shall provide each responsible person with an opportunity 
to cease distribution and recall such cosmetic. 
‘‘(b) PREHEARING ORDER TO CEASE DISTRIBUTION 
AND GIVE NOTICE.— 
‘‘(1) IN GENERAL.—If a responsible person re-
fuses to or does not voluntarily cease distribution or 
recall such cosmetic within the time and in the man-
ner prescribed by the Secretary (if so prescribed), 
the Secretary may, by order require, as the Sec-
retary deems necessary, such person to— 
‘‘(A) immediately cease distribution of 
such cosmetic; and 
‘‘(B) as applicable, immediately notify all 
persons— 
‘‘(i) manufacturing, packing, or hold-
ing such cosmetic, and 
‘‘(ii) to which such cosmetic has been 
distributed, transported, or sold, 
to immediately cease distribution of such cos-
metic. 
‘‘(2) DETERMINATION
TO
LIMIT
AREAS
AF-
FECTED.—If the Secretary requires a responsible 
person to cease distribution under paragraph (1)(A) 
of a cosmetic identified in subsection (a), the Sec-
retary may limit the size of the geographic area and 
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the markets affected by such cessation if such limi-
tation would not compromise the public health. 
‘‘(c) HEARING ON ORDER.—The Secretary shall pro-
vide a responsible person subject to an order under sub-
section (b) with an opportunity for an informal 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 cosmetic that is the subject 
of the order should not be recalled. 
‘‘(d) POST-HEARING RECALL ORDER AND MODIFICA-
TION OF ORDER.— 
‘‘(1) AMENDMENT OF ORDER.—If, after pro-
viding opportunity for an informal hearing under 
subsection (c), the Secretary determines that re-
moval of the cosmetic from commerce is necessary, 
the Secretary shall, as appropriate— 
‘‘(A) amend the order to require recall of 
such cosmetic 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 cosmetic was, or may have been, distrib-
uted. 
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‘‘(2) VACATING OF ORDER.—If, after such hear-
ing, the Secretary determines that adequate grounds 
do not exist to continue the actions required by the 
order, or that such actions should be modified, the 
Secretary shall vacate the order or modify the order. 
‘‘(e) COOPERATION AND CONSULTATION.—The Sec-
retary shall work with State and local public health offi-
cials in carrying out this section, as appropriate. 
‘‘(f) PUBLIC NOTIFICATION.—In conducting a recall 
under this section, the Secretary shall— 
‘‘(1) ensure that a press release is published re-
garding the recall, as well as alerts and public no-
tices, as appropriate, in order to provide notifica-
tion— 
‘‘(A) of the recall to consumers and retail-
ers to whom such cosmetic was, or may have 
been, distributed; and 
‘‘(B) that includes, at a minimum— 
‘‘(i) the name of the cosmetic subject 
to the recall; 
‘‘(ii) a description of the risk associ-
ated with such cosmetic; and 
‘‘(iii) to the extent practicable, infor-
mation for consumers about similar cos-
metics that are not affected by the recall; 
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‘‘(2) shall consider providing a list to the public 
of retail consignees receiving products involved in a 
Class I recall, as determined appropriate by the Sec-
retary; and 
‘‘(3) if available, publish on the Internet Web 
site of the Food and Drug Administration an image 
of the cosmetic that is the subject of the press re-
lease described in (1). 
‘‘(g) NO DELEGATION.—The authority conferred by 
this section to order a recall or vacate a recall order shall 
not be delegated to any officer or employee other than the 
Commissioner. 
‘‘(h) EFFECT.—Nothing in this section shall affect 
the authority of the Secretary to request or participate 
in a voluntary recall, or to issue an order to cease distribu-
tion or to recall under any other provision of this Act or 
under the Public Health Service Act. 
‘‘(i) RESPONSIBLE PERSON DEFINED.—In this sec-
tion, the term ‘responsible person’ has the meaning given 
to such term in section 604(c).’’. 
SEC. 8. EFFECTIVE DATES. 
(a) The amendments made by sections 2(a), 3, 4, 5, 
and 7 shall take effect 18 months after the date of enact-
ment of this Act. 
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(b) The amendments made by sections 2(b) and 6 
shall take effect 3 years after the date of enactment of 
this Act. 
Æ 
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