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HHS/FDA

RIN: 0910-AH19

Publication ID: Spring 2017

Title: Clarification of When Products Made or Derived From Tobacco are Regulated as Drugs, Devices, or Combination Products; Amendments To Regulations Regarding "Intended Use"
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: Completed Actions
Major: No	Unfunded Mandates: No
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	01/09/2017	82 FR 2193
Final Action--Delay of Effective Date Until 03/21/2017	02/07/2017	82 FR 9501
Final Action Effective	02/08/2017
Final Action--Further Delay of Effective Date Until 03/18/2018	03/21/2017	82 FR 14319

Regulatory Flexibility Analysis Required: No	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