made by subsections (a) and (b) [enacting and amending this section] shall take effect 90 days after the date of enactment of this Act []. An application or submission submitted before such effective date shall not be subject to the requirements under subsection (a) or (b) of section 524B of the Federal Food, Drug, and Cosmetic Act [, (b)], as added by this section.”
, , , provided that:

Pub. L. 117–328, div. FF, title III, § 3503(b)(1)136 Stat. 5859

“The amendments made by subsection (a) [amending this section and sections 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 [].”
, , , provided that:

Effective Date of 2018 Amendment

Pub. L. 115–271, title III, § 3012(d)132 Stat. 3936

21 U.S.C. 331(eee)21 U.S.C. 360bbb–8d“Sections 301(eee) [] and 569D [] 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 [].”
, , , provided that:

Effective Date of 2015 Amendment

Pub. L. 114–114, § 2(b)129 Stat. 3129

“(1)

In general .—

The amendment made by subsection (a) [amending this section] applies—
“(A)
with respect to manufacturing, beginning on , and with respect to introduction or delivery for introduction into interstate commerce, beginning on ; and
“(B)
notwithstanding subparagraph (A), in the case of a rinse-off cosmetic that is a nonprescription drug, with respect to manufacturing, beginning on , and with respect to the introduction or delivery for introduction into interstate commerce, beginning on .
“(2)

Nonprescription drug .—

21 U.S.C. 353(b)(1)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 ().”
, , , provided that:

Effective Date of 2011 Amendment

section 103(e) of Pub. L. 111–353section 350g(n) of this titlesection 103(i) of Pub. L. 111–353section 350g of this titleAmendment by effective 18 months after , and applicable to a small business (as defined in the regulations promulgated under ) beginning on the date that is 6 months after the effective date of such regulations and to a very small business (as defined in such regulations) beginning on the date that is 18 months after the effective date of such regulations, see , set out as an Effective Date note under .

Pub. L. 111–353, title III, § 301(d)124 Stat. 3955

section 384a of this titlesection 381 of this title“The amendments made by this section [enacting and amending this section and ] shall take effect 2 years after the date of enactment of this Act [].”
, , , provided that:

Effective Date of 2007 Amendment

Pub. L. 110–85, title IX, § 909121 Stat. 950

“(a)

Effective Date .—

Pub. L. 110–85section 262 of Title 42This subtitle [subtitle A (§§ 901–909) of title IX of , enacting sections 353b and 355–1 of this title, amending this section, sections 333, 352, and 355 of this title, and , 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 [].
“(b)

Drugs Deemed to Have Risk Evaluation and Mitigation Strategies.—

“(1)

In general .—

21 U.S.C. 355–1A 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 evaluation and mitigation strategy under section 505–1 of the Federal Food, Drug, and Cosmetic Act [] (as added by section 901) (referred to in this section 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 required under section 505–1(d) and any additional elements under subsections (e) and (f) of such section in effect for such drug on the effective date of this Act; and
“(B)
21 U.S.C. 333(f)(4) 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 [, 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 mitigation strategy is deemed to be in effect under paragraph (1) shall submit to the Secretary a proposed risk evaluation and mitigation strategy. Such proposed strategy is subject to section 505–1 of the Act as if included in such application at the time of submission of the application to the Secretary.”
, , , provided that:

Effective Date of 2006 Amendment

section 2(c) of Pub. L. 109–462section 2(e)(1) of Pub. L. 109–462section 352 of this titleAmendment by effective 1 year after , see , set out as a note under .

section 3(b) of Pub. L. 109–462section 3(d)(1) of Pub. L. 109–462section 343 of this titleAmendment by effective 1 year after , see , set out as a note under .

