[Federal Register Volume 60, Number 155 (Friday, August 11, 1995)]
[Proposed Rules]
[Pages 41314-41375]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-20051]
[[Page 41313]]
_______________________________________________________________________
Part V
Department of Health and Human Services
_______________________________________________________________________
Food and Drug Administration
_______________________________________________________________________
21 CFR Part 801, et al.
Regulations Restricting the Sale and Distribution of Cigarettes and
Smokeless Tobacco Products To Protect Children and Adolescents;
Proposed Rule
Analysis Regarding FDA's Jurisdiction Over Nicotine-Containing
Cigarettes and Smokeless Tobacco Products; Notice
Federal Register / Vol. 60, No. 155 / Friday, August 11, 1995 /
Proposed Rules
[[Page 41314]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 801, 803, 804, and 897
[Docket No. 95N-0253]
Regulations Restricting the Sale and Distribution of Cigarettes
and Smokeless Tobacco Products To Protect Children and Adolescents
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is proposing new
regulations governing the sale and distribution of nicotine-containing
cigarettes and smokeless tobacco products to children and adolescents
in order to address the serious public health problems caused by the
use of and addiction to these products. The proposed rule would reduce
children's and adolescents' easy access to cigarettes and smokeless
tobacco as well as significantly decrease the amount of positive
imagery that makes these products so appealing to them. The proposed
rule would not restrict the use of tobacco products by adults.
Specifically, the proposed rule would establish 18 years of age as
the Federal minimum age of purchase and would prohibit cigarette
vending machines, free samples, mail-order sales, and self-service
displays. It would also require that retailers comply with certain
conditions regarding sales of tobacco, especially verification that the
purchaser is at least 18 years of age before a tobacco sale is made.
Finally, the proposed rule would limit advertising and labeling to
which children and adolescents are exposed to a text-only format; ban
the sale or distribution of branded non-tobacco items such as hats and
tee shirts; restrict sponsorship of events to the corporate name only;
and require manufacturers to establish and maintain a national public
education campaign aimed at children and adolescents to counter the
pervasive imagery and reduce the appeal created by decades of pro-
tobacco messages and thus to help reduce young people's use of tobacco
products.
The objective of the proposed rule is to meet the goal of the
report ``Healthy People 2000'' by reducing roughly by half children's
and adolescents' use of tobacco products. If this objective is not met
within seven years of the date of publication of the final rule, the
agency will take additional measures to help achieve the reduction in
the use of tobacco products by young people. FDA is requesting comment
regarding the type of additional measures that would be most effective.
DATES: Written comments and recommendations by November 9, 1995.
ADDRESSES: Submit written comments and recommendations to the Dockets
Management Branch (HFA-305), Food and Drug Administration, rm. 1-23,
12420 Parklawn Dr., Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Philip Chao, Office of Policy (HF-23),
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD, 20857,
301-827-3380.
SUPPLEMENTARY INFORMATION:
I. Introduction
Approximately 50 million Americans currently smoke cigarettes and
another 6 million use smokeless tobacco products.1 These tobacco
products are responsible for more than 400,000 deaths each year due to
cancer, respiratory illnesses, heart disease, and other health
problems.2 Cigarettes kill more Americans each year than acquired
immune deficiency syndrome (AIDS), alcohol, car accidents, murders,
suicides, illegal drugs, and fires combined.3 On average, smokers
who die from a disease caused by smoking lose 12 to 15 years of life
because of tobacco use.4
In a separate document,5 FDA is addressing the issue of its
jurisdiction over nicotine-containing cigarettes and smokeless tobacco
products. The results of an extensive investigation and comprehensive
legal analysis support a finding at this time that the nicotine in
these products is a drug and that these products are nicotine-delivery
devices within the meaning of the Federal Food, Drug, and Cosmetic Act
(the act). FDA proposes to regulate cigarettes and smokeless tobacco
products by employing its restricted device authority, which affords
the most appropriate and flexible mechanism for regulating the sale,
distribution, and use of these products.
The primary objective of the proposed rule is to reduce the death
and disease caused by tobacco products. Rather than banning tobacco
products for the millions of Americans who are currently addicted to
them, this regulation focuses on preventing future generations from
developing an addiction to nicotine-containing tobacco products. In
addition, the scientific evidence strongly suggests that nicotine
addiction begins when most tobacco users are teenagers or younger and,
thus, is a pediatric disease. Therefore, reducing the number of young
people who regularly start to use tobacco products will help to prevent
future generations of individuals from becoming addicted to nicotine.
The goal of the proposed rule is to help the country achieve one of
the objectives of ``Healthy People 2000,'' which is to reduce the
number of children and adolescents who use tobacco products by roughly
one half by the year 2000. The agency has modified the goal to include
a different measurement tool and established 7 years after publication
of the final rule as the goal's endpoint. ``Healthy People 2000''
discussed national health promotion and disease prevention objectives
in this country. It was facilitated by the Institute of Medicine of the
National Academy of Sciences, with the help of the U.S. Public Health
Service, and included almost 300 national membership organizations and
all State health departments.6
To determine the most appropriate regulatory measures, the agency
reviewed the current patterns of use of tobacco products. According to
the 1994 Surgeon General's Report, ``Preventing Tobacco Use Among Young
People: A Report of the Surgeon General'' (the 1994 Surgeon General's
Report), more than 3 million American adolescents currently smoke
cigarettes and an additional 1 million adolescent males use smokeless
tobacco.7 Every day, another 3,000 young people become regular
smokers.8 U.S. data suggest that anyone who does not begin smoking
in childhood or adolescence is unlikely to ever begin.9 Eighty-two
percent of adults who ever smoked had their first cigarette before age
18, and more than half of them had already become regular smokers by
that age.10 Moreover, the younger one begins to smoke, the more
likely one is to become a heavy smoker.11
Many young tobacco users become addicted to nicotine, a chemical
substance in tobacco. Although they believe that they will not become
addicted to nicotine or become long-term users of tobacco products,
they often find themselves unable to quit smoking.12 In fact,
among smokers aged 12-17 years, 70 percent already regret their
decision to smoke and 66 percent state that they want to quit.13
Those who are able to quit experience relapse rates and withdrawal
symptoms similar to those reported in adults.14
Long-term addiction to nicotine can result in serious chronic
diseases and premature death. An adolescent whose cigarette use
continues into adulthood increases his or her risk of dying from
[[Page 41315]]
cancer, cardiovascular disease, or lung disease.15 In addition,
smokeless tobacco use has been linked to oral cancer and other adverse
effects.16
Although most segments of the American adult population have
decreased their use of cigarettes, the prevalence of smoking by young
people has failed to decline for more than a decade. Recently, smoking
among young people has begun to rise.17 Between 1991 and 1994, the
prevalence of smoking by eighth graders increased 30 percent, from 14.3
percent to 18.6 percent. Among 10th grade students, it increased from
20.8 percent to 25.4 percent and for 12th grade students, it rose from
28.3 percent to 31.2 percent.18 Between 1985 and 1994, smoking
among college freshmen increased from 9 percent to 12.5 percent.19
Millions of American children and adolescents can easily buy or
obtain cigarettes and smokeless tobacco products. The large number of
young people who use these products is especially noteworthy because
all States prohibit the sale of tobacco products to persons under the
age of 18, and a few States prohibit cigarette sales to persons under
the ages of 19 or 21.20 These State laws, however, are rarely
enforced. It is estimated that each year children and adolescents
consume between 516 million and 947 million cigarette packages and 26
million containers of smokeless tobacco products.21
In addition to easy access to tobacco products, advertising and
promotional activities can influence a young person's decision to smoke
or use smokeless tobacco products. Tobacco products are among the most
heavily advertised products in the United States.22 In 1993, the
tobacco industry spent a total of $6.2 billion on the advertising,
promotion, and marketing of cigarettes and smokeless tobacco. Of that
number, 31 percent ($1.9 billion) was spent on advertising and
promotional activities; 26 percent ($1.6 billion) was given to
retailers in the form of cash allowances or retailer items to
facilitate and enhance the sale of tobacco products, and finally, 43
percent ($2.6 billion) was in the form of financial incentives (e.g.
coupons, cents off, buy one/get one free, free samples) to
consumers.23
Tobacco product brand names, logos, and advertising messages are
pervasive, appearing on billboards, on buses and trains, in magazines
and newspapers, and on clothing and other goods. These ubiquitous
images and messages convey to young people that tobacco use is
desirable, socially acceptable, safe, healthy, and prevalent in
society. One study found that 30 percent of 3 years olds and 91 percent
of six year olds associate the ``Joe Camel'' cartoon figure with
cigarettes.24 Studies also show that most young people buy the
most heavily advertised cigarette brands, whereas many adults buy
generic or ``value category'' cigarette brands, which have little or no
image advertising.25
In proposing this regulation, FDA examined many domestic and
foreign tobacco control statutes, regulations, and legislation, as well
as numerous studies and reports. FDA also reviewed recommendations from
various public health organizations, including the World Health
Organization, the Office of the Surgeon General, the Centers for
Disease Control and Prevention (CDC), the National Cancer Institute
(NCI), and the Institute of Medicine (IOM). Two reports, the 1994
Surgeon General Report and the 1994 IOM Report ``Growing Up Tobacco
Free: Preventing Nicotine Addiction in Children and Youths,'' were
especially helpful and informative.
The agency has examined many options for reducing tobacco use by
children and adolescents, and believes that an effective program must
address the following two areas: (1) Restrictions on cigarette and
smokeless tobacco sales that will make these products less accessible
to young people; and (2) restrictions on labeling and advertising to
help reduce the appeal of tobacco products to young people along with
requirements for a manufacturer- funded national education campaign
aimed at those under 18 years of age to help reduce the products'
appeal to these young people. A brief description of the major
provisions of the proposed rule follows.
A. Sale and Distribution
The proposed rule would restrict the sale of cigarettes and
smokeless tobacco products to individuals age 18 and older. This age
restriction is based on the fact that most adult smokers became regular
smokers before age 18.
The proposed rule would require retailers to verify the age of
persons who wish to buy cigarettes or smokeless tobacco products and
would eliminate ``impersonal'' methods of sale that do not readily
allow age verification, such as mail orders, self-service displays, and
vending machines.
The proposed rule would make each manufacturer, distributor, and
retailer of tobacco products responsible for complying with the
proposed restrictions. Manufacturers would be required to remove all
manufacturer-supplied or manufacturer-owned self-service displays,
advertising, labeling, and other items that do not conform to the
requirements in the proposed rule.
The proposed rule would prohibit the distribution of free samples
and would allow the exchange of coupons and other non-cash certificates
only by individuals 18 or older and only in face-to-face transactions.
Currently, young people, including children in elementary school, are
often able to obtain free samples despite industry-imposed age
restrictions on such distributions.
The proposed rule would also prohibit the sale of single cigarettes
(``loosies'') and ``kiddie packs (less than 20 to a pack) which, due to
their relatively low price and easy concealment, have been shown to be
particularly appealing to children and adolescents.
Further, the proposed rule would prohibit manufacturers from using
a trade name or brand name of a non-tobacco product for a cigarette or
smokeless tobacco product. This will prevent a manufacturer from
transferring the images, good will, and appeal of a popular non-tobacco
product to a tobacco product.
B. Labeling, Advertising and Educational Programs
Advertising that reaches children would be in black and white,
text-only format. Studies indicate that children and adolescents are
very receptive to images and cartoons and less attentive to texts.
However, the proposed rule would not affect advertising in publications
with primarily adult readership--imagery and color would continue to be
permitted in such publications. Finally, outdoor advertising of tobacco
products located within 1,000 feet of schools and playgrounds would be
banned. Consequently, the proposed rule would help reduce the appeal of
advertising to children and adolescents without affecting informational
messages conveyed to adults.
