View Rule

View EO 12866 Meetings Printer-Friendly Version     Download RIN Data in XML

HHS/FDA RIN: 0910-AI06 Publication ID: Fall 2019 
Title: ENDS Safety Standards, Including Standards for Toxicants and Impurities in Nicotine, Propylene Glycol, and Vegetable Glycerin Used in E-Liquids; Tobacco Product Standard 
Abstract:

The Food and Drug Administration is proposing regulations to establish tobacco product standards for electronic nicotine delivery systems (ENDS), to include, among other things, standards for nicotine, propylene glycol, and vegetable glycerin purity in e-liquid. This rule, if finalized, would, among other things, establish limits on the level of toxicants and impurities found in nicotine, propylene glycol, and vegetable glycerin. Toxicants and impurities found in nicotine, propylene glycol, and  vegetable glycerin can cause death or other adverse health effects, and this rule would establish limits on the level of those toxicants that are appropriate for the protection of public health.

 
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 
EO 13771 Designation: Regulatory 
CFR Citation: 21 CFR 1172   
Legal Authority: 21 U.S.C. 331, 371(a), 381(e), 381(p)(2), 387b, 387c, 387f(d), 387g, 387i    21 U.S.C. 371(a)    21 U.S.C. 381(p)(2)    21 U.S.C. 387b and 387c    21 U.S.C. 387f(d)    21 U.S.C. 387g    21 U.S.C. 387i   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  07/00/2020 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Nathan Mease
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Avenue, WO 71, Room G335,
Silver Spring, MD 20993
Phone:877 287-1373
Email: ctpregulations@fda.hhs.gov