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HHS/FDA

RIN: 0910-AG41

Publication ID: Spring 2010

Title: ●Cigarette Warning Label Statements
Abstract: Section 4 of the Federal Cigarette Labeling and Advertising Act (FCLAA), as amended by sec. 201 of the Family Smoking Prevention and Tobacco Control Act, requires FDA to issue regulations that require color graphics depicting the negative health consequences of smoking to accompany required warning statements. 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: Other Significant
RIN Status: First time published in the Unified Agenda	Agenda Stage of Rulemaking: Proposed Rule Stage
Major: Undetermined	Unfunded Mandates: Undetermined
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 sec. 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.

Timetable:

Action	Date	FR Cite
NPRM	11/00/2010

Regulatory Flexibility Analysis Required: Undetermined	Government Levels Affected: Undetermined
Federalism: Undetermined
Included in the Regulatory Plan: No
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: No
Agency Contact: Darin Achilles Regulatory Counsel Department of Health and Human Services Food and Drug Administration 14-101-11, 10903 New Hampshire Avenue, Document Control Center, Building 71, Room G335, Silver Spring, MD 20993 Phone:877 287-1373 Fax:301 595-1426 Email: ctpregulations@fda.hhs.gov