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HHS/FDA RIN: 0910-AG42 Publication ID: Fall 2010 
Title: Smokeless Tobacco Warning Labels 
Abstract: Section 3 of the Comprehensive Smokeless Tobacco Health Education Act of 1986, as amended by section 204 of the Family Smoking Prevention and Tobacco Control Act, requires that packages of smokeless tobacco bear specific warning statements about the health effects of using these products and sets out specific requirements for the location, size, and appearance of such statements. In addition, the Tobacco Control Act requires that warning statements be equally distributed and displayed on packages and rotated quarterly in advertising and requires manufacturers, importers, distributors or retailers to submit warning plans for approval. Section 205 of the Tobacco Control Act authorizes FDA to use rulemaking to adjust the format, type size, and text of any of the label requirements, require color graphics to accompany the text, increase the required label area from 30 percent up to 50 percent of the front and rear panels of the package, or establish the format, type size, and text of any other disclosures required under the Federal Food, Drug, and Cosmetic Act, if FDA finds that such change would promote greater public understanding of the risks associated with the use of smokeless tobacco products. This proposed rule would clarify certain requirements in the statute. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Long-Term Actions 
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, sec 204, The Family Smoking Prevention and Tobacco Control Act   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  To Be Determined    
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