[Federal Register Volume 75, Number 190 (Friday, October 1, 2010)]
[Notices]
[Pages 60759-60760]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-24685]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0488]


Enforcement Action Plan for Promotion and Advertising 
Restrictions; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a document entitled ``Enforcement Action Plan for 
Promotion and Advertising Restrictions'' (Enforcement Action Plan), 
which describes FDA's plan to enforce the restrictions on promotion and 
advertising of menthol and other cigarettes to youth and other 
requirements relating to tobacco product promotion and advertising 
established by the Family Smoking Prevention and Tobacco Control Act 
(Tobacco Control Act). As described in the Enforcement Action Plan, FDA 
intends to use a multipronged approach that includes surveillance, 
inspections, enforcement actions, and education to enforce and 
facilitate compliance with these restrictions and requirements. The 
Enforcement Action Plan includes

[[Page 60760]]

provisions designed to ensure enforcement of the restrictions on 
promotion and advertising of menthol and other cigarettes to youth in 
minority communities. The Enforcement Action Plan will serve to satisfy 
FDA's obligation under the Tobacco Control Act. As described in this 
notice, FDA is publishing the Enforcement Action Plan on its Web site 
and providing copies upon request.

ADDRESSES: Submit written requests for single copies of the Enforcement 
Action Plan to the Center for Tobacco Products, Food and Drug 
Administration, 9200 Corporate Blvd., Rockville, MD 20850-3229. Send 
one self-addressed adhesive label to assist that office in processing 
your request or include a fax number to which the document may be sent. 
Single copies may also be requested by calling 1-877-287-1373. See the 
SUPPLEMENTARY INFORMATION section for information on electronic access 
to the Enforcement Action Plan.

FOR FURTHER INFORMATION CONTACT: Office of Compliance and Enforcement, 
Center for Tobacco Products, Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 877-287-1373, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    The Tobacco Control Act (Public Law 111-31, 123 Stat. 1776) was 
enacted on June 22, 2009, providing FDA with the authority to regulate 
tobacco products in order to protect the public health generally, and 
to prevent and reduce tobacco use by minors. In enacting the Tobacco 
Control Act, Congress found, among other things, that the use of 
tobacco products by children is a pediatric disease and virtually all 
new users of tobacco products are under the minimum legal age to 
purchase such products (sections 2(1) and (4) of the Tobacco Control 
Act). Advertising, marketing, and promotion of tobacco products have 
been ``especially directed to attract young persons to use tobacco 
products, and these efforts have resulted in increased use of such 
products by youth'' (section 2(15) of the Tobacco Control Act). 
Additionally, the rates of tobacco use and tobacco-related mortality 
are higher among certain racial and ethnic groups, including American 
Indian and Alaska Natives, Asian men and African-American men. As the 
National Cancer Institute (NCI) noted in Monograph 19, ``[t]argeting of 
various population groups--including * * * specific racial and ethnic 
populations * * * has been strategically important to the tobacco 
industry.''\1\
---------------------------------------------------------------------------

    \1\ National Cancer Institute, The Role of the Media in 
Promoting and Reducing Tobacco Use, Tobacco Control Monograph No. 
19, Bethesda, MD, U.S. Department of Health and Human Services, 
National Institutes of Health, National Cancer Institute, NIH Pub. 
No. 07-6242, June 2008, p. 11, available at http://www.cancercontrol.cancer.gov/tcrb/monographs/19/index.html.
---------------------------------------------------------------------------

    Section 105(a) of the Tobacco Control Act (21 U.S.C. 387f-1(a)) 
requires the Secretary of Health and Human Services (the Secretary) to 
develop and publish an action plan to enforce restrictions on promotion 
and advertising of menthol and other cigarettes to youth, including 
those provided in the final rule entitled ``Regulations Restricting the 
Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect 
Children and Adolescents'' (75 FR 13225, March 19, 2010; 21 CFR part 
1140). This action plan must also include provisions designed to ensure 
enforcement of the restrictions, including those provided in 
``Regulations Restricting the Sale and Distribution of Cigarettes and 
Smokeless Tobacco to Protect Children and Adolescents,'' on the 
promotion and advertising of menthol and other cigarettes to youth in 
minority communities.
    Section 105(a) of the Tobacco Control Act also requires that the 
Secretary develop the Enforcement Action Plan in consultation with 
public health organizations and other stakeholders with demonstrated 
expertise and experience in serving minority communities. FDA created 
two dockets to solicit information, data, and views from all interested 
persons, including public health organizations and other stakeholders 
with demonstrated expertise and experience in serving minority 
communities, about the advertising and promotion of menthol and other 
cigarettes to youth in general, and to youth in minority communities. 
In the first docket, which was for the document entitled ``Tobacco 
Product Advertising and Promotion to Youth and Racial and Ethnic 
Minority Populations; Request for Comments'' (Docket No. FDA-2010-N-
0207; 75 FR 29776, May 27, 2010), FDA requested information on ways in 
which the advertising and promotion of tobacco products may affect 
tobacco use among racial and ethnic minority populations; input on 
designing an action plan regarding enforcement of the regulations on 
advertising and promotion of menthol and other cigarettes to youth 
generally and to youth in minority communities; and information that 
will assist the Tobacco Products Scientific Advisory Committee to 
better understand, report on, and make recommendations regarding the 
impact of the use of menthol in cigarettes among children, African-
Americans, Hispanics, and other racial and ethnic minority communities.
    FDA also established a docket and published an announcement for a 
meeting entitled ``Web-Based Public Meeting to Discuss Issues Related 
to the Development of an Enforcement Action Plan; Request for Data, 
Information, and Views'' (Docket No. FDA-2010-N-0295; 75 FR 34750, June 
18, 2010). FDA held the Web-based public meeting on June 30, 2010, to 
seek participation, information, and views from all interested parties, 
including but not limited to, public health organizations, minority 
community groups and leaders, other stakeholders with demonstrated 
expertise and experience in serving minority communities, groups 
serving youth, patient groups, advertising agencies, and industry. In 
addition to general information, FDA sought information on specific 
topics relating to the restrictions on promotion and advertising of 
menthol and other cigarettes to youth, including youth in minority 
communities. FDA also encouraged stakeholders and other interested 
parties to submit data, information, and views on these topics as well 
as other pertinent information to the relevant docket.
    In developing the Enforcement Action Plan, FDA considered the 
available information, including the data, information, and views 
presented at the Web-based public meeting and provided in electronic 
and written materials submitted to FDA by public health organizations, 
other stakeholders with demonstrated expertise and experience in 
serving minority communities, and other parties.

II. Electronic Access

    An electronic version of the Enforcement Action Plan is available 
on the Internet at http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/default.htm.

    Dated: September 24, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-24685 Filed 9-30-10; 8:45 am]
BILLING CODE 4160-01-S