21 U.S.C. § 333 — Penalties

Page 56 TITLE 21—FOOD AND DRUGS § 332 1 So in original. Probably should be followed by a comma. 1 So in original. Words ‘‘of this section’’ probably should not appear. restrictions under such section 301(ddd) that have begun to apply under subsection (b) [set out as a note above].’’ Executive Documents TRANSFER OF FUNCTIONS For transfer of functions of Federal Security Admin- istrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title. § 332. Injunction proceedings (a) Jurisdiction of courts The district courts of the United States and the United States courts of the Territories shall have jurisdiction, for cause shown 1 to restrain violations of section 331 of this title, except paragraphs (h), (i), and (j). (b) Violation of injunction In case of violation of an injunction or re- straining order issued under this section, which also constitutes a violation of this chapter, trial shall be by the court, or, upon demand of the ac- cused, by a jury. (June 25, 1938, ch. 675, § 302, 52 Stat. 1043; Pub. L. 87–781, title I, § 103(d), title II, § 201(c), Oct. 10, 1962, 76 Stat. 784, 793; Pub. L. 103–80, § 3(d), Aug. 13, 1993, 107 Stat. 775.) Editorial Notes AMENDMENTS 1993—Subsec. (a). Pub. L. 103–80, § 3(d)(1), struck out ‘‘, and subject to the provisions of section 17 (relating to notice to opposite party) of the Act entitled ‘An Act to supplement existing laws against unlawful restraints and monopolies, and for other purposes’, approved Oc- tober 15, 1914, as amended (U.S.C., 1934 ed., title 28, sec. 381),’’ after ‘‘for cause shown’’. Subsec. (b). Pub. L. 103–80, § 3(d)(2), struck out at end ‘‘Such trial shall be conducted in accordance with the practice and procedure applicable in the case of pro- ceedings subject to the provisions of section 22 of such Act of October 15, 1914, as amended (U.S.C., 1934 ed., title 28, sec. 387).’’ 1962—Subsec. (a). Pub. L. 87–781, § 103(d), struck out ‘‘(e),’’ after ‘‘paragraphs’’. Pub. L. 87–781, § 201(c), struck out ‘‘(f),’’ after ‘‘para- graphs’’. Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 1962 AMENDMENT Amendment by section 103(c) of Pub. L. 87–781 effec- tive on first day of seventh calendar month following October 1962, see section 107 of Pub. L. 87–781, set out as a note under section 321 of this title. Pub. L. 87–781, title II, § 203, Oct. 10, 1962, 76 Stat. 793, provided that: ‘‘The amendments made by this title [amending this section and section 374 of this title and enacting provisions set out as notes under sections 321 and 374 of this title] shall take effect on the date of en- actment of this Act [Oct. 10, 1962].’’ § 333. Penalties (a) Violation of section 331 of this title; second violation; intent to defraud or mislead (1) Any person who violates a provision of sec- tion 331 of this title shall be imprisoned for not more than one year or fined not more than $1,000, or both. (2) Notwithstanding the provisions of para- graph (1) of this section,1 if any person commits such a violation after a conviction of him under this section has become final, or commits such a violation with the intent to defraud or mis- lead, such person shall be imprisoned for not more than three years or fined not more than $10,000, or both. (b) Prescription drug marketing violations (1) Notwithstanding subsection (a), any person who violates section 331(t) of this title by— (A) knowingly importing a drug in violation of section 381(d)(1) of this title, (B) knowingly selling, purchasing, or trading a drug or drug sample or knowingly offering to sell, purchase, or trade a drug or drug sample, in violation of section 353(c)(1) of this title, (C) knowingly selling, purchasing, or trading a coupon, knowingly offering to sell, purchase, or trade such a coupon, or knowingly counter- feiting such a coupon, in violation of section 353(c)(2) of this title, or (D) knowingly distributing drugs in viola- tion of section 353(e)(1) of this title, shall be imprisoned for not more than 10 years or fined not more than $250,000, or both. (2) Any manufacturer or distributor who dis- tributes drug samples by means other than the mail or common carrier whose representative, during the course of the representative’s em- ployment or association with that manufacturer or distributor, violated section 331(t) of this title because of a violation of section 353(c)(1) of this title or violated any State law prohibiting the sale, purchase, or trade of a drug sample subject to section 353(b) of this title or the offer to sell, purchase, or trade such a drug sample shall, upon conviction of the representative for such violation, be subject to the following civil penalties: (A) A civil penalty of not more than $50,000 for each of the first two such violations result- ing in a conviction of any representative of the manufacturer or distributor in any 10-year period. (B) A civil penalty of not more than $1,000,000 for each violation resulting in a con- viction of any representative after the second conviction in any 10-year period. For the purposes of this paragraph, multiple convictions of one or more persons arising out of the same event or transaction, or a related se- ries of events or transactions, shall be consid- ered as one violation. (3) Any manufacturer or distributor who vio- lates section 331(t) of this title because of a fail- ure to make a report required by section 353(d)(3)(E) of this title shall be subject to a civil penalty of not more than $100,000. (4)(A) If a manufacturer or distributor or any representative of such manufacturer or dis- tributor provides information leading to the in- stitution of a criminal proceeding against, and conviction of, any representative of that manu- facturer or distributor for a violation of section Page 57 TITLE 21—FOOD AND DRUGS § 333 331(t) of this title because of a sale, purchase, or trade or offer to purchase, sell, or trade a drug sample in violation of section 353(c)(1) of this title or for a violation of State law prohibiting the sale, purchase, or trade or offer to sell, pur- chase, or trade a drug sample, the conviction of such representative shall not be considered as a violation for purposes of paragraph (2). (B) If, in an action brought under paragraph (2) against a manufacturer or distributor relat- ing to the conviction of a representative of such manufacturer or distributor for the sale, pur- chase, or trade of a drug or the offer to sell, pur- chase, or trade a drug, it is shown, by clear and convincing evidence— (i) that the manufacturer or distributor con- ducted, 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 infor- mation 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 inde- pendent audit and security system designed to detect such a violation, the manufacturer or distributor