[Federal Register Volume 75, Number 53 (Friday, March 19, 2010)]
[Proposed Rules]
[Pages 13241-13243]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-6086]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1140

[Docket No. FDA-2010-N-0136]
RIN 0910-AG33


Request for Comment on Implementation of the Family Smoking 
Prevention and Tobacco Control Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Advance notice of proposed rulemaking.

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SUMMARY: The Food and Drug Administration (FDA) is issuing this advance 
notice of proposed rulemaking to obtain information related to the 
regulation of outdoor advertising of cigarettes and smokeless tobacco. 
Elsewhere in this issue of the Federal Register, FDA is reissuing a 
final rule restricting the sale, distribution, and use of cigarettes 
and smokeless tobacco to protect children and adolescents as required 
by the Family Smoking Prevention and Tobacco Control Act (Tobacco 
Control Act). FDA has reserved a section of that final rule for future 
rulemaking on restrictions related to the outdoor advertising of 
cigarettes and smokeless tobacco. FDA is requesting comments, data, 
research, or other information on the regulation of outdoor advertising 
of cigarettes and smokeless tobacco.

DATES: Submit electronic or written comments by May 18, 2010.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2010-
N-0136 and/or RIN number 0910-AG33, by any of the following methods:
Electronic Submissions
    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
Written Submissions
    Submit written submissions in the following ways:
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier (for paper, disk, or CD-ROM 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the agency name 
and docket number and Regulatory Information Number (RIN) for this 
rulemaking. All comments received may be posted without change to 
http://www.regulations.gov, including any personal information 
provided. For additional information on submitting comments, see the 
``Comments'' heading of the SUPPLEMENTARY INFORMATION section of this 
document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number, found in brackets in the heading of this document, into 
the ``Search'' box and follow the prompts and/or go to the Division of 
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:  Annette Marthaler, Center for Tobacco 
Products, Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850-3229, 1-877-287-1373, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Elsewhere in this issue of the Federal Register, FDA is reissuing a 
1996 final rule that restricts the sale, distribution, and use of 
cigarettes and smokeless tobacco. The reissuance of the final rule is 
required under section 102 of the Tobacco Control Act (Public Law 111-
31). More specifically, section 102 requires FDA to publish a final 
rule regarding cigarettes and smokeless tobacco identical in its 
provisions to the regulation promulgated by FDA in 1996 (61 FR 44396, 
August 28, 1996) (1996 final rule), with certain specified exceptions. 
Section 102 provides that the reissued 1996 final rule shall ``include 
such modifications to section 897.30(b), if any, that the Secretary 
determines are appropriate in light of governing First Amendment case 
law, including the decision of the Supreme Court of the United States 
in Lorillard Tobacco Co. v. Reilly (533 U.S. 525 (2001)).''
    As published in 1996, Sec.  897.30(b) stated that ``[n]o outdoor 
advertising for cigarettes or smokeless tobacco, including billboards, 
posters, or placards, may be placed within 1,000 feet of the perimeter 
of any public playground or playground area in a public park (e.g., a 
public park with equipment such as swings and seesaws, baseball 
diamonds, or basketball courts), elementary school, or secondary 
school.'' In Lorillard the Supreme Court struck down as violative of 
the First Amendment regulations promulgated by Massachusetts that, 
among other things, banned outdoor tobacco advertisements within 1,000 
feet of any school or playground. The Supreme Court concluded that 
Massachusetts had a substantial state interest in protecting children 
and adolescents from the harms of tobacco use and that the outdoor 
advertising restriction advanced that interest. However, the Court 
ruled that the regulation violated the First Amendment because it was 
not adequately tailored to achieve the substantial state interest of 
protecting children and adolescents from tobacco products.
    To best determine what modifications to Sec.  897.30(b), if any, 
are appropriate in light of governing First Amendment case law, FDA has 
determined that Sec.  897.30(b) (now renumbered as Sec.  1140.30(b)) 
should be reserved in the

