[Federal Register: March 19, 2010 (Volume 75, Number 53)]
[Rules and Regulations]               
[Page 13225-13232]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19mr10-5]                         

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1140

[Docket No. FDA-1995-N-0259] (formerly Docket No. 1995N-0253)
RIN 0910-AG33

 
Regulations Restricting the Sale and Distribution of Cigarettes 
and Smokeless Tobacco To Protect Children and Adolescents

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is reissuing a final 
rule restricting the sale, distribution, and use of cigarettes and 
smokeless tobacco. As required by the Family Smoking Prevention and 
Tobacco Control Act (Tobacco Control Act), FDA is issuing a final rule 
that is identical to the provisions of the final rule on cigarettes and 
smokeless tobacco published by FDA in 1996, with certain required 
exceptions. The rule prohibits the sale of cigarettes and smokeless 
tobacco to individuals under the age of 18 and imposes specific 
marketing, labeling, and advertising requirements. Elsewhere in this 
issue of the Federal Register, FDA is issuing an advance notice of 
proposed rulemaking to obtain information related to the regulation of 
outdoor advertising of cigarettes and smokeless tobacco.

DATES:  This rule is effective June 22, 2010.

FOR FURTHER INFORMATION CONTACT:  Annette Marthaler, Center for Tobacco 
Products, Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD 20850-3229, 877-287-1373, annette.marthaler@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background
II. Overview of the Final Rule
III. Scientific Information That Has Become Available Since the 
Publication of the 1996 Final Rule
    A. Access
    B. Marketing
IV. Legal Authority
V. Executive Order 12866

[[Page 13226]]

VI. Information Collection Provisions in the Final Rule

I. Background

    The Tobacco Control Act was enacted on June 22, 2009, amending the 
Federal Food, Drug, and Cosmetic Act (act) and providing FDA with the 
authority to regulate tobacco products (Public Law 111-31; 123 Stat. 
1776). Section 102 of the Tobacco Control Act requires FDA to publish a 
final rule regarding cigarettes and smokeless tobacco identical in its 
provisions to the regulation issued by FDA in 1996 (61 FR 44396, August 
28, 1996) (1996 final rule), with certain specified exceptions.
    In enacting the Tobacco Control Act, Congress made extensive 
legislative findings regarding the lethal and addictive nature of 
tobacco products, including that tobacco use is the foremost 
preventable cause of premature death in the United States (section 
2(13) of the Tobacco Control Act; 61 FR 44398). Tobacco use causes more 
than 400,000 deaths each year (section 2(13) of the Tobacco Control 
Act). Moreover, 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). 
The use of tobacco products is a ``pediatric disease'' and an effective 
program to address this disease must include restrictions on youth 
access and restrictions on labeling and advertising to help reduce the 
appeal of tobacco products to young people (section 2(1), (30) of the 
Tobacco Control Act; 60 FR 41314 at 41315; August 11, 1995).
    As Congress recognized, the 1996 final rule was ``the longest 
rulemaking proceeding in [FDA] history,'' with 700,000 comments 
received in the course of the rulemaking (Congressional Record, S6407, 
June 10, 2009, Statement of Senator Kennedy). ``[I]t makes no sense to 
require FDA to reinvent the wheel by conducting a new multiyear 
rulemaking process on the same issues * * * this legislation will give 
the youth access and advertising restrictions already developed by FDA 
the force of law'' (Congressional Record, S6407, June 10, 2009, 
Statement of Senator Kennedy). Both the 1996 final rule and the 1995 
proposed rule (60 FR 41314) included extensive discussions of the 
scientific information available at that time and the final rule 
included FDA's responses to the more than 700,000 comments on the 
proposed rule (61 FR 44396).

II. Overview of the Final Rule

    Consistent with the requirements of section 102 of the Tobacco 
Control Act, this rule prohibits the sale of cigarettes and smokeless 
tobacco to any person under age 18 and imposes restrictions on 
marketing, labeling, and advertising. The rule requires retailers to 
verify a purchaser's age by photographic identification; prohibits free 
samples of cigarettes and prohibits free samples of smokeless tobacco, 
except in qualified adult-only facilities; prohibits the sale of 
cigarettes and smokeless tobacco products through vending machines and 
self-service displays, except in facilities where individuals under the 
age of 18 are not present or permitted at any time; limits the 
advertising and labeling to which children and adolescents are exposed 
to a black-and-white, text-only format \1\; prohibits the sale or 
distribution of brand-identified promotional nontobacco items such as 
hats and tee shirts; and prohibits sponsorship of sporting and other 
events, teams, and entries in a brand name of a tobacco product, but 
permits such sponsorship in a corporate name.
---------------------------------------------------------------------------

    \1\ As discussed later in this section II, this provision is the 
subject of an injunction issued by the United States District Court 
for the Western District of Kentucky (Commonwealth Brands, Inc. v. 
United States, No. 1:09-CV-117-M (W.D. Ky. Jan. 4, 2010)).
---------------------------------------------------------------------------

