‘‘(1) IN GENERAL.—An order assessing a civil 
penalty against a person under subsection (a) shall 
be final unless the person—
‘‘(A) not later than 30 days after the effec-
tive date of the order, files a petition for judi-
cial review of the order in—
‘‘(i) the United States court of ap-
peals for the circuit in which the person re-
sides or has its principal place of business; 
or 
‘‘(ii) the United States Court of Ap-
peals for the District of Columbia Circuit; 
and 
‘‘(B) simultaneously sends a copy of the 
petition by certified mail to the Secretary. 
‘‘(2) FILING OF COPY OF RECORD.—The Sec-
retary shall promptly file in the court a certified 
copy of the record on which the order was issued. 
‘‘(c) COLLECTION ACTIONS FOR FAILURE TO PAY 
ASSESSMENT.—
‘‘(1) REFERRAL TO ATTORNEY GENERAL.—If a 
person fails to pay a civil penalty assessed under 
subsection (a) after the order assessing the civil pen-
alty has become a final order, or after the court of 
appeals has entered final judgment in favor of the
Secretary, the Secretary shall refer the matter to the 
Attorney General. 
‘‘(2) ACTION
BY
ATTORNEY
GENERAL.—The 
Attorney General shall bring a civil action to recover 
the amount of the civil penalty in United States dis-
trict court. 
‘‘(3) SCOPE
OF
REVIEW.—In a civil action 
under paragraph (2), the validity and appropriate-
ness of the order of the Secretary assessing the civil 
penalty shall not be subject to review. 
‘‘(d) REFUSAL
OR WITHDRAWAL
OF INSPECTION 
PENDING PAYMENT.—If a person fails to pay the amount 
of a civil penalty after the order assessing the civil penalty 
has become a final order, the Secretary may refuse to pro-
vide or withdraw inspection under this Act of the person 
until the civil penalty is paid or until the Secretary directs 
otherwise. 
‘‘(e) PENALTIES IN LIEU OF OTHER ACTIONS.—
Nothing in this Act requires the Secretary to report for 
prosecution, or for the commencement of an action, any 
violation of this Act in any case in which the Secretary 
believes that the public interest will be adequately served 
by the assessment of a civil penalty under this section.
‘‘(f) REMEDIES NOT EXCLUSIVE.—The remedies au-
thorized by this section shall be in addition to any other 
remedies that may be available.’’. 
SEC. 4. NOTIFICATION, NONDISTRIBUTION, AND RECALL 
OF ADULTERATED OR MISBRANDED ARTI-
CLES OF FOOD. 
(a) PROHIBITED ACTS.—Section 301 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amend-
ed by adding at the end the following: 
‘‘(hh)(1) The failure to notify the Secretary in viola-
tion of section 311(a). 
‘‘(2) The failure to comply with—
‘‘(A) an order issued under section 311(b) fol-
lowing any hearing requested under section 311(c); 
or 
‘‘(B) an amended order issued under section 
311(d)(1).’’. 
(b) NOTIFICATION, NONDISTRIBUTION, AND RECALL 
OF ADULTERATED OR MISBRANDED ARTICLES OF FOOD; 
CIVIL PENALTIES RELATING TO FOODS.—Chapter III of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331 
et seq.) is amended by adding at the end the following:
‘‘SEC. 311. NOTIFICATION, NONDISTRIBUTION, AND RECALL 
OF ADULTERATED OR MISBRANDED ARTI-
CLES OF FOOD. 
‘‘(a) NOTIFICATION TO SECRETARY OF VIOLATION.—
‘‘(1) IN
GENERAL.—A person (other than a 
household consumer or other individual who is the 
intended consumer of an article of food) that has 
reason to believe that an article of food when intro-
duced into or while in interstate commerce, or while 
held for sale (regardless of whether the first sale) 
after shipment in interstate commerce, is adulter-
ated or misbranded in a manner that, if consumed, 
may result in illness or injury shall, as soon as prac-
ticable, notify the Secretary of the identity and loca-
tion of the article. 
‘‘(2) MANNER OF NOTIFICATION.—Notification 
under paragraph (1) shall be made in such manner 
and by such means as the Secretary may require by 
regulation. 
‘‘(b) RECALL AND CONSUMER NOTIFICATION.—
‘‘(1) VOLUNTARY ACTIONS.—On receiving noti-
fication under subsection (a) or by other means, if 
the Secretary finds that an article of food when in-
troduced into or while in interstate commerce, or 
while held for sale (regardless of whether the first 
sale) after shipment in interstate commerce, is adul-
terated or misbranded in a manner that, if con-
sumed, may result in illness or injury (as determined 
by the Secretary), the Secretary shall provide all ap-
propriate persons (including the manufacturer, im-
porter, distributor, or retailer of the article) with an 
opportunity (as determined by the Secretary)—
‘‘(A) to cease distribution of the article; 
‘‘(B) to notify all persons—
‘‘(i) that produce, manufacture, pack, 
process, prepare, treat, package, distribute, 
or hold the article, to cease immediately 
those activities with respect to the article; 
or 
‘‘(ii) to which the article has been dis-
tributed, transported, or sold, to cease im-
mediately distribution of the article; 
‘‘(C) to recall the article; or 
‘‘(D) in consultation with the Secretary, to 
provide notice of the finding of the Secretary to 
all consumers to which the article was, or may 
have been, distributed. 