[[Page 13242]]

final rule published elsewhere in this issue of the Federal Register 
and that the agency should request the submission of any comments, 
data, research, or other information pertaining to potential outdoor 
advertising restrictions for tobacco products that may have developed 
since the 1996 issuance of Sec.  897.30(b). This approach enables the 
agency to implement a regulatory approach to outdoor advertising that 
reflects careful consideration of the U.S. Supreme Court's decision in 
Lorillard, other provisions in the Tobacco Control Act, and other 
developments and information, such as the Master Settlement Agreement 
between the State Attorneys General and the tobacco industry, that have 
occurred since the original publication of the 1996 final rule. FDA 
intends to use the information submitted in response to this document, 
along with information in the existing record and other information 
developed since the publication of the 1996 final rule, to inform its 
regulation of outdoor advertising of cigarettes and smokeless tobacco.
    For example, since the publication of the 1996 rule, the U.S. 
National Cancer Institute (NCI) published its 19th monograph in the 
Tobacco Control Monograph Series, The Role of the Media in Promoting 
and Reducing Tobacco Use (Monograph 19). Monograph 19 is a 
``comprehensive distillation of the scientific literature on media 
communications in tobacco promotion and tobacco control.'' In examining 
tobacco advertising, Monograph 19 stated that ``tobacco advertising 
forms part of an integrated marketing communications strategy combining 
sponsorship, brand merchandising, brand stretching, packaging, point-
of-sale promotions, and product placement.'' The major conclusions of 
Monograph 19 included the following: (1) Cigarettes are among the most 
heavily marketed products in the United States; (2) the targeting of 
various population groups, including youth and young adults, ``has been 
strategically important to the tobacco industry''; and (3) the weight 
of the evidence demonstrates a causal relationship between tobacco 
advertising and promotion and increased tobacco use. With respect to 
marketing of tobacco to children and adolescents, Monograph 19 
concluded, among other things, that: (1) Tobacco advertising targets 
the psychological needs of adolescents (e.g., popularity) and 
``adolescents who believe that smoking can satisfy their psychological 
needs, or whose desired image of themselves is similar to their image 
of smokers, are more likely to smoke cigarettes''; and (2) even brief 
exposure to tobacco advertising influences adolescents' intentions to 
smoke.
    Monograph 19 stated that ``cigarette advertising and promotion are 
heavy in volume and high in visibility at the point of sale, 
particularly in convenience stores.'' Monograph 19 also stated ``[i]n 
2001, a cross-section of 586 California retailers was found to have 
more than 17 tobacco point-of-purchase ads, on average, in or around 
the store * * * 11% had large exterior signs--in violation of the 
[Master Settlement Agreement].'' In addition, Monograph 19 cited a 
study involving 3,000 students in grades 9 to 12 who smoked, which 
found ``their cigarette brand preferences correlated with the brands 
most heavily advertised in the convenience stores within a one-mile 
radius of their schools.''
    Monograph 19 contained an extensive discussion of the colors and 
symbols associated with cigarette brands and found that colors and 
symbols can be used in ways that facilitate the circumvention of 
tobacco advertising restrictions. Monograph 19 found that the ``brand 
image of most tobacco products represents the end result of a 
multifaceted marketing effort involving brand identity * * * and the 
use of color. The development, enhancement, and reinforcement of this 
brand imagery are primary objectives of tobacco promotion.''

