Senior Regulatory Counsel

0910-AI39 201910 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS 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).

]]> Economically Significant Previously Published in The Unified Agenda Final Rule Stage Yes Private Sector Regulatory 21 CFR 1141 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 Judicial Final 03/15/2020 No NPRM 08/16/2019 84 FR 42754 NPRM Comment Period End 10/15/2019 Final Rule 03/00/2020 Yes Businesses None No No Yes No Courtney Smith Senior Regulatory Counsel 0910 Food and Drug Administration FDA 877 287-1373 877 287-1426 ctpregulations@fda.hhs.gov Center for Tobacco Products, Document Control Center, Building 71, Room G335, 10903 New Hampshire Avenue, Silver Spring MD 20993