TITLE III—ENFORCEMENT 
SEC. 301. AMENDMENTS TO THE FEDERAL FOOD, DRUG, 
AND COSMETIC ACT. 
(a) IN GENERAL.—The Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 301 et seq.) is amended by add-
ing after section 415 the following new sections: 
‘‘SEC. 416. NOTIFICATION AND RECALL. 
‘‘(a) NOTICE TO SECRETARY OF ADULTERATION OR 
MISBRANDING.—Any person (other than a household con-
sumer or other individual who is the intended consumer 
of an article of food) that has a reasonable basis for believ-
ing that any article of food introduced into or in interstate 
commerce, or held for sale (whether or not the first sale) 
after shipment in interstate commerce, may be adulterated 
or misbranded or otherwise in violation of the Consumer 
Food Safety Act of 2005 shall immediately notify the Sec-
retary, in such manner and by such means as the Sec-
retary may by regulation prescribe, of the identity and lo-
cation of such article. 
‘‘(b) RECALL AND CONSUMER NOTIFICATION.— 
‘‘(1) VOLUNTARY
PROCEDURES.—If the Sec-
retary finds, upon notification under subsection (a) 
or otherwise, that any article of food 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 and there is a reasonable probability that 
such article, if consumed, would present a threat to 
public health, as determined by the Secretary, the 
Secretary shall provide the appropriate persons (in-
cluding the manufacturers, importers, distributors, 
or retailers) with an opportunity to— 
‘‘(A) cease distribution of such article; 
‘‘(B) notify all persons— 
‘‘(i) producing, manufacturing, pack-
ing, processing, preparing, treating, pack-
aging, distributing, or holding such article; 
or 
‘‘(ii) to which such article has been 
distributed, transported, or sold, to imme-
diately cease distribution of such article; 
‘‘(C) recall such article; 
‘‘(D) provide, in consultation with the Sec-
retary, notice to consumers to whom such arti-
cle was, or may have been, distributed; or 
‘‘(E) take any combination of the above 
measures, as appropriate in the circumstances. 
‘‘(2) PRE-HEARING ORDER TO CEASE DISTRIBU-
TION AND GIVE NOTICE.—If such person refuses to 
or does not voluntarily cease distribution, make noti-
fication, recall such article, or provide notice to con-
sumers, as applicable, within the time and in the 
manner prescribed by the Secretary, the Secretary 
shall, by order, require, as the Secretary deems nec-
essary, such person to— 
‘‘(A) immediately cease distribution of 
such article; 
‘‘(B) immediately notify all persons— 
‘‘(i) producing, manufacturing, pack-
ing, processing, preparing, treating, pack-
aging, distributing, or holding such article; 
or 
‘‘(ii) to which such article has been 
distributed, transported, or sold, to imme-
diately cease distribution of such article; or 
‘‘(C) immediately take the actions specified 
in both subparagraphs (A) and (B). 
‘‘(3) NOTIFICATION
OF
CONSUMERS
BY
SEC-
RETARY.—The Secretary shall, as the Secretary 
deems necessary, provide notice to consumers to 
whom such article was, or may have been, distrib-
uted. 
‘‘(c) HEARING ON ORDER.—The Secretary shall pro-
vide any person subject to an order under subsection (b) 
with an opportunity for a hearing, to be held as soon as
possible but not later than 2 days after the issuance of 
the order, on the actions required by the order and on 
why the article that is the subject of the order should not 
be recalled. 
‘‘(d) POST-HEARING RECALL ORDER.— 
‘‘(1) AMENDMENT OF ORDER.—If, after pro-
viding opportunity for a hearing under subsection 
(c), the Secretary determines that there is a reason-
able probability that the article that is the subject 
of an order under subsection (b), if consumed, pre-
sents a threat to public health, the Secretary, as the 
Secretary deems necessary, may— 
‘‘(A) amend the order to require recall of 
such article or other appropriate action; 
‘‘(B) specify a timetable in which the recall 
shall occur; 
‘‘(C) require periodic reports to the Sec-
retary describing the progress of the recall; and 
‘‘(D) provide notice to consumers to whom 
such article was, or may have been, distributed. 
‘‘(2) VACATION OF ORDER.—If, after such a 
hearing, the Secretary determines that adequate 
grounds do not exist to continue the actions required 
by the order, the Secretary shall vacate the order.