--- kind: "range" citation: "21 U.S.C. §§ 331–334" title: "21" from: "331" to: "334" count: 5 release: "119-102" url: "https://uscodex.org/usc/21/331..334" --- # §331. Prohibited acts The following acts and the causing thereof are prohibited: - (a) The introduction or delivery for introduction into [interstate commerce](/usc/21/321.md?p=b) of any [food](/usc/21/321.md?p=f), [drug](/usc/21/321.md?p=g-1), [device](/usc/21/355–2.md?p=a-3), [tobacco product](/usc/21/321.md?p=rr-1), or [cosmetic](/usc/21/321.md?p=i) that is adulterated or [misbranded](/usc/21/1033.md?p=l). - (b) The adulteration or misbranding of any [food](/usc/21/321.md?p=f), [drug](/usc/21/321.md?p=g-1), [device](/usc/21/355–2.md?p=a-3), [tobacco product](/usc/21/321.md?p=rr-1), or [cosmetic](/usc/21/321.md?p=i) in [interstate commerce](/usc/21/321.md?p=b). - (c) The receipt in [interstate commerce](/usc/21/321.md?p=b) of any [food](/usc/21/321.md?p=f), [drug](/usc/21/321.md?p=g-1), [device](/usc/21/355–2.md?p=a-3), [tobacco product](/usc/21/321.md?p=rr-1), or [cosmetic](/usc/21/321.md?p=i) that is adulterated or [misbranded](/usc/21/1033.md?p=l), and the delivery or proffered delivery thereof for pay or otherwise. - (d) The introduction or delivery for introduction into [interstate commerce](/usc/21/321.md?p=b) of any article in violation of section [344](/usc/21/344.md), [350d](/usc/21/350d.md), [355](/usc/21/355.md),,[^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](/usc/21/350a.md), [350c](/usc/21/350c.md), [350f(j)](/usc/21/350f.md?p=j), [350e](/usc/21/350e.md), [354](/usc/21/354.md), [360bbb–3](/usc/21/360bbb–3.md), [364a](/usc/21/364a.md), [373](/usc/21/373.md), [374(a)](/usc/21/374.md?p=a), [379aa](/usc/21/379aa.md), or [379aa–1](/usc/21/379aa–1.md) of this title; or the failure to establish or maintain any record, or make any report, required under section [350a](/usc/21/350a.md), [350c(b)](/usc/21/350c.md?p=b), [350f](/usc/21/350f.md), [350e](/usc/21/350e.md), [354](/usc/21/354.md), [355(i)](/usc/21/355.md?p=i) or [(k)](/usc/21/355.md?p=k), [360b(a)(4)(C)](/usc/21/360b.md?p=a-4-C), [360b(j)](/usc/21/360b.md?p=j), [(l)](/usc/21/360b.md?p=l) or [(m)](/usc/21/360b.md?p=m), [360ccc–1(i)](/usc/21/360ccc–1.md?p=i), [360e(f)](/usc/21/360e.md?p=f), [360i](/usc/21/360i.md), [360bbb–3](/usc/21/360bbb–3.md), [364a](/usc/21/364a.md), [364g](/usc/21/364g.md), [379aa](/usc/21/379aa.md), [379aa–1](/usc/21/379aa–1.md), [387i](/usc/21/387i.md), or [387t](/usc/21/387t.md) of this title or the refusal to permit access to or [verification](/usc/21/360eee.md?p=28) or copying of any such required record; or the violation of any recordkeeping requirement under [section 2223](/usc/21/2223.md)[^2] of this title (except when such violation is committed by a farm). - (f) The refusal to permit entry or inspection as [authorized](/usc/21/360eee–1.md?p=a-6) by [section 374 of this title](/usc/21/374.md). - (g) The manufacture within any [Territory](/usc/21/321.md?p=a-2) of any [food](/usc/21/321.md?p=f), [drug](/usc/21/321.md?p=g-1), [device](/usc/21/355–2.md?p=a-3), [tobacco product](/usc/21/321.md?p=rr-1), or [cosmetic](/usc/21/321.md?p=i) that is adulterated or [misbranded](/usc/21/1033.md?p=l). - (h) The giving of a guaranty or undertaking referred to in [section 333(c)(2) of this title](/usc/21/333.md), which guaranty or undertaking is false, except by a [person](/usc/21/321.md?p=e) who relied upon a guaranty or undertaking to the same effect signed by, and containing the name and address of, the [person](/usc/21/321.md?p=e) residing in the United States from whom he received in good faith the [food](/usc/21/321.md?p=f), [drug](/usc/21/321.md?p=g-1), [device](/usc/21/355–2.md?p=a-3), [tobacco product](/usc/21/321.md?p=rr-1), or [cosmetic](/usc/21/321.md?p=i); or the giving of a guaranty or undertaking referred to in [section 333(c)(3) of this title](/usc/21/333.md), which guaranty or undertaking is false. - (i) - (1) Forging, counterfeiting, simulating, or falsely representing, or without proper authority using any mark, stamp, tag, [label](/usc/21/321.md?p=k), or other identification [device](/usc/21/355–2.md?p=a-3) [authorized](/usc/21/360eee–1.md?p=a-6) or required by regulations promulgated under the provisions of section [344](/usc/21/344.md) or [379e](/usc/21/379e.md) 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](/usc/21/355–2.md?p=a-3) of another or any likeness of any of the foregoing upon any [drug](/usc/21/321.md?p=g-1) or container or [labeling](/usc/21/321.md?p=m) thereof so as to render such [drug](/usc/21/321.md?p=g-1) a [counterfeit drug](/usc/21/321.md?p=g-2). - (3) The doing of any act which causes a [drug](/usc/21/321.md?p=g-1) to be a [counterfeit drug](/usc/21/321.md?p=g-2), or the sale or dispensing, or the holding for sale or dispensing, of a [counterfeit drug](/usc/21/321.md?p=g-2). - (j) The using by any [person](/usc/21/321.md?p=e) to his own advantage, or revealing, other than to the [Secretary](/usc/21/321.md?p=d) or officers or employees of the [Department](/usc/21/321.md?p=c), or to the courts when relevant in any judicial proceeding under this chapter, any information acquired under authority of section [344](/usc/21/344.md), [348](/usc/21/348.md), [350a](/usc/21/350a.md), [350c](/usc/21/350c.md), [355](/usc/21/355.md), [360](/usc/21/360.md), [360b](/usc/21/360b.md), [360c](/usc/21/360c.md), [360d](/usc/21/360d.md), [360e](/usc/21/360e.md), [360f](/usc/21/360f.md), [360h](/usc/21/360h.md), [360i](/usc/21/360i.md), [360j](/usc/21/360j.md), [360ccc](/usc/21/360ccc.md), [360ccc–1](/usc/21/360ccc–1.md), [360ccc–2](/usc/21/360ccc–2.md), [374](/usc/21/374.md), [379](/usc/21/379.md), [379e](/usc/21/379e.md), [387d](/usc/21/387d.md), [387e](/usc/21/387e.md), [387f](/usc/21/387f.md), [387g](/usc/21/387g.md), [387h](/usc/21/387h.md), [387i](/usc/21/387i.md), or [387t(b)](/usc/21/387t.md?p=b) of this title concerning any method or process which as a trade secret is entitled to protection; or the violating of [section 346a(i)(2) of this title](/usc/21/346a.md?p=i-2) or any regulation issued under that section..[^1]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](/usc/21/321.md?p=m) of, or the doing of any other act with respect to, a [food](/usc/21/321.md?p=f), [drug](/usc/21/321.md?p=g-1), [device](/usc/21/355–2.md?p=a-3), [tobacco product](/usc/21/321.md?p=rr-1), or [cosmetic](/usc/21/321.md?p=i), if such act is done while such article is held for sale (whether or not the first sale) after shipment in [interstate commerce](/usc/21/321.md?p=b) and results in such article being adulterated or [misbranded](/usc/21/1033.md?p=l). - (l) Repealed. Pub. L. 105–115, title IV, § 421, Nov. 21, 1997, 111 Stat. 2380. - (m) 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 [section 347 of this title](/usc/21/347.md). - (n) The using, in [labeling](/usc/21/321.md?p=m), advertising or other sales promotion of any reference to any report or analysis furnished in compliance with [section 374 of this title](/usc/21/374.md). - (o) In the case of a [prescription drug](/usc/21/360eee.md?p=12) distributed or offered for sale in [interstate commerce](/usc/21/321.md?p=b), the failure of the manufacturer, packer, or distributor thereof to maintain for transmittal, or to transmit, to any practitioner [licensed](/usc/21/360eee–1.md?p=a-6) by applicable [State](/usc/21/321.md?p=a-1) law to administer such [drug](/usc/21/321.md?p=g-1) who makes written request for information as to such [drug](/usc/21/321.md?p=g-1), true and correct copies of all printed matter which is required to be included in any package in which that [drug](/usc/21/321.md?p=g-1) is distributed or sold, or such other printed matter as is approved by the [Secretary](/usc/21/321.md?p=d). Nothing in this paragraph shall be construed to exempt any [person](/usc/21/321.md?p=e) from any [labeling](/usc/21/321.md?p=m) requirement imposed by or under other provisions of this chapter. - (p) The failure to register in accordance with section [360](/usc/21/360.md) or [387e](/usc/21/387e.md) of this title, the failure to provide any information required by section [360(j)](/usc/21/360.md?p=j), [360(k)](/usc/21/360.md?p=k), [387e(i)](/usc/21/387e.md?p=i), or [387e(j)](/usc/21/387e.md?p=j) of this title, or the failure to provide a notice required by section [360(j)(2)](/usc/21/360.md?p=j-2) or [387e(i)(3)](/usc/21/387e.md?p=i-3) of this title. - (q) - (1) The failure or refusal— - (A) to comply with any requirement prescribed under section [360h](/usc/21/360h.md), [360j(g)](/usc/21/360j.md?p=g), [387c(b)](/usc/21/387c.md?p=b), [387g](/usc/21/387g.md), [387h](/usc/21/387h.md), or [387o](/usc/21/387o.md) of this title; - (B) to furnish any notification or other material or information required by or under section [360i](/usc/21/360i.md), [360j(g)](/usc/21/360j.md?p=g), [387d](/usc/21/387d.md), [387i](/usc/21/387i.md), or [387t](/usc/21/387t.md) of this title; or - (C) to comply with a requirement under section [360l](/usc/21/360l.md) or [387m](/usc/21/387m.md) of this title. - (2) With respect to any [device](/usc/21/355–2.md?p=a-3) or [tobacco product](/usc/21/321.md?p=rr-1), the submission of any report that is required by or under this chapter that is false or misleading in any material respect. - (3) The failure to comply with any requirement under [section 360n–2(b)(2) of this title](/usc/21/360n–2.md?p=b-2) (relating to ensuring [device](/usc/21/355–2.md?p=a-3) cybersecurity). - (r) The movement of a [device](/usc/21/355–2.md?p=a-3), [drug](/usc/21/321.md?p=g-1), or [tobacco product](/usc/21/321.md?p=rr-1) in violation of an order under [section 334(g) of this title](/usc/21/334.md?p=g) or the removal or alteration of any mark or [label](/usc/21/321.md?p=k) required by the order to identify the [device](/usc/21/355–2.md?p=a-3), [drug](/usc/21/321.md?p=g-1), or [tobacco product](/usc/21/321.md?p=rr-1) as detained. - (s) The failure to provide the notice required by section [350a(c)](/usc/21/350a.md?p=c) or [350a(e)](/usc/21/350a.md?p=e) of this title, the failure to make the reports required by [section 350a(f)(1)(B) of this title](/usc/21/350a.md?p=f-1-B), the failure to retain the records required by [section 350a(b)(4) of this title](/usc/21/350a.md?p=b-4), or the failure to meet the requirements prescribed under [section 350a(f)(3) of this title](/usc/21/350a.md?p=f-3). - (t) The importation of a [drug](/usc/21/321.md?p=g-1) in violation of [section 381(d)(1) of this title](/usc/21/381.md?p=d-1), the sale, purchase, or trade of a [drug](/usc/21/321.md?p=g-1) or [drug](/usc/21/321.md?p=g-1) sample or the offer to sell, purchase, or trade a [drug](/usc/21/321.md?p=g-1) or [drug](/usc/21/321.md?p=g-1) sample in violation of [section 353(c) of this title](/usc/21/353.md?p=c), 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 [section 353(c)(2) of this title](/usc/21/353.md?p=c-2), the [distribution](/usc/21/360eee.md?p=5) of a [drug](/usc/21/321.md?p=g-1) sample in violation of [section 353(d) of this title](/usc/21/353.md?p=d) or the failure to otherwise comply with the requirements of [section 353(d) of this title](/usc/21/353.md?p=d), the [distribution](/usc/21/360eee.md?p=5) of [drugs](/usc/21/321.md?p=g-1) in violation of [section 353(e) of this title](/usc/21/353.md?p=e), failure to comply with the requirements under [section 360eee–1 of this title](/usc/21/360eee–1.md), the failure to comply with the requirements under [section 360eee–3 of this title](/usc/21/360eee–3.md), as applicable, or the failure to otherwise comply with the requirements of [section 353(e) of this title](/usc/21/353.md?p=e). - (u) The failure to comply with any requirements of the provisions of, or any regulations or orders of the [Secretary](/usc/21/321.md?p=d), under section [360b(a)(4)(A)](/usc/21/360b.md?p=a-4-A), [360b(a)(4)(D)](/usc/21/360b.md?p=a-4-D), or [360b(a)(5)](/usc/21/360b.md?p=a-5) of this title. - (v) The introduction or delivery for introduction into [interstate commerce](/usc/21/321.md?p=b) of a [dietary supplement](/usc/21/321.md?p=ff) that is unsafe under [section 350b of this title](/usc/21/350b.md). - (w) The making of a [knowingly](/usc/21/321.md?p=bb) false statement in any statement, certificate of analysis, record, or report required or requested under [section 381(d)(3) of this title](/usc/21/381.md?p=d-3); 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](/usc/21/321.md?p=b) of any article or portion thereof imported into the United States under such section or any finished [product](/usc/21/360eee.md?p=13) made from such article or portion, except for export in accordance with section [381(e)](/usc/21/381.md?p=e) or [382](/usc/21/382.md) of this title, or with [section 262(h) of title 42](/usc/42/262.md?p=h); or the failure to so export or to destroy such an article or portions thereof, or such a finished [product](/usc/21/360eee.md?p=13). - (x) The falsification of a declaration of conformity submitted under [section 360d(c) of this title](/usc/21/360d.md?p=c) or the failure or refusal to provide data or information requested by the [Secretary](/usc/21/321.md?p=d) under [paragraph (3)](/usc/21/360d.md?p=c-3) of such section. - (y) In the case of a [drug](/usc/21/321.md?p=g-1), [device](/usc/21/355–2.md?p=a-3), or [food](/usc/21/321.md?p=f)— - (1) the submission of a report or recommendation by a [person](/usc/21/321.md?p=e) accredited under [section 360m of this title](/usc/21/360m.md) that is false or misleading in any material respect; - (2) the disclosure by a [person](/usc/21/321.md?p=e) accredited under [section 360m of this title](/usc/21/360m.md) of confidential commercial information or any trade secret without the express written consent of the [person](/usc/21/321.md?p=e) who submitted such information or secret to such [person](/usc/21/321.md?p=e); or - (3) the receipt by a [person](/usc/21/321.md?p=e) accredited under [section 360m of this title](/usc/21/360m.md) of a bribe in any form or the doing of any corrupt act by such [person](/usc/21/321.md?p=e) associated with a responsibility delegated to such [person](/usc/21/321.md?p=e) under this chapter. - (z) Omitted. - (aa) The importation of a [prescription drug](/usc/21/360eee.md?p=12) in violation of [section 384 of this title](/usc/21/384.md), the falsification of any record required to be maintained or provided to the [Secretary](/usc/21/321.md?p=d) under such section, or any other violation of regulations under such section. - (bb) The transfer of an article of [food](/usc/21/321.md?p=f) in violation of an order under [section 334(h) of this title](/usc/21/334.md?p=h), or the removal or alteration of any mark or [label](/usc/21/321.md?p=k) required by the order to identify the article as detained. - (cc) The importing or offering for import into the United States of an article of [food](/usc/21/321.md?p=f) or a [drug](/usc/21/321.md?p=g-1) by, with the assistance of, or at the direction of, a [person](/usc/21/321.md?p=e) debarred from such activity under [section 335a(b)(3) of this title](/usc/21/335a.md?p=b-3). - (dd) The failure to register in accordance with [section 350d of this title](/usc/21/350d.md). - (ee) The importing or offering for import into the United States of an article of [food](/usc/21/321.md?p=f) in violation of the requirements under [section 381(m) of this title](/usc/21/381.md?p=m). - (ff) The importing or offering for import into the United States of a [drug](/usc/21/321.md?p=g-1) or [device](/usc/21/355–2.md?p=a-3) with respect to which there is a failure to comply with a request of the [Secretary](/usc/21/321.md?p=d) to submit to the [Secretary](/usc/21/321.md?p=d) a statement under [section 381(o)](/usc/21/381.md?p=o) of this title. - (gg) The knowing failure to comply with paragraph (7)(E) of [section 374(g) of this title](/usc/21/374.md?p=g); the knowing inclusion by a [person](/usc/21/321.md?p=e) accredited under [paragraph (2)](/usc/21/374.md?p=g-2) of such section of false information in an inspection report under [paragraph (7)(A)](/usc/21/374.md?p=g-7-A) of such section; or the knowing failure of such a [person](/usc/21/321.md?p=e) 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](/usc/21/321.md?p=e) engaged in the transportation of [food](/usc/21/321.md?p=f) to comply with the sanitary transportation practices prescribed by the [Secretary](/usc/21/321.md?p=d) under [section 350e of this title](/usc/21/350e.md). - (ii) The falsification of a report of a serious adverse event submitted to a [responsible person](/usc/21/364.md?p=4) (as defined under section [364](/usc/21/364.md), [379aa](/usc/21/379aa.md), or [379aa–1](/usc/21/379aa–1.md) of this title) or the falsification of a serious adverse event report (as defined under section [379aa](/usc/21/379aa.md) or [379aa–1](/usc/21/379aa–1.md) of this title or required under [section 364a(a) of this title](/usc/21/364a.md?p=a)) submitted to the [Secretary](/usc/21/321.md?p=d). - (jj) - (1) The failure to submit the certification required by [section 282(j)(5)(B) of title 42](/usc/42/282.md?p=j-5-B), or [knowingly](/usc/21/321.md?p=bb) submitting a false certification under such section. - (2) The failure to submit clinical trial information required under subsection (j) of [section 282 of title 42](/usc/42/282.md). - (3) The submission of clinical trial information under subsection (j) of [section 282 of title 42](/usc/42/282.md) that is false or misleading in any particular under paragraph (5)(D) of such [subsection (j)](#j). - (kk) The dissemination of a television advertisement without complying with [section 353c](/usc/21/353c.md)[^2] of this title. - (ll) The introduction or delivery for introduction into [interstate commerce](/usc/21/321.md?p=b) of any [food](/usc/21/321.md?p=f) to which has been added a [drug](/usc/21/321.md?p=g-1) approved under [section 355 of this title](/usc/21/355.md), a biological [product](/usc/21/360eee.md?p=13) [licensed](/usc/21/360eee–1.md?p=a-6) under [section 262 of title 42](/usc/42/262.md), or a [drug](/usc/21/321.md?p=g-1) or a biological [product](/usc/21/360eee.md?p=13) for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, unless— - (1) such [drug](/usc/21/321.md?p=g-1) or such biological [product](/usc/21/360eee.md?p=13) was marketed in [food](/usc/21/321.md?p=f) before any approval of the [drug](/usc/21/321.md?p=g-1) under [section 355 of this title](/usc/21/355.md), before licensure of the biological [product](/usc/21/360eee.md?p=13) under such [section 262 of title 42](/usc/42/262.md), and before any substantial clinical investigations involving the [drug](/usc/21/321.md?p=g-1) or the biological [product](/usc/21/360eee.md?p=13) have been instituted; - (2) the [Secretary](/usc/21/321.md?p=d), in the [Secretary](/usc/21/321.md?p=d)’s discretion, has issued a regulation, after notice and comment, approving the use of such [drug](/usc/21/321.md?p=g-1) or such biological [product](/usc/21/360eee.md?p=13) in the [food](/usc/21/321.md?p=f); - (3) the use of the [drug](/usc/21/321.md?p=g-1) or the biological [product](/usc/21/360eee.md?p=13) in the [food](/usc/21/321.md?p=f) is to enhance the safety of the [food](/usc/21/321.md?p=f) to which the [drug](/usc/21/321.md?p=g-1) or the biological [product](/usc/21/360eee.md?p=13) is added or applied and not to have independent biological or therapeutic effects on humans, and the use is in conformity with— - (A) a regulation issued under [section 348 of this title](/usc/21/348.md) prescribing conditions of safe use in [food](/usc/21/321.md?p=f); - (B) a regulation listing or affirming conditions under which the use of the [drug](/usc/21/321.md?p=g-1) or the biological [product](/usc/21/360eee.md?p=13) in [food](/usc/21/321.md?p=f) is generally recognized as safe; - (C) the conditions of use identified in a notification to the [Secretary](/usc/21/321.md?p=d) of a claim of exemption from the premarket approval requirements for [food additives](/usc/21/321.md?p=s) based on the notifier’s determination that the use of the [drug](/usc/21/321.md?p=g-1) or the biological [product](/usc/21/360eee.md?p=13) in [food](/usc/21/321.md?p=f) is generally recognized as safe, provided that the [Secretary](/usc/21/321.md?p=d) has not questioned the general recognition of safety determination in a letter to the notifier; - (D) a [food](/usc/21/321.md?p=f) contact substance notification that is effective under [section 348(h) of this title](/usc/21/348.md?p=h); or - (E) such [drug](/usc/21/321.md?p=g-1) or biological [product](/usc/21/360eee.md?p=13) had been marketed for smoking cessation prior to September 27, 2007; or - (4) the [drug](/usc/21/321.md?p=g-1) is a [new animal drug](/usc/21/321.md?p=v) whose use is not unsafe under [section 360b of this title](/usc/21/360b.md). - (mm) The failure to submit a report or provide a notification required under [section 350f(d) of this title](/usc/21/350f.md?p=d). - (nn) The falsification of a report or notification required under [section 350f(d) of this title](/usc/21/350f.md?p=d). - (oo) The sale of [tobacco products](/usc/21/321.md?p=rr-1) in