Senior Regulatory Counsel

0910-AH59 202404 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

The proposed regulation prescribes the format, content, and procedures for establishment registration and tobacco product listings for both domestic and foreign manufacturers of tobacco products. The registration submission would include a manufacturer submitting general information about the manufacturing operation (e.g., the name of the company, location of the facility, contact telephone number) and the product listing submission would include information about the tobacco products it manufactures. 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, and 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 21 CFR 1107 21 U.S.C. 387 No NPRM 05/00/2025 Undetermined Undetermined No No No Matthew Brenner Senior Regulatory Counsel 0910 Food and Drug Administration FDA 877 287-1373 ctpregulations@fda.hhs.gov Center for Tobacco Products, 10903 New Hampshire Avenue, Document Control Center, Building 71, Room G335, Silver Spring MD 20993