could not reasonably have been ex- pected to have detected such violation, the conviction of such representative shall not be considered as a conviction for purposes of paragraph (2). (5) If a person provides information leading to the institution of a criminal proceeding against, and conviction of, a person for a violation of sec- tion 331(t) of this title because of the sale, pur- chase, or trade of a drug sample or the offer to sell, purchase, or trade a drug sample in viola- tion of section 353(c)(1) of this title, such person 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), any person who is a manufacturer or importer of a prescrip- tion drug under section 384(b) of this title and knowingly fails to comply with a requirement of section 384(e) of this title 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), any per- son that knowingly and intentionally adulter- ates a drug such that the drug is adulterated under subsection (a)(1), (b), (c), or (d) of section 351 of this title and has a reasonable probability of causing serious adverse health consequences or death to humans or animals shall be impris- oned for not more than 20 years or fined not more than $1,000,000, or both. (8) Notwithstanding subsection (a), any person who violates section 331(i)(3) of this title by knowingly making, selling or dispensing, or holding for sale or dispensing, a counterfeit drug, or who violates section 331(fff)(3) of this title by knowingly making, selling or dis- pensing, or holding for sale or dispensing, a counterfeit device, shall be imprisoned for not more than 10 years or fined in accordance with title 18, or both. (c) Exceptions in certain cases of good faith, etc. No person shall be subject to the penalties of subsection (a)(1) of this section, (1) for having received in interstate commerce any article and delivered it or proffered delivery of it, if such delivery or proffer was made in good faith, un- less he refuses to furnish on request of an officer or employee duly designated by the Secretary the name and address of the person 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 hav- ing violated section 331(a) or (d) of this title, if he establishes a guaranty or undertaking signed by, and containing the name and address of, the person residing in the United States from whom he received in good faith the article, to the ef- fect, in case of an alleged violation of section 331(a) of this title, that such article is not adul- terated or misbranded, 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, that such article is not an ar- ticle which may not, under the provisions of sec- tion 344 or 355 of this title, be introduced into interstate commerce; or (3) for having violated section 331(a) of this title, where the violation exists because the article is adulterated by rea- son of containing a color additive not from a batch certified in accordance with regulations promulgated by the Secretary under this chap- ter, if such person establishes a guaranty or un- dertaking signed by, and containing the name and address of, the manufacturer of the color ad- ditive, to the effect that such color additive was from a batch certified in accordance with the applicable regulations promulgated by the Sec- retary under this chapter; or (4) for having vio- lated section 331(b), (c) or (k) of this title by failure to comply with section 352(f) of this title in respect to an article received in interstate commerce to which neither section 353(a) nor 353(b)(1) of this title is applicable, if the delivery or proffered delivery was made in good faith and the labeling at the time thereof contained the same directions for use and warning statements as were contained in the labeling at the time of such receipt of such article; or (5) for having vio- lated section 331(i)(2) of this title if such person 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 being a counterfeit drug, or for having violated section 331(i)(3) of this title if the person doing the act or causing it to be done acted in good faith and had no reason to believe that the drug was a counterfeit drug; or (6) for having violated sec- tion 331(fff)(2) of this title if such person 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 being a coun- terfeit device, or for having violated section 331(fff)(3) of this title if the person doing the act or causing it to be done acted in good faith and had no reason to believe that the device was a counterfeit device. (d) Exceptions involving misbranded food No person shall be subject to the penalties of subsection (a)(1) of this section for a violation of Page 58 TITLE 21—FOOD AND DRUGS § 333 2 See References in Text note below. section 331 of this title involving misbranded food if the violation exists solely because the food is misbranded under section 343(a)(2) of this title because of its advertising. (e) Prohibited distribution of human growth hor- mone (1) Except as provided in paragraph (2), who- ever knowingly distributes, or possesses with in- tent to distribute, human growth hormone for any use in humans other than the treatment of a disease or other recognized medical condition, where such use has been authorized by the Sec- retary of Health and Human Services under sec- tion 355 of this title 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 by title 18, or both. (2) Whoever commits any offense set forth in paragraph (1) and such offense involves an indi- vidual under 18 years of age is punishable by not more than 10 years imprisonment, such fines as are authorized by title 18, or both. (3) Any conviction for a violation of para- graphs (1) and (2) of this subsection shall be con- sidered a felony violation of the Controlled Sub- stances Act [21 U.S.C. 801 et seq.] for the pur- poses of forfeiture under section 413 of such Act [21 U.S.C. 853]. (4) As used in this subsection the term ‘‘human growth hormone’’ means somatrem, somatropin, or an analogue of either of them. (5) The Drug Enforcement Administration is authorized to investigate offenses punishable by this subsection. (f) Violations related to devices (1)(A) Except as provided in subparagraph (B), any person who violates a requirement of this chapter which relates to devices shall be liable to the United States for a civil penalty in an amount not to exceed $15,000 for each such viola- tion, and not to exceed $1,000,000 for all such vio- lations adjudicated in a single proceeding. For purposes of the preceding sentence, a person ac- credited under paragraph (2) of section 374(g) of this title 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 con- sidered to have violated a requirement of this chapter that relates to devices. (B) Subparagraph (A) shall not apply— (i) to any person who violates the require- ments