21 U.S.C. § 387h — Notification and other remedies

(a) Notification: If the Secretary determines that a tobacco product already sold across state lines presents an unreasonable risk of substantial harm to public health, and that notifying people is necessary to eliminate that risk because no more workable option exists under this subchapter, the Secretary may order notice to be given, in an appropriate form and by the persons and means best suited to the situation, to everyone who should properly receive it — including through public service announcements. Before issuing such an order, the Secretary must consult with the people who would be giving the notice. (b) No exemption from other liability: Complying with a notification order does not excuse anyone from liability under federal or state law. If a court later awards damages for economic loss in a related lawsuit, it must take into account the value the notification order already provided to the person suing. (c) Recall authority: (1) In general — If the Secretary finds a reasonable probability that a tobacco product has a manufacturing or other defect not ordinarily found in such products, and that the defect would cause serious, adverse health consequences or death, the Secretary must order the responsible party — manufacturer, importer, distributor, or retailer — to immediately stop distributing the product. The order must offer that party an informal hearing within 10 days on whether the required actions are correct and whether the order should be amended into a recall. If, after the hearing, the Secretary finds the order isn't adequately supported, the Secretary must vacate it. (2) Amendment of order to require recall — (A) If, after the hearing, the Secretary decides the order should be amended to require a recall, the Secretary must amend it that way (subject to (B)), set a recall timetable, and require periodic progress reports. (B) The amended order can't require recalling the product from individual consumers, but must provide for notice to people exposed to the product's risks — possibly using retailers' help to reach them. If a significant number of those people can't be identified this way, the Secretary must notify them under the separate notice procedure in section 375(b). (3) Remedy not exclusive — This recall power is in addition to, not instead of, the notification remedy in subsection (a).