Pub. L. 109–462, § 4(b)120 Stat. 3475

“The amendment made by this section [amending this section] shall take effect 1 year after the date of enactment of this Act [].”
, , , provided that:

Effective Date of 2005 Amendment

Pub. L. 109–59, title VII, § 7204119 Stat. 1914

Pub. L. 109–59section 350e of this titlesection 5701 of Title 49section 301 of this title“This subtitle [subtitle B (§§ 7201–7204) of title VII of , enacting , amending this section, sections 342 and 373 of this title, and , Transportation, omitting sections 5702 to 5714 of Title 49, and enacting provisions set out as a note under ] takes effect on .”
, , , provided that:

Effective Date of 2002 Amendment

Pub. L. 107–188, title III, § 321(c)116 Stat. 676

“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 [].”
, , , provided that:

Pub. L. 107–188, title III, § 322(c)116 Stat. 678

section 381 of this title“The amendments made by this section [amending this section and ] take effect upon the expiration of the 90-day period beginning on the date of the enactment of this Act [].”
, , , provided that:

Effective and Termination Dates of 1997 Amendment

Pub. L. 105–115section 501 of Pub. L. 105–115section 321 of this titleAmendment by sections 204, 210, and 421 of effective 90 days after , except as otherwise provided, see , set out as a note under .

section 401(b) of Pub. L. 105–115section 401(c) of Pub. L. 105–115Pub. L. 105–115section 360aaa of this titleAmendment by effective 1 year after , or upon Secretary’s issuance of final regulations pursuant to , whichever is sooner, and ceases to be effective , see section 401(d), (e) of , set out as an Effective and Termination Dates note under former .

Effective Date of 1994 Amendment

Pub. L. 103–396section 2(c) of Pub. L. 103–396section 360b of this titlesection 2(d) of Pub. L. 103–396section 360b of this titleAmendment by effective upon adoption of final regulations under , set out as a Regulations note under , see , set out as a note under .

Effective Date of 1990 Amendment

Pub. L. 101–508, title IV, § 4755(c)(2)104 Stat. 1388–210Pub. L. 101–239, title VI103 Stat. 228542 U.S.C. 300aa–1, , , 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, , §§ 6601, 6602, , , see note, 300aa–10 note.

Effective Date of 1988 Amendment

Pub. L. 100–293section 8(a) of Pub. L. 100–293section 353 of this titleAmendment by effective upon expiration of 90 days after , see , set out as a note under .

Effective Date of 1972 Amendment

Pub. L. 92–387section 5 of Pub. L. 92–387section 360 of this titleAmendment by effective on first day of sixth month beginning after , see , set out as a note under .

Effective Date of 1970 Amendment

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

Effective Date of 1968 Amendments

Pub. L. 90–399section 108(a) of Pub. L. 90–399section 360b of this titleAmendment by effective on first day of thirteenth calendar month after , see , set out as an Effective Date and Transitional Provisions note under .

Pub. L. 90–639section 6 of Pub. L. 90–639section 321 of this titleAmendment by applicable only with respect to violations of this chapter committed after , see , set out as an Effective Date of 1968 Amendments; Transitional Provisions note under .

Effective Date of 1965 Amendment

Pub. L. 89–74section 11 of Pub. L. 89–74section 321 of this titleAmendment by effective , see , set out as a note under .

Effective Date of 1962 Amendment

Pub. L. 87–781section 104(e)(1) of Pub. L. 87–781section 107 of Pub. L. 87–781section 321 of this titleAmendment by sections 103(c) and 106(c) of effective on first day of seventh calendar month following Oct. 1962, and amendment by effective , see , set out as a note under .

Pub. L. 87–781, title I, § 114(b)76 Stat. 791

“This section [amending this section] shall take effect on the first day of the seventh calendar month following the month in which this Act is enacted [October 1962].”
, , , provided that:

Effective Date of 1960 Amendment

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

Effective Date of 1958 Amendment

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

Effective Date of 1950 Amendment

section 347 of this titleAmendment by act , effective , see section 7 of that act, set out as an Effective Date note under .

Regulations

Pub. L. 113–54, title I, § 104127 Stat. 597

section 301 of this title“In promulgating any regulations to implement this title [enacting subpart 9 of part C of subchapter 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 ] (and the amendments made by this title), the Secretary of Health and Human Services shall—
“(1)
issue a notice of proposed rulemaking that includes 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.”
, , , provided that:

section 401 of Pub. L. 105–115section 401(c) of Pub. L. 105–115section 360aaa of this titleSecretary of Health and Human Services to promulgate regulations to implement amendments made by not later than 1 year after , see , set out as a note under .

