Sec. 3. Mandatory recall of ENDS pending premarket review
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Section 908(c) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 387h(c) ) is amended by adding at the end the following: Notwithstanding paragraphs
(1)and (2), in the case of a tobacco product that is an electronic nicotine delivery system with respect to which, as of the date of the enactment of this subparagraph, an order under section 910(c)(1)(A)(i) has not been issued, the Secretary shall, not later than 60 days after such date of enactment, issue an order requiring— the appropriate person (including a manufacturer, importer, distributor, or retailer of the tobacco product) to immediately cease distribution of such tobacco product; and the recall of such tobacco product. The order under subparagraph
(A)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 the terms of the recall required by such order. An order issued under subparagraph
(A)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. An order under subparagraph (A)— shall not include recall of a tobacco product from individuals; and shall provide for notice to persons subject to the risks associated with the use of such tobacco product. In providing the notice required by subparagraph (D)(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 705(b). The Secretary may only withdraw an order issued under subparagraph
(A)with respect to a tobacco product described in such subparagraph upon the issuance of an order section 910(c)(1)(A)(i) with respect to that product. .
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Sec. 3
Mandatory recall of ENDS pending premarket review
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