21 U.S.C. § 334 — Seizure

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. Page 65 TITLE 21—FOOD AND DRUGS § 334 (2) The following shall be liable to be pro- ceeded against at any time on libel of informa- tion and condemned in any district court of the United States or United States court of a Terri- tory within the jurisdiction of which they are found: (A) Any drug that is a counterfeit drug, (B) Any container of a counterfeit drug, (C) Any punch, die, plate, stone, labeling, container, or other thing used or designed for use in making a counterfeit drug or drugs, (D) Any adulterated or misbranded device, (E) Any adulterated or misbranded tobacco product, (F) Any device that is a counterfeit device, (G) Any container, packaging, or labeling of a counterfeit device, and (H) Any punch, die, plate, stone, labeling, container, or other thing used or designed for use in making a counterfeit device or devices. (3)(A) Except as provided in subparagraph (B), no libel for condemnation may be instituted under paragraph (1) or (2) against any food which— (i) is misbranded under section 343(a)(2) of this title because of its advertising, and (ii) is being held for sale to the ultimate con- sumer in an establishment other than an es- tablishment owned or operated by a manufac- turer, packer, or distributor of the food. (B) A libel for condemnation may be instituted under paragraph (1) or (2) against a food de- scribed in subparagraph (A) if— (i)(I) the food’s advertising which resulted in the food being misbranded under section 343(a)(2) of this title was disseminated in the establishment in which the food 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 adver- tising was paid by such owner or operator; and (ii) the owner or operator of such establish- ment used such advertising in the establish- ment to promote the sale of the food. (b) Procedure; multiplicity of pending pro- ceedings The article, equipment, or other thing pro- ceeded against shall be liable to seizure by proc- ess 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 dis- trict 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 rea- sonable 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 reason- able proximity to the claimant’s principal place of business, in which all such pending pro- ceedings 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 no- tification thereof to the other courts having ju- risdiction 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 at- torney or agent, to obtain a representative sam- ple 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 con- demnation; claims for remission or mitiga- tion of forfeitures (1) Any food, drug, device, tobacco product, or cosmetic condemned under this section shall, after entry of the decree, be disposed of by de- struction or sale as the court may, in accord- ance with the provisions of this section, direct and the proceeds thereof, if sold, less the legal costs and charges, shall be paid into the Treas- ury 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 ju- risdiction in which sold. After entry of the de- cree and upon the payment of the costs of such proceedings and the execution of a good and suf- ficient bond conditioned that such article shall not be sold or disposed of contrary to the provi- sions of this chapter or the laws of any State or Territory 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, and the ex- penses of such supervision shall be paid by the person obtaining release of the article under bond. If the article was imported into the United States and the person seeking its release estab- lishes (A) that the adulteration, misbranding, or violation did not occur after the article was im- ported, and (B) that he had no cause for believ- ing that it was adulterated, misbranded, 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 can and will be met. The provisions of this sen- tence shall not apply where condemnation is based upon violation of section 342(a)(1), (2), or (6), section 351(a)(3), section 352(j), or section 361(a) or (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 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 have Page 66 TITLE 21—FOOD AND DRUGS § 334 been met. Any person seeking to export an im- ported 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 or 355 of this title, be intro- duced into interstate commerce, shall be dis- posed of by destruction. (2) The provisions of paragraph (1) of this sub- section 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 para- graph (2) of subsection (a). (3) Whenever in any proceeding under this sec- tion, involving paragraph (2) of subsection (a), the condemnation of any equipment or thing (other than a drug) is decreed, the court shall allow the claim of any claimant, to the extent of such claimant’s interest, for remission or miti- gation 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) and has no