Savings Provisions

Pub. L. 113–54, title II, § 208127 Stat. 640

section 353 of this title21 U.S.C. 353(b)(1)21 U.S.C. 30142 U.S.C. 201“Except as provided in the amendments made by paragraphs (1), (2), and (3) of section 204(a) [amending ] 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 section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act () under any other provision of such Act [ et seq.] or the Public Health Service Act ( et seq.).”
, , , provided that:

Pub. L. 91–513section 702 of Pub. L. 91–513section 321 of this titleAmendment by not to affect or abate any prosecutions for violation of law or any civil seizures or forfeitures and injunctive proceedings commenced 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 , to be continued and brought to final determination in accord with laws and regulations in effect prior to , see , set out as a note under .

Construction of 2022 Amendment

section 3210(c) of Pub. L. 117–328section 356(c) of this titlesection 3210(f) of Pub. L. 117–328section 356 of this titleNothing in amendment made by to be construed to affect ongoing withdrawal proceedings for products approved pursuant to for which a notice of proposed withdrawal has been published in the Federal Register prior to , see , set out as a note under .

Pub. L. 117–328, div. FF, title III, § 3305(c)136 Stat. 5833

section 360n–2 of this titlesection 360n–2 of this title“Nothing in this section [enacting , amending this section, and enacting provisions set out as notes under this section and ], including 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 effectiveness 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 [].”
, , , provided that:

section 3305(c) of Pub. L. 117–328section 321(h) of this titlesection 3305(h) of Pub. L. 117–328section 360n–2 of this title[For definition of “device” as used in , set out above, see , as made applicable by , which is set out as a note under .]

Pub. L. 117–328section 331(j) of this titlesection 1905 of title 18section 552(b)(4) of title 5section 3503(c)(2) of Pub. L. 117–328section 364 of this titleNothing in amendment made by section 3503(a)(1), (4)(A), (B) of , to be construed to authorize the disclosure of information that is prohibited from disclosure under or or that is subject to withholding under , see , set out as a Construction; Confidentiality note under .

Construction of 2015 Amendment

Pub. L. 114–114, § 2(d)129 Stat. 3130

section 301 of this title21 U.S.C. 321“Nothing in this Act [amending this section and enacting provisions set out as notes under this section and ] (or the amendments made by this Act) shall be construed to apply with respect to drugs that are not also cosmetics (as such terms are defined in section 201 of the Federal Food, Drug, and Cosmetic Act ()).”
, , , provided that:

Construction of 2011 Amendment

Pub. L. 111–353section 2206 of this titleNothing in amendments by sections 103(e), 105(c), 106(d), 204(j)(1), 211(b), (c), and 301(b) of to be construed to apply to certain alcohol-related facilities, see .

Pub. L. 111–353Nothing in amendments by to be construed 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)123 Stat. 1838

“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.”
, , , provided that:

Construction of 2002 Amendments

Pub. L. 107–188, title III, § 315116 Stat. 675

section 247b–20 of Title 42section 43 of Title 18“Nothing in this title [enacting sections 350c, 350d, 398, 399, and 679c of this title, sections 3353, 3354, 8319, and 8320 of Title 7, Agriculture, and , The Public Health and Welfare, amending this section, sections 334, 335a, 342, 343, 360, 372, 374, and 381 of this title, and , Crimes and Criminal Procedure, and enacting provisions 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 jurisdiction between the Secretaries of Agriculture and of Health and Human Services, under applicable statutes and regulations.”
, , , provided that:

Preemption of State Laws

Pub. L. 114–114, § 2(c)129 Stat. 3129

“No State or political subdivision of a State may directly or indirectly establish under any authority or continue in effect restrictions with respect to the manufacture or introduction or delivery for introduction 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 restrictions under such section 301(ddd) that have begun to apply under subsection (b) [set out as a note above].”
, , , provided that:

Executive Documents

Transfer of Functions

section 321 of this titleFor transfer of functions of Federal Security Administrator 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 .