The proposed rule would prohibit the sale or distribution of brand
identifiable non- tobacco items and services, proof-of-purchase sales,
games and contests, and sponsorship of events in the brand name, as
well as advertising for these items, services, and events.
The proposed rule would require manufacturers to establish and
maintain a national educational campaign in order to counter the
pervasive imagery and reduce the appeal created by decades of pro-
tobacco messages and, thus, help reduce young people's use of tobacco
products. Evidence exists that mass media antismoking campaigns
conducted nationally between 1967 and 1970, and more recently, in
Vermont and California, have had a sustained
[[Page 41316]]
effect on preventing teens from starting to smoke and on significantly
reducing per capita cigarette consumption.
C. Healthy People 2000 Objective
Seven years after publication of the final rule, the agency would
determine whether additional restrictions on tobacco products are
required by using outcome-based objectives modeled on the ``Healthy
People 2000'' report. One of the goals for tobacco use established by
that report is to reduce by roughly one half the percentage of young
people using tobacco products by the year 2000. If this objective is
not met within the time specified by the rule, FDA would take
additional measures to help achieve the reduction in young people's use
of tobacco products. The proposed rule requests comment on which
additional measures should be adopted.
The agency intends to adopt one or more additional provisions only
if the continued use of cigarettes and smokeless tobacco products by
children and adolescents indicates that the goal of reducing tobacco
use by young people by roughly half had not been met.
The remainder of this discussion of the proposed rule (hereinafter
``preamble'') is organized as follows: Chapter II examines the use of
cigarettes and smokeless tobacco products by children and adolescents,
and the health consequences of using nicotine- containing tobacco
products; Chapter III describes the provisions of the proposed rule and
provides the rationale for each of the requirements; Chapter IV reviews
the legal authority for these specific requirements, and Chapters V
through VIII provide analyses required by the Paperwork Reduction Act
of 1980, various Executive Orders, as well as provides analyses of
various economic and environmental impacts.
References
1. Substance Abuse and Mental Health Services Administration,
``National Household Survey on Drug Abuse: Population Estimate
1993,'' Rockville, MD: Department of Health and Human Services,
Public Health Service, Substances Abuse and Mental Health Services
Administration, Office of Applied Studies, DHHS Pub. No. (SMA) 94-
3017, 1994, pp. 89, 95; ``Cigarette Smoking Among Adults--United
States, 1993,'' in ``Morbidity and Mortality Weekly Report (MMWR),''
CDC, Department of Health and Human Services (DHHS), vol. 43, No.
50, pp. 925-930, 1994; ``Use of Smokeless Tobacco Among Adults--
United States, 1991,'' in ``MMWR,'' CDC, DDS, vol. 42, pp. 263-266,
1993; Unpublished data from the 1992 Youth Risk Behavior Survey,
National Health Interview Supplement, CDC.
2. ``Cigarette Smoking--Attributable Mortality and Years of
Potential Life Lost--United States, 1990,'' in ``MMWR,'' CDC, DHHS,
vol. 42, no. 33, pp. 645-649 (1993).
3. IOM, p. 3. Collectively, AIDS, alcohol, car accidents,
murders, suicides, illegal drugs and fire combined cause nearly
251,000 deaths a year.
4. ``Cigarette Smoking--Attributable Mortality and Years of
Potential Life Lost--United States, 1990, in ``MMWR,'' CDC, DHHS,
vol. 42, no. 33, pp. 645-649, 1993; Peto, R., et al., ``Mortality
from Tobacco in Developed Countries: Indirect Estimation from
National Vital Statistics,'' The Lancet, vol. 339, pp. 1268-1278,
1992.
5. ``Nicotine In Cigarettes and Smokeless Tobacco Products is a
Drug and These Products are Nicotine-Delivery Devices Under the
Federal Food, Drug, and Cosmetic Act,'' FDA, DHHS, August, 1995.
6. DHHS, ``Healthy People 2000, ``U.S. Department of Health and
Human Services, Public Health Service, Intro. pp. 1-8, September
1990.
7. DHHS, ``Preventing Tobacco Use Among Young People: A Report
of the Surgeon General,'' Atlanta, Georgia: DHHS, PHS, CDC, NCCDPHP,
OSH, 1994 pp. 5 (hereinafter cited as ``1994 SGR'').
8. IOM Report p. 8.
9. 1994 SGR, pp. 5, 58, 65-67.
10. 1994 SGR, p. 65.
11. Taioli, E., E.L. Wynder, ``Effect of the Age at Which
Smoking Begins on Frequency of Smoking in Adulthood,'' The New
England Journal of Medicine, vol. 325, No. 13 pp. 968-969, 1991; and
L.G. Escobedo, et al., ``Sports Participation, Age of Smoking
Initiation, and the Risk of Smoking Among U.S. High School
Students,'' Journal of the American Medical Association, vol. 269,
No. 11, pp. 1391-1395, 1993.
12. IOM Report, pp. 51-52.
13. The George H. Gallup International Institute. ``Teenage
Attitudes and Behavior Concerning Tobacco,'' at p. 54, September
1992.
14. Reasons for Tobacco Use and Symptoms of Nicotine Withdrawal
Among Adolescent and Young Adult Tobacco Users--United States,
1993,'' in ``Morbidity and Mortality Weekly Report,'' CDC, DHHS,
vol. 43, No. 41, pp. 745-750, 1994; 1994 SGR, p. 78.
15. McGinnis, J.M., and W.H. Foege, ``Actual Causes of Death in
the United States,'' Journal of the American Medical Association,
vol. 270, No. 18, pp. 2207-2212, 1993; see generally DHHS,
``Reducing the Health Consequences of Smoking: 25 Years of Progress,
A Report of the Surgeon General.'' DHHS, PHS, CDC, NCCDPHP, OSH.
DHHS Publication No. (CDC) 89-8411, p. 5, 1989 (hereinafter cited as
``1989 SGR''); DHHS, ``The Health Consequences of Smoking Chronic
Obstructive Lung Disease: A Report of the Surgeon General, ``DHHS,
PHS, OSH, 1984 (hereinafter cited as ``1984 SGR''); DHHS, ``The
Health Consequences of Smoking: Cardiovascular Disease, A Report of
the Surgeon General,'' Public Health Service, OSH, DHHS, p. 76,
1983; DHHS, ``The Health Consequences of Smoking--Cancer--A Report
of the Surgeon General,'' DHHS, PHS, OSH, p. 8, 1982 (hereinafter
cited as ``1982 SGR'').
16. 1994 SGR, p. 39; DHHS, ``The Health Consequences of Using
Smokeless Tobacco: A Report of the Advisory Committee to the Surgeon
General,'' p. 32-47, Bethesda, Md., DHHS, PHS, NIH Publication No.
86-2874, April, 1986 (hereinafter cited as ``1986 SGR'').
17. ``Cigarette Smoking Among Adults--United States 1991, ``in
``MMWR,'' CDC, DHHS, Vol. 42, no. 12, pp. 230-233, 1993; Johnston,
L.D., P.M. O'Malley, and J.G. Bachman, ``National Survey Results on
Drug Use from The Monitoring the Future Study, 1975-1993, Volume I:
Secondary School Students,'' Rockville, MD: U.S. Department of
Health and Human Services, Public Health Service, National Institute
of Health, National Institute on Drug Abuse, NIH Pub. No. 94-3809,
pp. 9, 19, 1994; The University of Michigan, News and Information
Service, July 20, 1995, ``Smoking rates climb among American
teenagers, who find smoking increasingly acceptable and seriously
underestimate the risks.'' Table 1.
18. Johnston, L.D., P.M. O'Malley, and J.G. Bachman, ``National
Survey Results on Drug Use from the Monitoring the Future Study,
1975-1993, Volume I: Secondary School Students,'' Rockville, MD:
U.S. Department of Health and Human Services, Public Health Service,
National Institute of Health, National Institute on Drug Abuse, NIH
Pub. No. 94-3809, 1994; The University of Michigan, News and
Information Service, July 20, 1995, ``Smoking rates climb among
American teenagers, who find smoking increasingly acceptable and
seriously underestimate the risks.'' Table 1.
19. ``Washington Post,'' January 9, 1995, at p. A5, col. 3
(describing findings from a survey of approximately 238,000 freshman
conducted by the UCLA Higher Education Research Institute) and UCLA,
Health Education Research Institute, ``The American Freshman:
National Norms for Fall 1994.
20. Coalition on Smoking OR Health, ``State Legislated Actions
on Tobacco Issues,'' at Appendix G, 1993.
21. DiFranza, J.R., and J.B. Tye, ``Who Profits From Tobacco
Sales to Children?'' Journal of the American Medical Association,
vol. 263, No. 20, pp. 2784-2787, 1990; Cummings, K.M., T. Pechacek,
and D. Shopland, ``The Illegal Sale of Cigarettes to U.S. Minors:
Estimates by State,'' American Journal of Public Health, vol. 84,
No. 2, pp. 300-302, 1994 (conservative estimates of cigarette use by
teenagers in 1991 have teenagers smoking 516 million packs of
cigarettes and spending $962 million (of which the industry gained a
profit of $190 million); an estimated 255 million packs were sold
illegally to minors).
22. 1994 SGR, p. 160.
23. Federal Trade Commission, ``Report to Congress for 1993,
Pursuant to the Federal Cigarette Labeling and Advertising Act,''
Table 3D (1995) and Federal Trade Commission, ``Report to Congress,
Pursuant to the Comprehensive Smokeless Tobacco Health Education Act
of 1986,'' Table 4D (1995).
24. Pierce, J.P., et al., ``Does Tobacco Advertising Target
Young People to Start Smoking? Evidence from California,'' Journal
of the American Medical Association, vol. 266, No. 22, pp. 3154-
3158, 1991; See also Fischer, P.M. et al., ``Brand Logo Recognition
[[Page 41317]]
by Children Aged 3 to 6 Years, Mickey Mouse and Old Joe Camel,''
Journal of the American Medical Association, vol. 266, No. 22, pp.
3145-3148, 1991.
25. ``Changes in Cigarette Brand Preference of Adolescent
Smokers, United States, 1989-1993,'' in ``MMWR,'' DHHS, CDC, vol.
42, No. 32, pp. 577-581, 1994; Teinowitz, I., ``Add RJR to List of
Cigarette Price Cuts,'' Advertising Age, pp. 3, 46, April 26, 1993.
II. Cigarette and Smokeless Tobacco Product Use Among Children and
Adolescents
Each year, the cigarette industry loses about 1.7 million customers
in the United States; about 400,000 die from diseases caused by their
smoking and another 1.3 million quit smoking.\1\ To offset the sales
lost to smokers who die or quit smoking, cigarette manufacturers rely
on young people as the primary source of new customers. Each day,
approximately 3,000 young people become regular smokers,\2\ serving as
the industry's major domestic source of replacement smokers.