interest in any drug 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 facili- tate, the violation of laws of the United States relating to counterfeit drugs. (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, 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) or (b)— (1) The clerk of the court from which re- moval 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 re- moved 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 re- moved. (g) Administrative restraint; detention orders (1) If during an inspection conducted under section 374 of this title of a facility or a vehicle, a device, drug, or tobacco product which the of- ficer or employee making the inspection has reason to believe is adulterated or misbranded is found in such facility or vehicle, such officer or employee may order the device, drug, or tobacco product detained (in accordance with regula- tions prescribed by the Secretary) for a reason- able period which may not exceed twenty days unless the Secretary determines that a period of detention greater than twenty days is required to institute an action under subsection (a) or section 332 of this title, in which case he may authorize a detention period of not to exceed thirty days. Regulations of the Secretary pre- scribed under this paragraph shall require that before a device, drug, or tobacco product may be ordered detained under this paragraph the Sec- retary or an officer or employee designated by the Secretary approve such order. A detention order under this paragraph may require the la- beling or marking of a device, drug, or tobacco product during the period of its detention for the purpose of identifying the device, drug, or tobacco product as detained. Any person who would be entitled to claim a device, drug, or to- bacco product if it were seized under subsection (a) may appeal to the Secretary a detention of such device, drug, or tobacco product under this paragraph. Within five days of the date an ap- peal of a detention is filed with the Secretary, the Secretary shall after affording opportunity for an informal hearing by order confirm the de- tention or revoke it. (2)(A) Except as authorized by subparagraph (B), a device, drug, or tobacco product subject to a detention order issued under paragraph (1) shall not be moved by any person from the place at which it is ordered detained until— (i) released by the Secretary, or (ii) the expiration of the detention period ap- plicable to such order, whichever occurs first. (B) A device or drug subject to a detention order under paragraph (1) may be moved— (i) in accordance with regulations prescribed by the Secretary, and (ii) if not in final form for shipment, at the discretion of the manufacturer of the device or drug 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 employee of the Food and Drug Administration may order the detention, in accordance with this sub- section, of any article of food that is found during an inspection, examination, or inves- tigation under this chapter conducted by such officer or qualified employee, if the of- ficer or qualified employee has reason to be- lieve that such article is adulterated or mis- branded. (B) Secretary’s approval An article of food may be ordered detained under subparagraph (A) only if the Secretary or an official designated by the Secretary 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 offi- cial senior to such director. (2) Period of detention An article of food may be detained under paragraph (1) for a reasonable period, not to exceed 20 days, unless a greater period, not to exceed 30 days, is necessary, to enable the Sec- retary to institute an action under subsection (a) or section 332 of this title. The Secretary Page 67 TITLE 21—FOOD AND DRUGS § 334 shall by regulation provide for procedures for instituting such action on an expedited basis with respect to perishable foods. (3) Security of detained article An order under paragraph (1) with respect to an article of food may require that such arti- cle be labeled or marked as detained, and shall require that the article be removed to a secure facility, as appropriate. An article subject to such an order shall not be transferred by any person 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 or until the ex- piration of the detention period applicable under such order, whichever occurs first. This subsection may not be construed as author- izing 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 does not authorize the delivery of the ar- ticle 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 ordered detained under paragraph (1), any person who would be entitled to be a claimant for such article if the article were seized under subsection (a) may appeal the order to the Secretary. Within five days after such an ap- peal is filed, the Secretary, after providing opportunity for an informal hearing, shall confirm or terminate the order