Senior Regulatory Counsel

0910-AH91 202104 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 is proposing to establish tobacco product manufacturing practice (TPMP) requirements for manufacturers of finished and bulk tobacco products. This proposed rule, if finalized, would set forth requirements for the manufacture, pre-production design validation, packing, and storage of a tobacco product. This proposal would help prevent the manufacture and distribution of contaminated and otherwise nonconforming tobacco products. This proposed rule provides manufacturers with flexibility in the manner in which they comply with the proposed 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 Proposed Rule Stage Undetermined No Not Yet Determined 21 U.S.C. 371 21 U.S.C. 387b 21 U.S.C. 387f No NPRM 10/00/2021 Yes Businesses None No Yes 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