A. Epidemiology of Tobacco Use Among Children and Adolescents
In 1965, the year following the first Surgeon General's Report \3\
describing the relationship between smoking and diseases such as lung
cancer, chronic bronchitis, and emphysema, 42.4 percent of the overall
adult population in the United States smoked.\4\ By 1990, the
prevalence of smoking in the United States had declined to 25.5
percent.\5\ The greatest reduction in adult smoking occurred from 1987
to 1990, when the prevalence of smoking declined by 1.1 percentage
point annually, twice the rate of decline during the preceding 20
years.\6\ The prevalence of smoking among adults leveled off at 25.6
percent in 1991 and was 26.5 percent in 1992. This change was due to a
change in the definition of current smokers, rather than an increase in
prevalence. The new definition incorporates some day (i.e., less than
daily, occasional, or infrequent) smoking.\7\ The estimate for 1992
with the old definition was 25.6 percent--the same as in 1991. In 1993,
under the new definition, prevalence was 25.0 percent.\8\
The long-term downward trend in adult smoking contrasts with the
trends in smoking among young people. The Institute of Medicine noted
that the number of high school seniors who have smoked in the last 30
days remained ``basically unchanged since 1980,'' at approximately 30
percent, and further reported that 16.7 percent of 8th grade students
were current smokers (that is, had smoked within the past 30 days), and
8.3 percent smoked daily.\9\ The prevalence of cigarette smoking in
recent years among 8th and 10th grade students has risen significantly
and provides cause for great concern. For example, among 8th grade
students, 14.3 percent in 1991 and 18.6 percent in 1994 were current
smokers; among 10th grade students, 20.8 percent in 1991 and 25.4
percent in 1994 were current smokers.\10\
The 1994 Surgeon General's Report reviewed several different
surveys and found that the estimated percentage of adolescents who have
ever smoked cigarettes ranged from approximately 42 percent (as
reported by the 1991 National Household Survey on Drug Abuse) to 70
percent (as reported by the 1991 Youth Risk Behavior Survey).\11\ The
1994 Surgeon General's Report also found that 28 percent of high school
seniors were current smokers.\12\ (The most recent data reported by the
Monitoring the Future Project indicates that in 1994 the number of high
school seniors who were current smokers had risen to 31.2 percent.)\13\
Further, the 1994 Surgeon General's Report states that seven to 13
percent of adolescents were frequent or heavy smokers, consuming at
least one-half pack daily or smoking 20 days or more of the 30 days in
a survey period.\14\
Approximately 3 million children under the age of 18 are daily
smokers.\15\ One study found that children between the ages of 8 and 11
who are daily smokers consume an average of 4 cigarettes daily, and
those who are between the ages of 12 and 17 average nearly 14
cigarettes daily. The study also estimated that adolescents consume an
estimated 947 million packs of cigarettes and 26 million containers of
smokeless tobacco annually and account for annual tobacco sales of
$1.26 billion.\16\ Another study estimates that teenagers in 1991
smoked 516 million packs of cigarettes and spent $962 million
purchasing them.\17\ As stated previously, these figures are especially
significant given that all States prohibit the sale of tobacco to
persons under the age of 18 (with some States prohibiting sales to
persons under the age of 19 and one State, Pennsylvania, prohibiting
cigarette sales to persons under the age of 21).\18\ Unfortunately, few
States successfully enforce their laws restricting tobacco sales to
minors.\19\
Studies have also suggested that the age one begins smoking can
greatly influence the amount of smoking one will engage in as an adult
and will ultimately influence the smoker's risk of tobacco related
morbidity and mortality. Those who started smoking by early adolescence
were more likely to be heavy smokers than those who began smoking as
adults.\20\ Another study found that high school students who smoked
their first cigarette during childhood smoked more often and in greater
amount than those who first tried smoking during adolescence.\21\
The escalating use of smokeless tobacco products by underage
persons presents an additional and growing public health problem.
Smokeless tobacco products include chewing tobacco and snuff and are
also known as ``spit tobacco'' or ``spitting tobacco.'' In 1970, the
prevalence of snuff use among males was lowest in those 17 to 19 years
of age and the highest use was by men aged 50 or more. By 1985, a
dramatic shift had occurred, and males between 16 and 19 were twice as
likely to use snuff as men aged 50 and over.\22\ An estimated 3 million
users of smokeless tobacco products were under the age of 21 in
1986,\23\ when Congress enacted the Comprehensive Smokeless Tobacco
Health Education Act (the Smokeless Act) (15 U.S.C. 4401). The
Smokeless Act required the Secretary of Health and Human Services (the
Secretary) to inform the public of the health dangers associated with
smokeless tobacco use, required warning labels on packages, banned
advertising on electronic media subject to the Federal Communications
Commission's jurisdiction (such as television and radio), and
encouraged States to make 18 years the minimum age for purchasing
smokeless tobacco products. Despite the Smokeless Act and State laws
prohibiting sales to minors, a high percentage of persons under the age
of 18 use smokeless tobacco products. For example:
1991 school-based surveys estimated that 10.7 percent of
U.S. high school seniors and 19.2 percent of male 9th to 12th grade
students use smokeless tobacco.\24\
A 1992 national household-based survey of U.S. children
found that 11.9 percent of males 12-17 years of age were using
smokeless tobacco.\25\
Among high school seniors who had ever tried smokeless
tobacco, 73 percent did so by the ninth grade.\26\
In some parts of the United States the rates are especially high.
According to the 1990-91 Youth Risk Behavior Survey, the smokeless
tobacco product use rates among males in grades 9 through 12 were as
high as 34 percent in Tennessee, 33 percent in Montana, 32 percent in
Colorado, and 31 percent in Alabama and Wyoming.\27\
Native American youth are especially vulnerable to smokeless
tobacco product use. The rates for both males and females are extremely
high, ranging from 24 percent to 64 percent, and at rates that, in some
areas, are 10 times higher than those for non-Native
[[Page 41318]]
Americans.\28\ Studies also suggest that Native Americans begin using
smokeless tobacco products at much earlier ages than non-Native
Americans. A 1986 survey at the Rosebud Sioux Reservation in South
Dakota revealed that 21 percent of kindergarten children used smokeless
tobacco products,\29\ and a survey of Native Americans in the state of
Washington indicated that 33 percent of former users and 57 percent of
current users started using smokeless tobacco products before the age
of 10.\30\
The recent and very large increase in the use of smokeless tobacco
products by young people and the addictive nature of these products has
persuaded the agency that these products must be included in any
regulatory approach that is designed to help prevent future generations
of young people from becoming addicted to nicotine-containing tobacco
products.
B. The Health Effects Associated With Cigarettes and Smokeless Tobacco
Products
Over 400,000 Americans die each year from smoking-related
illnesses. This equates to more than one of every five deaths in the
United States.\31\ If an adolescent's tobacco use continues for a
lifetime, there is a 50 percent chance that the person will die
prematurely as a direct result of smoking.'' \32\ Moreover, the earlier
a young person's smoking habit begins, the more likely he or she will
become a heavy smoker and therefore suffer a greater risk of smoking
related diseases.\33\ Smoking is responsible for about 30 percent of
all cancer deaths,\34\ including 87 percent of all lung cancer deaths;
82 percent of deaths from chronic obstructive pulmonary disease (COPD);
\35\ 21 percent of deaths from coronary heart disease; \36\ and 18
percent of deaths from stroke.\37\ Further, a causal relationship
exists between cigarette smoking and cancers of the larynx, mouth,
esophagus, and bladder; and atherosclerotic peripheral vascular
disease, cerebrovascular disease (stroke), and low-birth weight
babies.\38\ Cigarette smoking is also a probable cause of infertility
and peptic ulcer disease and contributes to, or is associated with,
cancers of the pancreas, kidney, cervix, and stomach.\39\
Much of the following brief discussion is abstracted from several
Surgeon General's reports. The Surgeon General's reports summarize
thousands of peer-reviewed scientific studies and are themselves peer-
reviewed and subjected to significant scientific scrutiny.
1. Health Effects of Cigarette Smoking
Epidemiologic studies provide overwhelming evidence that smoking
causes lung cancer.\40\ The risk of getting lung cancer may be more
than 20 times greater for heavy smokers than nonsmokers.\41\ The
relationship between smoking and lung cancer is due to the numerous
carcinogens in cigarette smoke.\42\ Cigarette smoking caused an
estimated 117,000 deaths from lung cancer in 1990.\43\
The risk of getting lung cancer increases with the number of
cigarettes smoked and the duration of smoking, and decreases after
cessation of smoking.\44\ Starting smoking at an earlier age increases
the potential years of smoking and increases the risk of lung
cancer.\45\ Studies have shown that lung cancer mortality is highest
among adults who began smoking before the age of 15.\46\
Cigarette smoking also causes cancer of the larynx, mouth, and
esophagus.47 According to current estimates, 82 percent of
laryngeal cancers are due to smoking and about 80 percent of the 10,200
deaths from esophageal cancer in 1993 can be attributed to
smoking.48 The risk of oral cancer among current smokers ranges
from 2.0 to 18.1 times the risk in people who have never smoked and can
be reduced more than 50 percent after quitting.49 The risk of
esophageal cancer among current smokers ranges from 1.7 to 6.4 times
the risk in people who have never smoked and can also be reduced by
about 50 percent after quitting.50
Epidemiologic studies demonstrate that cigarette smoking
contributes to the development of pancreatic cancer.51 The reason
for this relationship is unclear, but may be due to carcinogens or
metabolites present in the bile or blood.52 In 1985, the
proportion of pancreatic cancer deaths in the United States
attributable to smoking was estimated to be 29 percent in men and 34
percent in women.53
Cigarette smoking accounts for an estimated 30 to 40 percent of all
bladder cancers and is a contributing factor for kidney cancer.54
The increased risk of kidney and bladder cancer may be related to the
number of cigarettes smoked per day, and the risk decreases following
smoking cessation.55
Smoking appears to be a contributing factor for cancer of the
cervix. The association between cigarette smoking and cervical cancer
persists after control is made for risk factors, such as age at first
intercourse and the number of sexual partners, that predispose a woman
to developing sexually-transmitted diseases. The inclusion of these
risk factors, however, may not completely rule out confounding by
sexually-transmitted diseases. However, the findings that components of
tobacco smoke can be found in the cervical mucus of smokers, that the
mucus of smokers is mutagenic, and that former smokers have a lower
risk of getting cervical cancer than current smokers are consistent
with the hypothesis that smoking is a contributing cause of cervical
cancer.56
The 1982 Surgeon General's Report concluded that stomach cancer is
associated with cigarette smoking.57 Studies show a slight
increase in mortality from stomach cancer in smokers compared with
nonsmokers.58
Smoking is a leading cause of heart disease. The 1964 Surgeon
General's Report noted that male cigarette smokers had higher death
rates from coronary heart disease than nonsmokers.59 Subsequent
reports have concluded that cigarette smoking contributes to the risk
of heart attacks, chest pain, and even sudden death.60 Overall,
smokers have a 70 percent greater death rate from coronary heart
disease than nonsmokers.61
Ischemic heart disease resulting from cigarette smoking claimed
nearly 99,000 lives in 1990.62 One study estimates that 30 to 40
percent of all coronary heart disease deaths are attributable to
smoking.63 Smokers between the ages of 40 and 64, who smoked more
than one pack a day, were shown to have a risk of coronary heart
disease that is 3.2 times higher than people who do not smoke.64
Several processes that are likely to contribute to heart attacks
are influenced or caused by smoking: atherosclerosis, thrombosis,
coronary artery spasm, cardiac arrhythmia, and reduced capacity of the
blood to deliver oxygen. The nicotine and carbon monoxide in cigarette
smoke are believed to be responsible for heart disease, but other
components, such as cadmium, nitric oxide, hydrogen cyanide, and carbon
disulfide, have also been implicated.65 Female smokers who also
use oral contraceptives increase their risk of heart attacks
tenfold.66
Smoking also increases a person's risk of atherosclerotic
peripheral vascular disease, especially if the smoker is
diabetic.67 Complications of this disease include decreased blood
delivery to the peripheral tissues, gangrene, and ultimately loss of
the affected limb. Smoking cessation is the most important intervention
in the management of peripheral vascular disease.68
Smoking is a cause of stroke.69 Stroke is the third leading
cause of death in the United States.70 The association of
[[Page 41319]]
smoking with stroke is believed to be mediated by the mechanisms
responsible for atherosclerosis (narrowing and hardening of the
arteries), thrombosis, and decreased cerebral blood flow in
smokers.71 Female smokers who use oral contraceptives are at an
increased risk of having a stroke.72
Cigarette smoking is the leading cause of chronic obstructive
pulmonary disease (COPD) in the United States. Approximately 84 percent
of the COPD deaths in men and 79 percent of the COPD deaths in women
are attributable to cigarette smoking.73 The risk of death from
COPD may depend on how many cigarettes a person smokes daily, how
deeply the person inhales, and the age when the person began
smoking.74 The number of cigarettes smoked per day is a strong
indicator for the presence of the principal symptoms of chronic
respiratory illness, including chronic cough, phlegm production,
wheezing, and shortness of breath.75
Smoking's effects on lung structure and function appear within a
few years after cigarette smoking begins.76 Children who smoke
suffer from respiratory illnesses more than children who do not smoke.