involved, and such confirmation by the Secretary shall be considered a final agency action for purposes of section 702 of title 5. If during such five- day period the Secretary fails to provide such an opportunity, or to confirm or termi- nate such order, the order is deemed to be terminated. (B) Effect of instituting court action The process under subparagraph (A) for the appeal of an order under paragraph (1) termi- nates if the Secretary institutes an action under subsection (a) or section 332 of this title regarding the article of food involved. (i) Procedures for promulgating regulations (1) In general In promulgating a regulation implementing this section, the Secretary 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 regula- tion; and (C) publish the final regulation not less than 30 days before the regulation’s effective date. (2) Restrictions Notwithstanding any other provision of Fed- eral law, in implementing this section, the Secretary shall only promulgate regulations as described in paragraph (1). (June 25, 1938, ch. 675, § 304, 52 Stat. 1044; June 24, 1948, ch. 613, § 2, 62 Stat. 582; Aug. 7, 1953, ch. 350, § 3, 67 Stat. 477; Pub. L. 85–250, Aug. 31, 1957, 71 Stat. 567; Pub. L. 89–74, § 6, July 15, 1965, 79 Stat. 232; Pub. L. 90–639, § 4(b), Oct. 24, 1968, 82 Stat. 1362; Pub. L. 91–513, title II, § 701(c), (d), Oct. 27, 1970, 84 Stat. 1281, 1282; Pub. L. 94–278, title V, § 502(a)(2)(C), Apr. 22, 1976, 90 Stat. 411; Pub. L. 94–295, §§ 3(c), 7(a), May 28, 1976, 90 Stat. 576, 582; Pub. L. 102–300, § 6(c), June 16, 1992, 106 Stat. 240; Pub. L. 103–80, § 3(f), Aug. 13, 1993, 107 Stat. 775; Pub. L. 105–115, title IV, § 418, Nov. 21, 1997, 111 Stat. 2379; Pub. L. 107–188, title III, § 303(a), June 12, 2002, 116 Stat. 663; Pub. L. 110–85, title IX, § 912(b)(1), Sept. 27, 2007, 121 Stat. 952; Pub. L. 111–31, div. A, title I, § 103(d), June 22, 2009, 123 Stat. 1836; Pub. L. 111–353, title II, § 207(a), Jan. 4, 2011, 124 Stat. 3944; Pub. L. 112–144, title VII, § 709(a), (b)(2), July 9, 2012, 126 Stat. 1069; Pub. L. 117–328, div. FF, title II, § 2513(c), Dec. 29, 2022, 136 Stat. 5805.) Editorial Notes AMENDMENTS 2022—Subsec. (a)(2)(F) to (H). Pub. L. 117–328 added cls. (F) to (H). 2012—Subsec. (g)(1). Pub. L. 112–144, § 709(a)(1), in- serted ‘‘, drug,’’ after ‘‘device’’ wherever appearing. Subsec. (g)(2)(A). Pub. L. 112–144, § 709(a)(2), inserted ‘‘, drug,’’ after ‘‘(B), a device’’. Subsec. (g)(2)(B). Pub. L. 112–144, § 709(a)(3), inserted ‘‘or drug’’ after ‘‘device’’ in introductory provisions and in cl. (ii). Subsec. (i). Pub. L. 112–144, § 709(b)(2), added subsec. (i). 2011—Subsec. (h)(1)(A). Pub. L. 111–353 substituted ‘‘reason to believe’’ for ‘‘credible evidence or informa- tion indicating’’ and ‘‘is adulterated or misbranded’’ for ‘‘presents a threat of serious adverse health con- sequences or death to humans or animals’’. 2009—Subsec. (a)(2)(E). Pub. L. 111–31, § 103(d)(1), added cl. (E). Subsec. (d)(1). Pub. L. 111–31, § 103(d)(2), inserted ‘‘to- bacco product,’’ after ‘‘device,’’ in first sentence. Subsec. (g)(1). Pub. L. 111–31, § 103(d)(3), inserted ‘‘or tobacco product’’ after ‘‘device’’ wherever appearing. Subsec. (g)(2)(A). Pub. L. 111–31, § 103(d)(4), inserted ‘‘or tobacco product’’ after ‘‘device’’ in introductory provisions. 2007—Subsec. (a)(1). Pub. L. 110–85 substituted ‘‘sec- tion 331(ll), 344, or 355’’ for ‘‘section 344 or 355’’. 2002—Subsec. (h). Pub. L. 107–188 added subsec. (h). 1997—Subsec. (d)(1). Pub. L. 105–115 substituted ‘‘sub- paragraphs (A) and (B) of section 381(e)(1) of this title’’ for ‘‘paragraphs (1) and (2) of section 381(e) of this title’’ and inserted ‘‘Any person seeking to export an im- ported 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.’’ before ‘‘Any article condemned by reason’’. 1993—Subsec. (a)(1). Pub. L. 103–80, § 3(f)(1), sub- stituted ‘‘found. No libel’’ for ‘‘found: Provided, however, That no libel’’. Subsec. (d)(1). Pub. L. 103–80, § 3(f)(2), substituted ‘‘sold. After entry’’ for ‘‘sold: Provided, That after entry’’, ‘‘met. The provisions of this sentence’’ for ‘‘met: Provided, however, That the provisions of this sentence’’, ‘‘title. Where such exportation’’ for ‘‘title: And provided further, That where such exportation’’, and ‘‘the preceding sentence shall not be applicable’’ for ‘‘the foregoing proviso shall not be applicable’’. 1992—Subsec. (d)(1). Pub. L. 102–300 substituted ‘‘381(e)’’ for ‘‘381(d)’’ in three places and ‘‘paragraphs’’ for ‘‘clauses’’ before ‘‘(1) and (2) of section 381(e)’’. 1976—Subsec. (a)(1). Pub. L. 94–295, § 3(c)(1), struck out ‘‘device,’’ after ‘‘Any article of food, drug,’’. Subsec. (a)(2). Pub. L. 94–295, § 3(c)(2), (3), added cl. (D) covering adulterated or misbranded devices. Subsec. (a)(3). Pub. L. 94–278 added par. (3). Page 68 TITLE 21—FOOD AND DRUGS § 335 Subsec. (g). Pub. L. 94–295, § 7(a), added subsec. (g). 