View Rule

View EO 12866 Meetings Printer-Friendly Version     Download RIN Data in XML
HHS/FDA RIN: 0910-AH19 Publication ID: Fall 2014 
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 following recent litigation.

 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 1100.5   
Legal Authority: 21 USC 321    21 USC 353(g)    21 USC 701(a)   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  06/00/2015 
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
Office of Clinical Policy, 10903 New Hampshire Avenue, WO 51, Room 5198,
Silver Spring, MD 20993
Phone:301 796-4040
Email: darin.achilles@fda.hhs.gov