II. Restrictions Under Consideration

    The agency is considering several options, including a regulation 
proposing to (1) Prohibit or otherwise limit billboards located within 
1,000 feet of any elementary or secondary school (k-12) and (2) 
prohibit or otherwise limit large signs or collections of 
advertisements greater than 14 square feet at retail establishments 
located in close proximity to any elementary or secondary school (e.g., 
within 350 feet or approximately one city block). As required by 
Lorillard and the governing First Amendment case law, any proposed 
restrictions would be more narrowly tailored than Sec.  897.30(b), as 
published in 1996. The agency is considering whether the restrictions 
under consideration in this advance notice of proposed rulemaking that 
would differentiate between large and small advertisements would 
appropriately tailor the rule. For example, we are considering 
tailoring the distance requirement by leaving the 1,000 foot 
restriction for the largest and most prominent advertisements 
(billboards) and narrowing the distance to 350 feet (approximately one 
city block) for smaller advertisements that are not as prominent. Under 
this approach, the restrictions would limit advertising near schools 
only, rather than schools and playgrounds.

III. Request for Comments and Information

    FDA is seeking data, research, information, and comments on whether 
restrictions on outdoor advertising of tobacco products are necessary 
to protect children and adolescents from the harms caused by tobacco 
use and, if they are, whether the restrictions under consideration, or 
close variations would be justified, lawful, and appropriate. FDA is 
also seeking data, research, information, and comments on other 
restrictions on outdoor advertising that, either in addition to or 
instead of the specific restrictions under consideration, would advance 
the public health goal of protecting children and adolescents from the 
harms caused by tobacco use.
    FDA is seeking data, research, information, and comments related to 
the following:
     Would restrictions advance the public health goal of 
protecting children and adolescents from the harms caused by tobacco 
use?
     If so, could this public health goal be achieved with 
narrower restrictions? For example,
    [ctrcir] by prohibiting billboards located at some distance less 
than 1,000 feet of an elementary or secondary school?
    [ctrcir] by prohibiting signs or collections of advertisements that 
are larger than some size greater than 14 square feet at retail 
establishments located within 350 feet of an elementary or secondary 
school?
    [ctrcir] by prohibiting signs or collections of advertisements 
greater than 14 square feet at retail establishments located within 
some distance less than within 350 feet of an elementary or secondary 
school?
     Or would a broader prohibition be necessary to achieve the 
public health goal? For example,
    [ctrcir] by prohibiting other outdoor advertisements in addition to 
those described in section II of this document?
    [ctrcir] by prohibiting smaller notices on store windows?
    [ctrcir] by prohibiting advertisements, not only near schools, but 
also near playgrounds (and, if so, how should ``playgrounds'' be 
defined)?
     Should FDA consider requiring stores that sell tobacco 
products to post graphic anti-tobacco messages in order to counter the 
effects of advertisements on children?

[[Page 13243]]

    FDA is also seeking data, research, information, and comments--not 
limited to the specific restrictions under consideration--related to 
the following:
     The impact and/or effect(s) of outdoor advertising 
restrictions on youth smoking behavior;
     The increased or decreased likelihood that persons exposed 
to outdoor advertising will start using tobacco products;
     The increased or decreased likelihood that persons exposed 
to outdoor advertising will continue to use tobacco products or will be 
less likely to stop using tobacco products;
     The impact of outdoor advertising restrictions based upon 
distance from schools in major metropolitan areas;
     The impact of outdoor advertising restrictions based upon 
distance from schools in rural, suburban, and urban areas and how the 
impact may differ in such areas;
     The impact of outdoor advertising restrictions based upon 
the size, type, or other characteristic of the advertisement;
     The impact of warnings included in promotional materials, 
including outdoor advertising;
     The impact of outdoor advertising restrictions on tobacco 
manufacturers or other sellers' ability to communicate with adult 
smokers;
     Restrictions on outdoor advertising that, either in 
addition to or instead of the specific restrictions under 
consideration, would advance the public health goal of protecting 
children and adolescents from the harms caused by tobacco use.

IV. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) electronic or written comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified 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.

    Dated: March 11, 2010.
Margaret A. Hamburg,
Commissioner of Food and Drugs.

    Dated: March 11, 2010.
Kathleen Sebelius,
Secretary of Health and Human Services.
[FR Doc. 2010-6086 Filed 3-18-10; 8:45 am]
BILLING CODE 4160-01-S