Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents, 13225-13232 [2010-6087]
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Federal Register / Vol. 75, No. 53 / Friday, March 19, 2010 / Rules and Regulations
21 CFR Part 522
approved as a generic copy of
BANAMINE–S, sponsored by ScheringPlough Animal Health Corp. under
NADA 101–479. The ANADA is
approved as of March 1, 2010, and the
regulations are amended in 21 CFR
522.970 to reflect the approval.
In accordance with the freedom of
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20 and 21 CFR 514.11(e)(2)(ii), a
summary of safety and effectiveness
data and information submitted to
support approval of this application
may be seen in the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
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a.m. and 4 p.m., Monday through
Friday.
The agency has determined under 21
CFR 25.33 that this action is of a type
that does not individually or
cumulatively have a significant effect on
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This rule does not meet the definition
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it is a rule of ‘‘particular applicability.’’
Therefore, it is not subject to the
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[Docket No. FDA–2010–N–0002]
List of Subjects in 21 CFR Part 522
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14 CFR Part 39
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On page 10660, in the table, under the
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[FR Doc. C1–2010–4511 Filed 3–18–10; 8:45 am]
BILLING CODE 1505–01–D
DEPARTMENT OF HEALTH AND
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Food and Drug Administration
Implantation or Injectable Dosage
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AGENCY:
Animal drugs.
Food and Drug Administration,
HHS.
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ACTION:
Final rule.
SUMMARY: The Food and Drug
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animal drug regulations to reflect
approval of an original abbreviated new
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ANADA provides for the use of flunixin
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DATES: This rule is effective March 19,
2010.
FOR FURTHER INFORMATION CONTACT: John
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Administration, 7500 Standish Pl.,
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SUPPLEMENTARY INFORMATION: Cross
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Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs and redelegated to
the Center for Veterinary Medicine, 21
CFR part 522 is amended as follows:
■
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
1. The authority citation for 21 CFR
part 522 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
2. In § 522.970, revise paragraphs
(b)(1) and (b)(4) to read as follows:
■
§ 522.970
Flunixin.
*
*
*
*
*
(b) * * *
(1) See Nos. 000061, 055529, and
061623 for use as in paragraph (e) of this
section.
*
*
*
*
*
(4) See No. 059130 for use as in
paragraphs (e)(1) and (e)(2) of this
section.
*
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13225
Dated: March 12, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010–6038 Filed 3–18–10; 8:45 am]
BILLING CODE 4160–01–S
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
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VI. Information Collection Provisions in the
Final Rule
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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).
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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.
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
§ 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
§ 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
§ 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 § 1140.16(d), and updated
the address in § 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
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)).
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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 § 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 § 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 § 897.30(b), which is now
renumbered as § 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
§ 1140.32(a) (formerly § 897.32(a) of the
1996 final rule), scheduled to go into
effect on June 22, 2010. (Commonwealth
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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.
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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
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. (https://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.
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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, pastmonth 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
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
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 (https://
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 (https://www.monitoring
thefuture.org/data/09data.html#2009data-cigs).
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 (https://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. TerryMcElrath, ‘‘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.
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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 multicomponent approach to reduce youth
tobacco initiation and use, which
should also include efforts to limit
tobacco industry marketing and
smoking restrictions.22,23 Moreover,
14 National Institutes of Health, ‘‘NIH State-of-theScience Conference Statement on Tobacco Use:
Prevention, Cessation and Controls,’’ 2006 (https://
consensus.nih.gov/2006/2006Tobacco
SOS029html.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
(https://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,
(https://www.thecommunityguide.org/Tobacco/
restrictingaccess/).
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
(https://prevention.samhsa.gov/tobacco/
synarreportfy2008.pdf).
21 Id.
22 National Institutes of Health, ‘‘NIH State-of-theScience Conference Statement on Tobacco Use:
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Federal Register / Vol. 75, No. 53 / Friday, March 19, 2010 / Rules and Regulations
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
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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
Prevention, Cessation and Controls,’’ 2006, (https://
consensus.nih.gov/2006/2006Tobacco
SOS029html.htm).
23 Institute of Medicine (IOM) of the National
Academies, ‘‘Ending the Tobacco Problem: A
Blueprint for the Nation,’’ (2007 IOM Report), 2007
(https://www.iom.edu/Reports/2007/Ending-theTobacco-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 (https://www.monitoring
thefuture.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. TerryMcElrath, ‘‘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.
28 Federal Trade Commission, ‘‘Federal Trade
Commission Cigarette Report for 2006,’’ 2009
(https://www.ftc.gov/os/2009/08/090812cigarette
report.pdf).
29 Federal Trade Commission, ‘‘Federal Trade
Commission Smokeless Tobacco Report for the Year
2006,’’ 2009 (https://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 (https://cancercontrol.cancer.gov/TCRB/
monographs/19/).
31 Federal Trade Commission, ‘‘Federal Trade
Commission Cigarette Report for 2004 and 2005,’’
2007 (https://www.ftc.gov/reports/tobacco/
2007cigarette2004-2005.pdf).
32 National Cancer Institute, ‘‘The Role of the
Media in Promoting and Reducing Tobacco Use,’’
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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
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,
NCI Tobacco Control Monograph Series,
Monograph 19, pp. 154–55, 180, NIH Publication
No. 07–6242, 2008 (https://cancercontrol.cancer.gov/
TCRB/monographs/19/).
33 Federal Trade Commission, ‘‘Federal Trade
Commission Cigarette Report for 2006,’’ 2009
(https://www.ftc.gov/os/2009/08/090812cigarette
report.pdf).
34 Federal Trade Commission, ‘‘Federal Trade
Commission Smokeless Tobacco Report for the Year
2006,’’ 2009 (https://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 (https://
deainfo.nci.nih.gov/advisory/pcp/pcp07-08rpt/
pcp07-08rpt.pdf).
