Disposable ENDS Product Enforcement Act of 2023

To require the Food and Drug Administration to prioritize enforcement of disposable electronic nicotine delivery system products. 1. Short title This Act may be cited as the Disposable ENDS Product Enforcement Act of 2023 2. Findings Congress finds the following: (1) In April 2020, the Food and Drug Administration issued guidance entitled Enforcement Priorities for Electronic Nicotine Delivery System (ENDS) and Other Deemed Products on the Market Without Premarket Authorization (2) In such guidance, Food and Drug Administration describes how the agency intends to prioritize enforcement against any flavored, cartridge-based electronic nicotine delivery system product (other than a tobacco- or menthol-flavored electronic nicotine delivery system product) marketed without authorization from the Food and Drug Administration. (3) In defining the term cartridge-based ENDS product, self-contained, disposable products (4) The guidance explains: FDA is continuously evaluating new information and adjusting its enforcement priorities in light of the best available data, and it will continue to do so with respect to these products. FDA will take appropriate action regarding tobacco products that are marketed without premarket authorization, including as warranted based on changed circumstances, new information, or to better address minors’ use of those products (5) In November 2022, the Food and Drug Administration and the Centers for Disease Control and Prevention released the findings from the 2022 National Youth Tobacco Survey. The data shows that self-contained disposable electronic nicotine delivery system products were the most common device type used by minors. 3. Updated enforcement prioritization (a) Guidance The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs (referred to in this Act as the Secretary Enforcement Priorities for Electronic Nicotine Delivery System (ENDS) and Other Deemed Products on the Market Without Premarket Authorization (b) Enforcement Nothing in this section shall be construed as preventing the Secretary from prioritizing enforcement against disposable ENDS products, including nicotine products not derived from tobacco, in advance of updating the guidance referred to in paragraph (1), particularly with respect to such products that are targeted to minors or whose marketing is likely to promote use of such products by minors. (c) Inclusion in tobacco regulation activities annual report The Secretary shall include in each annual report required to be submitted pursuant to section 112 of subtitle B of title I of division P of the Consolidated Appropriations Act, 2022 ( Public Law 117–103 (d) Disposable ENDS product defined In this Act, the term disposable ENDS product 21 U.S.C. 321(rr)

Summary: Disposable ENDS Product Enforcement Act of 2023 This bill requires the Food and Drug Administration (FDA) to update its enforcement guidance regarding Electronic Nicotine Delivery System (ENDS) products to include certain disposable ENDS products. In April 2020, the FDA published revised guidance on how it intends to prioritize enforcement resources with respect to ENDS products that do not have premarket authorization (i.e., that have not received FDA approval). The guidance specifies that the FDA intends to prioritize enforcement against (1) flavored, cartridge-based ENDS products (except for tobacco or menthol flavored products); (2) other ENDS products for which the manufacturer has not taken adequate measures to prevent access to minors; (3) any ENDS products that are targeted or promoted towards minors; and (4) any ENDS products for which the manufacturer has not submitted an application for market approval or did not receive approval. For purposes of this guidance, cartridge-based ENDS products do not include disposable products that are completely self-contained. The bill requires the FDA to incorporate these products, including nicotine products that are not derived from tobacco, into its enforcement priorities. The bill additionally specifies that the FDA may prioritize enforcement against these products in advance of updating the guidance. The FDA must also annually report on its enforcement actions with respect to these products.