of section 360i(a) or 360j(f) of this title unless such violation constitutes (I) a signifi- cant or knowing departure from such require- ments, or (II) a risk to public health, (ii) to any person who commits minor viola- tions of section 360i(e) or 360i(g) of this title (only with respect to correction reports) if such person demonstrates substantial compli- ance with such section, or (iii) to violations of section 351(a)(2)(A) of this title which involve one or more devices which are not defective. (2)(A) Any person who introduces into inter- state commerce or delivers for introduction into interstate commerce an article of food that is adulterated within the meaning of section 342(a)(2)(B) of this title or any person who does not comply with a recall order under section 350l 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 for such introduction or delivery, not to exceed $500,000 for all such violations ad- judicated in a single proceeding. (B) This paragraph shall not apply to any per- son who grew the article of food that is adulter- ated. If the Secretary assesses a civil penalty against any person under this paragraph, the Secretary may not use the criminal authorities under this section to sanction such person for the introduction or delivery for introduction into interstate commerce of the article of food that is adulterated. If the Secretary assesses a civil penalty against any person under this para- graph, the Secretary may not use the seizure au- thorities of section 334 of this title or the in- junction authorities of section 332 of this title with respect to the article of food that is adul- terated. (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 pre- siding officer has under section 346a(g)(2)(B) of this title. The third sentence of paragraph (5)(A) shall not apply to any investigation under this paragraph. (3)(A) Any person who violates section 331(jj) of this title shall be subject to a civil monetary penalty of not more than $10,000 for all viola- tions adjudicated in a single proceeding. (B) If a violation of section 331(jj) of this title is not corrected within the 30-day period fol- lowing notification under section 282(j)(5)(C)(ii) 2 of title 42, the person shall, in addition to any penalty under subparagraph (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 (as such term is used in section 355–1 of this title) that violates a requirement of section 355(o), 355(p), or 355–1 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 provides written notice to the responsible person, the responsible person shall be subject to a civil monetary penalty of $250,000 for the first 30-day period (or any por- tion thereof) that the responsible person con- tinues 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 ex- ceed $10,000,000 for all such violations adju- dicated in a single proceeding. (B) In determining the amount of a civil pen- alty under subparagraph (A)(ii), the Secretary shall take into consideration whether the re- sponsible person is making efforts toward cor- recting the violation of the requirement of sec- Page 59 TITLE 21—FOOD AND DRUGS § 333 tion 355(o), 355(p), or 355–1 of this title for which the responsible person is subject to such civil penalty. (5)(A) A civil penalty under paragraph (1), (2), (3), (4), or (9) shall be assessed, or a no-tobacco- sale order may be imposed, by the Secretary by an order made on the record after opportunity for a hearing provided in accordance with this subparagraph and section 554 of title 5. Before issuing such an order, the Secretary shall give written notice to the person to be assessed a civil penalty, or upon whom a no-tobacco-sale order is to be imposed, under such order of the Secretary’s proposal to issue such order and pro- vide such person an opportunity for a hearing on the order. In the course of any investigation, the Secretary may issue subpoenas requiring the at- tendance and testimony of witnesses and the production of evidence that relates to the mat- ter under investigation. (B) In determining the amount of a civil pen- alty, or the period to be covered by a no-to- bacco-sale order, the Secretary 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 prohib- iting an individual retail outlet from selling to- bacco products shall include provisions that allow the outlet, after a specified period of time, to request that the Secretary compromise, mod- ify, or terminate the order. (C) The Secretary may compromise, modify, or remit, with or without conditions, any civil pen- alty which may be assessed under paragraph (1), (2), (3), (4), or (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 charged. (D) The Secretary may compromise, modify, or terminate, with or without conditions, any no-tobacco-sale order. (6) Any person who requested, in accordance with paragraph (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 im- position of a no-tobacco-sale order may file a pe- tition 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 resides or transacts business. Such a petition may only be filed within the 60- day period beginning on the date the order mak- ing such assessment was issued, or on which the no-tobacco-sale order was imposed, as the case may be. (7) If any person fails to pay an assessment of a civil penalty— (A) after the order making the assessment becomes final, and if such person does not file a petition for judicial review of the order in accordance with paragraph (6), or (B) after a court in an action brought under paragraph (6) has entered a final judgment in favor of the Secretary, 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) 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 finds that a person has committed repeated violations of section 387f(d)(5) of this title or of restrictions promul- gated under section 387f(d) of this title at a par- ticular retail outlet then the Secretary may im- pose a no-tobacco-sale order on that person pro- hibiting the sale of tobacco products in that outlet. A no-tobacco-sale order may be imposed with a civil penalty under paragraph (1). Prior to the entry of a no-sale order under this para- graph, a person shall be entitled to a hearing pursuant to the procedures established through regulations of the Food and Drug Administra- tion for assessing civil money penalties, includ- ing at a retailer’s request a hearing by tele- phone, or at the nearest regional or field office of the Food and Drug Administration, or at a Federal, State, or county facility within 100 miles from the location of the retail outlet, if such a facility is available. (9) CIVIL MONETARY PENALTIES FOR VIOLATION OF TOBACCO PRODUCT REQUIREMENTS.— (A) IN GENERAL.