Title 21, Food and DrugsRelease 119-110

§387h Notification and Other Remedies

Title 21 › CHAPTER 9 — FEDERAL FOOD, DRUG, AND COSMETIC ACT › SUBCHAPTER IX — TOBACCO PRODUCTS › § 387h

Last updated Sep 22, 2026|Official source

Summary

The Secretary can force companies to warn people when a tobacco product sold across state lines poses an unreasonable risk to public health and no better method exists to fix the risk. The Secretary may require any kind of notice, such as public service announcements, and must talk with the people who will give the notice before ordering it. Following an ordered notice does not free anyone from other federal or state legal responsibility, and if someone sues for money loss, any help given under the order must be counted when deciding damages. If the Secretary finds a reasonable probability that a tobacco product has a defect that could cause serious harm or death, the Secretary must order the makers, importers, distributors, or retailers to stop distributing it right away. The person ordered gets a chance for a quick informal hearing within 10 days about the order and whether it should be changed to require a recall. If the Secretary later decides a recall is needed, the order must be changed to set a recall timetable and require progress reports. The recall order cannot force people to return products from individuals and must include notice to people at risk; the Secretary may use retailers to help or, if many people cannot be identified, must notify them under section 375(b). These recall steps do not replace the notice powers described above.

Full Legal Text

Title 21, §387h

Food and Drugs, Source: USLM XML via OLRC

(a)Notification
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,
the Secretary may issue such order as may be necessary to assure that adequate notification is provided in an appropriate form, by the persons and means best suited under the circumstances involved, to all persons who should properly receive such notification in order to eliminate such risk. The Secretary may order notification by any appropriate means, including public service announcements. Before issuing an order under this subsection, the Secretary shall consult with the persons who are to give notice under the order.
(b)No exemption from other liability
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)Recall authority
(1)In general
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)Amendment of order to require recall
(A)In general
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)Notice
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.
In providing the notice required by clause (ii), the Secretary may use the assistance of retailers and other persons who distributed such tobacco product. If a significant number of such persons cannot be identified, the Secretary shall notify such persons under section 375(b) of this title.
(3)Remedy not exclusive
The remedy provided by this subsection shall be in addition to remedies provided by subsection (a).

Legislative History

Notes & Related Subsidiaries

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.

Reference

Citations & Metadata

Citation

21 U.S.C. § 387h

Title 21, Food and Drugs

Last Updated

Sep 22, 2026

Release point: 119-110