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HHS/FDA RIN: 0910-AI39 Publication ID: Spring 2019 
Title: ●Required Warnings for Cigarette Packages and Advertisements 
Abstract:

This rule would require color graphics depicting the negative health consequences of smoking to accompany textual warning statements on cigarette packages and in cigarette advertisements. As directed by Congress in the Tobacco Control Act, which amends the Federal Cigarette Labeling and Advertising Act, the rule would require these new cigarette health warnings to occupy the top 50 percent of the area of the front and rear panels of cigarette packages and at least 20 percent of the area of cigarette advertisements. The original rule FDA issued in 2011 was vacated by the U.S. Court of Appeals for the District of Columbia Circuit in August 2012 (R.J. Reynolds Tobacco Co. v. United States Food & Drug Admin., 696 F.3d 1205 D.C. Cir. 2012).

 

 
Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Yes  Unfunded Mandates: No 
EO 14192 Designation: Regulatory 
CFR Citation: 21 CFR 1141   
Legal Authority: 15 U.S.C. 1333    21 U.S.C. 371    21 U.S.C. 387c    21 U.S.C. 387i    Secs 201 and 202, Pub. L. 111-31, 123 Stat. 1776    ...   
Legal Deadline:
Action Source Description Date
NPRM  Judicial  Deadline is for submitting NPRM to the OFR for publication  08/15/2019 
Timetable:
Action Date FR Cite
NPRM  08/00/2019 
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: Yes 
Agency Contact:
Courtney Smith
Senior Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Tobacco Products, Document Control Center, Building 71, Room G335, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:877 287-1373
Fax:877 287-1426
Email: ctpregulations@fda.hhs.gov