View Rule
View EO 12866 Meetings | Printer-Friendly Version Download RIN Data in XML |
HHS/FDA | RIN: 0910-AH19 | Publication ID: Spring 2015 |
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: Previously 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 U.S.C. 321 21 U.S.C. 353(g) 21 U.S.C. 701(a) |
Legal Deadline:
None |
||||||
Timetable:
|
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 |