Adolescents who smoke may experience inflammatory changes in the lung,
reduced lung growth, and may not achieve normal lung function as an
adult.77
Cigarette smoking is a probable cause of peptic ulcer
disease.78 Peptic ulcer disease is more likely to occur in smokers
than in nonsmokers, and the disease is less likely to heal, and more
likely to cause death in smokers than nonsmokers.79 Quitting
smoking reduces the chances of getting peptic ulcer disease and is an
important component of effective peptic ulcer treatment.80
Studies also show that women who smoke have reduced
fertility.81 One study showed that smokers were 3.4 times more
likely than nonsmokers to take more than 1 year to conceive.82
Smoking's severe detrimental effects during pregnancy are well
documented.83 Women who smoke are twice as likely to have low
birth weight infants as women who do not smoke. 84 Smoking also
causes intrauterine growth retardation of the fetus.85 Mothers who
smoke also have increased rates of premature delivery.86
Smoking may lead to premature infant death. Babies of mothers who
smoke are more likely to die than babies born to nonsmoking
mothers.87 A recent meta-analysis reported that use of tobacco
products by pregnant women results in 19,000 to 141,000 miscarriages
per year, and 3,100 to 7,000 infant deaths per year. In addition, the
meta-analysis attributed approximately two-thirds of deaths from sudden
infant death syndrome to maternal smoking during pregnancy.88 By
another estimate, if all pregnant women stopped smoking, there would be
4,000 fewer infant deaths per year in the United States.89
2. Health Effects of Smokeless Tobacco Products
Smokeless tobacco use can cause oral cancer.90 The risk of
oral cancer increases with increased exposure to smokeless tobacco
products, particularly in those areas of the mouth where smokeless
tobacco products are used.91 The risk of cheek and gum cancers is
nearly 50 times greater in long-term snuff users than in
nonusers.92 Snuff and chewing tobacco contain potent carcinogens,
including nitrosamines, polynuclear aromatic hydrocarbons, and
radioactive polonium.93
Smokeless tobacco use can cause oral leukoplakia, a precancerous
lesion of the soft tissue that consists of a white patch or plaque that
cannot be scraped off.94 One study of 117 high school students who
were smokeless tobacco users revealed that nearly 50 percent of these
students had oral tissue alterations.95 There is a 5 percent
chance that oral leukoplakias will transform into malignancies in 5
years.96 The leukoplakia appears to decrease or resolve upon
cessation of smokeless tobacco use.97
Smokeless tobacco use causes oral cancer and oral leukoplakia and
may be associated with an increased risk of cancer of the esophagus.
Smokeless tobacco use has been implicated in cancers of the gum, mouth,
pharynx, and larynx. Snuff use also causes gum recession and is
associated with discoloration of teeth and fillings, dental caries, and
abrasion of the teeth.98
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35. Id., p. 157.
36. Id., p. 97.
37. Id., p. 157.
38. Id., pp. 98-99; 1990 SGR, p. 10.
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85. 1989 SGR, p. 72; Ounsted, M., V.A. Moar, and A. Scott,
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86. 1990 SGR, p. 386; Andrews, J., and J.M. McGarry, ``A
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Pregnancy,'' The American Journal of Epidemiology, vol. 103, No. 5,
pp. 454-476, 1976.
87. 1989 SGR, p. 73.
88 DiFranza, J.R., and R.A. Lew, ``Effect of Maternal Cigarette
Smoking on Pregnancy Complications and Sudden Infant Death
Syndrome,'' Journal of Family Practice, vol. 40, No. 4, pp. 1-10,
April 1995.
89. 1989 SGR. p. 73.
90. 1994 SGR, p. 39; 1986 SGR, pp. 33-47.
91. 1986 SGR, p. 44.
92. 1986 SGR, p. 40; Winn, D.M., et al., ``Snuff Dipping and
Oral Cancer Among Women in the Southern United States,'' The New
England Journal of Medicine, vol. 304, No. 13, pp. 745-749, March
26, 1981.
93. 1986 SGR, pp. 58-69.
94. 1994 SGR, p. 39; WHO Collaborating Centre for Oral
Precancerous Lesions, ``Definition of Leukoplakia and Related
Lesions: An Aid to Studies on Oral Precancer,'' Oral Surgery, Oral
Medicine Oral Pathology, vol. 46, No. 4, pp. 518-539, October 1978.
95. Greer, R.O., and T.C. Poulson, ``Oral Tissue Alterations
Associated With the Use of Smokeless Tobacco by Teen-Agers,'' Oral
Surgery, Oral Medicine, Oral Pathology, vol. 56, No. 3, pp. 275-284,
September 1983.
96. 1994 SGR. p. 39.
97. Id.
98. Id., pp. 39-40; see generally 1986 SGR.
III. Description of the Proposed Rule
The proposed rule would create a new part 897 of Title 21 of the
Code of Federal Regulations governing the labeling, advertising, sale,
and distribution of cigarettes and smokeless tobacco. The Commissioner
has proposed that nicotine-containing cigarettes and smokeless tobacco
products be regulated as restricted devices within the meaning of
section 520(e) of the act (21 U.S.C. 360j(e)). The regulations are
being proposed pursuant to the authority of section 520(e) of the act,
which authorizes the agency to regulate the sale, distribution, and use
of certain devices. Certain of the provisions in the regulation are
also being proposed pursuant to the authority of sections 201, 502,
510, 701, and 704 of the act.
In brief, the proposed rule is intended to support current State
laws regarding sales to minors by reducing the appeal of cigarettes and
smokeless tobacco to, and limiting access by, persons under 18 years of
age. The overall goal of the proposed rule is to decrease the rates of
death and disease caused by tobacco products by substantially reducing
the number of young people who begin using cigarettes or smokeless
tobacco products.
The proposed rule consists of five subparts. Subpart A, General
Provisions, would set forth scope and purpose provisions and provide
definitions. Subpart B, Sale and Distribution to Persons Under 18 Years
of Age, would describe the responsibilities of manufacturers,
distributors, and retailers concerning the manufacture, sale, and
distribution of cigarettes and smokeless tobacco products. Subpart C,
Labels and Educational Messages, would require each manufacturer to
establish and maintain a national public educational program, including
major reliance on television messages, in order to combat the pervasive
imagery and appeal created by decades of pro-tobacco messages, and,
thus, to discourage young people from using cigarettes and smokeless
tobacco products. Subpart D, Labeling and Advertising, would limit
advertising and labeling to which children and adolescents are exposed
to a text-only format; ban the sale or distribution of branded non-
tobacco items such as hats and tee shirts; and restrict sponsorship of
events to the corporate name only. Finally Subpart E, Miscellaneous
Requirements, would describe the records and reports that must be
submitted to FDA or made available for inspection, discuss the rule's
relationship to State and local laws or requirements, and require one
or more additional measures to be taken if the prevalence of tobacco
use is not significantly reduced within seven years of the publication
of the final rule.
A. Subpart A--General Provisions
Subpart A would contain three provisions that describe the rule's
scope and purpose and provide definitions that apply throughout part
897.
[[Page 41322]]
1. Section 897.1--Scope
Proposed Sec. 897.1(a) would state that part 897 is intended to
establish conditions under which nicotine-containing cigarettes and
smokeless tobacco products may be sold, distributed, or used. The
proposed rule would not apply to pipe tobacco or to cigars because the
agency does not currently have sufficient evidence that these products
are drug delivery devices under the act. FDA has focused its
investigation of its authority over tobacco products on cigarettes and
smokeless tobacco products, and not on pipe tobacco or cigars, because
young people predominantly use cigarettes and smokeless tobacco
products. Proposed Sec. 897.1(b) would note that all references to
regulatory sections in the Code of Federal Regulations are to Title 21
unless otherwise noted.
2. Section 897.2--Purpose
Proposed 897.2(a) would state that part 897 is intended to help
prevent persons younger than 18 years of age from becoming addicted to
nicotine, thereby avoiding the life-threatening consequences often
associated with tobacco use. The proposed rule would accomplish this
goal by reducing the appeal of and access to cigarettes and smokeless
tobacco products by persons under 18 years of age; it would preserve
access to cigarettes and smokeless tobacco products by persons 18 years
of age and older. Proposed Sec. 897.2(b) would add that the provisions
are intended to provide important information about product use to
users and potential users.
3. Section 897.3--Definitions
Proposed 897.3 would establish definitions of terms used in the
proposed rule, such as ``cigarette'' (897.3(a)) and ``distributor''
(897.3(c)). In drafting the definitions, FDA examined existing
definitions in Federal laws and regulations and paid special attention
to existing definitions in other FDA regulations. These definitions are
contained in the proposed codified language.
Proposed 897.3(e) contains the definition of ``nicotine,''which is
based, in part, on the chemical name and formula for nicotine in the
``Merck Index''(10th Edition). The agency also notes that, while the
proposed rule defines ``cigarette,'' in part, as a product that
``contains or delivers nicotine,'' it is aware that some companies are
trying to develop chemical substances that are pharmacologically active
or are as addictive as nicotine or that would be used to enhance
nicotine's pharmacological qualities. The agency's investigation has
focused primarily on cigarettes and smokeless tobacco products that
contain nicotine, and FDA would therefore consider a cigarette-like
product that contains a pharmacologically active or addictive substance
in place of nicotine to be a ``new'' drug delivery device that would be
outside the scope of this regulation. To be legally marketed, such a
product would require premarket approval.
B. Subpart B--Sale and Distribution to Persons Under 18 Years of Age
Subpart B would establish certain conditions or requirements for
the sale and distribution of cigarettes and smokeless tobacco pursuant
to section 520(e) of the act. These provisions are intended to reduce
access to cigarettes and smokeless tobacco products by children and
adolescents. Studies show that it is easy for most young people to
obtain tobacco products. The University of Michigan Monitoring the
Future Study in 1993 reported that 75 percent of 8th graders and nearly
90 percent of 10th graders said it would be fairly easy or very easy to
get cigarettes.1 According to a 1990 survey of 9th graders, 67
percent of current smokers said they usually buy their own
cigarettes.2 Further, interviews conducted by the Department of
Health and Human Services' (DHHS) Office of the Inspector General in
1986 found that 94 percent of junior and high school students said that
``it was either never or only rarely difficult'' to buy smokeless
tobacco products.3
Most children and adolescents who smoke purchase their own
cigarettes. A 1991 study showed that an estimated 516 million packs are
consumed by young people every year; almost half of these packs are
sold to minors.4 The 1994 Surgeon General's Report examined 13
studies of over-the-counter sales and determined that approximately 67
percent of minors are able to purchase tobacco illegally. Moreover,
successful cigarette purchases by children and adolescents averaged 88
percent in studies of vending machines.5
A significant percentage of young people can also easily purchase
smokeless tobacco products directly from retailers. Studies examining
smokeless tobacco product purchases by young people suggest that direct
successful underage purchases range from 30 percent (for junior high
school students) to 62 percent (for senior high school students).6
Interviews conducted by the DHHS' Office of the Inspector General in
1986 found that 90 percent of smokeless tobacco users in junior and
senior high schools said they purchased their own smokeless tobacco
products.7
Youth access restrictions have been found to be effective in
reducing illegal sales and some studies have demonstrated that efforts
to reduce access have led to a decrease in tobacco use by young people.
