§387h — Title 21 Food and Drugs | U.S. Code

Summary

The Secretary can act when a tobacco product sold across state lines poses an unreasonable risk of big harm to public health, and a public notice is needed to stop that risk and no more practical legal option is available. If the Secretary finds a product probably has a manufacturing or similar defect that could cause serious injury or death, the Secretary must order the maker, importer, distributor, or seller to stop selling it immediately. The person ordered must be given a short informal hearing no later than 10 days after the order to discuss the actions required and whether a recall is needed. If the Secretary finds the order is not supported after the hearing, the order must be canceled. If the Secretary decides a recall is needed, the order will be changed to require the recall, include a timetable, and require regular progress reports. The recall cannot force people to give up products already in their possession, and people at risk must be notified. Following an order does not protect anyone from federal or state lawsuits, and courts must count the value of the Secretary’s remedy when deciding money awards for economic loss. The stop-sale and recall actions are in addition to any required notifications.

Title 21, §387h

Food and Drugs — Source: USLM XML via OLRC

(a)If the Secretary determines that—

(1)a tobacco product which is introduced or delivered for introduction into interstate commerce for commercial distribution presents an unreasonable risk of substantial harm to the public health; and

(2)notification under this subsection is necessary to eliminate the unreasonable risk of such harm and no more practicable means is available under the provisions of this subchapter (other than this section) to eliminate such risk,

(b)Compliance with an order issued under this section shall not relieve any person from liability under Federal or State law. In awarding damages for economic loss in an action brought for the enforcement of any such liability, the value to the plaintiff in such action of any remedy provided under such order shall be taken into account.

(c)(1)If the Secretary finds that there is a reasonable probability that a tobacco product contains a manufacturing or other defect not ordinarily contained in tobacco products on the market that would cause serious, adverse health consequences or death, the Secretary shall issue an order requiring the appropriate person (including the manufacturers, importers, distributors, or retailers of the tobacco product) to immediately cease distribution of such tobacco 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 and on whether the order should be amended to require a recall of such tobacco product. If, after providing an opportunity for such a hearing, the Secretary determines that inadequate grounds exist to support the actions required by the order, the Secretary shall vacate the order.

(2)(A)If, after providing an opportunity for an informal hearing under paragraph (1), the Secretary determines that the order should be amended to include a recall of the tobacco product with respect to which the order was issued, the Secretary shall, except as provided in subparagraph (B), amend the order to require a recall. The Secretary shall specify a timetable in which the tobacco product recall will occur and shall require periodic reports to the Secretary describing the progress of the recall.

(B)An amended order under subparagraph (A)—

(i)shall not include recall of a tobacco product from individuals; and

(ii)shall provide for notice to persons subject to the risks associated with the use of such tobacco product.

(3)The remedy provided by this subsection shall be in addition to remedies provided by subsection (a).

Editorial Notes

Prior Provisions

A prior section 908 of act June 25, 1938, was renumbered section 1008 and is classified to section 398 of this title.

§387h Notification and other remedies

Summary

Title 21, §387h

Notes & Related Subsidiaries

Editorial Notes

Prior Provisions

Citations & Metadata