    As required by section 102(a)(2) of the Tobacco Control Act, this 
final rule includes the following changes to the provisions of the 1996 
final rule:
     Strikes subpart C--Labels and Sec.  897.32(c) (section 
102(a)(2)(B));
     Replaces the definitions of ``cigarette,'' ``cigarette 
tobacco,'' and ``smokeless tobacco'' with the definitions of those 
terms included in the Tobacco Control Act (section 102(a)(2)(C));
     Inserts the phrase ``or roll-your-own paper'' in 21 CFR 
1140.34(a) (formerly Sec.  897.34(a) of the 1996 final rule) (section 
102(a)(2)(D)); and
     Reflects the language in section 102(a)(2)(G) of the 
Tobacco Control Act in 21 CFR 1140.16(d) (formerly Sec.  897.16(d)) of 
the 1996 final rule.
    FDA has also changed the section numbers of the codified provisions 
to reflect the rule's codification at part 1140 (21 CFR part 1140) (the 
1996 final rule codified the provisions at part 897, a part used for 
device regulations, because the products were regulated as devices at 
that time), made conforming edits, such as corrections to paragraph 
numbering, to Sec.  1140.16(d), and updated the address in Sec.  
1140.30(a)(2). In addition, the rule reflects the following 
considerations.
    Section 21 CFR 1140.16(a)--Under this final rule, manufacturers may 
not use a trade or brand name of a nontobacco product as the trade or 
brand name for a cigarette or smokeless tobacco product unless the 
trade or brand name was on both the tobacco product and a nontobacco 
product sold in the United States on January 1, 1995. FDA is aware of 
concerns regarding this provision and is considering what changes, if 
any, would be appropriate.
    Section 21 CFR 1140.30(b)--Consistent with section 102(a)(2)(E) of 
the Tobacco Control Act, FDA has carefully considered whether this 
section (formerly Sec.  897.30(b)) should be modified 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 
(Lorillard) (533 U.S. 525 (2001)). FDA has determined that it is 
appropriate in light of governing First Amendment case law to solicit 
additional information regarding outdoor advertising in order to 
determine what modifications to this section, if any, are appropriate. 
Accordingly, elsewhere in this Federal Register, FDA is publishing an 
advance notice of proposed rulemaking (ANPR) requesting comments and 
information on outdoor advertising. By issuing this ANPR, the Agency 
will obtain comments and data, research, or other information that may 
have developed since the 1996 issuance of Sec.  897.30(b). This will 
enable the Agency to implement a regulatory approach to outdoor 
advertising that reflects careful consideration of the U.S. Supreme 
Court's decision in Lorillard, the other provisions of 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 advance notice of proposed rulemaking, 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. 
Accordingly, FDA has reserved former Sec.  897.30(b), which is now 
renumbered as Sec.  1140.30(b), in this final rule.
    Section 21 CFR 1140.32(a)--The United States District Court for the 
Western District of Kentucky recently issued an order granting the 
plaintiffs' motion for an order enjoining FDA from enforcing against 
them section Sec.  1140.32(a) (formerly Sec.  897.32(a) of the 1996 
final rule), scheduled to go into effect on June 22, 2010. 
(Commonwealth

[[Page 13227]]

Brands, Inc. v. United States, No. 1:09-CV-117-M (W.D. Ky. Jan. 4, 
2010)). The government has noticed an appeal from the final judgment 
entered in that case on March 8, 2010.

III. Scientific Information That Has Become Available Since the 
Publication of the 1996 Final Rule

    In developing its proposed rule (60 FR 41314, August 11, 1995) and 
the 1996 final rule, FDA carefully considered the scientific reviews 
and information available at that time. Although not required to do so 
by the Tobacco Control Act, FDA reviewed scientific information that 
has become available since publication of the 1996 final rule and found 
that, consistent with the evidence in the record for the 1996 final 
rule, the provisions continue to be overwhelmingly supported by 
extensive studies on continued youth access to tobacco products, the 
targeted marketing of tobacco products to youth, and the immense public 
health harm that results. Following is an overview of some of the 
scientific information that has become available since the 1996 final 
rule.

A. Access

    The 2008 National Survey on Drug Use and Health found that the 
number of persons aged 12 or older who smoked cigarettes for the first 
time within the past 12 months was 2.4 million in 2008, which was 
significantly higher than the estimate for 2002 (1.9 million), 2003 
(2.0 million), and 2004 (2.1 million).\2\ In 2008, every day, nearly 
4,000 youth aged 12 to 17 became new cigarette smokers.\3\ 
Approximately 85 percent of persons who ever tried a cigarette did so 
by age 18.\4\ In addition, the number of persons aged 12 or older 
initiating use of smokeless tobacco was 1.4 million in 2008 and a 
little less than half (47.4 percent) were under age 18 when they first 
used smokeless tobacco.\5\ The President's Cancer Panel identified 
youth as a population group ``particularly vulnerable to tobacco 
initiation, continued use, and consequent diseases caused by tobacco 
use'' and reported that the ``younger people are when they begin to 
smoke, the more likely they are to be adult smokers.'' \6\ Based on 
2009 data from the Monitoring the Future survey, past-month cigarette 
smoking rates among 8th, 10th, and 12th grade students declined only 
slightly from 2007 to 2009, at a much slower pace than observed 
previously, while significant increases occurred from 2005 to 2009 in 
past-month use of smokeless tobacco among 10th and 12th grade 
students.\7\
---------------------------------------------------------------------------

    \2\ Substance Abuse and Mental Health Services Administration, 
``Results from the 2008 National Survey on Drug Use and Health: 
National Findings,'' p. 60, Office of Applied Studies, NSDUH Series 
H-34, DHHS Publication No. SMA 09-4434, Rockville, MD, 2009. (http:/
/www.oas.samhsa.gov/nsduh/2k8nsduh/2k8Results.cfm). (FDA has 
verified the Web site addresses in this document, but FDA is not 
responsible for any subsequent changes to the Web sites after this 
document publishes in the Federal Register.)
    \3\ Id.
    \4\ Memorandum from the Centers for Disease Control to the Food 
and Drug Administration, February 3, 2010.
    \5\ Substance Abuse and Mental Health Services Administration, 
``Results from the 2008 National Survey on Drug Use and Health: 
National Findings,'' p. 62, Office of Applied Studies, NSDUH Series 
H-34, DHHS Publication No. SMA 09-4434, Rockville, MD, 2009.
    \6\ President's Cancer Panel, ``Promoting Healthy Lifestyles,'' 
p. 64, U.S. Department of Health and Human Services, National 
Institutes of Health, National Cancer Institute, 2007 (http://
deainfo.nci.nih.gov/ADVISORY/pcp/pcp07rpt/pcp07rpt.pdf).
    \7\ Johnston, L.D., P.M. O'Malley, J.G. Bachman, et al., 
``Smoking continues gradual decline among U.S. teens, smokeless 
tobacco threatens a comeback'' (press release), University of 
Michigan News Service, December 14, 2009 (http://
www.monitoringthefuture.org/data/09data.html#2009data-cigs).
---------------------------------------------------------------------------

    Cigarette sources include social and commercial sources (e.g., gas 
stations, convenience stores). Despite state laws prohibiting the sale 
of cigarettes to youth, many middle school and high school students 
continue to report that cigarettes are easy to obtain.\8\ One study 
found that minors were 2.2 times more successful when attempting to buy 
a smokeless tobacco product than when trying to buy cigarettes.\9\ Age 
verification data indicate that minors are able to purchase cigarettes 
and other tobacco products from stores without age verification.\10,11\ 
In addition, youth continue to have some access to ``loosies'' (defined 
as less than a full pack of cigarettes).\12,13\
---------------------------------------------------------------------------