In Woodridge, IL, for example, a comprehensive community intervention
involving retailer licensing, regular compliance checks, and penalties
for merchant violations significantly reduced illegal sales from 70
percent to less than 5 percent almost 2 years later. Further, rates of
experimentation and regular smoking dropped by more than 50 percent
among seventh and eighth graders.8
In contrast, attempts to reduce sales to young people by relying
exclusively on educational programs for retailers were not nearly as
effective. For example, one study found that minors were able to buy
cigarettes in 73 percent of stores receiving informational packages on
preventing illegal sales to minors.9 After a comprehensive
retailer education program was conducted, illegal sales to minors
decreased to 68 percent of stores. However, after citations were issued
to violative establishments, over-the-counter illegal sales dropped to
31 percent.10
The proposed rule would prohibit the sale and distribution of
cigarettes and smokeless tobacco products to individuals younger than
18. This restriction parallels the age restrictions established by
almost all States. Moreover, it is based on the fact that most people
who become regular smokers do so at a young age. For instance, the IOM
reported that the average age when people become ``daily'' smokers is
17.7 years.11 According to the National Household Surveys on Drug
Abuse (1991), 53 percent of people who ever smoked became regular
smokers by the time they were 18 years old.12 Further, 82 percent
of those who had ever smoked daily first tried a cigarette before the
age of 18.13
Available data documenting the course of a young person's ability
to quit smoking after initiating smoking support the need for an age
restriction. A study tracking students from grades 6 to 12 in six
Minnesota communities noted a ``striking pattern'' that:
* * * once students become weekly smokers, they are unlikely to
give up cigarettes. Of the students who were current smokers, an
increasing percentage remained smokers over the years of follow-up;
they were either unable or unwilling to quit smoking. Of the self-
reported quitters, 13% to
[[Page 41323]]
46% returned to weekly smoking by the next year's measurement
period.14
The study found that ``students who smoke are increasingly unlikely to
quit as they get older.'' 15
Effectively prohibiting sales to people younger than 18 years of
age will therefore help reduce the number of adolescents and youths who
become daily smokers. FDA also selected the age limit of 18 to be
consistent with the 1992 Alcohol, Drug Abuse, and Mental Health
Administration (ADAMHA) Reorganization Act 16 that conditions
receipt of substance abuse grants on States adopting laws prohibiting
the sale and distribution of cigarette and smokeless tobacco products
to minors under age 18, and because the majority of States have set 18
as the age of purchase of these products.
1. Section 897.10--General Responsibilities of Manufacturers,
Distributors, and Retailers
Proposed 897.10 would describe the general responsibilities of
manufacturers, distributors, and retailers, and would make
manufacturers, distributors, and retailers responsible for ensuring
that the cigarettes and smokeless tobacco products they manufacture,
label, advertise, package, sell, distribute, or otherwise hold for sale
comply with all the applicable regulations under proposed Part 897.
2. Section 897.12--Additional Responsibilities of Manufacturers
Proposed 897.12 would provide that, in addition to its other
responsibilities, each manufacturer would be responsible for removing
all self-service displays, violative advertising, labeling, and other
manufacturer- or distributor-supplied items from each point of sale.
Proposed Sec. 897.12(b) would require each manufacturer to monitor,
through visual inspection on each visit to a point of sale (carried out
in the normal course of the manufacturer's business), to assure the
proper labeling, advertising, and distribution of its products. This
provision would not create a new responsibility or burden for companies
(typically the smaller ones) who do not visit retail locations as part
of their usual business practice. The obligation to inspect exists only
for those companies (typically the larger ones) for whom visits are
part of their usual business practice.
Further, because there are detailed contracts between the larger
cigarette manufacturers and retailers, proposed 897.12 should not
impose a significant burden on these manufacturers. For example, a Non-
Self-Service Carton Shelf Plan for the R.J. Reynolds Tobacco Co.
specified that `` [t]he height of the top shelf cannot exceed 72 inches
and must have a height capacity of seven cartons * * * '' and that the
cigarette display or shelves `` * * * must be in total view of the
consumer * * * '' and `` * * * may not be placed more than 10 feet from
point-of-purchase.'' 17 Another plan, titled ``R.J. Reynolds
Tobacco USA Savings Center Display Plan,'' created six different pay
scales for retailers; the retailers would receive more money if they
sold a large volume of cigarettes. Under this plan, R.J. Reynolds would
also provide a ``merchandiser'' to display its products, and the
retailer would agree to stock the ``designated RJR shelf rows'' ``no
less than five cartons high,'' and not alter the shelves or reduce the
amount allocated to R.J. Reynolds products.18 In both plans, the
retailer also agreed to permit R.J. Reynolds representatives to ``plan-
o-gram, adjust, and divide its allocated space as deemed necessary''
and to ``make reasonable audits of performance and to inspect and
rotate R.J.R's products in stores under contract.'' 19
Former sales representatives and managers interviewed by FDA stated
that manufacturers keep extremely detailed records about each retailer.
Some records noted whether the retailer should be visited weekly,
biweekly, monthly, etc.; other entries included the types of displays
in the retailer's establishment. At least one company also gave
portable computers to its representatives; the data entered into these
computers were downloaded nightly and sent to company headquarters.
These detailed contracts and records demonstrate that the manufacturers
are heavily involved in establishing and maintaining retailers'
displays and that the proposed rule's requirements that each
manufacturer be responsible for removing violative advertising,
labeling, and self-service displays, and for performing a visual
inspection on each subsequent business call are both feasible and
reasonable.
3. Section 897.14--Additional Responsibilities of Retailers
Proposed 897.14 would establish additional responsibilities for
retailers. Proposed 897.14(a) would require the retailer or the
retailer's employees to verify that people who intend to purchase
cigarettes or smokeless tobacco products are legally entitled to do so.
Verification would be by direct visual inspection of each prospective
purchaser and, if necessary, would include the use of a photographic
identification card with a birth date. Examples of documents that would
be acceptable are a driver's license or a college identification card.
The proposal would require an identification card with a picture and a
birth date because such identification cards are more reliable than
other forms of identification. FDA invites comment on whether the final
rule should contain more specific requirements concerning the types of
identification that would comply with this provision.
The agency has found strong support for the additional retailer
responsibilities that this section would impose. According to a recent
report endorsed by 26 State attorneys general, industry training films
and programs used by retailers regarding tobacco sales had little or no
impact on preventing illegal sales to minors and, in some retail
sectors, high employee turnover rates complicated training efforts.
Moreover, determining a young customer's age through visual examination
alone proved to be difficult. Thus, the attorneys general recommended
requiring proof of age of anyone who does not appear to be at least 26
years old.20
Additionally, studies indicate that minors who are able to purchase
cigarettes and other tobacco products from stores are rarely asked to
verify their age. For example, in one study, 67 percent of minors (mean
age: 15 years) were asked no questions when they attempted to purchase
cigarettes.21 Store cashiers tried discouraging the minors from
buying cigarettes in only 7 percent of the spot checks conducted by the
authors. In 14 percent of the cases, the cashiers actually ``encouraged
the minor's purchase by offering matches, suggesting a cheaper brand,
or offering to make up the difference if the minor was `short on
cash'.'' 22
In another report, five minors between the ages of 13 and 16 were
sent to various locations to buy cigarettes. Despite signs at some
locations that prohibited entry by persons under the age of 21, the
minors were able to buy cigarettes, even when they admitted they were
under 21. For smokeless tobacco products, studies show that half of the
stores examined were willing to sell smokeless tobacco products to
minors.23 In contrast, in Everett, WA, where a local ordinance
required proof of age if the prospective buyer did not appear to be of
legal age to purchase cigarettes, over 60 percent of students between
the ages of 14 and 17 reported being asked for proof of age when they
attempted to buy cigarettes, and tobacco use, among 14 to 17-year-olds,
declined from 25.3 percent to 19.7 percent overall.24
[[Page 41324]]
Proposed Sec. 897.14(b) would prevent the retailer or an employee
of the retailer from using any electronic or mechanical device in
providing cigarettes or smokeless tobacco products to the purchaser.
Requiring the retailer's employees to hand cigarettes or smokeless
tobacco products to customers, after checking identification, has the
practical effect of making access to such products more difficult for
young people.
Proposed Sec. 897.14(c) would prohibit the retailer or an employee
of the retailer from opening a cigarette, cigarette tobacco, or
smokeless tobacco product package to sell or distribute a cigarette, or
cigarettes (often referred to as ``singles'' or ``loosies'') or any
quantity of cigarette tobacco or of a smokeless tobacco product from
that package. The agency is proposing this restriction because the
primary market for ``loosies'' is children and adolescents. One
California study found that 101 of 206 stores sold single cigarettes to
minors and adults, and more stores sold single cigarettes to minors
than to adults.25 A survey in Nashville, TN, found that one-
quarter of the stores sold single cigarettes.26
Additionally, the IOM noted that the sale of single cigarettes is
attractive to children due to the low costs, could make children more
willing to experiment with tobacco products, and that single cigarettes
may be easier for children to shoplift.27 Consequently, the IOM
advocated banning the sale of single cigarettes.28 Several States,
including Mississippi, Oklahoma, South Dakota, Tennessee, and
Washington, already restrict the sale of unpackaged tobacco products,
and a working group of State attorneys general recently recommended
that single cigarette sales be prohibited.29
4. Section 897.16--Conditions of Manufacture, Sale and Distribution
a. Restrictions on product names. Proposed 897.16(a) would prohibit
prospectively the use of a trade or brand name for a non-tobacco
product as the trade or brand name for a cigarette or smokeless tobacco
product. The agency is aware of three brands of cigarettes that have
used this strategy: Harley-Davidson, Cartier, and Yves St. Laurent's
Ritz cigarettes. In the final rule, the agency intends to exempt those
brands that already use the trade or brand name of a non-tobacco
product.
This provision would complement the requirements in proposed
subpart D (regarding labeling and advertising) that would reduce the
appeal of cigarettes and smokeless tobacco products to people younger
than 18. FDA believes that this provision is necessary to prevent
manufacturers from circumventing the purpose of this proposed rule. As
discussed elsewhere, the imagery associated with tobacco products is an
important factor in why young people smoke. This provision would
prevent tobacco manufacturers from capitalizing on the imagery of other
consumer products by using the brand name of those products for tobacco
products.
b. Minimum package size. Proposed Sec. 897.16(b) would make 20
cigarettes the minimum package size for cigarettes. FDA selected 20
because the vast majority of cigarette packs in the United States
contain 20 cigarettes. The proposal is intended to preclude firms from
manufacturing packages that contain fewer than 20 cigarettes; these
packs, sometimes referred to as ``kiddie'' packs, usually contain a
small number of cigarettes, are easier to conceal, and are less
expensive than full-size packs. (Young people, who generally have
little disposable income, can be particularly sensitive to the price of
cigarettes and may choose not to smoke as the price increases.30)
Further, FDA is aware that Lorrilard Tobacco Company is offering a pack
containing only 10 cigarettes of its Newport brand for sale and that
another firm is experimenting with single cigarettes packed in
individual tubes.31
One study showed that 56.3 percent of all 14 to 15 year old
adolescent smokers surveyed in one urban area of Australia had
purchased kiddie packs in the month prior to the survey, compared with
only 8.8 percent of adult smokers. The study concluded, ``If we fail to
take strong action against the well targeted marketing methods of
tobacco companies then the adolescent smoking rates recorded in this
study are likely to remain high.'' 32
The Nova Scotia Council on Smoking and Health reported that 49
percent of tobacco users in the sixth grade purchased kiddie packs of
15 cigarettes.33 Another study of Australian schoolchildren
reported that 30 percent of the 12-year olds preferred packages
containing 15 cigarettes compared to 11 percent of the 17-year
olds.34 The Australian study, however, also reported that older
children preferred cigarette packages that contained 25 cigarettes.
