21 U.S.C. § 334 : US Code - Section 334: Seizure

Search 21 U.S.C. § 334 : US Code - Section 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.