    \8\ Id.
    \9\ Clark, P.I., S.L. Natanblut, C.L. Schmitt, et al., ``Factors 
Associated With Tobacco Sales to Minors: Lessons Learned From the 
FDA Compliance Checks,'' Journal of American Medical Association; 
284(6), pp.729-734, 2000.
    \10\ Centers for Disease Control and Prevention (CDC), ``Tobacco 
Use, Access, and Exposure to Tobacco in Media Among Middle and High 
School Students, United States, 2004,'' MMWR Highlights, April 1, 
2005 (http://www.cdc.gov/tobacco/data_statistics/mmwrs/byyear/2005/
mm5412a1/highlights.htm).
    \11\ Jones S.E., D.J. Sharp, C.G. Husten, et al., ``Cigarette 
acquisition and proof of age among U.S. high school students who 
smoke,'' Tobacco Control, 11(1), pp. 20-25, 2002.
    \12\ Johnston L.D., P.M. O'Malley, Y.M. Terry-McElrath, 
``Methods, Locations, and Ease of Cigarette Access for American 
Youth, 1997-2002,'' American Journal of Preventive Medicine; 27(4), 
pp. 267-276, 2004.
    \13\ Clegg Smith, K., F. Stillman, L. Bone, et al., ``Buying and 
Selling `Loosies' in Baltimore: The Informal Exchange of Cigarettes 
in the Community Context,'' Journal of Urban Health, 84(4), pp.494-
507, 2007.
---------------------------------------------------------------------------

    Youth access restrictions and enforcement of these laws continue to 
be identified as important interventions for preventing tobacco use 
among adolescents.\14,15,16,17\ One national study found that increases 
in state retailer compliance with state laws against selling tobacco 
products to minors were associated with decreases in daily cigarette 
smoking rates among 10th grade students.\18\ States have universally 
adopted youth access restrictions in light of the Synar Amendment 
(Public Law 102-321), which is aimed at decreasing youth access to 
tobacco, and most states have made considerable progress in achieving 
the goal of reducing retailer violation rates in random inspections to 
20 percent or less.\19,20\ In 2008, the national average retailer 
violation rate (tobacco sales to minors) was 9.9 percent.\21\ This was 
the lowest retailer violation rate in Synar's 12-year history. However, 
the Synar Amendment focuses on only one aspect of tobacco control: 
Reducing youth access to tobacco products through retail sources. 
Although important, reduction of youth access to tobacco products is 
generally recognized as only one aspect of an effective multi-component 
approach to reduce youth tobacco initiation and use, which should also 
include efforts to limit tobacco industry marketing and smoking 
restrictions.\22,23\ Moreover,

[[Page 13228]]

data indicate many teens still report access to cigarettes and 
smokeless tobacco through commercial and/or social sources even in 
communities with strong enforcement of youth access laws.\24,25,26,27\
---------------------------------------------------------------------------

    \14\ National Institutes of Health, ``NIH State-of-the-Science 
Conference Statement on Tobacco Use: Prevention, Cessation and 
Controls,'' 2006 (http://consensus.nih.gov/2006/
2006TobaccoSOS029html.htm).
    \15\ Substance Abuse and Mental Health Services Administration: 
Center for Substance Abuse Prevention: Division of State Programs, 
``FFY 2008 Annual Synar Reports: Youth Tobacco Sales,'' 2008 (http:/
/prevention.samhsa.gov/tobacco/synarreportfy2008.pdf).
    \16\ Stead, L.F., T. Lancaster, ``Interventions for preventing 
tobacco sales to minors (Review),'' Cochrane Database of Systematic 
Reviews, Issue 1, Article No. CD001497, 2005.
    \17\ Restricting minors' access to tobacco products, Guide to 
Community Preventive Services, 2009, (http://
www.thecommunityguide.org/Tobacco/restrictingaccess/index.html).
    \18\ DiFranza J.R., J.A. Savageau, K.E. Fletcher, ``Enforcement 
of underage sales laws as a predictor of daily smoking among 
adolescents--a national study,'' BioMed Central Public Health, 
9:107, pp. 1-7, 2009.
    \19\ DiFranza J.R., G.F. Dussault, ``The federal initiative to 
halt the sale of tobacco to children--the Synar Amendment, 1992-
2000: lessons learned,'' Tobacco Control, 14(2), pp. 93-98, 2005.
    \20\ Substance Abuse and Mental Health Services Administration: 
Center for Substance Abuse Prevention: Division of State Programs, 
``FFY 2008 Annual Synar Reports: Youth Tobacco Sales,'' 2008 (http:/
/prevention.samhsa.gov/tobacco/synarreportfy2008.pdf).
    \21\ Id.
    \22\ National Institutes of Health, ``NIH State-of-the-Science 
Conference Statement on Tobacco Use: Prevention, Cessation and 
Controls,'' 2006, (http://consensus.nih.gov/2006/
2006TobaccoSOS029html.htm).
    \23\ Institute of Medicine (IOM) of the National Academies, 
``Ending the Tobacco Problem: A Blueprint for the Nation,'' (2007 
IOM Report), 2007 (http://www.iom.edu/Reports/2007/Ending-the-
Tobacco-Problem-A-Blueprint-for-the-Nation.aspx).
    \24\ Johnston, L.D., P.M. O'Malley, J.G. Bachman, et al., 
``Smoking continues gradual decline among U.S. teens, smokeless 
tobacco threatens a comeback`` (press release). University of 
Michigan News Service, December 14, 2009 (http://
www.monitoringthefuture.org/data/09data.html#2009data-cigs).
    \25\ Clark, P.I., S.L. Natanblut, C.L. Schmitt, et al., 
``Factors Associated With Tobacco Sales to Minors: Lessons Learned 
From the FDA Compliance Checks,'' Journal of American Medical 
Association; 284(6), pp.729-734, 2000.
    \26\ Johnston L.D., P.M. O'Malley, Y.M. Terry-McElrath, 
``Methods, Locations, and Ease of Cigarette Access for American 
Youth, 1997-2002,'' American Journal of Preventive Medicine; 27(4), 
pp. 267-276, 2004.
    \27\ DiFranza J.R., M. Coleman, ``Sources of tobacco for youths 
in communities with strong enforcement of youth access laws,'' 
Tobacco Control, 10, pp. 323-328, 2001.
---------------------------------------------------------------------------