violation of a no-tobacco-sale order issued under [section 333(f) of this title](/usc/21/333.md?p=f). - (pp) The introduction or delivery for introduction into [interstate commerce](/usc/21/321.md?p=b) of a [tobacco product](/usc/21/321.md?p=rr-1) in violation of [section 387k of this title](/usc/21/387k.md). - (qq) - (1) Forging, counterfeiting, simulating, or falsely representing, or without proper authority using any mark, stamp (including tax stamp), tag, [label](/usc/21/321.md?p=k), or other identification [device](/usc/21/355–2.md?p=a-3) upon any [tobacco product](/usc/21/321.md?p=rr-1) or container or [labeling](/usc/21/321.md?p=m) thereof so as to render such [tobacco product](/usc/21/321.md?p=rr-1) a [counterfeit tobacco product](/usc/21/387.md?p=6). - (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](/usc/21/355–2.md?p=a-3) of another or any likeness of any of the foregoing upon any [tobacco product](/usc/21/321.md?p=rr-1) or container or [labeling](/usc/21/321.md?p=m) thereof so as to render such [tobacco product](/usc/21/321.md?p=rr-1) a [counterfeit tobacco product](/usc/21/387.md?p=6). - (3) The doing of any act that causes a [tobacco product](/usc/21/321.md?p=rr-1) to be a [counterfeit tobacco product](/usc/21/387.md?p=6), or the sale or dispensing, or the holding for sale or dispensing, of a [counterfeit tobacco product](/usc/21/387.md?p=6). - (rr) The charitable [distribution](/usc/21/360eee.md?p=5) of [tobacco products](/usc/21/321.md?p=rr-1). - (ss) The failure of a manufacturer or distributor to notify the Attorney General and the [Secretary](/usc/21/321.md?p=d) of the Treasury of their knowledge of [tobacco products](/usc/21/321.md?p=rr-1) used in illicit trade. - (tt) Making any express or implied statement or representation directed to consumers with respect to a [tobacco product](/usc/21/321.md?p=rr-1), in a [label](/usc/21/321.md?p=k) or [labeling](/usc/21/321.md?p=m) or through the media or advertising, that either conveys, or misleads or would mislead consumers into believing, that— - (1) the [product](/usc/21/360eee.md?p=13) is approved by the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration; - (2) the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration deems the [product](/usc/21/360eee.md?p=13) to be safe for use by consumers; - (3) the [product](/usc/21/360eee.md?p=13) is endorsed by the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration for use by consumers; or - (4) the [product](/usc/21/360eee.md?p=13) is safe or less harmful by virtue of— - (A) its regulation or inspection by the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration; or - (B) its compliance with regulatory requirements set by the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration; including any such statement or representation rendering the [product](/usc/21/360eee.md?p=13) [misbranded](/usc/21/1033.md?p=l) under [section 387c of this title](/usc/21/387c.md). - (uu) The operation of a [facility](/usc/21/350g.md?p=o-2) that manufactures, processes, packs, or holds [food](/usc/21/321.md?p=f) for sale in the United States if the owner, operator, or agent in charge of such [facility](/usc/21/350g.md?p=o-2) is not in compliance with [section 350g of this title](/usc/21/350g.md). - (vv) The failure to comply with the requirements under [section 350h of this title](/usc/21/350h.md). - (ww) The failure to comply with [section 350i of this title](/usc/21/350i.md). - (xx) The refusal or failure to follow an order under [section 350l](/usc/21/350l.md) of this title. - (yy) The knowing and willful failure to comply with the notification requirement under [section 350f(h) of this title](/usc/21/350f.md?p=h). - (zz) The importation or offering for importation of a [food](/usc/21/321.md?p=f) if the importer (as defined in [section 384a of this title](/usc/21/384a.md)) does not have in place a foreign supplier [verification](/usc/21/360eee.md?p=28) [program](/usc/21/1523.md?p=8) in compliance with such [section 384a of this title](/usc/21/384a.md). - (aaa) The failure to register in accordance with [section 381(s) of this title](/usc/21/381.md?p=s). - (bbb) The failure to notify the [Secretary](/usc/21/321.md?p=d) in violation of [section 360bbb–7 of this title](/usc/21/360bbb–7.md). - (ccc) - (1) The resale of a compounded [drug](/usc/21/321.md?p=g-1) that is labeled “not for resale” in accordance with [section 353b of this title](/usc/21/353b.md). - (2) With respect to a [drug](/usc/21/321.md?p=g-1) to be compounded pursuant to section [353a](/usc/21/353a.md) or [353b](/usc/21/353b.md) of this title, the intentional falsification of a prescription, as applicable. - (3) The failure to report [drugs](/usc/21/321.md?p=g-1) or adverse events by an entity that is registered in accordance with subsection (b) of [section 353b of this title](/usc/21/353b.md). - (ddd) - (1) The manufacture or the introduction or delivery for introduction into [interstate commerce](/usc/21/321.md?p=b) 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) The failure to comply with any order issued under [section 360bbb–8d of this title](/usc/21/360bbb–8d.md). - (fff) - (1) Forging, counterfeiting, simulating, or falsely representing, or without proper authority using any mark, stamp, tag, [label](/usc/21/321.md?p=k), or other identification upon any [device](/usc/21/355–2.md?p=a-3) or container, packaging, or [labeling](/usc/21/321.md?p=m) thereof so as to render such [device](/usc/21/355–2.md?p=a-3) a [counterfeit device](/usc/21/321.md?p=h-2). - (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](/usc/21/355–2.md?p=a-3) or container, packaging, or [labeling](/usc/21/321.md?p=m) thereof so as to render such [device](/usc/21/355–2.md?p=a-3) a [counterfeit device](/usc/21/321.md?p=h-2). - (3) The doing of any act which causes a [device](/usc/21/355–2.md?p=a-3) to be a [counterfeit device](/usc/21/321.md?p=h-2), or the sale or dispensing, or the holding for sale or dispensing, of a [counterfeit device](/usc/21/321.md?p=h-2). - (ggg) The failure of a [sponsor](/usc/21/379j–71.md?p=13) of a [product](/usc/21/360eee.md?p=13) approved under accelerated approval pursuant to [section 356(c) of this title](/usc/21/356.md?p=c)— - (1) to conduct with due diligence any postapproval study required under [section 356(c) of this title](/usc/21/356.md?p=c) with respect to such [product](/usc/21/360eee.md?p=13); or - (2) to submit timely reports with respect to such [product](/usc/21/360eee.md?p=13) in accordance with [section 356b(a)(2) of this title](/usc/21/356b.md?p=a-2). - (hhh) The failure to register or submit listing information in accordance with [section 364c of this title](/usc/21/364c.md). - (iii) The refusal or failure to follow an order under [section 364g of this title](/usc/21/364g.md). # §332. Injunction proceedings - (a) **Jurisdiction of courts—** The district courts of the United States and the United States courts of the [Territories](/usc/21/321.md?p=a-2) shall have jurisdiction, for cause shown[^1] to restrain violations of [section 331 of this title](/usc/21/331.md), except paragraphs (h), (i), and (j). - (b) **Violation of injunction—** In case of violation of an injunction or restraining order issued under this section, which also constitutes a violation of this chapter, trial shall be by the court, or, upon demand of the accused, by a jury. # §333. Penalties - (a) **Violation of section 331 of this title; second violation; intent to defraud or mislead—** - (1) Any [person](/usc/21/321.md?p=e) who violates a provision of [section 331 of this title](/usc/21/331.md) shall be imprisoned for not more than one year or fined not more than $1,000, or both. - (2) Notwithstanding the provisions of [paragraph (1)](#a-1) of this section,[^1] if any [person](/usc/21/321.md?p=e) 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 mislead, such [person](/usc/21/321.md?p=e) 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)](#a), any [person](/usc/21/321.md?p=e) who violates [section 331(t) of this title](/usc/21/331.md?p=t) by— - (A) [knowingly](/usc/21/321.md?p=bb) importing a [drug](/usc/21/321.md?p=g-1) in violation of [section 381(d)(1) of this title](/usc/21/381.md?p=d-1), - (B) [knowingly](/usc/21/321.md?p=bb) selling, purchasing, or trading a [drug](/usc/21/321.md?p=g-1) or [drug](/usc/21/321.md?p=g-1) sample or [knowingly](/usc/21/321.md?p=bb) offering to sell, purchase, or trade a [drug](/usc/21/321.md?p=g-1) or [drug](/usc/21/321.md?p=g-1) sample, in violation of [section 353(c)(1) of this title](/usc/21/353.md?p=c-1), - (C) [knowingly](/usc/21/321.md?p=bb) selling, purchasing, or trading a coupon, [knowingly](/usc/21/321.md?p=bb) offering to sell, purchase, or trade such a coupon, or [knowingly](/usc/21/321.md?p=bb) counterfeiting such a coupon, in violation of [section 353(c)(2) of this title](/usc/21/353.md?p=c-2), or - (D) [knowingly](/usc/21/321.md?p=bb) distributing [drugs](/usc/21/321.md?p=g-1) in violation of [section 353(e)(1) of this title](/usc/21/353.md?p=e-1), shall be imprisoned for not more than 10 years or fined not more than $250,000, or both. - (2) Any manufacturer or distributor who [distributes](/usc/21/360eee.md?p=5) [drug](/usc/21/321.md?p=g-1) samples by means other than the mail or common carrier whose representative, during the course of the representative’s employment or association with that manufacturer or distributor, violated [section 331(t) of this title](/usc/21/331.md?p=t) because of a violation of [section 353(c)(1) of this title](/usc/21/353.md?p=c-1) or violated any [State](/usc/21/321.md?p=a-1) law prohibiting the sale, purchase, or trade of a [drug](/usc/21/321.md?p=g-1) sample subject to [section 353(b) of this title](/usc/21/353.md?p=b) or the offer to sell, purchase, or trade such a [drug](/usc/21/321.md?p=g-1) 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 resulting 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 conviction 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](/usc/21/321.md?p=e) arising out of the same event or transaction, or a related series of events or transactions, shall be considered as one violation. - (3) Any manufacturer or distributor who violates [section 331(t) of this title](/usc/21/331.md?p=t) because of a failure to make a report required by [section 353(d)(3)(E) of this title](/usc/21/353.md?p=d-3-E) 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 distributor provides information leading to the institution of a criminal proceeding against, and conviction of, any