[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[H.R. 841 Introduced in House (IH)]

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.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Protect Consumers Act of 2009''.

SEC. 2. AUTHORITY TO IMPLEMENT MANDATORY RECALL.

    (a) In General.--If the Secretary of Health and Human Services 
determines that it is necessary to implement 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, manufacture, and 
        sale of such product,
            (2) to immediately provide for notice to individuals 
        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 inadequate 
grounds to support the actions required by the order, the Secretary 
shall vacate the order. If, after providing an opportunity for an 
informal hearing or holding such a hearing, the Secretary determines 
there are adequate 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 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 Services 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 determine 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 recommendations 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 subsection (b), the Secretary shall 
issue regulations implementing the recommendations described in such 
report.
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