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

This rule will 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 Family Smoking Prevention and Tobacco Control Act, which amends the Federal Cigarette Labeling and Advertising Act, the rule will 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: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: Yes  Unfunded Mandates: Private Sector 
EO 13771 Designation: Regulatory 
CFR Citation: 21 CFR 1141   
Legal Authority: 15 U.S.C. 1333    21 U.S.C. 371    21 U.S.C. 374    21 U.S.C. 387c    21 U.S.C. 387e    21 U.S.C. 387i    Pub. L. 111-31, secs. 201 and 202, 123 Stat. 1776   
Legal Deadline:
Action Source Description Date
Final  Judicial    03/15/2020 
Action Date FR Cite
NPRM  08/16/2019  84 FR 42754   
NPRM Comment Period End  10/15/2019 
Final Rule  03/00/2020 
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