0910-AH59 202504 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. This proposed rule covers registration and listing requirements for both domestic and foreign manufacturers of tobacco products. The proposed rule defines who would be required to register and list, when they would be required to register and list, and how they would be required to register and list. The proposed rule also describes the type of listing information that manufacturers would be required to submit to FDA. The proposed regulations generally would require the electronic submission of all registration and listing information. In addition, the rule would require owners or operators to maintain a historical file of labeling and advertisements.

]]> Other Significant Previously Published in The Unified Agenda Proposed Rule Stage Yes No Regulatory 21 CFR 1108 21 U.S.C. 387 No NPRM 05/00/2026 Undetermined Undetermined No No No May Nelson 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, Room G335, Silver Spring MD 20993