2010-14809. Web-Based Public Meeting To Discuss Issues Related to the Development of an Enforcement Action Plan; Request for Data, Information, and Views

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of Web-based public meeting; request for data, information, and views.

SUMMARY:

The Food and Drug Administration (FDA), Center for Tobacco Products is announcing that it is hosting a Web-based public meeting to discuss issues regarding the development of an enforcement action plan to enforce restrictions on promotion and advertising of menthol and other cigarettes to youth, including youth in minority communities. FDA is seeking participation in the Web-based public meeting and data, 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, the regulated industry, and other interested parties. This Web-based public meeting and the data, information, and views we receive are intended to help FDA in developing an enforcement action plan. FDA is seeking input on a number of specific issues, but is interested in other pertinent information as well.

DATES:

The Web-based public meeting will be held on June 30, 2010, from 9 a.m. to 5 p.m. EDT. Persons interested in participating in the Web-based public meeting must submit written or electronic registration by close of business on June 23, 2010. Submit written and electronic data, information, and views by August 2, 2010.

ADDRESSES:

Submit data, information, and views electronically to http://www.regulations.gov. Submit written data, information, and views to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic registration to [e-mail]. Submit written registration to Anthony W. Lee, Center for Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850.

FOR FURTHER INFORMATION CONTACT:

Anthony W. Lee, Center for Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850-3229, 877-287-1373, email: [e-mail].

SUPPLEMENTARY INFORMATION:

I. Background

The Family Smoking Prevention and Tobacco Control Act (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 reduce tobacco use by minors. Tobacco products are responsible for more than 440,000 deaths each year in the United States (Ref. 1). 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, 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. 2).

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. 3). Additionally, studies from the early 1990s document that outdoor tobacco advertising was disproportionately targeted to young people and to minority communities (Refs. 4 and 5). A longitudinal study conducted from 1990 to 1994 in four 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. 6). 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. 7). 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. 8). 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. 9). Tobacco marketing to Asian Americans is also under-studied.

Section 102 of the Tobacco Control Act directed the Secretary of Health and Human Services (the Secretary) to publish a final rule which, among other things, prohibits the sale of cigarettes and smokeless tobacco to persons under age 18 and imposes restrictions on the marketing, labeling, and advertising of such products (Youth Access and Advertising Regulation). FDA published the final rule on March 19, 2010 (75 FR 13225) and the rule takes effect on June 22, 2010. 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, including those provided in the Youth Access and Advertising Regulation, on 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. This action plan must also include provisions designed to ensure enforcement of the restrictions, including those provided in the Youth Access and Advertising Regulation, on the promotion and advertising of menthol and other cigarettes to youth in minority communities. FDA is requesting data, information, and views that will assist it in developing an action plan regarding enforcement of restrictions on promotion and advertising of menthol and other cigarettes to youth, including youth in minority communities.

II. Scope of the Web-Based Public Meeting and Request for Data, Information, and Views

We are interested in data, information, and views that will help FDA in developing an enforcement action plan to enforce restrictions on promotion and advertising of menthol and other cigarettes to youth, including youth in minority communities. FDA is seeking any pertinent information from all interested parties, including public health organizations and other stakeholders with demonstrated expertise and experience in serving youth and minority communities as well as others with relevant expertise. In addition to general information, we are specifically interested in information on the following topics as they relate to the restrictions on promotion and advertising of menthol and other cigarettes to youth:

1. A discussion of how FDA can identify companies and others who promote and advertise menthol or other cigarettes to youth in violation of applicable restrictions.

2. A discussion of how FDA can identify companies and others who promote and advertise menthol or other cigarettes to youth in minority communities in violation of applicable restrictions.

3. A discussion of how FDA can better understand the types and placement of promotion and advertising of menthol and other cigarettes to youth.

4. A discussion of how FDA can better understand the types and placement of promotion and advertising of menthol and other cigarettes to youth in minority communities.

5. A discussion of how FDA can understand the themes and techniques used in promotion and advertising of menthol and other cigarettes to youth.

6. A discussion of how FDA can understand the themes and techniques used in promotion and advertising of menthol and other cigarettes to youth in minority communities.

