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HHS/FDA

RIN: 0910-AG41

Publication ID: Spring 2011

Title: Cigarette Warning Label Statements
Abstract: Section 4 of the FCLAA, as amended by section 201 of the Tobacco Control Act, requires FDA to issue regulations that require color graphics depicting the negative health consequences of smoking to accompany required warning statements on cigarette packages and advertisements. FDA also may adjust the type size, text and format of the required label statements on product packaging and advertising if FDA determines that it is appropriate so that both the graphics and the accompanying label statements are clear, conspicuous, legible and appear within the specified area.
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
CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: PL 111-31, The Family Smoking Prevention and Tobacco Control Act, sec 201

Legal Deadline:

Action	Source	Description	Date
Final	Statutory		06/22/2011

Overall Description of Deadline: Section 4 of the Federal Cigarette Labeling and Advertising Act (FCLAA), as amended by section 201 of the Family Smoking Prevention and Tobacco Control Act (the Tobacco Control Act), requires FDA to issue regulations no later than 24 months after the date of enactment of the Tobacco Control Act that require color graphics depicting the negative health consequences of smoking to appear on cigarette packages and advertisements.

Timetable:

Action	Date	FR Cite
NPRM	11/12/2010	75 FR 69524
NPRM Comment Period End	01/11/2011
Final Action	06/00/2011

Regulatory Flexibility Analysis Required: Yes	Government Levels Affected: Undetermined
Small Entities Affected: Businesses	Federalism: Yes
Included in the Regulatory Plan: Yes
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.
RIN Data Printed in the FR: Yes
Agency Contact: Gerie Voss Director of Policy, Office of Dietary Supplement Programs Department of Health and Human Services Food and Drug Administration Humans Foods Program, College Park, MD 20705 Phone:240 620-9744 Fax:301 595-1426 Email: gerie.voss@fda.hhs.gov