‘‘(2) MANDATORY ACTIONS.—If the appropriate 
person referred to in paragraph (1) does not carry 
out the actions described in that paragraph with re-
spect to an article within the time period and in the
manner prescribed by the Secretary, the Secretary 
shall, by order, require, as the Secretary determines 
to be necessary, the person—
‘‘(A) to cease immediately distribution of 
the article; and 
‘‘(B) to make immediately the notification 
described in paragraph (1)(B). 
‘‘(3) NOTICE TO CONSUMERS.—The Secretary 
shall, as the Secretary determines to be necessary, 
provide notice of the finding of the Secretary under 
paragraph (1) to consumers to which the article was, 
or may have been, distributed. 
‘‘(c) HEARINGS ON ORDERS.—
‘‘(1) IN GENERAL.—The Secretary shall provide 
a person subject to an order under subsection (b) 
with an opportunity for a hearing on—
‘‘(A) the actions required by the order; and 
‘‘(B) any reasons why the article of food 
that is the subject of the order should not be 
recalled. 
‘‘(2) TIMING
OF
HEARINGS.—The Secretary 
shall hold a hearing under paragraph (1) as soon as 
practicable, but not later than 2 business days, after 
the date of issuance of the order. 
‘‘(d) POST-HEARING RECALL ORDERS.—
not exist to continue the actions required by the 
order, the Secretary shall vacate the order. 
‘‘(e) REMEDIES NOT EXCLUSIVE.—The remedies au-
thorized by this section shall be in addition to any other 
remedies that may be available. 
‘‘SEC. 312. CIVIL PENALTIES RELATING TO FOODS. 
‘‘(a) IN GENERAL.—
‘‘(1) ASSESSMENT.—The Secretary may assess 
against a person that commits an act prohibited by 
section 301 with respect to an article of food a civil 
penalty for each such act of not more than—
‘‘(A) $100,000, in the case of an indi-
vidual; and 
‘‘(B) $500,000, in the case of any other 
person. 
‘‘(2) SEPARATE
OFFENSES.—Each prohibited 
act and each day during which the act continues 
shall be considered to be a separate offense. 
‘‘(3) NOTICE
AND
OPPORTUNITY
FOR
HEAR-
ING.—The Secretary shall not assess a civil penalty 
under this section against a person unless the person 
is given notice and opportunity for a hearing on the 
record before the Secretary in accordance with sec-
tions 554 and 556 of title 5, United States Code.
‘‘(4) DETERMINATION
OF
CIVIL
PENALTY 
AMOUNT.—The amount of a civil penalty under this 
section—
‘‘(A) shall be assessed by the Secretary by 
written order, taking into account—
‘‘(i) the gravity of the violation; 
‘‘(ii) the degree of culpability of the 
person; 
‘‘(iii) the size and type of the business 
of the person; and 
‘‘(iv) any history of prior offenses by 
the person; and 
‘‘(B) shall be reviewed only in accordance 
with subsection (b). 
‘‘(b) JUDICIAL REVIEW.—
‘‘(1) IN GENERAL.—An order assessing a civil 
penalty against a person under subsection (a) shall 
be final unless the person—
‘‘(A) not later than 30 days after the effec-
tive date of the order, files a petition for judi-
cial review of the order in—
‘‘(i) the United States court of ap-
peals for the circuit in which the person re-
sides or has its principal place of business; 
or
‘‘(ii) the United States Court of Ap-
peals for the District of Columbia Circuit; 
and 
‘‘(B) simultaneously sends a copy of the 
petition by certified mail to the Secretary. 
‘‘(2) FILING OF COPY OF RECORD.—The Sec-
retary shall promptly file in the court a certified 
copy of the record on which the order was issued. 
‘‘(3) STANDARD OF REVIEW.—The findings of 
the Secretary relating to the order shall be set aside 
only if the findings are found to be unsupported by 
substantial evidence on the record as a whole. 
‘‘(c) COLLECTION ACTIONS FOR FAILURE TO PAY 
ASSESSMENT.—
‘‘(1) REFERRAL TO ATTORNEY GENERAL.—If a 
person fails to pay a civil penalty assessed under 
subsection (a) after the order assessing the civil pen-
alty has become a final order, or after the court of 
appeals has entered final judgment in favor of the 
Secretary, the Secretary may refer the matter to the 
Attorney General. 
‘‘(2) ACTION
BY
ATTORNEY
GENERAL.—The 
Attorney General shall bring a civil action to recover 
the amount of the civil penalty in United States dis-
trict court.
‘‘(3) SCOPE
OF
REVIEW.—In a civil action 
under paragraph (2), the validity and appropriate-
ness of the order of the Secretary assessing the civil 
penalty shall not be subject to review. 
‘‘(d) PENALTIES DEPOSITED
IN TREASURY.—All 
amounts collected as civil penalties under this section shall 
be deposited in the Treasury of the United States. 
‘‘(e) PENALTIES IN LIEU OF OTHER ACTIONS.—
Nothing in this Act requires the Secretary to report for 
prosecution, or for the commencement of any libel or in-
junction proceeding, any violation of this Act in any case 
in which the Secretary believes that the public interest will 
be adequately served by the assessment of a civil penalty 
under this section. 
‘‘(f) REMEDIES NOT EXCLUSIVE.—The remedies au-
thorized by this section shall be in addition to any other 
remedies that may be available.’’.
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