representative of that manufacturer or distributor for a violation of [section 331(t) of this title](/usc/21/331.md?p=t) because of a sale, purchase, or trade or offer to purchase, sell, or trade a [drug](/usc/21/321.md?p=g-1) sample in violation of [section 353(c)(1) of this title](/usc/21/353.md?p=c-1) or for a violation of [State](/usc/21/321.md?p=a-1) law prohibiting the sale, purchase, or trade or offer to sell, purchase, or trade a [drug](/usc/21/321.md?p=g-1) sample, the conviction of such representative shall not be considered as a violation for purposes of [paragraph (2)](#b-2). - (B) If, in an action brought under [paragraph (2)](#b-2) against a manufacturer or distributor relating to the conviction of a representative of such manufacturer or distributor for the sale, purchase, or trade of a [drug](/usc/21/321.md?p=g-1) or the offer to sell, purchase, or trade a [drug](/usc/21/321.md?p=g-1), it is shown, by clear and convincing evidence— - (i) that the manufacturer or distributor conducted, before the institution of a criminal proceeding against such representative for the violation which resulted in such conviction, an investigation of events or transactions which would have led to the reporting of information leading to the institution of a criminal proceeding against, and conviction of, such representative for such purchase, sale, or trade or offer to purchase, sell, or trade, or - (ii) that, except in the case of the conviction of a representative employed in a supervisory function, despite diligent implementation by the manufacturer or distributor of an independent audit and security system designed to detect such a violation, the manufacturer or distributor could not reasonably have been expected to have detected such violation, the conviction of such representative shall not be considered as a conviction for purposes of [paragraph (2)](#b-2). - (5) If a [person](/usc/21/321.md?p=e) provides information leading to the institution of a criminal proceeding against, and conviction of, a [person](/usc/21/321.md?p=e) for a violation of [section 331(t) of this title](/usc/21/331.md?p=t) because of the sale, purchase, or trade of a [drug](/usc/21/321.md?p=g-1) sample or the offer to sell, purchase, or trade a [drug](/usc/21/321.md?p=g-1) sample in violation of [section 353(c)(1) of this title](/usc/21/353.md?p=c-1), such [person](/usc/21/321.md?p=e) shall be entitled to one-half of the criminal fine imposed and collected for such violation but not more than $125,000. - (6) Notwithstanding [subsection (a)](#a), any [person](/usc/21/321.md?p=e) who is a manufacturer or importer of a [prescription drug](/usc/21/360eee.md?p=12) under [section 384(b) of this title](/usc/21/384.md?p=b) and [knowingly](/usc/21/321.md?p=bb) fails to comply with a requirement of [section 384(e) of this title](/usc/21/384.md?p=e) that is applicable to such manufacturer or importer, respectively, shall be imprisoned for not more than 10 years or fined not more than $250,000, or both. - (7) Notwithstanding [subsection (a)(2)](#a-2), any [person](/usc/21/321.md?p=e) that [knowingly](/usc/21/321.md?p=bb) and intentionally adulterates a [drug](/usc/21/321.md?p=g-1) such that the [drug](/usc/21/321.md?p=g-1) is adulterated under subsection (a)(1), (b), (c), or (d) of [section 351 of this title](/usc/21/351.md) and has a reasonable probability of causing serious adverse health consequences or death to humans or animals shall be imprisoned for not more than 20 years or fined not more than $1,000,000, or both. - (8) Notwithstanding [subsection (a)](#a), any [person](/usc/21/321.md?p=e) who violates [section 331(i)(3) of this title](/usc/21/331.md?p=i-3) by [knowingly](/usc/21/321.md?p=bb) making, selling or dispensing, or holding for sale or dispensing, a [counterfeit drug](/usc/21/321.md?p=g-2), or who violates [section 331(fff)(3) of this title](/usc/21/331.md?p=fff-3) by [knowingly](/usc/21/321.md?p=bb) making, selling or dispensing, or holding for sale or dispensing, a [counterfeit device](/usc/21/321.md?p=h-2), shall be imprisoned for not more than 10 years or fined in accordance with [title 18](/usc/18.md), or both. - (c) **Exceptions in certain cases of good faith, etc.** No [person](/usc/21/321.md?p=e) shall be subject to the penalties of [subsection (a)(1)](#a-1) of this section, (1) for having received in [interstate commerce](/usc/21/321.md?p=b) any article and delivered it or proffered delivery of it, if such delivery or proffer was made in good faith, unless he refuses to furnish on request of an officer or employee duly designated by the [Secretary](/usc/21/321.md?p=d) the name and address of the [person](/usc/21/321.md?p=e) from whom he purchased or received such article and copies of all documents, if any there be, pertaining to the delivery of the article to him; or (2) for having violated section [331(a)](/usc/21/331.md?p=a) or [(d)](/usc/21/331.md?p=d) of this title, if he establishes a guaranty or undertaking signed by, and containing the name and address of, the [person](/usc/21/321.md?p=e) residing in the United States from whom he received in good faith the article, to the effect, in case of an alleged violation of [section 331(a) of this title](/usc/21/331.md?p=a), that such article is not adulterated or [misbranded](/usc/21/1033.md?p=l), within the meaning of this chapter designating this chapter or to the effect, in case of an alleged violation of [section 331(d) of this title](/usc/21/331.md?p=d), that such article is not an article which may not, under the provisions of section [344](/usc/21/344.md) or [355](/usc/21/355.md) of this title, be introduced into [interstate commerce](/usc/21/321.md?p=b); or (3) for having violated [section 331(a) of this title](/usc/21/331.md?p=a), where the violation exists because the article is adulterated by reason of containing a [color additive](/usc/21/321.md?p=t-1) not from a batch certified in accordance with regulations promulgated by the [Secretary](/usc/21/321.md?p=d) under this chapter, if such [person](/usc/21/321.md?p=e) establishes a guaranty or undertaking signed by, and containing the name and address of, the manufacturer of the [color additive](/usc/21/321.md?p=t-1), to the effect that such [color additive](/usc/21/321.md?p=t-1) was from a batch certified in accordance with the applicable regulations promulgated by the [Secretary](/usc/21/321.md?p=d) under this chapter; or (4) for having violated section [331(b)](/usc/21/331.md?p=b), [(c)](/usc/21/331.md?p=c) or [(k)](/usc/21/331.md?p=k) of this title by failure to comply with [section 352(f) of this title](/usc/21/352.md?p=f) in respect to an article received in [interstate commerce](/usc/21/321.md?p=b) to which neither [section 353(a)](/usc/21/353.md?p=a) nor [353(b)(1)](/usc/21/353.md?p=b-1) of this title is applicable, if the delivery or proffered delivery was made in good faith and the [labeling](/usc/21/321.md?p=m) at the time thereof contained the same directions for use and warning statements as were contained in the [labeling](/usc/21/321.md?p=m) at the time of such receipt of such article; or (5) for having violated [section 331(i)(2) of this title](/usc/21/331.md?p=i-2) if such [person](/usc/21/321.md?p=e) acted in good faith and had no reason to believe that use of the punch, die, plate, stone, or other thing involved would result in a [drug](/usc/21/321.md?p=g-1) being a [counterfeit drug](/usc/21/321.md?p=g-2), or for having violated [section 331(i)(3) of this title](/usc/21/331.md?p=i-3) if the [person](/usc/21/321.md?p=e) doing the act or causing it to be done acted in good faith and had no reason to believe that the [drug](/usc/21/321.md?p=g-1) was a [counterfeit drug](/usc/21/321.md?p=g-2); or (6) for having violated [section 331(fff)(2) of this title](/usc/21/331.md?p=fff-2) if such [person](/usc/21/321.md?p=e) acted in good faith and had no reason to believe that use of the punch, die, plate, stone, or other thing involved would result in a [device](/usc/21/355–2.md?p=a-3) being a [counterfeit device](/usc/21/321.md?p=h-2), or for having violated [section 331(fff)(3) of this title](/usc/21/331.md?p=fff-3) if the [person](/usc/21/321.md?p=e) doing the act or causing it to be done acted in good faith and had no reason to believe that the [device](/usc/21/355–2.md?p=a-3) was a [counterfeit device](/usc/21/321.md?p=h-2). - (d) **Exceptions involving misbranded food—** No [person](/usc/21/321.md?p=e) shall be subject to the penalties of [subsection (a)(1)](#a-1) of this section for a violation of [section 331 of this title](/usc/21/331.md) involving [misbranded](/usc/21/1033.md?p=l) [food](/usc/21/321.md?p=f) if the violation exists solely because the [food](/usc/21/321.md?p=f) is [misbranded](/usc/21/1033.md?p=l) under [section 343(a)(2) of this title](/usc/21/343.md) because of its advertising. - (e) **Prohibited distribution of human growth hormone—** - (1) Except as provided in [paragraph (2)](#e-2), whoever [knowingly](/usc/21/321.md?p=bb) [distributes](/usc/21/360eee.md?p=5), or possesses with intent to [distribute](/usc/21/360eee.md?p=5), [human growth hormone](#e-4) for any use in humans other than the treatment of a disease or other recognized medical condition, where such use has been [authorized](/usc/21/360eee–1.md?p=a-6) by the [Secretary](/usc/21/321.md?p=d) of Health and Human Services under [section 355 of this title](/usc/21/355.md) and pursuant to the order of a physician, is guilty of an offense punishable by not more than 5 years in prison, such fines as are [authorized](/usc/21/360eee–1.md?p=a-6) by [title 18](/usc/18.md), or both. - (2) Whoever commits any offense set forth in [paragraph (1)](#e-1) and such offense involves an individual under 18 years of age is punishable by not more than 10 years imprisonment, such fines as are [authorized](/usc/21/360eee–1.md?p=a-6) by [title 18](/usc/18.md), or both. - (3) Any conviction for a violation of paragraphs (1) and (2) of this subsection shall be considered a felony violation of the Controlled Substances Act [[21 U.S.C. 801](/usc/21/801.md) et seq.] for the purposes of forfeiture under section 413 of such Act [[21 U.S.C. 853](/usc/21/853.md)]. - (4) As used in this subsection the term “human growth hormone” means somatrem, somatropin, or an analogue of either of them. - (5) The [Drug](/usc/21/321.md?p=g-1) Enforcement Administration is [authorized](/usc/21/360eee–1.md?p=a-6) to investigate offenses punishable by this subsection. - (f) **Violations related to devices—** - (1) - (A) Except as