I 
110TH CONGRESS 
1ST SESSION H. R. 2099 
To authorize the Secretary of Health and Human Services to order a manda-
tory recall of any product that is regulated by the Food and Drug 
Administration, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 1, 2007 
Ms. SUTTON introduced the following bill; which was referred to the 
Committee on Energy and Commerce 
A BILL 
To authorize the Secretary of Health and Human Services 
to order a mandatory recall of any product that is regu-
lated by the Food and Drug Administration, and for 
other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Protect Consumers Act 
of 2007’’. 
SEC. 2. AUTHORITY TO IMPLEMENT MANDATORY RECALL. 
(a) IN GENERAL.—If the Secretary of Health and 
Human Services determines that it is necessary to imple-
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ment a mandatory recall of any product that is regulated 
by the Food and Drug Administration, the Secretary shall 
issue an order requiring the appropriate person (including 
the manufacturers, importers, distributors, or retailers of 
the product)— 
(1) to immediately cease distribution, manufac-
ture, and sale of such product, 
(2) to immediately provide for notice to individ-
uals subject to the risks associated with the use of 
such product, and 
(3) to implement an immediate recall of such 
product. 
The order shall provide the person subject to the order 
with an opportunity for an informal hearing, to be held 
not later than 10 days after the date of the issuance of 
the order, on the actions required by the order. If, after 
providing an opportunity for such a hearing or holding 
such a hearing, the Secretary determines there are inad-
equate grounds to support the actions required by the 
order, the Secretary shall vacate the order. If, after pro-
viding an opportunity for an informal hearing or holding 
such a hearing, the Secretary determines there are ade-
quate grounds to support the actions required by the 
order, the order shall remain in effect until such a time 
the Secretary finds otherwise. In the case of an informal 
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hearing, the order shall remain in effect pending a decision 
by the Secretary. 
(b) ENFORCEMENT.—The failure to comply with an 
order issued by the Secretary of Health and Human Serv-
ices under subsection (a) shall be treated as a violation 
of section 301 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 331) for the purpose of sections 302 and 
303 of such Act. 
SEC. 3. STUDY ON EFFECTIVENESS OF RECALLS. 
(a) STUDY.—The Secretary of Health and Human 
Services, in consultation with manufacturers, distributors, 
retailers, public health groups, consumer groups, and 
other affected organizations, shall conduct a study to de-
termine new procedures for implementing voluntary and 
mandatory recalls and enhancing their effectiveness. 
(b) REPORT.—Not later than 180 days after the date 
of the enactment of this Act, the Secretary shall submit 
to the Congress a report describing findings and rec-
ommendations made as a result of carrying out subsection 
(a). 
(c) REGULATIONS.—Not later than 180 days after 
submitting to the Congress the report described in sub-
section (b), the Secretary shall issue regulations imple-
menting the recommendations described in such report. 
Æ 
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