--- kind: "section" citation: "21 U.S.C. § 387h" title: "21" title_heading: "Food and Drugs" number: "387h" heading: "Notification and other remedies" release: "119-102" date: "2026-07-12" url: "https://uscodex.org/usc/21/387h" units: - "Chapter 9 — Federal Food, Drug, and Cosmetic Act" - "Subchapter IX — Tobacco Products" --- # §387h. Notification and other remedies - (a) **Notification—** If the [Secretary](/usc/21/321.md?p=d) determines that— - (1) a [tobacco product](/usc/21/321.md?p=rr-1) which is introduced or delivered for introduction into [interstate commerce](/usc/21/321.md?p=b) for commercial [distribution](/usc/21/360eee.md?p=5) 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](/usc/21/321.md?p=d) may issue such order as may be necessary to assure that adequate notification is provided in an appropriate form, by the [persons](/usc/21/321.md?p=e) and means best suited under the circumstances involved, to all [persons](/usc/21/321.md?p=e) who should properly receive such notification in order to eliminate such risk. The [Secretary](/usc/21/321.md?p=d) may order notification by any appropriate means, including public service announcements. Before issuing an order under this subsection, the [Secretary](/usc/21/321.md?p=d) shall consult with the [persons](/usc/21/321.md?p=e) 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](/usc/21/321.md?p=e) from liability under Federal or [State](/usc/21/387.md?p=19) 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](/usc/21/321.md?p=d) finds that there is a reasonable probability that a [tobacco product](/usc/21/321.md?p=rr-1) contains a manufacturing or other defect not ordinarily contained in [tobacco products](/usc/21/321.md?p=rr-1) on the market that would cause serious, adverse health consequences or death, the [Secretary](/usc/21/321.md?p=d) shall issue an order requiring the appropriate [person](/usc/21/321.md?p=e) (including the [manufacturers](/usc/21/360hh.md?p=3), importers, [distributors](/usc/21/387.md?p=7), or [retailers](/usc/21/387.md?p=14) of the [tobacco product](/usc/21/321.md?p=rr-1)) to immediately cease [distribution](/usc/21/360eee.md?p=5) of such [tobacco product](/usc/21/321.md?p=rr-1). The order shall provide the [person](/usc/21/321.md?p=e) subject to the order with an opportunity for an [informal hearing](/usc/21/321.md?p=x), 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](/usc/21/321.md?p=rr-1). If, after providing an opportunity for such a hearing, the [Secretary](/usc/21/321.md?p=d) determines that inadequate grounds exist to support the actions required by the order, the [Secretary](/usc/21/321.md?p=d) shall vacate the order. - (2) **Amendment of order to require recall—** - (A) **In general—** If, after providing an opportunity for an [informal hearing](/usc/21/321.md?p=x) under [paragraph (1)](#c-1), the [Secretary](/usc/21/321.md?p=d) determines that the order should be amended to include a recall of the [tobacco product](/usc/21/321.md?p=rr-1) with respect to which the order was issued, the [Secretary](/usc/21/321.md?p=d) shall, except as provided in [subparagraph (B)](#c-2-B), amend the order to require a recall. The [Secretary](/usc/21/321.md?p=d) shall specify a timetable in which the [tobacco product](/usc/21/321.md?p=rr-1) recall will occur and shall require periodic reports to the [Secretary](/usc/21/321.md?p=d) describing the progress of the recall. - (B) **Notice—** An amended order under [subparagraph (A)](#c-2-A)— - (i) shall not include recall of a [tobacco product](/usc/21/321.md?p=rr-1) from individuals; and - (ii) shall provide for notice to [persons](/usc/21/321.md?p=e) subject to the risks associated with the use of such [tobacco product](/usc/21/321.md?p=rr-1). In providing the notice required by [clause (ii)](#c-2-B-ii), the [Secretary](/usc/21/321.md?p=d) may use the assistance of [retailers](/usc/21/387.md?p=14) and other [persons](/usc/21/321.md?p=e) who distributed such [tobacco product](/usc/21/321.md?p=rr-1). If a significant number of such [persons](/usc/21/321.md?p=e) cannot be identified, the [Secretary](/usc/21/321.md?p=d) shall notify such [persons](/usc/21/321.md?p=e) under [section 375(b) of this title](/usc/21/375.md?p=b). - (3) **Remedy not exclusive—** The remedy provided by this subsection shall be in addition to remedies provided by [subsection (a)](#a). ## Source credit (June 25, 1938, ch. 675, § 908, as added Pub. L. 111–31, div. A, title I, § 101(b)(3), June 22, 2009, 123 Stat. 1804.) ## Notes ### 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.