provided in [subparagraph (B)](#f-1-B), any [person](/usc/21/321.md?p=e) who violates a requirement of this chapter which relates to [devices](/usc/21/355–2.md?p=a-3) shall be liable to the United States for a civil penalty in an amount not to exceed $15,000 for each such violation, and not to exceed $1,000,000 for all such violations adjudicated in a single proceeding. For purposes of the preceding sentence, a [person](/usc/21/321.md?p=e) accredited under paragraph (2) of [section 374(g) of this title](/usc/21/374.md?p=g) who is substantially not in compliance with the standards of accreditation under such section, or who poses a threat to public health or fails to act in a manner that is consistent with the purposes of such section, shall be considered to have violated a requirement of this chapter that relates to [devices](/usc/21/355–2.md?p=a-3). - (B) [Subparagraph (A)](#f-1-A) shall not apply— - (i) to any [person](/usc/21/321.md?p=e) who violates the requirements of section [360i(a)](/usc/21/360i.md?p=a) or [360j(f)](/usc/21/360j.md?p=f) of this title unless such violation constitutes (I) a significant or knowing departure from such requirements, or (II) a risk to public health, - (ii) to any [person](/usc/21/321.md?p=e) who commits minor violations of section [360i(e)](/usc/21/360i.md?p=e) or [360i(g)](/usc/21/360i.md?p=g) of this title (only with respect to correction reports) if such [person](/usc/21/321.md?p=e) demonstrates substantial compliance with such section, or - (iii) to violations of [section 351(a)(2)(A) of this title](/usc/21/351.md) which involve one or more [devices](/usc/21/355–2.md?p=a-3) which are not defective. - (2) - (A) Any [person](/usc/21/321.md?p=e) who introduces into [interstate commerce](/usc/21/321.md?p=b) or delivers for introduction into [interstate commerce](/usc/21/321.md?p=b) an article of [food](/usc/21/321.md?p=f) that is adulterated within the meaning of [section 342(a)(2)(B) of this title](/usc/21/342.md) or any [person](/usc/21/321.md?p=e) who does not comply with a recall order under [section 350l](/usc/21/350l.md) of this title shall be subject to a civil money penalty of not more than $50,000 in the case of an individual and $250,000 in the case of any other [person](/usc/21/321.md?p=e) for such introduction or delivery, not to exceed $500,000 for all such violations adjudicated in a single proceeding. - (B) This paragraph shall not apply to any [person](/usc/21/321.md?p=e) who grew the article of [food](/usc/21/321.md?p=f) that is adulterated. If the [Secretary](/usc/21/321.md?p=d) assesses a civil penalty against any [person](/usc/21/321.md?p=e) under this paragraph, the [Secretary](/usc/21/321.md?p=d) may not use the criminal authorities under this section to sanction such [person](/usc/21/321.md?p=e) for the introduction or delivery for introduction into [interstate commerce](/usc/21/321.md?p=b) of the article of [food](/usc/21/321.md?p=f) that is adulterated. If the [Secretary](/usc/21/321.md?p=d) assesses a civil penalty against any [person](/usc/21/321.md?p=e) under this paragraph, the [Secretary](/usc/21/321.md?p=d) may not use the seizure authorities of [section 334 of this title](/usc/21/334.md) or the injunction authorities of [section 332 of this title](/usc/21/332.md) with respect to the article of [food](/usc/21/321.md?p=f) that is adulterated. - (C) In a hearing to assess a civil penalty under this paragraph, the presiding officer shall have the same authority with regard to compelling testimony or production of documents as a presiding officer has under [section 346a(g)(2)(B) of this title](/usc/21/346a.md?p=g-2-B). The third sentence of [paragraph (5)(A)](#f-5-A) shall not apply to any investigation under this paragraph. - (3) - (A) Any [person](/usc/21/321.md?p=e) who violates [section 331(jj) of this title](/usc/21/331.md?p=jj) shall be subject to a civil monetary penalty of not more than $10,000 for all violations adjudicated in a single proceeding. - (B) If a violation of [section 331(jj) of this title](/usc/21/331.md?p=jj) is not corrected within the 30-day period following notification under section 282(j)(5)(C)(ii)[^2] of [title 42](/usc/42.md), the [person](/usc/21/321.md?p=e) shall, in addition to any penalty under [subparagraph (A)](#f-3-A), be subject to a civil monetary penalty of not more than $10,000 for each day of the violation after such period until the violation is corrected. - (4) - (A) Any [responsible person](/usc/21/364.md?p=4) (as such term is used in [section 355–1 of this title](/usc/21/355–1.md)) that violates a requirement of section [355(o)](/usc/21/355.md?p=o), [355(p)](/usc/21/355.md?p=p), [355–1](/usc/21/355–1.md), or [355c](/usc/21/355c.md) of this title shall be subject to a civil monetary penalty of— - (i) not more than $250,000 per violation, and not to exceed $1,000,000 for all such violations adjudicated in a single proceeding; or - (ii) in the case of a violation that continues after the [Secretary](/usc/21/321.md?p=d) provides written notice to the [responsible person](/usc/21/364.md?p=4), the [responsible person](/usc/21/364.md?p=4) shall be subject to a civil monetary penalty of $250,000 for the first 30-day period (or any portion thereof) that the [responsible person](/usc/21/364.md?p=4) continues to be in violation, and such amount shall double for every 30-day period thereafter that the violation continues, not to exceed $1,000,000 for any 30-day period, and not to exceed $10,000,000 for all such violations adjudicated in a single proceeding. - (B) In determining the amount of a civil penalty under [subparagraph (A)(ii)](#f-4-A-ii), the [Secretary](/usc/21/321.md?p=d) shall take into consideration whether the [responsible person](/usc/21/364.md?p=4) is making efforts toward correcting the violation of the requirement of section [355(o)](/usc/21/355.md?p=o), [355(p)](/usc/21/355.md?p=p), or [355–1](/usc/21/355–1.md) of this title for which the [responsible person](/usc/21/364.md?p=4) is subject to such civil penalty. - (5) - (A) A civil penalty under paragraph [(1)](#f-1), [(2)](#f-2), [(3)](#f-3), [(4)](#f-4), or [(9)](#f-9) shall be assessed, or a no-tobacco-sale order may be imposed, by the [Secretary](/usc/21/321.md?p=d) by an order made on the record after opportunity for a hearing provided in accordance with this subparagraph and [section 554 of title 5](/usc/5/554.md). Before issuing such an order, the [Secretary](/usc/21/321.md?p=d) shall give written notice to the [person](/usc/21/321.md?p=e) to be assessed a civil penalty, or upon whom a no-tobacco-sale order is to be imposed, under such order of the [Secretary](/usc/21/321.md?p=d)’s proposal to issue such order and provide such [person](/usc/21/321.md?p=e) an opportunity for a hearing on the order. In the course of any investigation, the [Secretary](/usc/21/321.md?p=d) may issue subpoenas requiring the attendance and testimony of witnesses and the production of evidence that relates to the matter under investigation. - (B) In determining the amount of a civil penalty, or the period to be covered by a no-tobacco-sale order, the [Secretary](/usc/21/321.md?p=d) shall take into account the nature, circumstances, extent, and gravity of the violation or violations and, with respect to the violator, ability to pay, effect on ability to continue to do business, any history of prior such violations, the degree of culpability, and such other matters as justice may require. A no-tobacco-sale order permanently prohibiting an individual retail outlet from selling [tobacco products](/usc/21/321.md?p=rr-1) shall include provisions that allow the outlet, after a specified period of time, to request that the [Secretary](/usc/21/321.md?p=d) compromise, modify, or terminate the order. - (C) The [Secretary](/usc/21/321.md?p=d) may compromise, modify, or remit, with or without conditions, any civil penalty which may be assessed under paragraph [(1)](#f-1), [(2)](#f-2), [(3)](#f-3), [(4)](#f-4), or [(9)](#f-9). The amount of such penalty, when finally determined, or the amount agreed upon in compromise, may be deducted from any sums owing by the United States to the [person](/usc/21/321.md?p=e) charged. - (D) The [Secretary](/usc/21/321.md?p=d) may compromise, modify, or terminate, with or without conditions, any no-tobacco-sale order. - (6) Any [person](/usc/21/321.md?p=e) who requested, in accordance with [paragraph (5)(A)](#f-5-A), a hearing respecting the assessment of a civil penalty or the imposition of a no-tobacco-sale order and who is aggrieved by an order assessing a civil penalty or the imposition of a no-tobacco-sale order may file a petition for judicial review of such order with the United States Court of Appeals for the District of Columbia Circuit or for any other circuit in which such [person](/usc/21/321.md?p=e) resides or transacts business. Such a petition may only be filed within the 60-day period beginning on the date the order making such assessment was issued, or on which the no-tobacco-sale order was imposed, as the case may be. - (7) If any [person](/usc/21/321.md?p=e) fails to pay an assessment of a civil penalty— - (A) after the order making the assessment becomes final, and if such [person](/usc/21/321.md?p=e) does not file a petition for judicial review of the order in accordance with [paragraph (6)](#f-6), or - (B) after a court in an action brought under [paragraph (6)](#f-6) has entered a final judgment in favor of the [Secretary](/usc/21/321.md?p=d), the Attorney General shall recover the amount assessed (plus interest at currently prevailing rates from the date of the expiration of the 60-day period referred to in [paragraph (6)](#f-6) or the date of such final judgment, as the case may be) in an action brought in any appropriate district court of the United States. In such an action, the validity, amount, and appropriateness of such penalty shall not be subject to review. - (8) If the [Secretary](/usc/21/321.md?p=d) finds that a [person](/usc/21/321.md?p=e) has committed repeated violations of [section 387f(d)(5) of this title](/usc/21/387f.md?p=d-5) or of restrictions promulgated under [section 387f(d) of this title](/usc/21/387f.md?p=d) at a particular retail outlet then the [Secretary](/usc/21/321.md?p=d) may impose a no-tobacco-sale order on that [person](/usc/21/321.md?p=e) prohibiting the sale of [tobacco products](/usc/21/321.md?p=rr-1) in that outlet. A no-tobacco-sale order may be imposed with a civil penalty under [paragraph (1)](#f-1). Prior to the entry of a no-sale order under this paragraph, a [person](/usc/21/321.md?p=e) shall be entitled to a hearing pursuant to the procedures established through regulations of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration for assessing civil money penalties, including at a retailer’s request a hearing by telephone, or at the nearest regional or field [office](/usc/21/1701.md?p=14) of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration, or at a Federal, [State](/usc/21/321.md?p=a-1), or county [facility](/usc/21/350g.md?p=o-2) within 100 miles from the location of the retail outlet, if such a [facility](/usc/21/350g.md?p=o-2) is available. - (9) **Civil Monetary Penalties for Violation of Tobacco Product Requirements.