View all text of Subchapter III [§ 331 - § 337a]
§ 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 condemned 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 instituted under this chapter, for any alleged misbranding if there is pending in any court a libel for condemnation proceeding under this chapter based upon the same alleged misbranding, and not more than one such proceeding shall be instituted if no such proceeding is so pending, except that such limitations shall not apply (A) when such misbranding has been the basis of a prior judgment in favor of the United States, in a criminal, injunction, or libel for condemnation proceeding under this chapter, or (B) when the Secretary has probable cause to believe from facts found, without hearing, by him or any officer or employee of the Department that the misbranded article is dangerous to health, or that the labeling of the misbranded article is fraudulent, or would be in a material respect misleading to the injury or damage of the purchaser or consumer. In any case where the number of libel for condemnation proceedings is limited as above provided the proceeding pending or instituted shall, on application of the claimant, seasonably made, be removed for trial to any district agreed upon by stipulation between the parties, or, in case of failure to so stipulate within a reasonable time, the claimant may apply to the court of the district in which the seizure has been made, and such court (after giving the United States attorney for such district reasonable notice and opportunity to be heard) shall by order, unless good cause to the contrary is shown, specify a district of reasonable proximity to the claimant’s principal place of business, to which the case shall be removed for trial.
(2) The following shall be liable to be proceeded against at any time on libel of information and condemned in any district court of the United States or United States court of a Territory 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 consumer in an establishment other than an establishment owned or operated by a manufacturer, packer, or distributor of the food.
(B) A libel for condemnation may be instituted under paragraph (1) or (2) against a food described 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 advertising was paid by such owner or operator; and
(ii) the owner or operator of such establishment used such advertising in the establishment to promote the sale of the food.
(b) Procedure; multiplicity of pending proceedings
(c) Availability of samples of seized goods prior to trial
(d) Disposition of goods after decree of condemnation; claims for remission or mitigation 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 destruction or sale as the court may, in accordance with the provisions of this section, direct and the proceeds thereof, if sold, less the legal costs and charges, shall be paid into the Treasury of the United States; but such article shall not be sold under such decree contrary to the provisions of this chapter or the laws of the jurisdiction in which sold. After entry of the decree and upon the payment of the costs of such proceedings and the execution of a good and sufficient bond conditioned that such article shall not be sold or disposed of contrary to the provisions of this chapter or the laws of any State 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 expenses 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 establishes (A) that the adulteration, misbranding, or violation did not occur after the article was imported, and (B) that he had no cause for believing that it was adulterated, misbranded, 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 sentence 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 been met. Any person seeking to export an imported article pursuant to any of the provisions of this subsection shall establish that the article was intended for export at the time the article entered commerce. Any article condemned by reason of its being an article which may not, under section 344 or 355 of this title, be introduced into interstate commerce, shall be disposed of by destruction.
(2) The provisions of paragraph (1) of this subsection shall, to the extent deemed appropriate by the court, apply to any equipment or other thing which is not otherwise within the scope of such paragraph and which is referred to in paragraph (2) of subsection (a).
(3) Whenever in any proceeding under this section, 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 mitigation of such forfeiture if such claimant proves to the satisfaction of the court (i) that he has not committed or caused to be committed any prohibited act referred to in such paragraph (2) 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 facilitate, the violation of laws of the United States relating to counterfeit drugs.
(e) Costs
(f) Removal of case for trialIn the case of removal for trial of any case as provided by subsection (a) or (b)—
(1) The clerk of the court from which removal is made shall promptly transmit to the court in which the case is to be tried all records in the case necessary in order that such court may exercise jurisdiction.
(2) The court to which such case was removed shall have the powers and be subject to the duties, for purposes of such case, which the court from which removal was made would have had, or to which such court would have been subject, if such case had not been removed.
(g) Administrative restraint; detention orders
(1) If during an inspection conducted under section 374 of this title of a facility or a vehicle, a device, drug, or tobacco product which the officer 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 regulations prescribed by the Secretary) for a reasonable 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 prescribed under this paragraph shall require that before a device, drug, or tobacco product may be ordered detained under this paragraph the Secretary or an officer or employee designated by the Secretary approve such order. A detention order under this paragraph may require the labeling 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 tobacco 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 appeal of a detention is filed with the Secretary, the Secretary shall after affording opportunity for an informal hearing by order confirm the detention 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 applicable 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
(B) Secretary’s approval
(2) Period of detention
(3) Security of detained article
(4) Appeal of detention order
(A) In general
(B) Effect of instituting court action
(i) Procedures for promulgating regulations
(1) In generalIn 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 regulation; and
(C) publish the final regulation not less than 30 days before the regulation’s effective date.
(2) Restrictions
(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.)