Consequently, even though FDA has no evidence that firms intend to
market cigarette packages that contain more than 20 cigarettes, the
agency invites comment as to whether proposed Sec. 897.16(b) should
also state the maximum package size for cigarettes.
c. Impersonal modes of sale. Proposed Sec. 897.16(c) would permit
cigarettes and smokeless tobacco products to be sold only in a direct,
face-to-face exchange between the retailer or the retailer's employees
and the consumer. The proposal would prohibit specifically cigarette
vending machines, self-service displays, mail-order sales, and mail-
order redemption of coupons.
i. Vending Machines. Studies indicate that a significant percentage
of adolescents are able to obtain their cigarettes from vending
machines and that such purchases occur regardless of locks, warning
signs, and other restrictions. In 1994, CDC examined 15 recent tobacco
inspection surveys to investigate underage sales to minors. While 73
percent of over-the-counter outlets made illegal sales to children and
adolescents, 96 percent of vending machine sales were
successful.35
A 1989 survey of 10th grade students in Minnesota indicated that 71
percent had purchased tobacco from vending machines.36 Another
1989 report found that, in California, minors between the ages of 14
and 16 were able to purchase cigarettes from vending machines 100
percent of the time.37 A 1992 study in Minnesota involving minors
between the ages of 12 and 15 reported a 79 percent success rate in
purchasing cigarettes from vending machines.38 Children in the
Washington, D.C. area, New York, Colorado, and New Jersey who were sent
to purchase cigarettes from vending machines achieved 100 percent
success rates.39 The 1994 Surgeon General's Report examined nine
studies on cigarette purchases from vending machines and found that
underage persons were able to purchase cigarettes 82 to 100 percent of
the time, with a weighted-average rate of 88 percent.40
Moreover, younger children use vending machines to purchase
cigarettes more often than older adolescents. A study commissioned by
the vending machine industry revealed that 22 percent of 13-year olds
who smoke reported purchasing cigarettes from vending machines
``often'' compared with only 2 percent of 17-year olds. Twenty-two
percent of 13- to 17-year- olds who smoke report purchasing cigarettes
from vending machines ``often''or ``occasionally.''41
FDA is aware that some jurisdictions have attempted to place locks,
post warning signs, or restrict placement of vending machines to
curtail access by young people. These efforts have had only limited
success. A 1992 report examining vending machines in St. Paul, MN,
indicates the limitations of requiring locking devices on vending
machines. Despite a 1990 city ordinance requiring locking devices on
vending machines, the rate of noncompliance by
[[Page 41325]]
merchants was 34 percent after 3 months and 30 percent after 1
year.42 Underage buying increased from 30 percent 3 months after
the ordinance had been enacted to 48 percent after 1 year.43
Further, in those locations where locking devices were not placed on
vending machines, underage buying was successful 91 percent of the
time.44 The study concluded that the use of locking devices on
vending machines was less effective than a vending machine ban.
In 1994, CDC examined minors' access to cigarette vending machines
in Texas. CDC noted that Texas law requires cigarette vending machine
owners to post signs on their machines stating that sales to persons
under the age of 18 are illegal. Despite these laws, minors between the
ages of 15 and 17 successfully bought cigarettes from vending machines
98 percent of the time.45
Laws restricting placement of vending machines also appear to be
ineffective. In one study, 14-year-old children were able to purchase
cigarettes from vending machines 77 percent of the time despite State
laws requiring the machines to be ``in the immediate vicinity, plain
view and control of an employee'' and to bear signs concerning illegal
purchases by minors.46 Six surveys conducted in bars, taverns,
private clubs, and liquor stores in five states found that minors were
able to successfully purchase cigarettes in vending machines between 70
percent and 100 percent of the time, about the same rate as
elsewhere.47 In these surveys, the sales rates for ``adult only''
locations were similar to the rates for vending machine cigarette sales
located elsewhere in the communities, indicating that restricting
cigarette vending machines to places such as bars and liquor stores
does not serve as an impediment to young people buying cigarettes.
Additionally, according to the vending machine industry's research,
77.5 percent of all cigarette vending machines are already in ``adult''
areas such as bars, lounges, offices, college campuses, and industrial
plants.48 Therefore, it is likely that restricting cigarette
vending machines to these areas would have a minimal effect on reducing
sales to young people.
Studies also have shown that the use of vending machines by young
people appears to be highest in those areas with strong access
restrictions. In Santa Fe, New Mexico, where selling to minors was not
against the law, vending machines were used 18 percent of the time by
teen smokers.49 By contrast, in Vallejo, California, where local
merchants were actively requiring photographic identification, a survey
found that teen smokers used vending machines 56 percent of the time
(thereby making vending machines the most common source of cigarettes
for young people.50) Therefore, if access restrictions are imposed
such as requiring retailers to verify age, it is likely that vending
machines may become an even more important source of cigarettes for
young people.
Because minors, especially very young children who try smoking,
rely on vending machines to purchase tobacco products, and because
State and local laws restricting placement of, or requiring locking
devices on, vending machines appear to be ineffective, the agency
believes that the only practical approach to curtailing young people's
access to such products is to eliminate vending machines and other
impersonal modes of sale. Moreover, government enforcement of vending
machine locking devices would entail a greater regulatory burden than
enforcing a complete ban because authorities would need to ensure the
devices were installed and operating properly, and that store employees
were using them correctly.51
Consequently, proposed Sec. 897.16(c) would require retailers to
hand the product to the consumer. This proposed requirement would have
the added effect of preventing persons younger than 18 from evading the
proposed rule's age requirement by shifting their purchasing patterns
from stores to vending machines or mail orders. Further, the agency
notes that this aspect of the proposed rule is consistent with
recommendations from the IOM,52 the Public Health Service,53
a working group of State attorneys general,54 and findings by the
Office of the Inspector General, DHHS.55
Finally, data from the vending machine industry show that
cigarettes account for a small and declining portion of total vending
machine revenues.56 Using industry data from 1993, calculations
indicate that daily sales from cigarette vending machines average
approximately $10 per machine/per day.57 In 1993, cigarettes
comprised 4.7 percent of total vending machine revenues compared to
45.5 percent in 1960.58 Between 1992 and 1993, vending machine
revenues from cigarettes dropped 25 percent.59 While total
revenues from cigarette vending machines have been decreasing, revenues
from most other product categories sold in vending machines, such as
juice and other cold drinks, rose dramatically.60 Further, the
number of cigarette vending machines decreased significantly from
373,800 to 181,755 between 1988 and 1993.61 Recognizing that more
and more states and localities have enacted restrictions or bans on
cigarette vending machines, machines are being produced that can be
converted to dispense other products.62 Furthermore, according to
the National Automatic Merchandising Association, the association
representing the vending machine industry, virtually no new shipments
of cigarette vending machines have been made since 1990, compared with
32,065 shipments in 1976.63
ii. Self-service displays. Proposed Sec. 897.16(c) would also
prohibit self-service displays. Self-service displays enable young
people to quickly, easily, and independently obtain tobacco products.
This restriction is intended to prevent young people from helping
themselves to tobacco products and to increase the direct interaction
between the sales clerk and the underage customer. This restriction is
also consistent with the 1994 IOM Report's recommendation. IOM reviewed
surveys of grade school students in New York, and Wisconsin, and noted
that many students--over 40 percent of daily smokers in Erie County, NY
and Fond du Lac, WI--shoplifted cigarettes from self-service
displays.64 IOM found that eliminating self-service displays would
make it more difficult for children to obtain cigarettes, especially if
the children had to purchase the cigarettes from a store clerk (as
would be required under this proposal). IOM further noted that
``placing the products out of reach reinforces the message that tobacco
products are not in the same class as candy or potato chips.'' 65
A California study compared smoking prevalence among minors in five
counties before and after the institution of ordinances prohibiting
self-service merchandising (display and sale) and requiring only
vender-assisted sales. The rate of tobacco sales to minors in the five
counties dropped 40 to 80 percent and the decrease was still in
evidence 2 years after the survey. Moreover, the study found that the
ban on self-service significantly increased the checking of young
purchasers' identification by retail clerks and, in particular,
discouraged younger adolescents from attempting to buy tobacco.66
iii. Mail-order sales. In addition to prohibiting the sale of
tobacco products in vending machines and the use of self-service
displays, proposed Sec. 897.16(c) would prohibit mail-order sales and
redemption of mail-order coupons. Mail-order sales provide no face-to-
face interaction to verify the age of the consumer. The current
industry practice merely requires that the customer provide a birth
date or check a box on
[[Page 41326]]
the mail-order card to verify, for example, that he/she is 21. The
agency concludes that proposed Sec. 897.16(c) would significantly
reduce access to cigarettes and smokeless tobacco products by persons
younger than 18. The ban of mail-order sales is recommended by the IOM
67 and Philip Morris recently announced that it would discontinue
mail-order sales in order to reduce access to young people.68
d. Free samples. Proposed Sec. 897.16(d) would prohibit
manufacturers, distributors, and retailers from distributing free
samples of tobacco products. The agency is proposing this restriction
because many young people, including elementary school children,
receive free samples.69 Free samples are often distributed at
``mass intercept locations'' such as street corners and shopping malls,
and events such as music festivals, rock concerts, and baseball games.
They have been distributed at zoos, at bars and restaurants where
entertainers perform and promote the product, and through the
mail.70 Free samples give young people a ``risk-free and cost-free
way to satisfy their curiosity'' about tobacco products and, when
distributed at cultural or social events, may increase social pressure
on young people to accept and use the free samples.71
For smokeless tobacco products, distribution of free samples to
young people has been a foundation of the growth strategy of the UST
(makers of Skoal, Copenhagen, Happy Days, and other smokeless tobacco
products).72 In 1992 and 1993, the smokeless tobacco industry
spent nearly $16 million annually on the distribution of free samples.
The industry's largest expenditure in 1993 was on coupons and retail
value-added articles to encourage trial use ($32 million).73
Despite industry-imposed age restrictions on the distribution of
samples, underage persons are able to obtain samples either by lying
about their age or by enlisting older friends and relatives to obtain
samples for them.74 The lure of free samples can also be quite
attractive; one advertising campaign offering a sample pack of Skoal
Bandits reportedly generated 400,000 responses in a 3-month
period.75
Even elementary school children are able to obtain free cigarette
samples easily. One survey examined five schools in Chicago and a
sample of students at DePaul University. Four percent of the elementary
school students reported receiving free samples of cigarettes
themselves. Nearly half of the elementary and high school students and
one-quarter of the college students ``* * * reported having seen free
cigarettes given to children and adolescents.'' 76 In another
survey, one-third of approximately 500 New Jersey high school students
who were current or former smokers reported receiving free cigarette
samples before the age of 16.77
The distribution of free samples to minors occurs despite the
industry's voluntary code against distributing cigarettes to persons
under the age of 21. The recent IOM report noted several problems with
the industry's voluntary code, stating that ``distribution to minors
appears to be nearly inevitable.'' 78 While the voluntary code
instructs employees distributing samples to ask for identification and
ask other questions if they suspect a potential recipient to be under
age, distribution of samples to minors occurs anyway because the
samplers are often placed in crowded places and constrained by time:
There is a significant time constraint in asking for proof of
age from all young-looking individuals who solicit samples, not to
mention the time required for the myriad of other questions which
samplers are instructed to ask. Samplers are often surrounded on all
sides by those soliciting samples and a dozen or more outstretched
arms waiting (or grabbing) for samples * * * those passing out
samples are usually quite young themselves. These youthful
distributors may lack the psychological wherewithal to request proof
of age and refuse solicitations from those in their own peer
group.79
Consequently, the ineffectiveness of the industry's voluntary code and
the fact that State laws that ban or restrict the distribution of free
samples are rarely enforced led IOM to recommend prohibiting
distribution of free samples in public places and through the
mail.80 The National Cancer Institute reached a similar conclusion
in 1991, and stated, ``The offer of free cigarettes and smokeless
tobacco products is reminiscent of the drug pusher who gives the first
sample free to get his customer hooked.'' 81 The proposed rule is
consistent with IOM's and NCI's recommendations.