—** - (A) **In general.—** Subject to [subparagraph (B)](#f-9-B), any [person](/usc/21/321.md?p=e) who violates a requirement of this chapter which relates to [tobacco products](/usc/21/321.md?p=rr-1) shall be liable to the United States for a civil penalty in an amount not to exceed $15,000 for each such violation, and not to exceed $1,000,000 for all such violations adjudicated in a single proceeding. - (B) **Enhanced penalties.—** - (i) Any [person](/usc/21/321.md?p=e) who intentionally violates a requirement of section [387b(5)](/usc/21/387b.md?p=5), [387b(6)](/usc/21/387b.md?p=6), [387d](/usc/21/387d.md), [387h(c)](/usc/21/387h.md?p=c), or [387k(a)](/usc/21/387k.md?p=a) of this title, shall be subject to a civil monetary penalty of— - (I) not to exceed $250,000 per violation, and not to exceed $1,000,000 for all such violations adjudicated in a single proceeding; or - (II) in the case of a violation that continues after the [Secretary](/usc/21/321.md?p=d) provides written notice to such [person](/usc/21/321.md?p=e), $250,000 for the first 30-day period (or any portion thereof) that the [person](/usc/21/321.md?p=e) continues to be in violation, and such amount shall double for every 30-day period thereafter that the violation continues, not to exceed $1,000,000 for any 30-day period, and not to exceed $10,000,000 for all such violations adjudicated in a single proceeding. - (ii) Any [person](/usc/21/321.md?p=e) who violates a requirement of section [387k(g)(2)(C)(ii)](/usc/21/387k.md?p=g-2-C-ii) or [387k(i)(1)](/usc/21/387k.md?p=i-1) of this title, shall be subject to a civil monetary penalty of— - (I) not to exceed $250,000 per violation, and not to exceed $1,000,000 for all such violations adjudicated in a single proceeding; or - (II) in the case of a violation that continues after the [Secretary](/usc/21/321.md?p=d) provides written notice to such [person](/usc/21/321.md?p=e), $250,000 for the first 30-day period (or any portion thereof) that the [person](/usc/21/321.md?p=e) continues to be in violation, and such amount shall double for every 30-day period thereafter that the violation continues, not to exceed $1,000,000 for any 30-day period, and not to exceed $10,000,000 for all such violations adjudicated in a single proceeding. - (iii) In determining the amount of a civil penalty under clause [(i)(II)](#f-9-B-i-II) or [(ii)(II)](#f-9-B-ii-II), the [Secretary](/usc/21/321.md?p=d) shall take into consideration whether the [person](/usc/21/321.md?p=e) is making efforts toward correcting the violation of the requirements of the section for which such [person](/usc/21/321.md?p=e) is subject to such civil penalty. - (g) **Violations regarding direct-to-consumer advertising—** - (1) With respect to a [person](/usc/21/321.md?p=e) who is a holder of an approved application under [section 355 of this title](/usc/21/355.md) for a [drug](/usc/21/321.md?p=g-1) subject to [section 353(b) of this title](/usc/21/353.md?p=b) or under [section 262 of title 42](/usc/42/262.md), any such [person](/usc/21/321.md?p=e) who disseminates or causes another party to disseminate a direct-to-consumer advertisement that is false or misleading shall be liable to the United States for a civil penalty in an amount not to exceed $250,000 for the first such violation in any 3-year period, and not to exceed $500,000 for each subsequent violation in any 3-year period. No other civil monetary penalties in this chapter (including the civil penalty in [subsection (f)(4)](#f-4)) shall apply to a violation regarding direct-to-consumer advertising. For purposes of this paragraph: (A) Repeated dissemination of the same or similar advertisement prior to the receipt of the written notice referred to in [paragraph (2)](#g-2) for such advertisements shall be considered one violation. (B) On and after the date of the receipt of such a notice, all violations under this paragraph occurring in a single day shall be considered one violation. With respect to advertisements that appear in magazines or other publications that are published less frequently than daily, each issue date (whether weekly or monthly) shall be treated as a single day for the purpose of calculating the number of violations under this paragraph. - (2) A civil penalty under [paragraph (1)](#g-1) shall be assessed by the [Secretary](/usc/21/321.md?p=d) by an order made on the record after providing written notice to the [person](/usc/21/321.md?p=e) to be assessed a civil penalty and an opportunity for a hearing in accordance with this paragraph and [section 554 of title 5](/usc/5/554.md). If upon receipt of the written notice, the [person](/usc/21/321.md?p=e) to be assessed a civil penalty objects and requests a hearing, then in the course of any investigation related to such hearing, the [Secretary](/usc/21/321.md?p=d) may issue subpoenas requiring the attendance and testimony of witnesses and the production of evidence that relates to the matter under investigation, including information pertaining to the factors described in [paragraph (3)](#g-3). - (3) The [Secretary](/usc/21/321.md?p=d), in determining the amount of the civil penalty under [paragraph (1)](#g-1), shall take into account the nature, circumstances, extent, and gravity of the violation or violations, including the following factors: - (A) Whether the [person](/usc/21/321.md?p=e) submitted the advertisement or a similar advertisement for review under [section 379h–1 of this title](/usc/21/379h–1.md). - (B) Whether the [person](/usc/21/321.md?p=e) submitted the advertisement for review if required under [section 353c](/usc/21/353c.md)[^2] of this title. - (C) Whether, after submission of the advertisement as described in subparagraph [(A)](#g-3-A) or [(B)](#g-3-B), the [person](/usc/21/321.md?p=e) disseminated or caused another party to disseminate the advertisement before the end of the 45-day comment period. - (D) Whether the [person](/usc/21/321.md?p=e) incorporated any comments made by the [Secretary](/usc/21/321.md?p=d) with regard to the advertisement into the advertisement prior to its dissemination. - (E) Whether the [person](/usc/21/321.md?p=e) ceased [distribution](/usc/21/360eee.md?p=5) of the advertisement upon receipt of the written notice referred to in [paragraph (2)](#g-2) for such advertisement. - (F) Whether the [person](/usc/21/321.md?p=e) had the advertisement reviewed by [qualified](/usc/21/357.md?p=e-7) medical, regulatory, and legal reviewers prior to its dissemination. - (G) Whether the violations were material. - (H) Whether the [person](/usc/21/321.md?p=e) who created the advertisement or caused the advertisement to be created acted in good faith. - (I) Whether the [person](/usc/21/321.md?p=e) who created the advertisement or caused the advertisement to be created has been assessed a civil penalty under this provision within the previous 1-year period. - (J) The scope and extent of any voluntary, subsequent remedial action by the [person](/usc/21/321.md?p=e). - (K) Such other matters, as justice may require. - (4) - (A) Subject to [subparagraph (B)](#g-4-B), no [person](/usc/21/321.md?p=e) shall be required to pay a civil penalty under [paragraph (1)](#g-1) if the [person](/usc/21/321.md?p=e) submitted the advertisement to the [Secretary](/usc/21/321.md?p=d) and disseminated or caused another party to disseminate such advertisement after incorporating each comment received from the [Secretary](/usc/21/321.md?p=d). - (B) The [Secretary](/usc/21/321.md?p=d) may retract or modify any prior comments the [Secretary](/usc/21/321.md?p=d) has provided to an advertisement submitted to the [Secretary](/usc/21/321.md?p=d) based on new information or changed circumstances, so long as the [Secretary](/usc/21/321.md?p=d) provides written notice to the [person](/usc/21/321.md?p=e) of the new views of the [Secretary](/usc/21/321.md?p=d) on the advertisement and provides a reasonable time for modification or correction of the advertisement prior to seeking any civil penalty under [paragraph (1)](#g-1). - (5) The [Secretary](/usc/21/321.md?p=d) may compromise, modify, or remit, with or without conditions, any civil penalty which may be assessed under [paragraph (1)](#g-1). The amount of such penalty, when finally determined, or the amount charged upon in compromise, may be deducted from any sums owed by the United States to the [person](/usc/21/321.md?p=e) charged. - (6) Any [person](/usc/21/321.md?p=e) who requested, in accordance with [paragraph (2)](#g-2), a hearing with respect to the assessment of a civil penalty and who is aggrieved by an order assessing a civil penalty, may file a petition for de novo judicial review of such order with the United States Court of Appeals for the District of Columbia Circuit or for any other circuit in which such [person](/usc/21/321.md?p=e) resides or transacts business. Such a petition may only be filed within the 60-day period beginning on the date the order making such assessments was issued. - (7) If any [person](/usc/21/321.md?p=e) fails to pay an assessment of a civil penalty under [paragraph (1)](#g-1)— - (A) after the order making the assessment becomes final, and if such [person](/usc/21/321.md?p=e) does not file a petition for judicial review of the order in accordance with [paragraph (6)](#g-6), or - (B) after a court in an action brought under [paragraph (6)](#g-6) has entered a final judgment in favor of the [Secretary](/usc/21/321.md?p=d), the Attorney General of the United States shall recover the amount assessed (plus interest at currently prevailing rates from the date of the expiration of the 60-day period referred to in [paragraph (6)](#g-6) or the date of such final judgment, as the case may be) in an action brought in any appropriate district court of the United States. In such an action, the validity, amount, and appropriateness