[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]
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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.
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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\
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\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.
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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]
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