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HHS/FDA

RIN: 0910-AG33

Publication ID: Fall 2010

Title: Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents
Abstract: This rule establishes regulations restricting the sale and distribution of cigarettes and smokeless tobacco to children and adolescents, implementing section 102 of the Family Smoking Prevention and Tobacco Control Act (FSPTCA). FSPTCA sections 102 and 6(c)(1) require the Secretary to publish, within 270 days of enactment, a final rule regarding cigarettes and smokeless tobacco. This final rule must be identical, except for several changes identified in section 102(a)(2) of FSPTCA, to part 897 of the regulations promulgated by the Secretary of HHS in the August 28, 1996, issue of the Federal Register (61 FR 44396). This final rule prohibits the sale of cigarettes and smokeless tobacco to individuals under the age of 18 and requires manufacturers, distributors, and retailers to comply with certain conditions regarding access to, and promotion of, these products. Among other things, the final rule requires retailers to verify a purchaser's age by photographic identification. It also prohibits, with limited exception, free samples and prohibits the sale of these products through vending machines and self-service displays except in facilities where individuals under the age of 18 are not present or permitted at any time. The rule also limits the advertising and labeling to which children and adolescents are exposed. The rule accomplishes this by generally restricting advertising to which children and adolescents are exposed to a black-and-white, text-only format. The rule also prohibits the sale or distribution of brand-identified promotional, non-tobacco items such as hats and tee shirts. Furthermore, the rule prohibits sponsorship of sporting and other events, teams, and entries in a brand name of a tobacco product, but permits such sponsorship in a corporate name. FDA also published in the same issue of the Federal Register an advance notice of proposed rulemaking requesting comments, data, research, or other information on the regulation of outdoor advertising of cigarettes and smokeless tobacco.
Agency: Department of Health and Human Services(HHS)	Priority: Economically Significant
RIN Status: Previously published in the Unified Agenda	Agenda Stage of Rulemaking: Completed Actions
Major: Yes	Unfunded Mandates: State, local, or tribal governments; Private Sector
CFR Citation: 21 CFR 1140
Legal Authority: 21 USC 301 et seq, The Federal Food, Drug, and Cosmetic Act PL 111-31, Family Smoking Prevention and Tobacco Control Act

Legal Deadline:

Action	Source	Description	Date
Final	Statutory	Public Law 111-31 sections 6(c)(1) and 102(a)(1)	03/19/2010

Overall Description of Deadline: Family Smoking Prevention and Tobacco Control Act sections 6(c)(1) and 102(a)(1) require publication of this final rule within 270 days of enactment.

Timetable:

Action	Date	FR Cite
ANPRM	03/19/2010	75 FR 13241
Final Rule	03/19/2010	75 FR 13225
ANPRM Comment Period End	05/18/2010
Final Rule Effective	06/22/2010

Regulatory Flexibility Analysis Required: Yes	Government Levels Affected: Federal, Local, State, Tribal
Small Entities Affected: Businesses	Federalism: Yes
Included in the Regulatory Plan: No
RIN Data Printed in the FR: Yes
Related RINs: Related to 0910-AG40
Agency Contact: Annette Marthaler Senior Regulatory Counsel Department of Health and Human Services Food and Drug Administration Office of Combination Products, 10903 New Hampshire Avenue, WO32, Room 5129, Silver Spring, MD 20993 Phone:240 753-3043 Email: annette.marthaler@fda.hhs.gov