I 

111TH CONGRESS 

1ST SESSION H. R. 841 

To authorize the Secretary of Health and Human Services to order a mandatory recall of any product that is regulated by the Food and Drug 

Administration, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

FEBRUARY 3, 2009 

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 regulated by the Food and Drug Administration, and for 

other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Protect Consumers Act 

5 of 2009’’. 

6 SEC. 2. AUTHORITY TO IMPLEMENT MANDATORY RECALL. 

7 (a) IN GENERAL.—If the Secretary of Health and 

8 Human Services determines that it is necessary to impleVerDate Nov 24 2008 02:31 Feb 05, 2009 Jkt 079200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H841.IH H841

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•HR 841 IH

1 ment a mandatory recall of any product that is regulated 

2 by the Food and Drug Administration, the Secretary shall 

3 issue an order requiring the appropriate person (including 

4 the manufacturers, importers, distributors, or retailers of 

5 the product)— 

6 (1) to immediately cease distribution, manufac7 ture, and sale of such product, 

8 (2) to immediately provide for notice to individ9 uals subject to the risks associated with the use of 

10 such product, and 

11 (3) to implement an immediate recall of such 

12 product. 

13 The order shall provide the person subject to the order 

14 with an opportunity for an informal hearing, to be held 

15 not later than 10 days after the date of the issuance of 

16 the order, on the actions required by the order. If, after 

17 providing an opportunity for such a hearing or holding 

18 such a hearing, the Secretary determines there are inad19 equate grounds to support the actions required by the 

20 order, the Secretary shall vacate the order. If, after pro21 viding an opportunity for an informal hearing or holding 

22 such a hearing, the Secretary determines there are ade23 quate grounds to support the actions required by the 

24 order, the order shall remain in effect until such a time 

25 the Secretary finds otherwise. In the case of an informal 


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•HR 841 IH

1 hearing, the order shall remain in effect pending a decision 

2 by the Secretary. 

3 (b) ENFORCEMENT.—The failure to comply with an 

4 order issued by the Secretary of Health and Human Serv5 ices under subsection (a) shall be treated as a violation 

6 of section 301 of the Federal Food, Drug, and Cosmetic 

7 Act (21 U.S.C. 331) for the purpose of sections 302 and 

8 303 of such Act. 

9 SEC. 3. STUDY ON EFFECTIVENESS OF RECALLS. 

10 (a) STUDY.—The Secretary of Health and Human 

11 Services, in consultation with manufacturers, distributors, 

12 retailers, public health groups, consumer groups, and 

13 other affected organizations, shall conduct a study to de14 termine new procedures for implementing voluntary and 

15 mandatory recalls and enhancing their effectiveness. 

16 (b) REPORT.—Not later than 180 days after the date 

17 of the enactment of this Act, the Secretary shall submit 

18 to the Congress a report describing findings and rec19 ommendations made as a result of carrying out subsection 

20 (a). 

21 (c) REGULATIONS.—Not later than 180 days after 

22 submitting to the Congress the report described in sub23 section (b), the Secretary shall issue regulations imple24 menting the recommendations described in such report. 

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