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HHS/FDA RIN: 0910-AG38 Publication ID: Fall 2011 
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 FDA authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. Section 901 of 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 proposed rule would deem products meeting the statutory definition of "tobacco product" found at section 201(rr) of the FD&C Act to be subject to Chapter IX of the FD&C Act and would clarify additional restrictions under the FD&C Act. The scope of the proposed rule deeming cigars that was previously included in the Unified Agenda is being broadened to encompass products that meet the statutory definition of "tobacco product." 
Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Yes  Unfunded Mandates: Undetermined 
CFR Citation: Not Yet Determined     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: 21 USC 301 et seq, The Federal Food, Drug, and Cosmetic Act    PL 111-31, The Family Smoking Prevention and Tobacco Control Act   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  12/00/2011    
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Undetermined 
Small Entities Affected: Businesses  Federalism: Undetermined 
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