110 HR 2099 IH: Protect Consumers Act of 2007 U.S. House of Representatives 2007-05-01 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

I 110th CONGRESS 1st Session H. R. 2099 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 regulated by the Food and Drug Administration, and for other purposes.

1.

Short title

This Act may be cited as the Protect Consumers Act of 2007.

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.

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.