B. Marketing

    In 2006, the U.S. tobacco industry spent $12.5 billion on 
advertising and promoting cigarettes and another $354 million on 
advertising and promoting smokeless tobacco products.\28,29\ Combined 
advertising and promotion expenditures for cigarettes and smokeless 
tobacco in 2006 amounted to $35 million a day. ``As direct advertising 
channels have become increasingly restricted by policy interventions on 
both the domestic and global levels, promotional expenditures for 
tobacco continue to increase in areas such as point-of-purchase 
displays, promotional allowances, and viral, or `stealth,' marketing.'' 
\30\ Sponsorship expenditures, including sponsorship of sports teams 
and athletes, were $30.6 million in 2005.\31,32\ Price discounts 
accounted for 74 percent of total cigarette marketing expenditures in 
2006 ($9.2 billion), with the broader category of promotional 
allowances (which includes price discounts) accounting for 81 percent 
of these expenditures ($10.6 billion).\33\ The largest category of 
advertising and promotion for smokeless tobacco products in 2006 was 
price discounts, which accounted for 58 percent of total spending ($204 
million).\34\ The broader category of promotional allowances (which 
includes price discounts) accounted for 61 percent of total spending 
($216 million).\35\ In comparison, as a general matter, ``the 
assessment of State tobacco control funding indicates little progress 
in the past year toward the level needed for effective, comprehensive 
state tobacco control efforts, as recommended by the Centers for 
Disease Control and Prevention'' and is ``miniscule'' compared to the 
amount tobacco companies spend on marketing.\36\
---------------------------------------------------------------------------

    \28\ Federal Trade Commission, ``Federal Trade Commission 
Cigarette Report for 2006,'' 2009 (http://www.ftc.gov/os/2009/08/
090812cigarettereport.pdf).
    \29\ Federal Trade Commission, ``Federal Trade Commission 
Smokeless Tobacco Report for the Year 2006,'' 2009 (http://
www.ftc.gov/os/2009/08/090812smokelesstobaccoreport.pdf).
    \30\ National Cancer Institute, ``The Role of the Media in 
Promoting and Reducing Tobacco Use,'' NCI Tobacco Control Monograph 
Series, Monograph 19, pp. 7-8, NIH Publication No. 07-6242, 2008 
(http://cancercontrol.cancer.gov/TCRB/monographs/19/index.html).
    \31\ Federal Trade Commission, ``Federal Trade Commission 
Cigarette Report for 2004 and 2005,'' 2007 (http://www.ftc.gov/
reports/tobacco/2007cigarette2004-2005.pdf).
    \32\ National Cancer Institute, ``The Role of the Media in 
Promoting and Reducing Tobacco Use,'' NCI Tobacco Control Monograph 
Series, Monograph 19, pp. 154-55, 180, NIH Publication No. 07-6242, 
2008 (http://cancercontrol.cancer.gov/TCRB/monographs/19/
index.html).
    \33\ Federal Trade Commission, ``Federal Trade Commission 
Cigarette Report for 2006,'' 2009 (http://www.ftc.gov/os/2009/08/
090812cigarettereport.pdf).
    \34\ Federal Trade Commission, ``Federal Trade Commission 
Smokeless Tobacco Report for the Year 2006,'' 2009 (http://
www.ftc.gov/os/2009/08/090812smokelesstobaccoreport.pdf).
    \35\ Id.
    \36\ President's Cancer Panel 2007-2008 Annual Report, 
``Maximizing Our Nation's Investment in Cancer: Three Crucial 
Actions for America's Health,''U.S. Department of Health and Human 
Services, National Institutes of Health, National Cancer Institute, 
p. 54, 2008 (http://deainfo.nci.nih.gov/advisory/pcp/pcp07-08rpt/
pcp07-08rpt.pdf).
---------------------------------------------------------------------------

    NCI Monograph 19--In 2008, the Department of Health and Human 
Services (HHS) 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.'' \37\ 
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.'' \38\ The 
major conclusions of Monograph 19 included the following: (1) 
Cigarettes are one of 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.\39\ 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.\40\
---------------------------------------------------------------------------

    \37\ National Cancer Institute, ``The Role of the Media in 
Promoting and Reducing Tobacco Use,'' NCI Tobacco Control Monograph 
Series, Monograph 19, p. xvii, NIH Publication No. 07-6242, 2008 
(http://cancercontrol.cancer.gov/TCRB/monographs/19/index.html).
    \38\ Id., p. 7.
    \39\ Id., pp. 11-12.
    \40\ Id., pp. 280-281.
---------------------------------------------------------------------------

    Monograph 19 reviewed studies and literature related to point of 
sale advertising, use of promotional items in marketing, restrictions 
on the use of color in labeling and advertising, and tobacco industry 
sponsorship of sporting and other events. 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.'' 
\41\ Further, point of purchase retail settings and bars have become 
important sites of promotion.\42,43,44,45,46,47\ The tobacco industry 
has also directed more resources toward public relations activities, 
personal selling, direct marketing campaigns, internet

[[Page 13229]]

advertising, package design, and trademark diversification.\48,49,50\
---------------------------------------------------------------------------