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 (https://cancercontrol.cancer.gov/TCRB/
monographs/19/).
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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
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
38 Id.,
p. 7.
pp. 11–12.
40 Id., pp. 280–281.
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. https://www.iom.edu/
Reports/2007/Ending-the-Tobacco-Problem-ABlueprint-for-the-Nation.aspx.
39 Id.,
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advertising, package design, and
trademark diversification.48,49,50
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
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
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, https://cancercontrol.cancer.gov/TCRB/
monographs/19/.
51 Id., p. 85.
52 Id., p. 87.
53 Institute of Medicine (IOM) of the National
Academies, ‘‘Ending the Tobacco Problem: A
Blueprint for the Nation,’’ (2007 IOM Report), p. 77,
2007. https://www.iom.edu/Reports/2007/Endingthe-Tobacco-Problem-A-Blueprint-for-theNation.aspx.
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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 longterm 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
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,
54 Id.,
p. 93.
pp. 322–323.
56 Id., pp.154, 272.
57 World Health Organization, ‘‘WHO Framework
Convention on Tobacco Control,’’ Geneva: World
Health Organization, 2003, https://www.who.int/fctc/
text_download/en/.
55 Id.,
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13229
promotion and sponsorship aimed at
encouraging the use of tobacco
products.’’ 58
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).
58 Id.,
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VI. Information Collection Provisions in
the Final Rule
Subpart A—General Provisions
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.
(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.
List of Subjects in 21 CFR Part 1140
Tobacco, Smoking, Advertising,
Labeling.
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.
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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.
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§ 1140.1
§ 1140.2
Scope.
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 lifethreatening consequences associated
with tobacco use.
§ 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-2pyrrolidinyl)pyridine or C[10]H[14]N[2],
including any salt or complex of
nicotine.
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(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
§ 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.
§ 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.
§ 1140.14
retailers.
Additional responsibilities of
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
§ 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
§ 1140.16(c)(2)(ii), a retailer may sell
cigarettes or smokeless tobacco only in
a direct, face-to-face exchange without
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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 § 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.
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§ 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, faceto-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 mailorder 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.
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(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 adultonly 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
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13231
that the manufacturer, distributor, or
retailer has a sponsorship that would
violate § 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.
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Subpart C—[Reserved]
Subpart D—Labeling and Advertising
§ 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-ofsale promotional material (including
direct mail); in point-of-sale
promotional material; and in audio or
video formats delivered at a point-ofsale.
(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.
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§ 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
VerDate Nov<24>2008
14:13 Mar 18, 2010
Jkt 220001
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.
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]
§ 1140.34 Sale and distribution of
nontobacco items and services, gifts, and
sponsorship of events.
BILLING CODE 4160–01–S
(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
DEPARTMENT OF HOMELAND
SECURITY
PO 00000
Frm 00016
Fmt 4700
Sfmt 4700
Coast Guard
33 CFR Part 165
[Docket No. USCG–2009–1031]
RIN 1625–AA00
Safety Zone; Lake Mead Intake
Construction, Lake Mead, Boulder City,
NV
Coast Guard, DHS.
Temporary final rule.
AGENCY:
ACTION:
SUMMARY: The Coast Guard is
establishing a safety zone on the
navigable waters of Lake Mead in
support of the construction project for
Lake Mead’s Intake #3. This safety zone
is necessary to ensure non-authorized
personnel and vessels remain safe by
keeping clear of the hazardous area
during blasting, excavating, and any
other general construction work.
Persons and vessels are prohibited from
entering into, transiting through, or
anchoring within this safety zone unless
authorized by the Captain of the Port
(COTP) or his designated representative.
DATES: Effective Date: This rule is
effective in the CFR on March 19, 2010
through December 31, 2010. This rule is
effective with actual notice for purposes
of enforcement prior to publication.
ADDRESSES: Documents indicated in this
preamble as being available in the
docket are part of docket USCG–2009–
1031 and are available online by going
to https://www.regulations.gov, inserting
E:\FR\FM\19MRR1.SGM
19MRR1
]]>Agencies
[Federal Register Volume 75, Number 53 (Friday, March 19, 2010)]
[Rules and Regulations]
[Pages 13225-13232]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-6087]
-----------------------------------------------------------------------
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. (https://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 (https://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 (https://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 (https://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 (https://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 (https://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, (https://www.thecommunityguide.org/Tobacco/restrictingaccess/).
\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 (https://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, (https://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 (https://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 (https://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 (https://www.ftc.gov/os/2009/08/090812cigarettereport.pdf).
\29\ Federal Trade Commission, ``Federal Trade Commission
Smokeless Tobacco Report for the Year 2006,'' 2009 (https://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
(https://cancercontrol.cancer.gov/TCRB/monographs/19/).
\31\ Federal Trade Commission, ``Federal Trade Commission
Cigarette Report for 2004 and 2005,'' 2007 (https://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 (https://cancercontrol.cancer.gov/TCRB/monographs/19/).
\33\ Federal Trade Commission, ``Federal Trade Commission
Cigarette Report for 2006,'' 2009 (https://www.ftc.gov/os/2009/08/090812cigarettereport.pdf).
\34\ Federal Trade Commission, ``Federal Trade Commission
Smokeless Tobacco Report for the Year 2006,'' 2009 (https://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 (https://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
(https://cancercontrol.cancer.gov/TCRB/monographs/19/).
\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\
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\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. https://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,
https://cancercontrol.cancer.gov/TCRB/monographs/19/.
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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. https://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, https://www.who.int/fctc/text_download/en/.
\58\ Id., pp. 1-2.
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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
