[Federal Register Volume 75, Number 102 (Thursday, May 27, 2010)]
[Notices]
[Pages 29776-29777]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-12684]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0207]


Tobacco Product Advertising and Promotion to Youth and Racial and 
Ethnic Minority Populations; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for data and information.

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

SUMMARY: The Food and Drug Administration (FDA) is soliciting 
information, research, and ideas to assist FDA in fulfilling its 
responsibilities regarding tobacco product advertising and promotion 
that is designed to appeal to specific racial and ethnic minority 
populations in the United States. For the same reasons, we are also 
interested in receiving information about the advertising and promotion 
of menthol and other cigarettes to youth in general, and to youth in 
minority communities. After reviewing the submitted information, 
research, and ideas, FDA will be better able to fulfill its 
responsibilities under The Family Smoking Prevention and Tobacco 
Control Act (Tobacco Control Act).

DATES: Submit electronic or written comments by July 26, 2010.

ADDRESSES: Submit electronic comments to http://www.regulations.gov. 
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kathleen K. Quinn, Center for Tobacco 
Products, Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850-3229, 240-276-1717, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Tobacco products are responsible for more than 440,000 deaths each 
year. The rates of tobacco use and tobacco-related mortality are higher 
among certain racial/ethnic groups, including American Indian and 
Alaska Natives, 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.'' (Ref. 1).
    The first Surgeon General's Report to address the tobacco 
industry's history of targeting its marketing to minority communities 
was published in 1998 (Ref. 2). Additionally, studies from the early 
1990s document that outdoor tobacco advertising was disproportionately 
targeted to young people and to minority communities (Refs. 3 and 4). A 
longitudinal study conducted from 1990 to 1994 in 4 types of Los 
Angeles ethnic neighborhoods found that, ``[c]ompared with White 
neighborhood thoroughfares, African American and Hispanic neighborhoods 
contained a greater tobacco ad density, and all minority neighborhoods 
contained greater tobacco ad concentration along the roadsides * * *. 
These data are consistent with the assertion that tobacco companies 
target ethnic minorities with higher rates of advertising and 
ethnically tailored campaigns.'' (Ref. 5). A meta-analysis published in 
2007 confirmed that ``African Americans are exposed to a higher volume 
of pro-tobacco advertising in terms of both concentration and 
density.'' (Ref. 6). In addition to the volume of advertising, the 
methods used in targeting advertisements to some specific communities 
have also been studied. For example, Monograph 19 discusses how 
advertising for mentholated brands to African-Americans was designed 
around lifestyle appeals relating to ``fantasy and escapism,'' 
``expensive objects,'' and ``nightlife, entertainment, and music'' 
themes (Ref. 7). However, as NCI noted, ``little attention has been 
paid to understanding tobacco marketing aimed at American Indians and 
Alaska Natives, despite their high prevalence of tobacco use.'' (Ref. 
8). Tobacco marketing to Asian Americans is also under-studied.
    On June 22, 2009, the President signed the Tobacco Control Act into 
law. The Tobacco Control Act grants FDA important new authority to 
regulate the manufacture, marketing, and distribution of tobacco 
products to protect the public health generally and to reduce tobacco 
use by minors. Among its many provisions, the Tobacco Control Act added 
section 907(e)(1) to the Federal Food, Drug, and Cosmetic Act (the act) 
(21 U.S.C. 387g(e)(1)). Section 907(e)(1) of the act requires the 
Secretary of Health and Human Services (the Secretary) to ``refer to 
the [Tobacco Products Scientific Advisory] Committee for report and 
recommendation * * * the issue of the impact of the use of menthol in 
cigarettes on the public health, including such use among children,

[[Page 29777]]