—Subject to subparagraph (B), any person who violates a requirement of this chapter which relates to tobacco products 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 who intentionally violates a requirement of section 387b(5), 387b(6), 387d, 387h(c), or 387k(a) of this title, shall be sub- ject 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 pro- ceeding; or (II) in the case of a violation that con- tinues after the Secretary provides written notice to such person, $250,000 for the first 30-day period (or any portion thereof) that the person 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 sin- gle proceeding. (ii) Any person who violates a requirement of section 387k(g)(2)(C)(ii) or 387k(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 pro- ceeding; or (II) in the case of a violation that con- tinues after the Secretary provides written notice to such person, $250,000 for the first 30-day period (or any portion thereof) that the person continues to be in violation, and such amount shall double for every 30- Page 60 TITLE 21—FOOD AND DRUGS § 333 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 sin- gle proceeding. (iii) In determining the amount of a civil penalty under clause (i)(II) or (ii)(II), the Secretary shall take into consideration whether the person is making efforts toward correcting the violation of the requirements of the section for which such person is sub- ject to such civil penalty. (g) Violations regarding direct-to-consumer ad- vertising (1) With respect to a person who is a holder of an approved application under section 355 of this title for a drug subject to section 353(b) of this title or under section 262 of title 42, any such person who disseminates or causes another party to disseminate a direct-to-consumer ad- vertisement 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 pen- alties in this chapter (including the civil pen- alty in subsection (f)(4)) shall apply to a viola- tion regarding direct-to-consumer advertising. For purposes of this paragraph: (A) Repeated dissemination of the same or similar advertise- ment prior to the receipt of the written notice referred to in paragraph (2) for such advertise- ments shall be considered one violation. (B) On and after the date of the receipt of such a no- tice, all violations under this paragraph occur- ring in a single day shall be considered one vio- lation. With respect to advertisements that ap- pear 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 calcu- lating the number of violations under this para- graph. (2) A civil penalty under paragraph (1) shall be assessed by the Secretary by an order made on the record after providing written notice to the person to be assessed a civil penalty and an op- portunity for a hearing in accordance with this paragraph and section 554 of title 5. If upon re- ceipt of the written notice, the person to be as- sessed a civil penalty objects and requests a hearing, then in the course of any investigation related to such hearing, the Secretary may issue subpoenas requiring the attendance and testi- mony of witnesses and the production of evi- dence that relates to the matter under inves- tigation, including information pertaining to the factors described in paragraph (3). (3) The Secretary, in determining the amount of the civil penalty under paragraph (1), shall take into account the nature, circumstances, ex- tent, and gravity of the violation or violations, including the following factors: (A) Whether the person submitted the adver- tisement or a similar advertisement for review under section 379h–1 of this title. (B) Whether the person submitted the adver- tisement for review if required under section 353c 2 of this title. (C) Whether, after submission of the adver- tisement as described in subparagraph (A) or (B), the person disseminated or caused another party to disseminate the advertisement before the end of the 45-day comment period. (D) Whether the person incorporated any comments made by the Secretary with regard to the advertisement into the advertisement prior to its dissemination. (E) Whether the person ceased distribution of the advertisement upon receipt of the writ- ten notice referred to in paragraph (2) for such advertisement. (F) Whether the person had the advertise- ment reviewed by qualified medical, regu- latory, and legal reviewers prior to its dis- semination. (G) Whether the violations were material. (H) Whether the person who created the ad- vertisement or caused the advertisement to be created acted in good faith. (I) Whether the person who created the ad- vertisement or caused the advertisement to be created has been assessed a civil penalty under this provision within the previous 1-year pe- riod. (J) The scope and extent of any voluntary, subsequent remedial action by the person. (K) Such other matters, as justice may re- quire. (4)(A) Subject to subparagraph (B), no person shall be required to pay a civil penalty under paragraph (1) if the person submitted the adver- tisement to the Secretary and disseminated or caused another party to disseminate such adver- tisement after incorporating each comment re- ceived from the Secretary. (B) The Secretary may retract or modify any prior comments the Secretary has provided to an advertisement submitted to the Secretary based on new information or changed cir- cumstances, so long as the Secretary provides written notice to the person of the new views of the Secretary on the advertisement and provides a reasonable time for modification or correction of the advertisement prior to seeking any civil penalty under paragraph (1). (5) The Secretary may compromise, modify, or remit, with or without conditions, any civil pen- alty which may be assessed under paragraph (1). The amount of such penalty, when finally deter- mined, or the amount charged upon in com- promise, may be deducted from any sums owed by the United States to the person charged. (6) Any person who requested, in accordance with paragraph (2), a hearing with respect to the assessment of a civil penalty and who is ag- grieved 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 Ap- peals for the District of Columbia Circuit or for any other circuit in which such person 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 fails to pay an assessment of a civil penalty under paragraph (1)— (A) after the order making the assessment becomes final, and if such person does not file a petition for judicial review of the order in accordance with paragraph (6), or Page 61 TITLE 21—FOOD AND DRUGS § 333 (B) after a court in an action brought under paragraph (6) has entered a final judgment in favor of the Secretary, 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) 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 ap- propriateness of such penalty shall not be sub- ject to review. (June 25, 