of such penalty shall not be subject to review. # [§333a. Repealed. Pub. L. 101–647, title XIX, § 1905, Nov. 29, 1990, 104 Stat. 4853 — repealed] # §334. Seizure - (a) **Grounds and jurisdiction—** - (1) Any article of [food](/usc/21/321.md?p=f), [drug](/usc/21/321.md?p=g-1), or [cosmetic](/usc/21/321.md?p=i) that is adulterated or [misbranded](/usc/21/1033.md?p=l) when introduced into or while in [interstate commerce](/usc/21/321.md?p=b) or while held for sale (whether or not the first sale) after shipment in [interstate commerce](/usc/21/321.md?p=b), or which may not, under the provisions of section [331(ll)](/usc/21/331.md?p=ll), [344](/usc/21/344.md), or [355](/usc/21/355.md) of this title, be introduced into [interstate commerce](/usc/21/321.md?p=b), shall be liable to be proceeded against while in [interstate commerce](/usc/21/321.md?p=b), or at any time thereafter, on libel of information and condemned in any district court of the United States or United States court of a [Territory](/usc/21/321.md?p=a-2) within the jurisdiction of which the article is found. No libel for condemnation shall be instituted under this chapter, for any alleged misbranding if there is pending in any court a libel for condemnation proceeding under this chapter based upon the same alleged misbranding, and not more than one such proceeding shall be instituted if no such proceeding is so pending, except that such limitations shall not apply (A) when such misbranding has been the basis of a prior judgment in favor of the United States, in a criminal, injunction, or libel for condemnation proceeding under this chapter, or (B) when the [Secretary](/usc/21/321.md?p=d) has probable cause to believe from facts found, without hearing, by him or any officer or employee of the [Department](/usc/21/321.md?p=c) that the [misbranded](/usc/21/1033.md?p=l) article is dangerous to health, or that the [labeling](/usc/21/321.md?p=m) of the [misbranded](/usc/21/1033.md?p=l) article is fraudulent, or would be in a material respect misleading to the injury or damage of the purchaser or consumer. In any case where the number of libel for condemnation proceedings is limited as above provided the proceeding pending or instituted shall, on application of the claimant, seasonably made, be removed for trial to any district agreed upon by stipulation between the parties, or, in case of failure to so stipulate within a reasonable time, the claimant may apply to the court of the district in which the seizure has been made, and such court (after giving the United States attorney for such district reasonable notice and opportunity to be heard) shall by order, unless good cause to the contrary is shown, specify a district of reasonable proximity to the claimant’s principal place of business, to which the case shall be removed for trial. - (2) The following shall be liable to be proceeded against at any time on libel of information and condemned in any district court of the United States or United States court of a [Territory](/usc/21/321.md?p=a-2) within the jurisdiction of which they are found: (A) Any [drug](/usc/21/321.md?p=g-1) that is a [counterfeit drug](/usc/21/321.md?p=g-2), (B) Any container of a [counterfeit drug](/usc/21/321.md?p=g-2), (C) Any punch, die, plate, stone, [labeling](/usc/21/321.md?p=m), container, or other thing used or designed for use in making a [counterfeit drug](/usc/21/321.md?p=g-2) or [drugs](/usc/21/321.md?p=g-1), (D) Any adulterated or [misbranded](/usc/21/1033.md?p=l) [device](/usc/21/355–2.md?p=a-3), (E) Any adulterated or [misbranded](/usc/21/1033.md?p=l) [tobacco product](/usc/21/321.md?p=rr-1), (F) Any [device](/usc/21/355–2.md?p=a-3) that is a [counterfeit device](/usc/21/321.md?p=h-2), (G) Any container, packaging, or [labeling](/usc/21/321.md?p=m) of a [counterfeit device](/usc/21/321.md?p=h-2), and (H) Any punch, die, plate, stone, [labeling](/usc/21/321.md?p=m), container, or other thing used or designed for use in making a [counterfeit device](/usc/21/321.md?p=h-2) or [devices](/usc/21/355–2.md?p=a-3). - (3) - (A) Except as provided in [subparagraph (B)](#a-3-B), no libel for condemnation may be instituted under paragraph [(1)](#a-1) or [(2)](#a-2) against any [food](/usc/21/321.md?p=f) which— - (i) is [misbranded](/usc/21/1033.md?p=l) under [section 343(a)(2) of this title](/usc/21/343.md) because of its advertising, and - (ii) is being held for sale to the ultimate consumer in an establishment other than an establishment owned or operated by a manufacturer, packer, or distributor of the [food](/usc/21/321.md?p=f). - (B) A libel for condemnation may be instituted under paragraph [(1)](#a-1) or [(2)](#a-2) against a [food](/usc/21/321.md?p=f) described in [subparagraph (A)](#a-3-A) if— - (i) - (I) the [food](/usc/21/321.md?p=f)’s advertising which resulted in the [food](/usc/21/321.md?p=f) being [misbranded](/usc/21/1033.md?p=l) under [section 343(a)(2) of this title](/usc/21/343.md) was disseminated in the establishment in which the [food](/usc/21/321.md?p=f) is being held for sale to the ultimate consumer, - (II) such advertising was disseminated by, or under the direction of, the owner or operator of such establishment, or - (III) all or part of the cost of such advertising was paid by such owner or operator; and - (ii) the owner or operator of such establishment used such advertising in the establishment to promote the sale of the [food](/usc/21/321.md?p=f). - (b) **Procedure; multiplicity of pending proceedings—** The article, equipment, or other thing proceeded against shall be liable to seizure by process pursuant to the libel, and the procedure in cases under this section shall conform, as nearly as may be, to the procedure in admiralty; except that on demand of either party any issue of fact joined in any such case shall be tried by jury. When libel for condemnation proceedings under this section, involving the same claimant and the same issues of adulteration or misbranding, are pending in two or more jurisdictions, such pending proceedings, upon application of the claimant seasonably made to the court of one such jurisdiction, shall be consolidated for trial by order of such court, and tried in (1) any district selected by the claimant where one of such proceedings is pending; or (2) a district agreed upon by stipulation between the parties. If no order for consolidation is so made within a reasonable time, the claimant may apply to the court of one such jurisdiction and such court (after giving the United States attorney for such district reasonable notice and opportunity to be heard) shall by order, unless good cause to the contrary is shown, specify a district of reasonable proximity to the claimant’s principal place of business, in which all such pending proceedings shall be consolidated for trial and tried. Such order of consolidation shall not apply so as to require the removal of any case the date for trial of which has been fixed. The court granting such order shall give prompt notification thereof to the other courts having jurisdiction of the cases covered thereby. - (c) **Availability of samples of seized goods prior to trial—** The court at any time after seizure up to a reasonable time before trial shall by order allow any party to a condemnation proceeding, his attorney or agent, to obtain a representative sample of the article seized and a true copy of the analysis, if any, on which the proceeding is based and the identifying marks or numbers, if any, of the packages from which the samples analyzed were obtained. - (d) **Disposition of goods after decree of condemnation; claims for remission or mitigation of forfeitures—** - (1) Any [food](/usc/21/321.md?p=f), [drug](/usc/21/321.md?p=g-1), [device](/usc/21/355–2.md?p=a-3), [tobacco product](/usc/21/321.md?p=rr-1), or [cosmetic](/usc/21/321.md?p=i) condemned under this section shall, after entry of the decree, be disposed of by destruction or sale as the court may, in accordance with the provisions of this section, direct and the proceeds thereof, if sold, less the legal costs and charges, shall be paid into the Treasury of the United States; but such article shall not be sold under such decree contrary to the provisions of this chapter or the laws of the jurisdiction in which sold. After entry of the decree and upon the payment of the costs of such proceedings and the execution of a good and sufficient bond conditioned that such article shall not be sold or disposed of contrary to the provisions of this chapter or the laws of any [State](/usc/21/321.md?p=a-1) or [Territory](/usc/21/321.md?p=a-2) in which sold, the court may by order direct that such article be delivered to the owner thereof to be destroyed or brought into compliance with the provisions of this chapter, under the supervision of an officer or employee duly designated by the [Secretary](/usc/21/321.md?p=d), and the expenses of such supervision shall be paid by the [person](/usc/21/321.md?p=e) obtaining release of the article under bond. If the article was imported into the United States and the [person](/usc/21/321.md?p=e) seeking its release establishes (A) that the adulteration, misbranding, or violation did not occur after the article was imported, and (B) that he had no cause for believing that it was adulterated, [misbranded](/usc/21/1033.md?p=l), or in violation before it was released from customs custody, the court may permit the article to be delivered to the owner for exportation in lieu of destruction upon a showing by the owner that all of the conditions of [section 381(e) of this title](/usc/21/381.md?p=e) can and will be met. The provisions of this sentence shall not apply where condemnation is based upon violation of section [342(a)(1)](/usc/21/342.md?p=a-1), [(2)](/usc/21/342.md), or [(6)](/usc/21/342.md), [section 351(a)(3)](/usc/21/351.md), [section 352(j)](/usc/21/352.md?p=j), or section [361(a)](/usc/21/361.md?p=a) or [(d)](/usc/21/361.md?p=d) of this title. Where such exportation is made to the original foreign supplier, then subparagraphs (A) and (B) of [section 381(e)(1) of this title](/usc/21/381.md?p=e-1) and the preceding sentence shall not be applicable; and in all cases of exportation the bond shall be conditioned that the article shall not be sold or disposed of until the applicable conditions of [section 381(e) of this title](/usc/21/381.md?p=e) have been met. Any [person](/usc/21/321.md?p=e) seeking to export an imported article pursuant to any of the provisions of this subsection shall establish that the article