    \41\ Id., pp.132, 133.
    \42\ Id., p. 84.
    \43\ Feighery, E. C., K.M. Ribisl, N. Schleicher, R.E. Lee, et 
al. , ``Cigarette advertising and promotional strategies in retail 
outlets: results of a statewide survey in California,'' Tobacco 
Control 10(1), pp. 184-88, 2001.
    \44\ Katz, S.K., A.M. Lavack, ``Tobacco related bar promotions: 
insights from tobacco industry documents,'' Tobacco Control 11, 
Suppl. 1: i92-i101, 2002.
    \45\ Sepe, E., P.M. Ling, S.A. Glantz, ``Smooth Moves: Bar and 
Nightclub Tobacco Promotions That Target Young Adults,'' American 
Journal of Public Health vol. 92 (3), pp. 414-19, 2002.
    \46\ Dewhirst, T, ``POP goes the power wall? Taking aim at 
tobacco promotional strategies utilised at retail,'' Tobacco Control 
vol. 13(3), pp. 209-10, 2004.
    \47\ Institute of Medicine (IOM) of the National Academies, 
``Ending the Tobacco Problem: A Blueprint for the Nation,'' (2007 
IOM Report), Appendix L, L-5, 2007. http://www.iom.edu/Reports/2007/
Ending-the-Tobacco-Problem-A-Blueprint-for-the-Nation.aspx.
    \48\ Freeman, B., S. Chapman, ``Open source marketing: Camel 
cigarette brand marketing in the `Web 2.0' world,'' Tobacco Control, 
18, pp. 212-217, 2009.
    \49\ Hamilton, W.L., D.M. Turner-Bowker, C.C. Celebucki, et al., 
``Cigarette advertising in magazines: the tobacco industry response 
to the Master Settlement Agreement and to public pressure,'' Tobacco 
Control 11 Suppl. pp. ii54-ii58, 2002.
    \50\ National Cancer Institute, ``The Role of the Media in 
Promoting and Reducing Tobacco Use,'' NCI Tobacco Control Monograph 
Series, Monograph 19, p. 84, NIH Publication No. 07-6242, 2008, 
http://cancercontrol.cancer.gov/TCRB/monographs/19/index.html.
---------------------------------------------------------------------------

    Monograph 19 also 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.\51\ 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.'' \52\
---------------------------------------------------------------------------

    \51\ Id., p. 85.
    \52\ Id., p. 87.
---------------------------------------------------------------------------

    Other Information--In addition to Monograph 19's comprehensive 
discussion of the many studies and reviews related to youth access and 
tobacco industry marketing to youth, other recent reports and documents 
also reflect the need to address these issues. In 2007 the Institute of 
Medicine of the National Academies issued a report entitled ``Ending 
the Tobacco Problem: A Blueprint for the Nation'' (2007 IOM report). In 
discussing factors that have slowed reductions in tobacco use 
initiation and kept the annual rate of cessation among smokers fairly 
low, the 2007 IOM report noted ``First and foremost, tobacco products 
are highly addictive because they contain nicotine, one of the most 
addictive substances used by humans. Nicotine's addictive power thus 
poses significant challenges to smoking cessation efforts at both the 
individual and the population levels. Second, factors such as distorted 
risk and harm perceptions, which are associated with the initiation and 
maintenance of tobacco use among young smokers, pose a continuing 
obstacle for prevention and control strategies.'' \53\
---------------------------------------------------------------------------

    \53\ Institute of Medicine (IOM) of the National Academies, 
``Ending the Tobacco Problem: A Blueprint for the Nation,'' (2007 
IOM Report), p. 77, 2007. http://www.iom.edu/Reports/2007/Ending-
the-Tobacco-Problem-A-Blueprint-for-the-Nation.aspx.
---------------------------------------------------------------------------

    With respect to adolescent cigarette smoking, the 2007 IOM report 
stated that ``research suggests that adolescents misperceive the 
magnitude of smoking harms and the addictive properties of tobacco and 
fail to appreciate the long-term dangers of smoking, especially when 
they apply the dangers to their own behavior. When taken together with 
the general tendencies of adolescents to take a short-term perspective 
and to given [sic] substantial weight to peer influences, they tend to 
unduly discount the risks and overstate the benefits of smoking. These 
distorted risk perceptions are associated with adolescents' decisions 
to initiate tobacco use, a decision that they will later regret.'' \54\ 
Moreover, ``[t]he evidence clearly shows that youth exposure to images 
that create a positive association with smoking is associated with a 
higher likelihood of smoking'' and ``prevailing scientific opinion 
regards the relationship between promotional exposures and smoking to 
be a causal one.'' \55\ The 2007 IOM report recommended a two-pronged 
strategy for reducing tobacco use in the United States. The first prong 
would strengthen traditional tobacco control measures, including 
restricting youth access within the context of a comprehensive 
approach, and the second prong would increase the Federal presence in 
tobacco control, including Federal regulation over tobacco industry 
products and marketing.\56\
---------------------------------------------------------------------------

    \54\ Id., p. 93.
    \55\ Id., pp. 322-323.
    \56\ Id., pp.154, 272.
---------------------------------------------------------------------------

    In 2003, the World Health Organization's Framework Convention on 
Tobacco Control (FCTC) opened for signature, and has since been signed 
by the United States and ratified by 168 countries. The FCTC was 
developed in response to the global ``tobacco epidemic'' and is aimed 
at reducing the supply and demand for tobacco. The core demand 
reduction provisions include articles aimed at tobacco labeling, 
advertising, promotion, and sponsorship, including provisions that 
these be accompanied by health or other appropriate warnings.\57\ The 
core supply reduction provisions include provisions aimed at sales to 
minors. The FCTC's preamble includes language reflecting concerns 
``about the escalation in smoking and other forms of tobacco 
consumption by children and adolescents worldwide, particularly smoking 
at increasingly early ages'' and ``the impact of all forms of 
advertising, promotion and sponsorship aimed at encouraging the use of 
tobacco products.'' \58\
---------------------------------------------------------------------------

    \57\ World Health Organization, ``WHO Framework Convention on 
Tobacco Control,'' Geneva: World Health Organization, 2003, http://
www.who.int/fctc/text_download/en/index.html.
    \58\ Id., pp. 1-2.
---------------------------------------------------------------------------

    In enacting the Tobacco Control Act, Congress found, among other 
things, that the use of tobacco products is a pediatric disease, 
virtually all new users of tobacco products are under the minimum legal 
age to purchase such products, children are exposed to substantial and 
unavoidable tobacco advertising that leads to favorable beliefs about 
tobacco use and are more influenced by tobacco marketing than are 
adults, and that tobacco company documents indicate that young people 
are an important and often crucial segment of the tobacco market 
(section 2(1), (4), (20), (23), (24)) of the Tobacco Control Act). In 
addition, Congress found that reducing the use of tobacco by minors by 
50 percent would prevent well over 10,000,000 of today's children from 
becoming regular, daily smokers, saving over 3,000,000 of them from 
premature death due to tobacco-induced disease (section 2(14) of the 
Tobacco Control Act). Accordingly, Congress directed FDA to reissue 
provisions contained in its 1996 final rule that restrict youth access 
to tobacco products and target the advertising practices used by the 
industry to recruit children and adolescents (section 2(30), (31)).