1938, ch. 675, § 303, 52 Stat. 1043; Oct. 26, 1951, ch. 578, § 2, 65 Stat. 649; Pub. L. 86–618, title I, § 105(b), July 12, 1960, 74 Stat. 403; Pub. L. 89–74, §§ 7, 9(d), July 15, 1965, 79 Stat. 233, 235; Pub. L. 90–639, § 3, Oct. 24, 1968, 82 Stat. 1361; Pub. L. 91–513, title II, § 701(b), Oct. 27, 1970, 84 Stat. 1281; Pub. L. 94–278, title V, § 502(a)(2)(B), Apr. 22, 1976, 90 Stat. 411; Pub. L. 100–293, § 7(b), Apr. 22, 1988, 102 Stat. 99; Pub. L. 100–690, title II, § 2403, Nov. 18, 1988, 102 Stat. 4230; Pub. L. 101–629, § 17(a), Nov. 28, 1990, 104 Stat. 4526; Pub. L. 101–647, title XIX, § 1904, Nov. 29, 1990, 104 Stat. 4853; Pub. L. 102–353, § 3, Aug. 26, 1992, 106 Stat. 941; Pub. L. 103–80, § 3(e), Aug. 13, 1993, 107 Stat. 775; Pub. L. 103–322, title XXXIII, § 330015, Sept. 13, 1994, 108 Stat. 2146; Pub. L. 104–170, title IV, § 407, Aug. 3, 1996, 110 Stat. 1535; Pub. L. 106–387, § 1(a) [title VII, § 745(d)(2)], Oct. 28, 2000, 114 Stat. 1549, 1549A–40; Pub. L. 107–250, title II, § 201(c), Oct. 26, 2002, 116 Stat. 1609; Pub. L. 108–173, title XI, § 1121(b)(2), Dec. 8, 2003, 117 Stat. 2469; Pub. L. 110–85, title II, § 226(b), title VIII, § 801(b)(2), title IX, §§ 901(d)(4), 902(b), Sept. 27, 2007, 121 Stat. 854, 920, 940, 943; Pub. L. 111–31, div. A, title I, § 103(c), June 22, 2009, 123 Stat. 1835; Pub. L. 111–353, title II, § 206(c), Jan. 4, 2011, 124 Stat. 3943; Pub. L. 112–144, title VII, § 716, July 9, 2012, 126 Stat. 1075; Pub. L. 113–54, title II, § 207(a), Nov. 27, 2013, 127 Stat. 640; Pub. L. 115–52, title VI, § 604(b), Aug. 18, 2017, 131 Stat. 1048; Pub. L. 116–94, div. N, title I, § 603(d)(2), Dec. 20, 2019, 133 Stat. 3124; Pub. L. 117–328, div. FF, title II, § 2513(b), Dec. 29, 2022, 136 Stat. 5805.) Editorial Notes REFERENCES IN TEXT The Controlled Substances Act, referred to in subsec. (e)(3), is title II of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1242, which is classified principally to subchapter I (§ 801 et seq.) of chapter 13 of this title. For complete classification of this Act to the Code, see Short Title note set out under section 801 of this title and Tables. Section 282(j)(5)(C)(ii) of title 42, referred to in subsec. (f)(3)(B), was in the original ‘‘section 402(j)(5)(C)(ii)’’, and was translated as meaning section 402(j)(5)(C)(ii) of the Public Health Service Act to reflect the probable intent of Congress because there is no subsec. (j) of sec- tion 402 of the Federal Food, Drug, and Cosmetic Act and section 402(j)(5)(C)(ii) of the Public Health Service Act relates to notification of noncompliance with clin- ical trial information requirements. Section 353c of this title, referred to in subsec. (g)(3)(B), was in the original a reference to section 503B of act June 25, 1938, and was translated as if it referred to section 503C of that Act, to reflect the probable in- tent of Congress and the renumbering of section 503B as 503C by Pub. L. 113–54, title I, § 102(a)(1), Nov. 27, 2013, 127 Stat. 587, and its transfer to section 353c of this title. A new section 503B, which was enacted by section 102(a)(2) of Pub. L. 113–54, is classified to section 353b of this title and does not relate to television advertise- ments. AMENDMENTS 2022—Subsec. (b)(8). Pub. L. 117–328, § 2513(b)(1), in- serted ‘‘, or who violates section 331(fff)(3) of this title by knowingly making, selling or dispensing, or holding for sale or dispensing, a counterfeit device,’’ after ‘‘a counterfeit drug’’. Subsec. (c)(6). Pub. L. 117–328, § 2513(b)(2), added cl. (6). 2019—Subsec. (f)(8). Pub. L. 116–94 inserted ‘‘section 387f(d)(5) of this title or of’’ after ‘‘repeated violations of’’. 2017—Subsec. (b)(8). Pub. L. 115–52 added par. (8). 2013—Subsec. (b)(1)(D). Pub. L. 113–54 substituted ‘‘353(e)(1)’’ for ‘‘353(e)(2)(A)’’. 2012—Subsec. (b)(7). Pub. L. 112–144 added par. (7). 2011—Subsec. (f)(2)(A). Pub. L. 111–353 inserted ‘‘or any person who does not comply with a recall order under section 350l of this title’’ after ‘‘section 342(a)(2)(B) of this title’’. 2009—Subsec. (f)(5)(A). Pub. L. 111–31, § 103(c)(1)(A), (B), substituted ‘‘paragraph (1), (2), (3), (4), or (9)’’ for ‘‘paragraph (1), (2), (3), or (4)’’, ‘‘shall be assessed, or a no-tobacco-sale order may be imposed,’’ for ‘‘shall be assessed’’, and ‘‘assessed a civil penalty, or upon whom a no-tobacco-sale order is to be imposed,’’ for ‘‘assessed a civil penalty’’. Subsec. (f)(5)(B). Pub. L. 111–31, § 103(c)(1)(C), inserted ‘‘or the period to be covered by a no-tobacco-sale order,’’ after ‘‘penalty,’’ and inserted at end ‘‘A no-to- bacco-sale order permanently prohibiting an individual retail outlet from selling tobacco products shall in- clude provisions that allow the outlet, after a specified period of time, to request that the Secretary com- promise, modify, or terminate the order.’’ Subsec. (f)(5)(C). Pub. L. 111–31, § 103(c)(1)(A), sub- stituted ‘‘paragraph (1), (2), (3), (4), or (9)’’ for ‘‘para- graph (1), (2), (3), or (4)’’. Subsec. (f)(5)(D). Pub. L. 111–31, § 103(c)(1)(D), added subpar. (D). Subsec. (f)(6). Pub. L. 111–31, § 103(c)(2), inserted ‘‘or the imposition of a no-tobacco-sale order’’ after ‘‘pen- alty’’ in two places and substituted ‘‘issued, or on which the no-tobacco-sale order was imposed, as the case may be.’’ for ‘‘issued.’’ Subsec. (f)(8), (9). Pub. L. 111–31, § 103(c)(3), added pars. (8) and (9). 2007—Subsec. (f). Pub. L. 110–85, § 226(b)(1), redesig- nated subsec. (g) as (f). Subsec. (f)(1)(B)(ii). Pub. L. 110–85, § 226(b)(2), sub- stituted ‘‘360i(g)’’ for ‘‘360i(f)’’. Subsec. (f)(2)(C). Pub. L. 110–85, § 801(b)(2)(C), sub- stituted ‘‘paragraph (5)(A)’’ for ‘‘paragraph (3)(A)’’. Subsec. (f)(3). Pub. L. 110–85, § 801(b)(2)(B), added par. (3). Former par. (3) redesignated (5). Subsec. (f)(4). Pub. L. 110–85, § 902(b)(1), added par. (4). Pub. L. 110–85, § 801(b)(2)(A), redesignated par. (4) as (6). Subsec. (f)(5). Pub. L. 110–85, § 801(b)(2)(A), redesig- nated par. (3) as (5). Former par. (5) redesignated (7). Subsec. (f)(5)(A), (C). Pub. L. 110–85, § 902(b)(2), sub- stituted ‘‘paragraph (1), (2), (3), or (4)’’ for ‘‘paragraph (1), (2), or (3)’’. Pub. L. 110–85, § 801(b)(2)(D), substituted ‘‘paragraph (1), (2), or (3)’’ for ‘‘paragraph (1) or (2)’’. Subsec. (f)(6). Pub. L. 110–85, § 801(b)(2)(A), (E), redes- ignated par. (4) as (6) and substituted ‘‘paragraph (5)(A)’’ for ‘‘paragraph (3)(A)’’. Subsec. (f)(7). Pub. L. 110–85, § 801(b)(2)(A), (F), redes- ignated par. (5) as (7) and substituted ‘‘paragraph (6)’’ for ‘‘paragraph (4)’’ wherever appearing. Subsec. (g). Pub. L. 110–85, § 901(d)(4), added subsec. (g). Pub. L. 110–85, § 226(b)(1), redesignated subsec. (g) as (f). 