§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 to public health and telling people about it is the only practical way to stop the danger. If the product likely has a manufacturing or other defect that could cause serious harm or death, the Secretary must order the maker, importer, distributor, or retailer to immediately stop selling the product. The company gets a short informal hearing no later than 10 days after the order to argue against the action or ask for a recall. If the Secretary finds no adequate grounds, the order is canceled. If the Secretary decides a recall is needed, the order will set a timetable and require progress reports. The recall will not force individuals to return products they already have, but it must include notice to people at risk. Following a Secretary’s order does not shield anyone from other federal or state legal liability, and any court award for economic loss must account for the value of the Secretary’s remedy.

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