§ 334. — Seizure.
[Laws in effect as of January 24, 2002]
[Document not affected by Public Laws enacted between
January 24, 2002 and December 19, 2002]
[CITE: 21USC334]
TITLE 21--FOOD AND DRUGS
CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER III--PROHIBITED ACTS AND PENALTIES
Sec. 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
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, and (D) Any adulterated or
misbranded device.
(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
The article, equipment, or other thing proceeded against shall be
liable to seizure by process pursuant to the libel, and the procedure in
cases under this section shall conform, as nearly as may be, to the
procedure in admiralty; except that on demand of either party any issue
of fact joined in any such case shall be tried by jury. When libel for
condemnation proceedings under this section, involving the same claimant
and the same issues of adulteration or misbranding, are pending in two
or more jurisdictions, such pending proceedings, upon application of the
claimant seasonably made to the court of one such jurisdiction, shall be
consolidated for trial by order of such court, and tried in (1) any
district selected by the claimant where one of such proceedings is
pending; or (2) a district agreed upon by stipulation between the
parties. If no order for consolidation is so made within a reasonable
time, the claimant may apply to the court of one such jurisdiction and
such court (after giving the United States attorney for such district
reasonable notice and opportunity to be heard) shall by order, unless
good cause to the contrary is shown, specify a district of reasonable
proximity to the claimant's principal place of business, in which all
such pending proceedings shall be consolidated for trial and tried. Such
order of consolidation shall not apply so as to require the removal of
any case the date for trial of which has been fixed. The court granting
such order shall give prompt notification thereof to the other courts
having jurisdiction of the cases covered thereby.
(c) Availability of samples of seized goods prior to trial
The court at any time after seizure up to a reasonable time before
trial shall by order allow any party to a condemnation proceeding, his
attorney or agent, to obtain a representative sample of the article
seized and a true copy of the analysis, if any, on which the proceeding
is based and the identifying marks or numbers, if any, of the packages
from which the samples analyzed were obtained.
(d) Disposition of goods after decree of condemnation; claims for
remission or mitigation of forfeitures
(1) Any food, drug, device, 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) of this section.
(3) Whenever in any proceeding under this section, involving
paragraph (2) of subsection (a) of this section, 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
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) of this section--
(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 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 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) of
this section 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 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 during the period of its detention for
the purpose of identifying the device as detained. Any person who would
be entitled to claim a device if it were seized under subsection (a) of
this section may appeal to the Secretary a detention of such device
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 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 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 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
subsection, of any article of food that is found during an
inspection, examination, or investigation under this chapter
conducted by such officer or qualified employee, if the officer
or qualified employee has credible evidence or information
indicating that such article presents a threat of serious
adverse health consequences or death to humans or animals.
(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 official 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 Secretary to
institute an action under subsection (a) of this section or section
332 of this title. The Secretary 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 article 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 expiration of the detention period applicable under such
order, whichever occurs first. This subsection may not be construed
as authorizing the delivery of the article pursuant to the execution
of a bond while the article is subject to the order, and section
381(b) of this title does not authorize the delivery of the article
pursuant to the execution of a bond while the article is subject to
the order.
(4) Appeal of detention order
(A) In general
With respect to an article of food 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)
of this section may appeal the order to the Secretary. Within
five days after such an appeal 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
terminate 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) terminates if the Secretary institutes
an action under subsection (a) of this section or section 332 of
this title regarding the article of food involved.
(June 25, 1938, ch. 675, Sec. 304, 52 Stat. 1044; June 24, 1948, ch.
613, Sec. 2, 62 Stat. 582; Aug. 7, 1953, ch. 350, Sec. 3, 67 Stat. 477;
Pub. L. 85-250, Aug. 31, 1957, 71 Stat. 567; Pub. L. 89-74, Sec. 6, July
15, 1965, 79 Stat. 232; Pub. L. 90-639, Sec. 4(b), Oct. 24, 1968, 82
Stat. 1362; Pub. L. 91-513, title II, Sec. 701(c), (d), Oct. 27, 1970,
84 Stat. 1281, 1282; Pub. L. 94-278, title V, Sec. 502(a)(2)(C), Apr.
22, 1976, 90 Stat. 411; Pub. L. 94-295, Secs. 3(c), 7(a), May 28, 1976,
90 Stat. 576, 582; Pub. L. 102-300, Sec. 6(c), June 16, 1992, 106 Stat.
240; Pub. L. 103-80, Sec. 3(f), Aug. 13, 1993, 107 Stat. 775; Pub. L.
105-115, title IV, Sec. 418, Nov. 21, 1997, 111 Stat. 2379; Pub. L. 107-
188, title III, Sec. 303(a), June 12, 2002, 116 Stat. 663.)
Amendments
2002--Subsec. (h). Pub. L. 107-188 added subsec. (h).
1997--Subsec. (d)(1). Pub. L. 105-115 substituted ``subparagraphs
(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 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.'' before ``Any article
condemned by reason''.
1993--Subsec. (a)(1). Pub. L. 103-80, Sec. 3(f)(1), substituted
``found. No libel'' for ``found: Provided, however, That no libel''.
Subsec. (d)(1). Pub. L. 103-80, Sec. 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, Sec. 3(c)(1), struck out
``device,'' after ``Any article of food, drug,''.
Subsec. (a)(2). Pub. L. 94-295, Sec. 3(c)(2), (3), added cl. (D)
covering adulterated or misbranded devices.
Subsec. (a)(3). Pub. L. 94-278 added par. (3).
Subsec. (g). Pub. L. 94-295, Sec. 7(a), added subsec. (g).
1970--Subsec. (a)(2). Pub. L. 91-513, Sec. 701(c), struck out cls.
(A) and (D) which dealt with depressant or stimulant drugs, struck out
reference to depressant or stimulant 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, Sec. 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, Sec. 6(a), designated existing
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, Sec. 6(b)(1), inserted ``equipment, or
other thing proceeded against'' after ``article'' in first sentence.
Subsec. (d). Pub. L. 89-74, Sec. 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 certain
circumstances, reexportation of articles condemned 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 shipment in interstate
commerce'' to make this subsection coextensive with section 331(k) of
this title.
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
Section 502(c) of Pub. L. 94-278 provided that: ``The amendments
made by subsection (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 respect to
violations of this chapter committed after Oct. 24, 1968, see section 6
of Pub. L. 90-639, set out as an Effective Date of 1968 Amendments;
Transitional Provisions 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 section 321 of this title.
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 commenced 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 accord 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.
Transfer of Functions
For transfer of functions of Federal Security Administrator 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 note set out under section
41 of this title.
Section Referred to in Other Sections
This section is referred to in sections 331, 333, 360j, 372 of this
title; title 42 section 1396r-8.