IV. Legal Authority

    Section 102 of the Tobacco Control Act directs the Secretary to 
issue a final rule identical in its provisions to the final rule issued 
on August 28, 1996 (61 FR 44615 to 44618), with certain exceptions. 
Under section 102(a)(1)(B), the rule issued under this section is, 
``deemed to be in compliance with all applicable provisions of chapter 
5, title 5, United States Code, and all other provisions of law related 
to rulemaking procedures.''

V. Executive Order 12866

    This rule has been determined to be economically significant for 
the purposes of Executive Order 12866 and, therefore, it has been 
reviewed by the Office of Management and Budget (OMB). Because section 
102 of the Tobacco Control Act directs the Secretary to issue a final 
rule identical in its provisions to the final rule issued on August 28, 
1996 (61 FR 44615 to 44618), OMB has not required a Regulatory Impact 
Analysis beyond that done at that time (see 61 FR 44568 to 44606).

[[Page 13230]]

VI. Information Collection Provisions in the Final Rule

    This final rule contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 1995 
proposed rule provided a 90-day comment period (extended to 144 days in 
the Federal Register of October 16, 1995 (60 FR 53560)). The 
information collection provisions in the proposed rule were approved 
under OMB control number 0910-0312. FDA will be submitting the 
information collection provisions of the final rule to OMB for 
reinstatement. Prior to the effective date of this final rule, FDA will 
publish a notice in the Federal Register of OMB's decision to approve, 
modify, or disapprove the information collection provisions in the 
final rule.

List of Subjects in 21 CFR Part 1140

    Tobacco, Smoking, Advertising, Labeling.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, chapter I of 
title 21 of the Code of Federal Regulations is amended by adding a new 
subchapter K, consisting of part 1140 to read as follows:

SUBCHAPTER K--TOBACCO PRODUCTS

PART 1140--CIGARETTES AND SMOKELESS TOBACCO

Subpart A--General Provisions

Sec.
1140.1 Scope.
1140.2 Purpose.
1140.3 Definitions.

Subpart B--Prohibition of Sale and Distribution to Persons Younger Than 
18 Years of Age

1140.10 General responsibilities of manufacturers, distributors, and 
retailers.
1140.12 Additional responsibilities of manufacturers.
1140.14 Additional responsibilities of retailers.
1140.16 Conditions of manufacture, sale, and distribution.

Subpart C--[Reserved]

Subpart D--Labeling and Advertising

1140.30 Scope of permissible forms of labeling and advertising.
1140.32 Format and content requirements for labeling and 
advertising.
1140.34 Sale and distribution of nontobacco items and services, 
gifts, and sponsorship of events.

    Authority:  21 U.S.C. 301 et seq., Sec. 102, Pub. L. 111-31, 123 
Stat. 1776.

Subpart A--General Provisions


Sec.  1140.1   Scope.

    (a) This part sets out the restrictions under the Federal Food, 
Drug, and Cosmetic Act (the act) on the sale, distribution, and use of 
cigarettes and smokeless tobacco that contain nicotine.
    (b) The failure to comply with any applicable provision in this 
part in the sale, distribution, and use of cigarettes and smokeless 
tobacco renders the product misbranded under the act.
    (c) References in this part to regulatory sections of the Code of 
Federal Regulations are to chapter I of title 21, unless otherwise 
noted.


Sec.  1140.2   Purpose.

    The purpose of this part is to establish restrictions on the sale, 
distribution, and use of cigarettes and smokeless tobacco in order to 
reduce the number of children and adolescents who use these products, 
and to reduce the life-threatening consequences associated with tobacco 
use.


Sec.  1140.3   Definitions.

    (a) Cigarette. (1) Means a product that:
    (i) Is a tobacco product; and
    (ii) Meets the definition of the term ``cigarette'' in section 3(1) 
of the Federal Cigarette Labeling and Advertising Act; and
    (2) Includes tobacco, in any form, that is functional in the 
product, which, because of its appearance, the type of tobacco used in 
the filler, or its packaging and labeling, is likely to be offered to, 
or purchased by, consumers as a cigarette or as roll-your-own tobacco.
    (b) Cigarette tobacco means any product that consists of loose 
tobacco that is intended for use by consumers in a cigarette. Unless 
otherwise stated, the requirements applicable to cigarettes under this 
chapter shall also apply to cigarette tobacco.
    (c) Distributor means any person who furthers the distribution of 
cigarettes or smokeless tobacco, whether domestic or imported, at any 
point from the original place of manufacture to the person who sells or 
distributes the product to individuals for personal consumption. Common 
carriers are not considered distributors for the purposes of this part.
    (d) Manufacturer means any person, including any repacker and/or 
relabeler, who manufactures, fabricates, assembles, processes, or 
labels a finished cigarette or smokeless tobacco product.
    (e) Nicotine means the chemical substance named 3-(1-Methyl-2-
pyrrolidinyl)pyridine or C[10]H[14]N[2], including any salt or complex 
of nicotine.
    (f) Package means a pack, box, carton, or container of any kind in 
which cigarettes or smokeless tobacco are offered for sale, sold, or 
otherwise distributed to consumers.
    (g) Point of sale means any location at which a consumer can 
purchase or otherwise obtain cigarettes or smokeless tobacco for 
personal consumption.
    (h) Retailer means any person who sells cigarettes or smokeless 
tobacco to individuals for personal consumption, or who operates a 
facility where vending machines or self-service displays are permitted 
under this part.
    (i) Smokeless tobacco means any tobacco product that consists of 
cut, ground, powdered, or leaf tobacco and that is intended to be 
placed in the oral or nasal cavity.

Subpart B--Prohibition of Sale and Distribution to Persons Younger 
Than 18 Years of Age


Sec.  1140.10   General responsibilities of manufacturers, 
distributors, and retailers.