was intended for export at the time the article entered commerce. Any article condemned by reason of its being an article which may not, under section [344](/usc/21/344.md) or [355](/usc/21/355.md) of this title, be introduced into [interstate commerce](/usc/21/321.md?p=b), shall be disposed of by destruction. - (2) The provisions of paragraph (1) of this subsection shall, to the extent deemed appropriate by the court, apply to any equipment or other thing which is not otherwise within the scope of such paragraph and which is referred to in [paragraph (2)](#a-2) of subsection (a). - (3) Whenever in any proceeding under this section, involving [paragraph (2)](#a-2) of subsection (a), the condemnation of any equipment or thing (other than a [drug](/usc/21/321.md?p=g-1)) is decreed, the court shall allow the claim of any claimant, to the extent of such claimant’s interest, for remission or mitigation of such forfeiture if such claimant proves to the satisfaction of the court (i) that he has not committed or caused to be committed any prohibited act referred to in such [paragraph (2)](#d-2) and has no interest in any [drug](/usc/21/321.md?p=g-1) referred to therein, (ii) that he has an interest in such equipment or other thing as owner or lienor or otherwise, acquired by him in good faith, and (iii) that he at no time had any knowledge or reason to believe that such equipment or other thing was being or would be used in, or to facilitate, the violation of laws of the United States relating to [counterfeit drugs](/usc/21/321.md?p=g-2). - (e) **Costs—** When a decree of condemnation is entered against the article, court costs and fees, and storage and other proper expenses, shall be awarded against the [person](/usc/21/321.md?p=e), if any, intervening as claimant of the article. - (f) **Removal of case for trial—** In the case of removal for trial of any case as provided by subsection [(a)](#a) or [(b)](#b)— - (1) The clerk of the court from which removal is made shall promptly transmit to the court in which the case is to be tried all records in the case necessary in order that such court may exercise jurisdiction. - (2) The court to which such case was removed shall have the powers and be subject to the duties, for purposes of such case, which the court from which removal was made would have had, or to which such court would have been subject, if such case had not been removed. - (g) **Administrative restraint; detention orders—** - (1) If during an inspection conducted under [section 374 of this title](/usc/21/374.md) of a [facility](/usc/21/350g.md?p=o-2) or a vehicle, a [device](/usc/21/355–2.md?p=a-3), [drug](/usc/21/321.md?p=g-1), or [tobacco product](/usc/21/321.md?p=rr-1) which the officer or employee making the inspection has reason to believe is adulterated or [misbranded](/usc/21/1033.md?p=l) is found in such [facility](/usc/21/350g.md?p=o-2) or vehicle, such officer or employee may order the [device](/usc/21/355–2.md?p=a-3), [drug](/usc/21/321.md?p=g-1), or [tobacco product](/usc/21/321.md?p=rr-1) detained (in accordance with regulations prescribed by the [Secretary](/usc/21/321.md?p=d)) for a reasonable period which may not exceed twenty days unless the [Secretary](/usc/21/321.md?p=d) determines that a period of detention greater than twenty days is required to institute an action under [subsection (a)](#a) or [section 332 of this title](/usc/21/332.md), in which case he may authorize a detention period of not to exceed thirty days. Regulations of the [Secretary](/usc/21/321.md?p=d) prescribed under this paragraph shall require that before a [device](/usc/21/355–2.md?p=a-3), [drug](/usc/21/321.md?p=g-1), or [tobacco product](/usc/21/321.md?p=rr-1) may be ordered detained under this paragraph the [Secretary](/usc/21/321.md?p=d) or an officer or employee designated by the [Secretary](/usc/21/321.md?p=d) approve such order. A detention order under this paragraph may require the [labeling](/usc/21/321.md?p=m) or marking of a [device](/usc/21/355–2.md?p=a-3), [drug](/usc/21/321.md?p=g-1), or [tobacco product](/usc/21/321.md?p=rr-1) during the period of its detention for the purpose of identifying the [device](/usc/21/355–2.md?p=a-3), [drug](/usc/21/321.md?p=g-1), or [tobacco product](/usc/21/321.md?p=rr-1) as detained. Any [person](/usc/21/321.md?p=e) who would be entitled to claim a [device](/usc/21/355–2.md?p=a-3), [drug](/usc/21/321.md?p=g-1), or [tobacco product](/usc/21/321.md?p=rr-1) if it were seized under [subsection (a)](#a) may appeal to the [Secretary](/usc/21/321.md?p=d) a detention of such [device](/usc/21/355–2.md?p=a-3), [drug](/usc/21/321.md?p=g-1), or [tobacco product](/usc/21/321.md?p=rr-1) under this paragraph. Within five days of the date an appeal of a detention is filed with the [Secretary](/usc/21/321.md?p=d), the [Secretary](/usc/21/321.md?p=d) shall after affording opportunity for an [informal hearing](/usc/21/321.md?p=x) by order confirm the detention or revoke it. - (2) - (A) Except as [authorized](/usc/21/360eee–1.md?p=a-6) by [subparagraph (B)](#g-2-B), a [device](/usc/21/355–2.md?p=a-3), [drug](/usc/21/321.md?p=g-1), or [tobacco product](/usc/21/321.md?p=rr-1) subject to a detention order issued under [paragraph (1)](#g-1) shall not be moved by any [person](/usc/21/321.md?p=e) from the place at which it is ordered detained until— - (i) released by the [Secretary](/usc/21/321.md?p=d), or - (ii) the expiration of the detention period applicable to such order, whichever occurs first. - (B) A [device](/usc/21/355–2.md?p=a-3) or [drug](/usc/21/321.md?p=g-1) subject to a detention order under [paragraph (1)](#g-1) may be moved— - (i) in accordance with regulations prescribed by the [Secretary](/usc/21/321.md?p=d), and - (ii) if not in final form for shipment, at the discretion of the manufacturer of the [device](/usc/21/355–2.md?p=a-3) or [drug](/usc/21/321.md?p=g-1) for the purpose of completing the work required to put it in such form. - (h) **Administrative detention of foods—** - (1) **Detention authority—** - (A) **In general—** An officer or [qualified](/usc/21/357.md?p=e-7) employee of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration may order the detention, in accordance with this subsection, of any article of [food](/usc/21/321.md?p=f) that is found during an inspection, examination, or investigation under this chapter conducted by such officer or [qualified](/usc/21/357.md?p=e-7) employee, if the officer or [qualified](/usc/21/357.md?p=e-7) employee has reason to believe that such article is adulterated or [misbranded](/usc/21/1033.md?p=l). - (B) **Secretary’s approval—** An article of [food](/usc/21/321.md?p=f) may be ordered detained under [subparagraph (A)](#h-1-A) only if the [Secretary](/usc/21/321.md?p=d) or an official designated by the [Secretary](/usc/21/321.md?p=d) approves the order. An official may not be so designated unless the official is the director of the district under this chapter in which the article involved is located, or is an official senior to such director. - (2) **Period of detention—** An article of [food](/usc/21/321.md?p=f) may be detained under [paragraph (1)](#h-1) for a reasonable period, not to exceed 20 days, unless a greater period, not to exceed 30 days, is necessary, to enable the [Secretary](/usc/21/321.md?p=d) to institute an action under [subsection (a)](#a) or [section 332 of this title](/usc/21/332.md). The [Secretary](/usc/21/321.md?p=d) shall by regulation provide for procedures for instituting such action on an expedited basis with respect to perishable [foods](/usc/21/321.md?p=f). - (3) **Security of detained article—** An order under [paragraph (1)](#h-1) with respect to an article of [food](/usc/21/321.md?p=f) may require that such article be labeled or marked as detained, and shall require that the article be removed to a secure [facility](/usc/21/350g.md?p=o-2), as appropriate. An article subject to such an order shall not be transferred by any [person](/usc/21/321.md?p=e) from the place at which the article is ordered detained, or from the place to which the article is so removed, as the case may be, until released by the [Secretary](/usc/21/321.md?p=d) or until the expiration of the detention period applicable under such order, whichever occurs first. This subsection may not be construed as authorizing the delivery of the article pursuant to the execution of a bond while the article is subject to the order, and [section 381(b) of this title](/usc/21/381.md?p=b) does not authorize the delivery of the article pursuant to the execution of a bond while the article is subject to the order. - (4) **Appeal of detention order—** - (A) **In general—** With respect to an article of [food](/usc/21/321.md?p=f) ordered detained under [paragraph (1)](#h-1), any [person](/usc/21/321.md?p=e) who would be entitled to be a claimant for such article if the article were seized under [subsection (a)](#a) may appeal the order to the [Secretary](/usc/21/321.md?p=d). Within five days after such an appeal is filed, the [Secretary](/usc/21/321.md?p=d), after providing opportunity for an [informal hearing](/usc/21/321.md?p=x), shall confirm or terminate the order involved, and such confirmation by the [Secretary](/usc/21/321.md?p=d) shall be considered a final agency action for purposes of [section 702 of title 5](/usc/5/702.md). If during such five-day period the [Secretary](/usc/21/321.md?p=d) fails to provide such an opportunity, or to confirm or terminate such order, the order is deemed to be terminated. - (B) **Effect of instituting court action—** The process under [subparagraph (A)](#h-4-A) for the appeal of an order under [paragraph (1)](#h-1) terminates if the [Secretary](/usc/21/321.md?p=d) institutes an action under [subsection (a)](#a) or [section 332 of this title](/usc/21/332.md) regarding the article of [food](/usc/21/321.md?p=f) involved. - (i) **Procedures for promulgating regulations—** - (1) **In general—** In promulgating a regulation implementing this section, the [Secretary](/usc/21/321.md?p=d) shall— - (A) issue a notice of proposed rulemaking that includes the proposed regulation; - (B) provide a period of not less than 60 days for comments on the proposed regulation; and - (C) publish the final regulation not less than 30 days before the regulation’s effective date. - (2) **Restrictions—** Notwithstanding any other provision of Federal law, in implementing this section, the [Secretary](/usc/21/321.md?p=d) shall only promulgate regulations as described in [paragraph (1)](#i-1).