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###### Department of Health and Human Services

###### Food and Drug Administration

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

# 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:                         *Kathleen.Quinn@fda.hhs.gov*.                    

# 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,                           ( print 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