Senior Regulatory Counsel

0910-AH91 202310 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 Requirements for Tobacco Product Manufacturing Practice

The rule would establish tobacco product manufacturing practice (TPMP) requirements for manufacturers of finished and bulk tobacco products. This rule, if finalized, would set forth requirements for the manufacture, pre-production design validation, packing, and storage of a tobacco product. This rule would help prevent the manufacture and distribution of contaminated and otherwise nonconforming tobacco products. This rule provides manufacturers with flexibility in the manner in which they comply with the requirements while giving FDA the ability to enforce regulatory requirements, thus helping to assure the protection of public health.

]]> Other Significant Previously Published in The Unified Agenda Final Rule Stage Yes No 21 CFR 1120 21 U.S.C. 371 21 U.S.C. 374 21 U.S.C. 381(a) 21 U.S.C. 387b 21 U.S.C. 387c 21 U.S.C. 387f 21 U.S.C. 387i ... No NPRM 03/10/2023 88 FR 15174 NPRM Comment Period End 09/06/2023 NPRM Comment Period Extension to Oct. 06, 2023 08/29/2023 88 FR 59481 Final Action 10/00/2024 Yes Businesses None No Yes Yes 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