0910-AH59 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 Establishment Registration and Product Listing for Tobacco Products

FDA is proposing regulations to prescribe the format, content, and procedures for establishment registration and tobacco product listing for manufacturers of tobacco products. FDA needs complete and accurate establishment registration and product listing information to accomplish important statutory, regulatory, and public health objectives. Currently, only domestic manufacturers are required to register their establishments and list their tobacco products, creating significant gaps in agency information. This action, if finalized, would extend registration and listing requirements and FDA inspections to include foreign establishments and new categories of domestic establishments.

]]> Other Significant Previously Published in The Unified Agenda Proposed Rule Stage Yes No Regulatory 21 CFR 1108 21 U.S.C. 331(p) 21 U.S.C. 371(a) 21 U.S.C. 374 21 U.S.C. 381(a) 21 U.S.C. 381(p)(2) 21 U.S.C. 387c 21 U.S.C. 387e 21 U.S.C. 387g 21 U.S.C. 387i 21 U.S.C. 387j 21 U.S.C. 387k No NPRM 07/00/2026 No None No No No James Anthony 0910 Food and Drug Administration FDA 877 287-1373 askctp@fda.hhs.gov Center for Tobacco Products, 10903 New Hampshire Avenue, Document Control Center, Bldg. 71, Rm. G335, Silver Spring MD 20993