2003—Subsec. (b)(6). Pub. L. 108–173, which directed amendment of subsec. (a)(6) by substituting ‘‘prescrip- tion drug under section 384(b)’’ for ‘‘covered product Page 62 TITLE 21—FOOD AND DRUGS § 333 pursuant to section 384(a)’’, was executed by making the substitution in subsec. (b)(6), to reflect the probable intent of Congress. 2002—Subsec. (g)(1)(A). Pub. L. 107–250 inserted at end ‘‘For purposes of the preceding sentence, a person ac- credited under paragraph (2) of section 374(g) of this title 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 man- ner that is consistent with the purposes of such section, shall be considered to have violated a requirement of this chapter that relates to devices.’’ 2000—Subsec. (b)(6). Pub. L. 106–387 added par. (6). 1996—Subsec. (g)(2). Pub. L. 104–170, § 407(1), (2), added par. (2). Former par. (2) redesignated (3). Subsec. (g)(3). Pub. L. 104–170, § 407(1), (3), redesig- nated par. (2) as (3) and substituted ‘‘paragraph (1) or (2)’’ for ‘‘paragraph (1)’’ in subpars. (A) and (C). Former par. (3) redesignated (4). Subsec. (g)(4). Pub. L. 104–170, § 407(1), (4), redesig- nated par. (3) as (4) and substituted ‘‘paragraph (3)(A)’’ for ‘‘paragraph (2)(A)’’. Former par. (4) redesignated (5). Subsec. (g)(5). Pub. L. 104–170, § 407(1), (5), redesig- nated par. (4) as (5) and substituted ‘‘paragraph (4)’’ for ‘‘paragraph (3)’’ wherever appearing. 1994—Subsec. (e). Pub. L. 103–322 amended directory language of Pub. L. 101–647. See 1990 Amendment note below. 1993—Subsecs. (e) to (g). Pub. L. 103–80, which di- rected the amendment of this section by redesignating the second subsec. (e) and subsec. (f) as subsecs. (f) and (g), respectively, could only be executed by designating subsec. (f) as (g) because this section did not contain a second subsec. (e) subsequent to amendment of Pub. L. 101–647 by Pub. L. 103–322. See 1990 and 1994 amendment notes for subsec. (e) under this section. 1992—Subsec. (b)(1). Pub. L. 102–353, § 3(a), amended par. (1) generally. Prior to amendment, par. (1) read as follows: ‘‘Notwithstanding subsection (a) of this sec- tion, any person who violates section 331(t) of this title because of an importation of a drug in violation of sec- tion 381(d)(1) of this title, because of a sale, purchase, or trade of a drug or drug sample or the offer to sell, purchase, or trade a drug or drug sample in violation of section 353(c) of this title, because of the sale, pur- chase, 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, or the distribution of drugs in violation of section 353(e)(2)(A) of this title shall be imprisoned for not more than 10 years or fined not more than $250,000, or both.’’ Subsec. (b)(4)(A). Pub. L. 102–353, § 3(b)(1), substituted ‘‘the institution of a criminal proceeding against, and conviction of,’’ for ‘‘the arrest and conviction of’’. Subsec. (b)(4)(B)(i). Pub. L. 102–353, § 3(b)(1), (2), sub- stituted ‘‘before the institution of a criminal pro- ceeding against’’ for ‘‘before the arrest of’’ and ‘‘the in- stitution of a criminal proceeding against, and convic- tion of,’’ for ‘‘the arrest and conviction of’’. Subsec. (b)(5). Pub. L. 102–353, § 3(b)(3), substituted ‘‘the institution of a criminal proceeding against, and conviction of,’’ for ‘‘the arrest and conviction of’’. Subsec. (c). Pub. L. 102–353, § 3(b)(4), substituted ‘‘sub- section (a)(1) of this section’’ for ‘‘subsection (a) of this section’’. Subsec. (d). Pub. L. 102–353, § 3(b)(4), (5), substituted ‘‘subsection (a)(1) of this section’’ for ‘‘subsection (a) of this section’’ and struck out ‘‘, and no person shall be subject to the penalties of subsection (b) of this section for such a violation unless the violation is committed with the intent to defraud or mislead’’ after ‘‘adver- tising’’. 1990—Subsec. (e). Pub. L. 101–647, as amended by Pub. L. 103–322, amended subsec. (e) generally. Prior to amendment, subsec. (e) read as follows: ‘‘(e)(1) Except as provided in paragraph (2), any per- son who distributes or possesses with the intent to dis- tribute any anabolic steroid for any use in humans other than the treatment of disease pursuant to the order of a physician shall be imprisoned for not more than three years or fined under title 18, or both. ‘‘(2) Any person who distributes or possesses with the intent to distribute to an individual under 18 years of age, any anabolic steroid for any use in humans other than the treatment of disease pursuant to the order of a physician shall be imprisoned for not more than six years or fined under title 18, or both.’’ Subsec. (f). Pub. L. 101–629 added subsec. (f). 1988—Subsecs. (a), (b). Pub. L. 100–293 designated ex- isting subsecs. (a) and (b) as pars. (1) and (2) of subsec. (a), substituted ‘‘paragraph (1)’’ for ‘‘subsection (a)’’ in par. (2), and added subsec. (b). Subsec. (e). Pub. L. 100–690 added subsec. (e). 1976—Subsec. (d). Pub. L. 94–278 added subsec. (d). 1970—Subsec. (a). Pub. L. 91–513 struck out reference to subsec. (b) and transferred to subsec. (b) provisions covering second offenses and offenses committed with intent to defraud or mislead. Subsec. (b). Pub. L. 91–513 inserted provisions cov- ering second offenses and offenses committed with in- tent to defraud or mislead formerly set out in subsec. (a) and struck out provisions covering violations in- volving depressant and stimulant drugs. See section 801 et seq. of this title. 1968—Subsecs. (a), (b). Pub. L. 90–639 made a general revision in the penalties prescribed for offenses involv- ing depressant or stimulant drugs, set a fine of not to exceed $10,000 or imprisonment of not more than 5 years for offenses involving the unlawful manufac- turing of, sale, or disposal of, or possession with intent to sell, a depressant or stimulant drug or involving counterfeit depressant or stimulant drugs, stiffened the penalties for unlawful sales or other disposals by per- sons over 18 to persons under 21, and set new penalties for possession of a depressant or stimulant drug for purposes other than sale or other disposal. 1965—Subsec. (a). Pub. L. 89–74, § 7(a), inserted proviso limiting the penalties for depressant or stimulant drug violations to two years imprisonment or $5,000 fine or both for first offense and to two years imprisonment or $15,000 fine or both for subsequent offenses. Subsec. (b). Pub. L. 89–74, § 7(b), inserted parenthet- ical exception provision. Subsec. (c)(5). Pub. L. 89–74, § 9(d), added cl. (5). 1960—Subsec. (c)(3). Pub. L. 86–618 substituted ‘‘a color additive’’ for ‘‘a coal-tar color’’, ‘‘the color addi- tive’’ for ‘‘the coal-tar color’’ and ‘‘such color additive was’’ for ‘‘such color was’’. 1951—Subsec. (c)(4). Act Oct. 26, 1951, added cl. (4). Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 2013 AMENDMENT Pub. L. 113–54, title II, § 207(b), Nov. 27, 2013, 127 Stat. 640, provided that: ‘‘The amendment made by sub- section (a) [amending this section] shall take effect on January 1, 2015.’’ EFFECTIVE DATE OF 2009 AMENDMENT Pub. L. 111–31, div. A, title I, § 103(q)(3), (4), June 22, 2009, 123 Stat. 1840, provided that: ‘‘(3) GENERAL EFFECTIVE DATE.—The amendments made by paragraphs (2) [amending this section], (3) [amending this section], and (4) [no par. (4) has been en- acted] of subsection (c) shall take effect upon the issuance of guidance described in paragraph (1) of this subsection [set out as a Guidance note below]. ‘‘(4) SPECIAL EFFECTIVE DATE.—The amendment made by subsection (c)(1) [amending this section] shall take effect on the date of enactment of this Act [June 22, 2009].’’ EFFECTIVE DATE OF 2007 AMENDMENT Amendment by sections 901(d)(4) and 902(b) of Pub. L. 110–85 effective 180 days after Sept. 27, 2007, see section 909 of Pub. L. 110–85, set out as a note under section 331 of this title. EFFECTIVE DATE OF 1994 AMENDMENT Pub. L. 103–322, title XXXIII, § 330015, Sept. 13, 1994, 108 Stat. 2146, provided that the amendment made by Page 63 TITLE 21—FOOD AND DRUGS § 333 that section is effective as of the date on which section 1904 of Pub. L. 101–647, which amended this section, took effect. EFFECTIVE DATE OF 1990 AMENDMENT Pub. L. 101–629, § 17(b), Nov. 28, 1990, 104 Stat. 4528, provided that: ‘‘(b) EFFECTIVE DATE OF APPLICATION TO DEVICE USER FACILITIES.— ‘‘(1) The Secretary of Health and Human Services shall conduct a study to determine whether there has been substantial compliance with the requirements of section 519(b) of the Federal Food, Drug, and Cos- metic Act [21 U.S.C. 360i(b)] by device user facilities (as defined in section 519(b)(5)(A) of such Act). The Secretary shall report the results of the study to the Congress after the expiration of 45 months after the date of the enactment of this Act [Nov. 28, 1990]. ‘‘(2)(A) If upon the expiration of 48 months after the date of the enactment of this Act [Nov. 28, 1990] the Secretary has not made the report required by para- graph (1), section 303(f) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 333(f)], as added by the amendment made by subsection (a), shall take effect with respect to device user facilities (as defined in section 519(b)(5)(A) of such Act). [Secretary of Health and Human Services had not made the report re- quired by par. (1) on the expiration of 48 months after Nov. 28, 1990.] ‘‘(B) If in the report under paragraph (1) the Sec- retary reports that there has been substantial com- pliance with the requirements of such section 519(b) by a type of device user facility and if the Secretary does not make a determination under subparagraph (C) with respect to such type of facility, such section 303(f) shall not take effect with respect to such type of facility. ‘‘(C) If the Secretary determines in the report under paragraph (1) that there is not substantial compli- ance with the requirements of such section 519(b) by a type of device user facility or if the Secretary makes such a determination after making the report under paragraph (1), such section 303(f) shall take ef- fect with respect to such type of facility upon the ef- fective date of the report.’’ EFFECTIVE DATE OF 1988 AMENDMENT Amendment by Pub. L. 100–293 effective upon expira- tion of 90 days after Apr. 22, 1988, see section 8(a) of Pub. L. 100–293, set out as a note under section 353 of this title. EFFECTIVE DATE OF 1976 AMENDMENT Amendment by Pub. L. 94–278 effective 180 days after Apr. 22, 1976, see section 502(c) of Pub. L. 94–278, set out as a note under section 334 of this title. EFFECTIVE DATE OF 1970 AMENDMENT Amendment by Pub. L. 91–513 effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of Pub. L. 91–513, set out as an Effective Date note under section 801 of this title. EFFECTIVE DATE OF 1968 AMENDMENT Amendment by Pub. L. 90–639 applicable only with re- spect to violations of this chapter committed after Oct. 24, 1968, see section 6 of Pub. L. 90–639, set out as an Ef- fective Date of 1968 Amendments; Transitional Provi- sions note under section 321 of this title. EFFECTIVE DATE OF 1965 AMENDMENT Amendment by Pub. L. 89–74 effective Feb. 1, 1966, see section 11 of Pub. L. 89–74, set out as a note under sec- tion 321 of this title. EFFECTIVE DATE OF 1960 AMENDMENT Amendment by Pub. L. 86–618 effective July 12, 1960, subject to the provisions of section 203 of Pub. L. 86–618, see section 202 of Pub. L. 86–618, set out as a note under section 379e of this title. EFFECTIVE DATE OF 1951 AMENDMENT Act Oct. 26, 1951, ch. 578, § 3, 65 Stat. 649, provided that: ‘‘The provisions of this Act [amending this sec- tion and section 353 of this title] shall take effect six months after the date of its enactment [Oct. 26, 1951].’’ SAVINGS PROVISION Amendment by Pub. L. 91–513 not to affect or abate any prosecutions for violation of law or any civil sei- zures or forfeitures and injunctive proceedings com- menced prior to the effective date of such amendment, and all administrative proceedings pending before the Bureau of Narcotics and Dangerous Drugs [now the Drug Enforcement Administration] on Oct. 27, 1970, to be continued and brought to final determination in ac- cord with laws and regulations in effect prior to Oct. 27, 1970, see section 702 of Pub. L. 91–513, set out as a note under section 321 of this title. GUIDANCE Pub. L. 111–31, div. A, title I, § 103(q)(1), (2), June 22, 2009, 123 Stat. 1838, 1839, as amended by Pub. L. 116–94, div. N, title I, § 603(d)(1), Dec. 20, 2019, 133 Stat. 3124, provided that: ‘‘(1) IN GENERAL.—The Secretary of Health and Human Services shall issue guidance [see 76 F.R. 22905, effective Apr. 15, 2011]— ‘‘(A) defining the term ‘repeated violation’, as used in section 303(f)(8) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)(8)) as amended by sub- section (c), as including at least 5 violations of par- ticular requirements over a 36-month period at a par- ticular retail outlet that constitute a repeated viola- tion and providing for civil penalties in accordance with paragraph (2); ‘‘(B) providing for timely and effective notice by certified or registered mail or personal delivery to the retailer of each alleged violation at a particular retail outlet prior to conducting a followup compli- ance check, such notice to be sent to the location specified on the retailer’s registration or to the re- tailer’s registered agent if the retailer has provider [sic] such agent information to the Food and Drug Administration prior to the violation; ‘‘(C) providing for a hearing pursuant to the proce- dures established through regulations of the Food and Drug Administration for assessing civil money penalties, including at a retailer’s request a hearing by telephone or at the nearest regional or field office of the Food and Drug Administration, and providing for