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HHS/FDA RIN: 0910-AH19 Publication ID: Fall 2016 
Title: Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs or Devices  
Abstract:

The rule will describe the circumstances in which a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device, or a combination product. This action is intended to provide direction to regulated industry and to help avoid consumer confusion.

 
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: No  Unfunded Mandates: No 
EO 13771 Designation: uncollected 
CFR Citation: 21 CFR 1100.5   
Legal Authority: 21 U.S.C. 321    21 U.S.C. 353(g)    21 U.S.C. 371(a)   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  09/25/2015  80 FR 57756   
NPRM Comment Period End  11/24/2015 
Final Action  12/00/2016 
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Darin Achilles
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
Fax:301 595-1426
Email: ctpregulations@fda.hhs.gov