    Each manufacturer, distributor, and retailer is responsible for 
ensuring that the cigarettes or smokeless tobacco it manufactures, 
labels, advertises, packages, distributes, sells, or otherwise holds 
for sale comply with all applicable requirements under this part.


Sec.  1140.12   Additional responsibilities of manufacturers.

    In addition to the other responsibilities under this part, each 
manufacturer shall remove from each point of sale all self-service 
displays, advertising, labeling, and other items that the manufacturer 
owns that do not comply with the requirements under this part.


Sec.  1140.14   Additional responsibilities of retailers.

    In addition to the other requirements under this part, each 
retailer is responsible for ensuring that all sales of cigarettes or 
smokeless tobacco to any person comply with the following requirements:
    (a) No retailer may sell cigarettes or smokeless tobacco to any 
person younger than 18 years of age;
    (b)(1) Except as otherwise provided in Sec.  1140.16(c)(2)(i) and 
in paragraph (b)(2) of this section, each retailer shall verify by 
means of photographic identification containing the bearer's date of 
birth that no person purchasing the product is younger than 18 years of 
age;
    (2) No such verification is required for any person over the age of 
26;
    (c) Except as otherwise provided in Sec.  1140.16(c)(2)(ii), a 
retailer may sell cigarettes or smokeless tobacco only in a direct, 
face-to-face exchange without

[[Page 13231]]

the assistance of any electronic or mechanical device (such as a 
vending machine);
    (d) No retailer may break or otherwise open any cigarette or 
smokeless tobacco package to sell or distribute individual cigarettes 
or a number of unpackaged cigarettes that is smaller than the quantity 
in the minimum cigarette package size defined in Sec.  1140.16(b), or 
any quantity of cigarette tobacco or smokeless tobacco that is smaller 
than the smallest package distributed by the manufacturer for 
individual consumer use; and
    (e) Each retailer shall ensure that all self-service displays, 
advertising, labeling, and other items, that are located in the 
retailer's establishment and that do not comply with the requirements 
of this part, are removed or are brought into compliance with the 
requirements under this part.


Sec.  1140.16   Conditions of manufacture, sale, and distribution.

    (a) Restriction on product names. A manufacturer shall not use a 
trade or brand name of a nontobacco product as the trade or brand name 
for a cigarette or smokeless tobacco product, except for a tobacco 
product whose trade or brand name was on both a tobacco product and a 
nontobacco product that were sold in the United States on January 1, 
1995.
    (b) Minimum cigarette package size. Except as otherwise provided 
under this section, no manufacturer, distributor, or retailer may sell 
or cause to be sold, or distribute or cause to be distributed, any 
cigarette package that contains fewer than 20 cigarettes.
    (c) Vending machines, self-service displays, mail-order sales, and 
other ``impersonal'' modes of sale. (1) Except as otherwise provided 
under this section, a retailer may sell cigarettes and smokeless 
tobacco only in a direct, face-to-face exchange between the retailer 
and the consumer. Examples of methods of sale that are not permitted 
include vending machines and self-service displays.
    (2) Exceptions. The following methods of sale are permitted:
    (i) Mail-order sales, excluding mail-order redemption of coupons 
and distribution of free samples through the mail; and
    (ii) Vending machines (including vending machines that sell 
packaged, single cigarettes) and self-service displays that are located 
in facilities where the retailer ensures that no person younger than 18 
years of age is present, or permitted to enter, at any time.
    (d)(1) Except as provided in paragraph (d)(2) of this section, no 
manufacturer, distributor, or retailer may distribute or cause to be 
distributed any free samples of cigarettes, smokeless tobacco, or other 
tobacco products (as such term is defined in section 201 of the Federal 
Food, Drug, and Cosmetic Act).
    (2)(i) Paragraph (d)(1) of this section does not prohibit a 
manufacturer, distributor, or retailer from distributing or causing to 
be distributed free samples of smokeless tobacco in a qualified adult-
only facility.
    (ii) Paragraph (d)(2) of this section does not affect the authority 
of a State or local government to prohibit or otherwise restrict the 
distribution of free samples of smokeless tobacco.
    (iii) For purposes of paragraph (d) of this section, the term 
``qualified adult-only facility'' means a facility or restricted area 
that:
    (A) Requires each person present to provide to a law enforcement 
officer (whether on or off duty) or to a security guard licensed by a 
governmental entity government-issued identification showing a 
photograph and at least the minimum age established by applicable law 
for the purchase of smokeless tobacco;
    (B) Does not sell, serve, or distribute alcohol;
    (C) Is not located adjacent to or immediately across from (in any 
direction) a space that is used primarily for youth-oriented marketing, 
promotional, or other activities;
    (D) Is a temporary structure constructed, designated, and operated 
as a distinct enclosed area for the purpose of distributing free 
samples of smokeless tobacco in accordance with this paragraph (d)(2) 
of this section;
    (E) Is enclosed by a barrier that:
    (1) Is constructed of, or covered with, an opaque material (except 
for entrances and exits);
    (2) Extends from no more than 12 inches above the ground or floor 
(which area at the bottom of the barrier must be covered with material 
that restricts visibility but may allow airflow) to at least 8 feet 
above the ground or floor (or to the ceiling); and
    (3) Prevents persons outside the qualified adult-only facility from 
seeing into the qualified adult-only facility, unless they make 
unreasonable efforts to do so; and
    (F) Does not display on its exterior:
    (1) Any tobacco product advertising;
    (2) A brand name other than in conjunction with words for an area 
or enclosure to identify an adult-only facility; or
    (3) Any combination of words that would imply to a reasonable 
observer that the manufacturer, distributor, or retailer has a 
sponsorship that would violate Sec.  1140.34(c).
    (iv) Distribution of samples of smokeless tobacco under paragraph 
(d)(2) of this section permitted to be taken out of the qualified 
adult-only facility shall be limited to one package per adult consumer 
containing no more than 0.53 ounces (15 grams) of smokeless tobacco. If 
such package of smokeless tobacco contains individual portions of 
smokeless tobacco, the individual portions of smokeless tobacco shall 
not exceed eight individual portions, and the collective weight of such 
individual portions shall not exceed 0.53 ounces (15 grams). Any 
manufacturer, distributor, or retailer who distributes or causes to be 
distributed free samples also shall take reasonable steps to ensure 
that the amounts in this paragraph (d)(2)(iv) are limited to one such 
package per adult consumer per day.
    (3) Notwithstanding paragraph (d)(2) of this section, no 
manufacturer, distributor, or retailer may distribute or cause to be 
distributed any free samples of smokeless tobacco:
    (i) To a sports team or entertainment group; or
    (ii) At any football, basketball, baseball, soccer, or hockey event 
or any other sporting or entertainment event determined by the 
Secretary to be covered by paragraph (d)(3) of this section.
    (4) The Secretary shall implement a program to ensure compliance 
with paragraph (d) of this section and submit a report to the Congress 
on such compliance not later than 18 months after the date of enactment 
of the Family Smoking Prevention and Tobacco Control Act.
    (5) Nothing in paragraph (d) of this section shall be construed to 
authorize any person to distribute or cause to be distributed any 
sample of a tobacco product to any individual who has not attained the 
minimum age established by applicable law for the purchase of such 
product.
    (e) Restrictions on labels, labeling, and advertising. No 
manufacturer, distributor, or retailer may sell or distribute, or cause 
to be sold or distributed, cigarettes or smokeless tobacco with labels, 
labeling, or advertising not in compliance with subpart D of this part, 
and other applicable requirements.

