Title 21 › CHAPTER 9 — FEDERAL FOOD, DRUG, AND COSMETIC ACT › SUBCHAPTER IX — TOBACCO PRODUCTS › § 387h
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.
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Food and Drugs, Source: USLM XML via OLRC
Legislative History
Reference
Citation
21 U.S.C. § 387h
Title 21, Food and Drugs
Last Updated
Sep 22, 2026
Release point: 119-110