duced into or while in interstate commerce, or while 
held for sale (regardless of whether such sale is the 
first sale of such cosmetic) after shipment in inter-
state commerce, is misbranded under section 602(g) 
shall notify the Secretary of the identity and location 
of the cosmetic. 
‘‘(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 or guidance. 
‘‘(3) RESPONSIBLE PARTY DEFINED.—For pur-
poses of this subsection, the term ‘responsible party’ 
means a brand owner, manufacturer, packager, re-
tailer, or distributor of the cosmetic. 
‘‘(c) VOLUNTARY RECALL.—The Secretary may re-
quest that any person who distributes a cosmetic that the 
Secretary has reason to believe is misbranded under sec-
tion 602(g) voluntarily— 
‘‘(1) recall such cosmetic; and 
‘‘(2) provide for notice, including to individuals 
as appropriate, to persons who may be affected by 
the recall. 
‘‘(d) ORDER TO CEASE DISTRIBUTION.— 
‘‘(1) IN GENERAL.—If the Secretary has reason 
to believe that the cosmetic is misbranded under sec-
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tion 602(g), the Secretary shall have the authority 
to issue an order requiring any person who distrib-
utes such cosmetic to immediately cease distribution 
of such cosmetic. 
‘‘(2) CEASE DISTRIBUTION AND NOTICE.—Any 
person who is subject to an order under paragraph 
(1) shall immediately cease distribution of such cos-
metic and provide notification as required by such 
order. 
‘‘(3) APPEAL.— 
‘‘(A) 48 HOURS.—A person subject to an 
order under paragraph (1) may appeal such 
order to the Secretary within 48 hours of the 
issuance of such order. 
‘‘(B) CONTENTS OF APPEAL.—Such appeal 
may include a request for an informal hearing 
and a description of any efforts to recall such 
cosmetic undertaken voluntarily by the person, 
including after a request under subsection (b). 
‘‘(C) INFORMAL
HEARING.—An informal 
hearing shall be held as soon as practicable, but 
not later than 5 calendar days (or less as deter-
mined by the Secretary) after such an appeal is 
filed, unless the parties jointly agree to an ex-
tension. 
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‘‘(D) IMPACT ON RECALL.—If an appeal is 
filed under subparagraph (A), the Secretary 
may not amend the order to require a recall 
under subsection (d) until after the conclusion 
of the hearing under subparagraph (C). 
‘‘(4) VACATION OF ORDER.—If the Secretary 
determines that inadequate grounds exist to support 
the actions required by the order under paragraph 
(1), the Secretary shall vacate the order. 
‘‘(e) NOTICE TO CONSUMERS AND HEALTH OFFI-
CIALS.—The Secretary shall, as the Secretary determines 
to be necessary, provide public notice of an order to cease 
distribution or recalling a misbranded cosmetic under this 
section to all consumers in a prominent manner on the 
website of the Food and Drug Administration and to ap-
propriate State and local health officials. 
‘‘(f) SUPPLY CHAIN INFORMATION.— 
‘‘(1) IN GENERAL.—In the case of a cosmetic 
that the Secretary has reason to believe is mis-
branded under section 602(g), the Secretary shall 
request that the brand owner named on the label of 
such cosmetic (as required under section 602(b)(1)) 
submit all of the following information: 
‘‘(A) The name and place of business of 
the manufacturer, packager, supplier, or dis-
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tributor from which such entity received the 
cosmetic or ingredients for manufacturing such 
cosmetic. 
‘‘(B) The name and place of business of 
any entity (including any retailer) that was pro-
vided with such cosmetic by the entity named 
on the label. 
‘‘(2) COLLECTION
OF
ADDITIONAL
SUPPLY 
CHAIN
INFORMATION.—In the case of a cosmetic 
that the Secretary has reason to believe is mis-
branded under section 602(g), to the extent nec-
essary to protect the safety of the public, the Sec-
retary may request that any entity (including a sup-
plier of an ingredient, manufacturer, packer, dis-
tributor, or retailer) in the supply chain of such cos-
metic submit to the Secretary information that is 
similar to the information described under subpara-
graphs (A) and (B) of paragraph (1). 
‘‘(3) MAINTENANCE OF RECORDS.—Any entity 
in the supply chain of a cosmetic (including the 
brand owner named on the label of a cosmetic) 
shall— 
‘‘(A) maintain records sufficient to provide 
the information described in subparagraphs (A) 
and (B) of paragraph (1); and 
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‘‘(B) provide such information to the Sec-
retary upon the request of the Secretary. 
‘‘(g) SAVINGS CLAUSE.—Nothing contained in this 
section shall be construed as limiting the authority of the 
Secretary to issue an order to cease distribution of, or to 
recall, a cosmetic under any other provision of this Act.’’. 
Æ 
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