[[Page 13232]]

Subpart C--[Reserved]

Subpart D--Labeling and Advertising


Sec.  1140.30   Scope of permissible forms of labeling and advertising.

    (a)(1) A manufacturer, distributor, or retailer may, in accordance 
with this subpart D, disseminate or cause to be disseminated 
advertising or labeling which bears a cigarette or smokeless tobacco 
brand name (alone or in conjunction with any other word) or any other 
indicia of tobacco product identification, in newspapers; in magazines; 
in periodicals or other publications (whether periodic or limited 
distribution); on billboards, posters, and placards; in nonpoint-of-
sale promotional material (including direct mail); in point-of-sale 
promotional material; and in audio or video formats delivered at a 
point-of-sale.
    (2) A manufacturer, distributor, or retailer intending to 
disseminate, or to cause to be disseminated, advertising or labeling 
for cigarettes or smokeless tobacco in a medium that is not listed in 
paragraph (a)(1) of this section, shall notify the agency 30 days prior 
to the use of such medium. The notice shall describe the medium and 
discuss the extent to which the advertising or labeling may be seen by 
persons younger than 18 years of age. The manufacturer, distributor, or 
retailer shall send this notice to the Office of Compliance, Center for 
Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd., 
Rockville, MD, 20850-3229.
    (b) [Reserved]
    (c) This subpart D does not apply to cigarette or smokeless tobacco 
package labels.


Sec.  1140.32   Format and content requirements for labeling and 
advertising.

    (a) Except as provided in paragraph (b) of this section, each 
manufacturer, distributor, and retailer advertising or causing to be 
advertised, disseminating or causing to be disseminated, any labeling 
or advertising for cigarettes or smokeless tobacco shall use only black 
text on a white background. This section does not apply to advertising:
    (1) In any facility where vending machines and self- service 
displays are permitted under this part, provided that the advertising 
is not visible from outside the facility and that it is affixed to a 
wall or fixture in the facility; or
    (2) Appearing in any publication (whether periodic or limited 
distribution) that the manufacturer, distributor, or retailer 
demonstrates is an adult publication. For the purposes of this section, 
an adult publication is a newspaper, magazine, periodical, or other 
publication:
    (i) Whose readers younger than 18 years of age constitute 15 
percent or less of the total readership as measured by competent and 
reliable survey evidence; and
    (ii) That is read by fewer than 2 million persons younger than 18 
years of age as measured by competent and reliable survey evidence.
    (b) Labeling and advertising in an audio or video format shall be 
limited as follows:
    (1) Audio format shall be limited to words only with no music or 
sound effects.
    (2) Video formats shall be limited to static black text only on a 
white background. Any audio with the video shall be limited to words 
only with no music or sound effects.


Sec.  1140.34   Sale and distribution of nontobacco items and services, 
gifts, and sponsorship of events.

    (a) No manufacturer and no distributor of imported cigarettes or 
smokeless tobacco may market, license, distribute, sell, or cause to be 
marketed, licensed, distributed, or sold any item (other than 
cigarettes or smokeless tobacco or roll-your-own paper) or service, 
which bears the brand name (alone or in conjunction with any other 
word), logo, symbol, motto, selling message, recognizable color or 
pattern of colors, or any other indicia of product identification 
identical or similar to, or identifiable with, those used for any brand 
of cigarettes or smokeless tobacco.
    (b) No manufacturer, distributor, or retailer may offer or cause to 
be offered any gift or item (other than cigarettes or smokeless 
tobacco) to any person purchasing cigarettes or smokeless tobacco in 
consideration of the purchase thereof, or to any person in 
consideration of furnishing evidence, such as credits, proofs-of-
purchase, or coupons, of such a purchase.
    (c) No manufacturer, distributor, or retailer may sponsor or cause 
to be sponsored any athletic, musical, artistic, or other social or 
cultural event, or any entry or team in any event, in the brand name 
(alone or in conjunction with any other word), logo, symbol, motto, 
selling message, recognizable color or pattern of colors, or any other 
indicia of product identification identical or similar to, or 
identifiable with, those used for any brand of cigarettes or smokeless 
tobacco. Nothing in this paragraph prevents a manufacturer, 
distributor, or retailer from sponsoring or causing to be sponsored any 
athletic, musical, artistic, or other social or cultural event, or team 
or entry, in the name of the corporation which manufactures the tobacco 
product, provided that both the corporate name and the corporation were 
registered and in use in the United States prior to January 1, 1995, 
and that the corporate name does not include any brand name (alone or 
in conjunction with any other word), logo, symbol, motto, selling 
message, recognizable color or pattern of colors, or any other indicia 
of product identification identical or similar to, or identifiable 
with, those used for any brand of cigarettes or smokeless tobacco.

    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. 2010-6087 Filed 3-18-10; 8:45 am]
BILLING CODE 4160-01-S