an expedited procedure for the administrative ap- peal of an alleged violation; ‘‘(D) providing that a person may not be charged with a violation at a particular retail outlet unless the Secretary has provided notice to the retailer of all previous violations at that outlet; ‘‘(E) establishing that civil money penalties for multiple violations shall increase from one violation to the next violation pursuant to paragraph (2) with- in the time periods provided for in such paragraph; ‘‘(F) providing that good faith reliance on the pres- entation of a false government-issued photographic identification that contains a date of birth does not constitute a violation of any minimum age require- ment for the sale of tobacco products if the retailer has taken effective steps to prevent such violations, including— ‘‘(i) adopting and enforcing a written policy against sales to minors; ‘‘(ii) informing its employees of all applicable laws; ‘‘(iii) establishing disciplinary sanctions for em- ployee noncompliance; and ‘‘(iv) requiring its employees to verify age by way of photographic identification or electronic scan- ning device; and Page 64 TITLE 21—FOOD AND DRUGS § 333a ‘‘(G) providing for the Secretary, in determining whether to impose a no-tobacco-sale order and in de- termining whether to compromise, modify, or termi- nate such an order, to consider whether the retailer has taken effective steps to prevent violations of the minimum age requirements for the sale of tobacco products, including the steps listed in subparagraph (F). ‘‘(2) PENALTIES FOR VIOLATIONS.— ‘‘(A) IN GENERAL.—The amount of the civil penalty to be applied for violations of section 906(d)(5) [prob- ably means section 906(d)(5) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 387f(d)(5)] or of re- strictions promulgated under section 906(d) [21 U.S.C. 387f(d)], as described in paragraph (1), shall be as fol- lows: ‘‘(i) With respect to a retailer with an approved training program, the amount of the civil penalty shall not exceed— ‘‘(I) in the case of the first violation, $0.00 to- gether with the issuance of a warning letter to the retailer; ‘‘(II) in the case of a second violation within a 12-month period, $250; ‘‘(III) in the case of a third violation within a 24-month period, $500; ‘‘(IV) in the case of a fourth violation within a 24-month period, $2,000; ‘‘(V) in the case of a fifth violation within a 36- month period, $5,000; and ‘‘(VI) in the case of a sixth or subsequent viola- tion within a 48-month period, $10,000 as deter- mined by the Secretary on a case-by-case basis. ‘‘(ii) With respect to a retailer that does not have an approved training program, the amount of the civil penalty shall not exceed— ‘‘(I) in the case of the first violation, $250; ‘‘(II) in the case of a second violation within a 12-month period, $500; ‘‘(III) in the case of a third violation within a 24-month period, $1,000; ‘‘(IV) in the case of a fourth violation within a 24-month period, $2,000; ‘‘(V) in the case of a fifth violation within a 36- month period, $5,000; and ‘‘(VI) in the case of a sixth or subsequent viola- tion within a 48-month period, $10,000 as deter- mined by the Secretary on a case-by-case basis. ‘‘(B) TRAINING PROGRAM.—For purposes of subpara- graph (A), the term ‘approved training program’ means a training program that complies with stand- ards developed by the Food and Drug Administration for such programs. ‘‘(C) CONSIDERATION OF STATE PENALTIES.—The Sec- retary shall coordinate with the States in enforcing the provisions of this Act [probably means div. A of Pub. L. 111–31, see Short Title of 2009 Amendment note set out under section 301 of this title and Tables for classifications] and, for purposes of mitigating a civil penalty to be applied for a violation by a re- tailer of section 906(d)(5) [21 U.S.C. 387f(d)(5)] or of any restriction promulgated under section 906(d) [21 U.S.C. 387f(d)], shall consider the amount of any pen- alties paid by the retailer to a State for the same vio- lation.’’ CONSTRUCTION OF 2011 AMENDMENT Nothing in amendment by Pub. L. 111–353 to be con- strued to alter jurisdiction and authorities established under certain other Acts or in a manner inconsistent with international agreements to which the United States is a party, see sections 2251 and 2252 of this title. ENFORCEMENT Pub. L. 99–660, title I, § 103, Nov. 14, 1986, 100 Stat. 3751, provided that: ‘‘For the fines authorized to be im- posed under section 303 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 333], see section 3623 of title 18, United States Code, for the period ending October 31, 1986 [probably should be October 31, 1987], and sections 3559 and 3571 of such title for the period beginning No- vember 1, 1986 [probably should be November 1, 1987].’’ Executive Documents TRANSFER OF FUNCTIONS For transfer of functions of Federal Security Admin- istrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title. § 333a. Repealed. Pub. L. 101–647, title XIX, § 1905, Nov. 29, 1990, 104 Stat. 4853 Section, Pub. L. 100–690, title II, § 2401, Nov. 18, 1988, 102 Stat. 4230, related to forfeiture and illegal traf- ficking in steroids or human growth hormones. § 334. Seizure (a) Grounds and jurisdiction (1) Any article of food, drug, or cosmetic that is adulterated or misbranded when introduced into or while in interstate commerce or while held for sale (whether or not the first sale) after shipment in interstate commerce, or which may not, under the provisions of section 331(ll), 344, or 355 of this title, be introduced into interstate commerce, shall be liable to be proceeded against while in interstate commerce, or at any time thereafter, on libel of information and con- demned in any district court of the United States or United States court of a Territory within the jurisdiction of which the article is found. No libel for condemnation shall be insti- tuted under this chapter, for any alleged mis- branding 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 in- stituted if no such proceeding is so pending, ex- cept 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 has probable cause to believe from facts found, without hearing, by him or any offi- cer or employee of the Department that the mis- branded article is dangerous to health, or that the labeling of the misbranded article is fraudu- lent, or would be in a material respect mis- leading 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 insti- tuted shall, on application of the claimant, sea- sonably made, be removed for trial to any dis- trict 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 giv- ing 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 prox- imity to the claimant’s principal place of busi- ness, to which the case shall be removed for trial.