[Federal Register Volume 75, Number 117 (Friday, June 18, 2010)]
[Notices]
[Pages 34750-34752]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-14809]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0295 ]


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.

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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 [email protected]. 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: 
[email protected].

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

[[Page 34751]]

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

[[Page 34752]]

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.
[FR Doc. 2010-14809 Filed 6-14-10; 4:15 pm]
BILLING CODE 4160-01-S