C. Subpart C--Labels and Educational Programs
Proposed subpart C would provide the established name for
cigarettes and smokeless tobacco products that is required by sections
502 of the act. In addition, it would require that cigarette and
smokeless tobacco manufacturers fund a national program including
educational messages in order to undo the effects of young people's
near constant exposure to pro-tobacco messages and, thus, to discourage
young people from using cigarettes and smokeless tobacco products,
pursuant to sections 201, 502, and 520(e) of the act.
1. Section 897.24--Established Names for Cigarettes and Smokeless
Tobacco Products
Proposed Sec. 897.24 would provide the ``established name'' for
cigarettes, cigarette tobacco, and smokeless tobacco products. This
provision is intended to implement section 502(e)(2) of the act, which
states that a device shall be deemed misbranded if its label fails to
display the established name for the device ``in type at least half as
large as that used thereon for any proprietary name or designation for
such device.'' Section 502(e)(4) of the act, in turn, explains that the
``established name'' for a device is the applicable official name of
the device designated under section 508 of the act (21 U.S.C. 358), the
official title in a compendium if the device is recognized in an
official compendium but has no official name, or ``any common or usual
name of such device.''
In this case, no official names have been designated under section
508 of the act, and no compendium provides an established name for
these products. Consequently, proposed Sec. 897.24 would consider
``cigarettes,'' ``cigarette tobacco,'' and the common or usual names
for smokeless tobacco products (such as ``moist snuff'' or ``loose leaf
chewing tobacco'') as established names.
2. Section 897.29-Educational Programs Concerning Cigarettes and
Smokeless Tobacco Products
The Surgeon General's 1994 Report suggested that ``a nationwide,
well-funded antismoking campaign could effectively counter the effects
of cigarette advertising in its currently permitted media forms.''
82 IOM also recommended that ``counter-tobacco advertisements
should be intensified to reverse the image appeal of pro-tobacco
messages, especially those that appeal to children and youths.''
83
FDA's proposal is consistent with the Surgeon General's and IOM's
findings. Proposed 897.29 would require each manufacturer to establish
and maintain a national public educational program, including major
reliance on television messages, to combat the effects of the pervasive
and positive imagery that has for decades helped to foster a youth
market for tobacco products.
FDA based proposed 897.29, in part, on historical experience. From
July 1, 1967 to December 31, 1970, the Federal Communications
Commission, as part of
[[Page 41327]]
the ``Fairness Doctrine,'' required broadcasters to provide a
significant amount of time for antismoking messages on television and
radio. Thus, one antismoking message appeared for every three or four
industry-sponsored, prosmoking advertisements. This amounted to
approximately $75 million (in 1970 dollars) in commercial air time for
antismoking messages annually, until a ban on prosmoking advertisements
on television and radio became effective on January 1, 1971. Thus, for
several years, the American public was exposed to both pro- and
antismoking messages.
During this time, per capita cigarette consumption declined 7
percent, from 4,280 in 1967 to 3,985 in 1970. Most of the 7 percent
decline (6.2 percent) was attributable to the anti-smoking
messages.84 This was the first time since the early 1930's that
per capita consumption declined consecutively for 3 years and was one
of the largest declines ever recorded. Additionally, a study of nearly
7,000 adolescents found that adolescent smoking rates declined during
this period.85 The greatest decline occurred in the first year
that the antismoking messages appeared. A 1972 econometric analysis
confirmed that the antismoking messages had up to a 5.6 times greater
effect on cigarette consumption than promotional cigarette
advertising.86 When the antismoking messages ended on television
and radio (due to the Federally-mandated ban on advertising on
television and radio, thereby ending the application of the Fairness
Doctrine), per capita cigarette consumption began to rise.
A similar experience occurred in Greece during the late
1970's.87 In an effort to reduce cigarette consumption, the Greek
government launched an antismoking campaign and, in 1978, banned
cigarette advertising on television and radio. In 1979, the Greek
Government intensified its antismoking effort by adding television and
radio counter-advertising as well as a community-based print education
campaign. This enhanced campaign lasted 2 years but was discontinued
following a change in government, with the ban on television and radio
advertising remaining. Evaluation of this experience revealed that,
during the counter-advertising phase, the annual increase in per capita
tobacco consumption dropped to zero, compared to the pre-campaign
advertising ban rate of 6 percent increase in consumption. When the
campaign ended, the annual rate of increase in tobacco consumption
quickly increased to earlier levels. This experience suggests that
intensive health education and counter-advertising campaigns can be
effective.
There have been numerous research and demonstration projects
evaluating the effectiveness of counter-advertising and mass-media
smoking cessation programs.88 As the research designs have
evolved, more has been learned about which types of programs are
effective and under what conditions. Most recently, well-evaluated
studies of programs in Vermont, California, and elsewhere suggest that
mass-media and counter-advertising campaigns can have a sustained
effect on both preventing teens from starting to smoke and in helping
smokers quit.
In Vermont, researchers tested the effect of mass-media and school
health education programs.89 Students exposed to both school and
media interventions were 35 percent less likely to have smoked in the
past week than students exposed only to the school program, and this
preventive effect persisted for at least 2 years following the
completion of the intervention program. The decrease occurred even in
students who were considered to be at slightly higher risk of becoming
smokers because of demographic considerations (lower family income).
There have been similar results in helping smokers interested in
quitting. In California, the Department of Health Services has been
conducting a $26 million multi-year media campaign to prevent teens
from starting to smoke and help adult smokers quit. In a preliminary
study of the campaign's effectiveness, researchers found that the state
media campaign ``had a negative impact on cigarette consumption, while
industry advertising had a positive impact on cigarette consumption.''
The authors concluded that ``[t]his suggests, as one would expect, that
increasing state media expenditures and decreasing industry advertising
are both effective ways to deter smoking.'' 90 According to a
recent evaluation, the media campaign's advertisements directly
influenced 7 percent (33,000) of Californians who quit smoking in 1990
to 1991, and contributed to the quitting of another 173,000.91 The
California media program has also resulted in high levels of awareness
among young people,92 and may have contributed to stopping the
rise in teen smoking that had been occurring in California prior to the
campaign.93
FDA has proposed general criteria in the codified language. The
following describes one set of requirements for such a program that the
agency is considering requiring in a final rule. FDA is soliciting
comments on whether the described program would accomplish the goal of
creating an effective national program that would correct and combat
the effects of the pervasive positive imagery in advertising and, thus,
help reduce young people's use of tobacco products or whether
additional or different requirements would be preferable. The program
would be national in scope and could require that the companies
purchase certain times and places on television programming (referred
to in the industry as a ``buy''). For example, a television buy could:
(1) Devote at least 80 percent of its resources to television messages,
both on network and on cable television, during prime time hours
(between the hours of 8 p.m. and 11 p.m.), early fringe time (between
the hours of 4 p.m. and 6 p.m.), and access time (time that is
allocated to local broadcasting stations); (2) be directed to persons
between the ages of 12 and 17 years; and (3) be national in scope.
Moreover, the buy could include advertising time in at least 50 percent
of television programs rated by a national rating service as being in
the top 20 for persons between the ages of 12 and 17 and corresponding
to the demographic profile of underage tobacco users by gender, racial,
and ethnic characteristics, and the remaining percentage in programs
with either high concentration or high coverage to young people. The
buy could ensure that the manufacturer reach an average of 70 to 90
percent of all persons between the ages of 12 and 17 years five to
seven times per 4-week period. (The 4-week period is often referred to
as a ``flight.'') Such requirements would help to ensure that the
educational messages reach large numbers of young people and are
consistent with the way in which advertising is typically purchased. In
addition, to ensure that the messages change over time and remain novel
and of interest to young people, each message could be limited in use
so that each message would be presented no more than 15 times per
quarter to the top two-fifths (referred to as top two quintiles) of
television viewers between the ages of 12 and 17 and who watch the most
television.
The industry members could select from a variety of messages
maintained by FDA. FDA could collect and maintain a file of messages
developed by states with active tobacco control programs (such as
California and Massachusetts), from voluntary health organizations (as
was done by broadcasters during the Fairness Doctrine period), and from
other appropriate sources, including messages developed and submitted
by the tobacco
[[Page 41328]]
companies. FDA could determine which messages would be appropriate in
consultation with other entities and offices within the Department of
Health and Human Services, such as CDC's Office on Smoking and Health;
with other federal agencies with expertise in consumer behavior and
marketing, such as the Federal Trade Commission; and with consultants
and contractors who are expert in communications theory and practice.
FDA, in consultation with other federal agencies and other experts,
could review the messages to ensure that their language and imagery are
effective with 12- to 17-year olds. Each message would be evaluated to
determine if it were designed to influence those beliefs and attitudes
of 12- to 17- year olds that are most likely to affect the initial
decision to smoke (or to start using smokeless tobacco products), the
decision to continue smoking (or continue to use smokeless tobacco
products), and/or the decision to quit. Examples of appropriate
messages include those addressing addiction, weight control, effective
ways to refuse a cigarette and other social influences that are related
to youth smoking.
Moreover, an appropriate educational program could require each
manufacturer to submit, on a quarterly basis, analyses of every
television buy by time period on network television (referred to as
``day part''), cable, and other media, prepared and executed by the
party or parties responsible for the advertising. This requirement
could fulfill the manufacturer's responsibility to report on the
effectiveness of the program.
In addition, each manufacturer could conduct tracking studies of
persons between the ages of 12 and 17. This would enable the
manufacturers to determine how effective their educational programs and
buys were. The studies could be performed twice per year and would need
to meet recognized industry standards for tracking studies, such as
measuring recall and recognition of the televised messages. These
studies could be given to FDA, which could review the results of the
industry's testing in consultation with other experts as needed, in
order to help the agency refine its selection criteria for messages.
Finally, the remaining 20 percent of the messages could be placed
in other media, with emphasis on radio and outdoor advertising.
Consideration should be given to ensuring that these messages appear in
media that are heavily used by young people.
Under proposed Sec. 897.29, each manufacturer would devote an
amount of money to the corrective educational program proportionate to
its share of the total advertising and promotional expenditures of the
cigarette and smokeless tobacco industry. Thus, a company whose
expenditures equal 40 percent of total industry expenditures would be
required to allocate an amount equal to 40 percent of the total monies
required. The agency calculated the amount of money that would be
allocated to the initial corrective educational program by looking at
the period of time when the Fairness Doctrine was in effect. It was
estimated that, at that time, approximately $75 million a year in air
time was provided by broadcasters for anti-smoking messages, which
translates to $290 million in 1994 dollars. In order to ensure an
effective program, the agency is proposing that approximately half that
amount, or $150 million a year, be allocated initially. Under this
proposal, the agency could determine each manufacturer's proportionate
share of the overall advertising and promotional expenditures of the
cigarette or smokeless tobacco industry by referring to the most recent
figures reported to the FTC under the Cigarette Act or the Smokeless
Act. This provision is intended to ensure that the corrective
educational programs are adequately funded in proportion to each
manufacturer's overall reported advertising and promotion expenses.