1970—Subsec. (a)(2). Pub. L. 91–513, § 701(c), struck out cls. (A) and (D) which dealt with depressant or stimu- lant drugs, struck out reference to depressant or stimu- lant drugs in cl. (C), and redesignated cls. (B), (C), and (E) as cls. (A), (B), and (C), respectively. Subsec. (d)(3)(iii). Pub. L. 91–513, § 701(d), struck out reference to depressant or stimulant drugs. 1968—Subsec. (a). Pub. L. 90–639 inserted references to the United States courts of Territories. 1965—Subsec. (a). Pub. L. 89–74, § 6(a), designated ex- isting provisions as par. (1), redesignated cls. (1) and (2) of proviso as (A) and (B), and added par. (2). Subsec. (b). Pub. L. 89–74, § 6(b)(1), inserted ‘‘equip- ment, or other thing proceeded against’’ after ‘‘article’’ in first sentence. Subsec. (d). Pub. L. 89–74, § 6(b)(2), designated existing provisions as par. (1), redesignated cls. (1) and (2) of the second sentence thereof as (A) and (B), and added pars. (2) and (3). 1957—Subsec. (d). Pub. L. 85–250 permitted, under cer- tain circumstances, reexportation of articles con- demned at places other than original port of entry. 1953—Subsec. (c). Act Aug. 7, 1953, provided that a true copy of the analysis in any case shall be furnished the owner. 1948—Subsec. (a). Act June 24, 1948, inserted ‘‘or while held for sale (whether or not the first sale) after ship- ment in interstate commerce’’ to make this subsection coextensive with section 331(k) of this title. Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 2012 AMENDMENT Pub. L. 112–144, title VII, § 709(c), July 9, 2012, 126 Stat. 1070, provided that: ‘‘The amendments made by sub- section (a) [amending this section] shall not take effect until the Secretary has issued a final regulation under subsection (b) [amending this section and enacting pro- visions set out as a note under this section].’’ [Final regulation issued May 29, 2014, effective June 30, 2014. See 79 F.R. 30716.] EFFECTIVE DATE OF 2011 AMENDMENT Pub. L. 111–353, title II, § 207(c), Jan. 4, 2011, 124 Stat. 3944, provided that: ‘‘The amendment made by this sec- tion [amending this section] shall take effect 180 days after the date of enactment of this Act [Jan. 4, 2011].’’ EFFECTIVE DATE OF 1997 AMENDMENT Amendment by Pub. L. 105–115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as a note under section 321 of this title. EFFECTIVE DATE OF 1976 AMENDMENT Pub. L. 94–278, title V, § 502(c), Apr. 22, 1976, 90 Stat. 413, provided that: ‘‘The amendments made by sub- section (a) [amending this section and sections 321, 333, and 343 of this title] shall take effect 180 days after the date of the enactment of this Act [Apr. 22, 1976].’’ 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. REGULATIONS Pub. L. 112–144, title VII, § 709(b)(1), July 9, 2012, 126 Stat. 1069, provided that: ‘‘Not later than 2 years after the date of the enactment of this Act [July 9, 2012], the Secretary of Health and Human Services shall promul- gate regulations in accordance with section 304(i) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 334(i)], as added by paragraph (2) of this subsection, to imple- ment administrative detention authority with respect to drugs, as authorized by the amendments made by subsection (a) [amending this section]. Before promul- gating such regulations, the Secretary shall consult with stakeholders, including manufacturers of drugs.’’ Pub. L. 111–353, title II, § 207(b), Jan. 4, 2011, 124 Stat. 3944, provided that: ‘‘Not later than 120 days after the date of enactment of this Act [Jan. 4, 2011], the Sec- retary shall issue an interim final rule amending sub- part K of part 1 of title 21, Code of Federal Regulations, to implement the amendment made by this section [amending this section].’’ SAVINGS PROVISION Amendment by Pub. L. 91–513 not to affect or abate any prosecutions for any violation of law or any civil seizures or forfeitures and injunctive proceedings com- menced prior to the effective date of such amendment, and all administrative proceedings pending before the Bureau of Narcotics and Dangerous Drugs [now the Drug Enforcement Administration] on Oct. 27, 1970, to be continued and brought to final determination in ac- cord with laws and regulations in effect prior to Oct. 27, 1970, see section 702 of Pub. L. 91–513, set out as a note under section 321 of this title. CONSTRUCTION OF 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. 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. § 335. Hearing before report of criminal violation Before any violation of this chapter is re- ported by the Secretary to any United States at- torney for institution of a criminal proceeding, the person against whom such proceeding is con- templated shall be given appropriate notice and an opportunity to present his views, either oral- ly or in writing, with regard to such con- templated proceeding. (June 25, 1938, ch. 675, § 305, 52 Stat. 1045.) 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.