III. How to Submit Data, Information, and Views and Participate in the Web-Based Public Meeting

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) either or electronic or written data, information, and views 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. Where relevant, you should annotate and organize your data, information, and views to identify the specific topic addressed by the discussion topic number referenced in section II of this document. Received data, information, and views may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

If you wish to participate in the Web-based public meeting, you must submit written or electronic registration as specified previously in this document (see ADDRESSES). Registration is free and will be accepted on a first-come, first-served basis, as participation is limited. We strongly encourage members from public health organizations and other stakeholders with demonstrated expertise and experience in serving youth and minority communities to make an oral presentation at this Web-based public meeting. Other interested parties may also be able to make an oral presentation. If you wish to make an oral presentation during the Web-based public meeting, you must state your intention on your registration submission (see ADDRESSES) and submit your name, title, company or organization (if applicable), address, telephone and fax numbers, and email address. FDA has included specific topics for discussion in section II of this document. You should also identify by number each discussion topic(s) you wish to address in your presentation, if relevant, and the approximate desired length of your presentation. FDA will do its best to accommodate requests to speak, and attempt to include equal representation from public health organizations and other stakeholders with demonstrated expertise and experience in serving youth and minority communities. FDA requests that speakers make their presentations onsite at White Oak Bldg. 1, 10903 New Hampshire Ave., Silver Spring, MD 20993. Presenters unable to appear onsite may submit a slide presentation to be shown during the Web-based public meeting. If possible, individuals and organizations with common interests should consolidate or coordinate their presentations and request time for a joint presentation. FDA will determine the amount of time allotted to each presenter and the approximate time that each oral presentation is scheduled to begin. FDA will contact each presenter prior to the Web-based public meeting with the amount of time available and the approximate time at which his or her presentation is scheduled to begin. Once FDA notifies presenters of their scheduled times, each presenter must submit to FDA an electronic copy of the presentation to be given. In order to be included in the Web-based public meeting, presentations must be received no later than June 25 at 5 P.M. (EDT). Please refer to FDA's Web site (http://www.fda.gov/​Tobacco) for more information and updates on the Web-based public meeting. Transcripts of the Web-based public meeting will be available for review at the Division of Dockets Management (see ADDRESSES) and on the Internet at http://www.regulations.gov approximately 30 days after the Web-based public meeting.

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. (FDA has verified the Web site addresses, but we are not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.)

1. Centers for Disease Control and Prevention, “Smoking-Attributable Mortality, Years of Potential Life Lost, and Productivity Losses—United States, 2000-2004,” Morbidity and Mortality Weekly Report (serial online); 57(45), pp. 1226-1228, 2008 (http://www.cdc.gov/​mmwr/​preview/​mmwrhtml/​mm5745a3.htm).

2. National Cancer Institute, U.S. Department of Health & Human Services, “The Role of the Media in Promoting and Reducing Tobacco Use,” Tobacco Control Monograph No. 19; p. 11, 2008 (http://www.cancercontrol.cancer.gov/​tcrb/​monographs/​19/​index.html).

3. 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 (http://profiles.nlm.nih.gov/​NN/​B/​B/​F/​Q/​_/​nnbbfq.pdf).

4. Mitchell, O. and 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.)

5. Ammerman, S.D. and M. Nolden, “Neighborhood-Based Tobacco Advertising Targeting Adolescents,” Western Journal of Medicine; 162, pp. 514-518, 1995 (http://www.ncbi.nlm.nih.gov/​pmc/​articles/​PMC1022829/​pdf/​westjmed00058-0028.pdf ) (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.”)

6. Stoddard, J.L., et. al., “Tailoring Outdoor Tobacco Advertising to Minorities in Los Angeles County,” Journal of Health Communication; 3. p. 137, 1998.

7. 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.

8. 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 (http://www.cancercontrol.cancer.gov/​tcrb/​monographs/​19/​index.html).

9. Id., p. 15.

Dated: June 15, 2010.

David Dorsey,

Acting Deputy Commissioner for Policy, Planning and Budget.