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HHS/FDA RIN: 0910-AG38 Publication ID: Fall 2016 
Title: "Tobacco Products" Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act 
Abstract:

The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) provides the Food and Drug Administration (FDA) authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Tobacco Control Act, permits FDA to issue regulations deeming other tobacco products to be subject to the FD&C Act. This rule would deem additional products meeting the statutory definition of "tobacco product" to be subject to the FD&C Act, and would specify additional restrictions.

 
Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
Major: Yes  Unfunded Mandates: Private Sector 
CFR Citation: 21 CFR 1100    21 CFR 1140    21 CFR 1143   
Legal Authority: 21 U.S.C. 301 et seq.    The Federal Food, Drug, and Cosmetic Act    Pub. L. 111-31    The Family Smoking Prevention and Tobacco Control Act   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  04/25/2014  79 FR 23142   
NPRM Comment Period End  07/09/2014 
NPRM Comment Period Extended  06/24/2014  79 FR 35711   
NPRM Comment Period Extended End  08/08/2014 
Final Action  05/10/2016  81 FR 28974   
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:
Gerie Voss
Senior Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
HFS-32, Center for Tobacco Products, 10903 New Hampshire Avenue, Document Control Center, Building 71, Room G335,
Silver Spring, MD 20993
Phone:877 287-1373
Email: ctpregulations@fda.hhs.gov