African-Americans, Hispanics, and other racial and ethnic minorities.''
    In addition, section 906(d) of the act (21 U.S.C. 387f(d)) gives 
the Secretary authority to impose restrictions on the advertising and 
promotion of a tobacco product that the Secretary determines are 
appropriate to protect the public health.
    Section 105(a) of the Tobacco Control Act (21 U.S.C. 387f-1) 
requires the Secretary to develop and publish an action plan to enforce 
restrictions on the sale, distribution, promotion, and advertising of 
menthol and other cigarettes to youth. The provision requires that the 
Secretary develop this plan in consultation with public health 
organizations and other stakeholders with demonstrated experience and 
expertise in serving minority communities. The action plan must also 
include provisions designed to ensure enforcement of the restrictions 
on the sale, distribution, promotion, and advertising of menthol and 
other cigarettes to youth in minority communities.
    More information about tobacco advertising, promotion, and 
marketing to minority population groups will assist FDA in implementing 
the public health goals of the Tobacco Control Act. To assist FDA in 
carrying out the previously mentioned provisions in a manner that will 
protect the public health, FDA seeks information about the advertising 
and promotion of tobacco products to particular racial and ethnic 
minority populations. A better understanding of this advertising and 
promotion will help FDA understand what steps, if any, may be 
appropriate under section 906(d) of the act. In addition, we are 
requesting comments that will assist the agency's development of an 
action plan regarding enforcement of regulations on advertising and 
promotion of menthol and other cigarettes to youth generally and to 
youth in minority communities. FDA is also seeking information that 
will assist the Tobacco Products Scientific Advisory Committee in 
understanding and developing recommendations regarding the impact of 
the use of menthol in cigarettes among children, African-Americans, 
Hispanics, and other racial and ethnic minorities. A copy of the 
Tobacco Control Act is available at http://www.fda.gov/tobacco.

II. Request for Information

    1. Product advertising and promotion play a critical role in 
fostering brand loyalty and communicating messages to consumers. FDA is 
aware that messages can be conveyed through a variety of visual cues 
and that, historically, messages about tobacco products have been 
created to appeal to specific racial and ethnic communities. Increased 
understanding of such messaging will assist FDA in determining what 
steps to take, if any, regarding the sale, distribution, advertising, 
and promotion of tobacco products that may be appropriate for the 
protection of public health. We are therefore requesting information on 
ways in which the advertising and promotion of tobacco products may 
affect tobacco use among racial and ethnic minority populations.
    2. In the Federal Register of March 19, 2010 (75 FR 13225), FDA 
published final regulations restricting the sale and distribution of 
cigarettes and smokeless tobacco to protect children and adolescents. 
Those regulations take effect June 22, 2010. Therefore, FDA is also 
seeking input specifically on designing an action plan regarding 
enforcement of the final regulations on advertising and promotion of 
menthol and other cigarettes to youth generally and to youth in 
minority communities.
    3. FDA is also requesting 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 minorities.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

IV. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
    1. National Cancer Institute, U.S. Department of Health and 
Human Services, ``The Role of the Media in Promoting and Reducing 
Tobacco Use,'' Tobacco Control Monograph No. 19; p. 11, 2008.
    2. U.S. Department of Health and Human Services, ``Tobacco Use 
Among U.S. Racial/Ethnic Minority Groups--African Americans, 
American Indians and Alaska Natives, Asian Americans and Pacific 
Islanders, and Hispanics,'' A Report of the Surgeon General; p. 220, 
1998.
    3. Mitchell, O. & M. Greenberg, ``Outdoor Advertising of 
Addictive Products,'' New Jersey Medicine; 88, p. 331, 1991 (finding 
that billboards in black and Hispanic neighborhoods in four New 
Jersey cities disproportionately contained advertisements for 
tobacco and alcohol products.)
    4. Ammerman, S.D. & M. Nolden, ``Neighborhood-Based Tobacco 
Advertising Targeting Adolescents,'' Western Journal of Medicine; 
162, pp. 514-518, 1995 (finding that adolescent exposure to tobacco 
billboard advertisements in San Francisco in 1992 and 1993 was 
greater in Latino neighborhoods due to a greater adolescent 
population, and finding that qualitative analyses of the tobacco 
advertisements ``suggested that adolescents are the primary 
targets.'')
    5. Stoddard, J.L., et. al., ``Tailoring Outdoor Tobacco 
Advertising to Minorities in Los Angeles County,'' Journal of Health 
Communication; 3, p. 137, 1998.
    6. Primack, B.A., et al., ``Volume of Tobacco Advertising in 
African American Markets: Systematic Review and Meta-Analysis,'' 
Public Health Reports; 122, p. 607, 2007.
    7. National Cancer Institute, U.S. Department of Health and 
Human Services, ``The Role of the Media in Promoting and Reducing 
Tobacco Use,'' Tobacco Control Monograph No. 19; p. 57, 2008.
    8. Id., p. 15.

    Dated: May 21, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-12684 Filed 5-26-10; 8:45 am]
BILLING CODE 4160-01-S