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HHS/FDA RIN: 0910-AH91 Publication ID: Fall 2023 
Title: 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.

Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: Yes  Unfunded Mandates: No 
CFR Citation: 21 CFR 1120   
Legal Authority: 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    ...   
Legal Deadline:  None
Action Date FR Cite
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 
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.
RIN Data Printed in the FR: Yes 
Agency Contact:
Matthew Brenner
Senior Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Tobacco Products, 10903 New Hampshire Avenue, Document Control Center, Building 71, Room G335,
Silver Spring, MD 20993
Phone:877 287-1373