Director, Office of Regulations

0910-AJ28 202510 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Product Standards for Electronic Nicotine Delivery Systems

This rule would establish new product standards under section 907 of the Federal Food, Drug, and Cosmetic Act for electronic nicotine delivery systems (ENDS). Specifically, this rule would establish product standards for ENDS products to provide greater clarity and predictability for industry and stakeholders by describing standards applicants must meet as part of premarket review.

]]> Other Significant First Time Published in The Unified Agenda Proposed Rule Stage No Undetermined Regulatory 21 CFR 1100 21 CFR 1105 21 CFR 1107 21 CFR 1114 Section 910 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387j) Section 910(b)(1)(G) of the FD&C Act Section 910(c)(4) of the FD&C Act Section 906(e) of the FD&C Act (21 U.S.C. 387f(e)) Section 901(b) of the FD&C Act (21 U.S.C. 387a(b)) No NPRM 07/00/2026 Undetermined Undetermined Undetermined No Yes May Nelson Director, Office of Regulations 0910 Food and Drug Administration FDA 877 287-1373 askctp@fda.hhs.gov Center for Tobacco Products, 10903 New Hampshire Avenue, Document Control Center, Building 71, Room G335, Silver Spring MD 20993