Grounds and jurisdiction
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.
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, and (E) Any adulterated or misbranded tobacco product.
Except as provided in subparagraph (B), no libel for condemnation may be instituted under paragraph (1) or (2) against any food which—
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.
A libel for condemnation may be instituted under paragraph (1) or (2) against a food described in subparagraph (A) if—
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,
such advertising was disseminated by, or under the direction of, the owner or operator of such establishment, or
all or part of the cost of such advertising was paid by such owner or operator; and
the owner or operator of such establishment used such advertising in the establishment to promote the sale of the food.
Disposition of goods after decree of condemnation; claims for remission or mitigation of forfeitures
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
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).
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.
[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].)