D. Subpart D--Labeling and Advertising
1. Introduction
Proposed subpart D would establish certain requirements for
cigarette and smokeless tobacco product labeling (excluding product
labels) and advertising pursuant to sections 520(e), 502(q), and 502(r)
of the act. The proposal would apply similar requirements to labeling
and advertising in print media because both are used to convey
information about the product; to promote consumer awareness, interest,
and desire; to change or shape consumer attitudes and images about the
product; and/or to promote good will for the product. Therefore, FDA
has decided to place the labeling provisions with the advertising
requirements rather than place the labeling provisions with those
pertaining to product labels.
Regulating cigarette and smokeless tobacco product labeling and
advertising is essential to decrease young people's use of tobacco
products. Proposed subpart D would preserve the informational component
of labeling and advertising while decreasing their appeal to children
and adolescents.
Briefly, the proposed regulations would require that advertising in
any publication with a youth readership of more than 15 percent (youth
being defined as under 18) or more than 2 million children and
adolescents under 18 be limited to a text-only format in black and
white. Advertising in any publication that is read primarily by adults
would be permitted to continue to use imagery and color. Pursuant to
section 502(r), the proposed regulations would require that cigarette
advertising contain a statement of the product's established name,
intended use, and a brief statement regarding relevant warnings,
precautions, side effects, and contradictions. In addition, brand
identifiable non-tobacco items, such as hats and tee shirts, and brand
identifiable sponsorship of events, such as the Virginia Slims Tennis
Tournament or a sponsored event using a tobacco product logo or symbol,
would be prohibited.
Section 201(m) of the act (21 U.S.C. 321(m)) defines ``labeling''
as ``all labels and other written, printed, or graphic matter'' that
are on an article or its containers or wrappers, or ``accompanying such
article.'' In interpreting the phrase ``accompanying such article,''
the Supreme Court has held that it is not necessary for the labeling to
physically accompany the product (see Kordel v. United States, 338 U.S.
345, 350 (1948)). Thus, labeling includes traditional promotional
items, such as booklets, calendars, movies, etc., and also less obvious
types of labeling, such as clocks, coffee mugs, desktop toys, and even
tee shirts.94 FDA would, therefore, consider non-tobacco items
distributed by cigarette and smokeless tobacco companies with the
product's brand name or product identification printed on them (e.g.,
tee shirts, hats, pens, golf tees) to be ``labeling,'' and these would
be prohibited.
Subpart D is based, in part, on the recommendations of major U.S.
and world health organizations and on current efforts by other
countries to reduce tobacco use. These organizations and countries
support advertising restrictions as an essential part of any
comprehensive program to reduce or eliminate smoking by young people.
The American Medical Association, American Heart Association, American
Cancer Society, American Lung Association, American Academy of Family
Physicians, the World Health Assembly, and the World Health
Organization have recommended restrictions on advertising and promotion
including a total ban of all promotional and advertising
activities.95
[[Page 41329]]
Additionally, the recent IOM report recommended that, to ensure
that one clear message about the health risks of tobacco use is
disseminated, the government should see to it that the ``contradictory
message [minimizing the risk] now conveyed by the tobacco industry''is
stopped.96 The report recommended many restrictions that are
similar to those in the proposed rule. For example, the report
recommended that advertising either be banned entirely or restricted to
a text-only format.97 The IOM said that such an approach would
``eliminate all the images that imply that tobacco use is beneficial
and make it attractive, and that encourage young people to use tobacco
products.'' 98
The proposed labeling and advertising regulations are also based
upon numerous studies and reports. The first and most compelling piece
of evidence supporting restrictions on cigarette and smokeless tobacco
product labeling, advertising, and promotion is that these products are
among the most heavily advertised products in America. Between 1970 (1
year before Federal law prohibited cigarette advertisements on
television and radio) and 1993, cigarette advertising and promotional
expenditures increased from $361 million to $6 billion, a 1,562 percent
increase.99 These messages were disseminated in print media, on
billboards, at point of sale, by direct mail, on specialty items (hats,
tee shirts, lighters), at concerts and sporting events, in direct mail
solicitations, as sponsorships on television, and in other media. FDA
is concerned that the amount of advertising, its attractive imagery,
and the fact that it appears in so many forums, overwhelms the
government's health messages.
Advertising and promotion of smokeless tobacco products, although a
much smaller market than cigarettes, also increased over the years. The
largest increase in advertising expenditures for smokeless tobacco
products occurred for moist snuff. U.S.Tobacco (UST), the market leader
in moist snuff, increased its television advertising expenditures from
$800,000 in 1972 to $4.6 million in 1984,100 an increase of 485
percent. By 1993, total advertising and promotional expenditures for
smokeless tobacco products exceeded $119 million. This increase was
largely attributable to the advertising of moist snuff ($71.4
million).101 This increase in expenditures corresponds to the
growth of the moist snuff portion of the smokeless tobacco market, from
36 million pounds in 1986 to 50 million pounds in 1993. All other
segments of the smokeless tobacco market declined during that
period.102
In addition to spending large amounts on advertising, the cigarette
and smokeless tobacco product industries have disseminated a variety of
advertising and promotional messages that have had an enormous impact
upon young people's attitudes towards smoking. In summarizing its
analysis of the industry's advertising practices, IOM stated:
The images typically associated with advertising and promotion
convey the message that tobacco use is a desirable, socially
approved, safe and healthful, and widely practiced behavior among
young adults, whom children and youths want to emulate. As a result,
tobacco advertising and promotion undoubtedly contribute to the
multiple and convergent psychosocial influences that lead children
and youths to begin using these products and become addicted to
them.103
The pervasiveness and magnitude of the labeling and advertising for
these products create an atmosphere of ``friendly familiarity''
104 that affects and shapes a young person's views towards tobacco
products. Thus, FDA's decision to propose stringent regulations for
labeling and advertising is based upon compelling evidence that
advertising and labeling play an important role in shaping a young
person's attitude towards, and willingness to experiment with,
cigarettes and smokeless tobacco products.
2. Advertising, Labeling, and Adolescents
Products may be advertised and promoted for their symbolic or
fanciful attributes. Advertising utilizing this technique tries to
convey that consumption of the product will enhance the user's self
image 105 or image in the community. Consumers purchasing products
for these symbolic attributes hope to acquire the image as well as the
product itself.106 This psychosocial consumer phenomenon is
particularly descriptive of adolescent consumer behavior. As one
consumer psychologist remarked:
[adolescence] create[s] a lot of uncertainty about the self, and
the need to belong and to find one's unique identity as a person
becomes extremely important. At this age, choices of activities,
friends, and ``looks''often are crucial to social acceptance. Teens
actively search for cues from their peers and from advertising for
the ``right''way to look and behave.* * * Teens use products to
express their identities, to explore the world and their new-found
freedoms in it, and also to rebel against the authority of their
parents and other socializing agents. Consumers in this age sub-
culture have a number of needs, including experimentation,
belonging, independence, responsibility, and approval from others.
Product usage is a significant medium to express these
needs.107
For example, adolescent males often use ``such 'macho' products as
cars, clothing, and cologne to bolster developing and fragile masculine
self-concepts.'' 108
Adolescents view cigarettes as a symbol to be used in helping to
create a desired self image and to communicate that image to others.
Cigarette advertising reinforces this symbolism and links smoking to
success, social acceptance, sophistication, and a desirable lifestyle.
The rugged and masculine Marlboro Man conveying, in the words of the
Chief Executive Officer and President of Philip Morris, ``elements of
adventure, freedom, being in charge of your own destiny,'' 109 and
the cool Joe Camel, giving humorous dating tips, provide imagery that
adolescents can accept as identifying badges. Not surprisingly, these
brands are among the most popular with young people. One Canadian
tobacco company described its ``masculine''targeting in these words:
Since 1971, [the company's] marketing strategy has been to
position [a cigarette brand] as a ``masculine trademark for young
males.'' It has been our belief that lifestyle imagery conveying a
feeling of independence/freedom should be used to trigger the desire
for individuality usually felt by maturing young males.110
Advertising for cigarette brands targeted to women have proven
successful in attracting young female smokers. One study correlated
trends in rising smoking initiation rates among girls with the
introduction of several brands targeted at women. Some of these
campaigns utilized themes thought to be appealing to women (e.g.
liberation and feminism, images of slimness and sophistication). The
advertising campaigns preceded a rapid increase in smoking initiation
rates among girls under 18 that was not accompanied by any increase in
smoking rates for women, boys, or men.
Thus, advertising can play an important role in a youth's decision
to use tobacco. Many researchers, including those within the cigarette
industry, have advanced a stage-based model of smoking uptake.111
The first, preparatory stage is when a child or adolescent starts
forming his or her attitudes and beliefs about smoking, and sees
smoking as a coping mechanism, as a badge of maturity, as a way to
enter a new peer group, or as a means to display independence.112
During this stage, pervasive advertising imagery that glamorizes
tobacco use may be an important factor in shaping beliefs. The
[[Page 41330]]
middle, trying and experimenting stages occur when the first cigarette
is smoked, often at the urging of a peer, and becomes repeated but
irregular. It is important to note that those who experiment often, or
begin smoking at an early age, are much more likely to become regular
smokers.113 Therefore, age of initiation is important.
The final stage, nicotine dependence and addiction, is
characterized by a physiological need for nicotine. At this stage, the
adolescent develops a tolerance for nicotine and can experience
withdrawal symptoms (such as dysphoric or depressed mood, insomnia,
irritability, frustration or anger, anxiety, and difficulty
concentrating) if he or she attempts to quit. However, of those who try
to quit, few succeed without help, and there is a high probability of
relapse.114
In the early stages of smoking, i.e., at initiation, psychosocial
factors are decisive, and those factors are most often capitalized on
in the themes used in tobacco product advertising. In the final stage,
as smoking takes hold, physiological factors (and even health concerns)
dominate. A document prepared by Imperial Tobacco Ltd. stated:
At a younger age, taste requirements and satisfaction in a
cigarette are thought to play a secondary role to the social
requirements. Therefore taste, until a certain nicotine dependence
has been developed, is somewhat less important than other
things.115
Many behavioral and personal characteristics influence an
adolescent's decision to use cigarettes or smokeless tobacco products,
including: rebelliousness; risk-taking personality; use of other legal
or illegal drugs; belief in the perceived utility of smoking (to cope
with stress, control weight, or improve one's self-image); low self-
esteem or depression; disbelief of or discounting health risks; and
poor academic achievement.116 Cognitive factors specific to
children and adolescents also play a role in the early decision to
smoke. Children and adolescents often focus on present needs and
concerns, and ignore risks that might exist in the future. They exhibit
a sense of personal invulnerability that permits them to act as if they
were immortal.117 Tobacco advertising plays on these feelings and
exploits these adolescent vulnerabilities. As one report, created for a
Canadian cigarette company, stated:
Starters no longer disbelieve the dangers of smoking, but they
almost universally assume these risks will not apply to themselves
because they will not become addicted. Once addiction does take
place, it becomes necessary for the smoker to make peace with the
accepted hazards. This is done by a wide range of
rationalizations.118
3. Industry's Marketing Practices
Industry documents indicate that cigarette manufacturers have
conducted extensive research on smoking behavior and attitudes in young
people and how advertisements should be made to appeal to young people.
Documents from Philip Morris' files indicate that the company did, at
least on one occasion, conduct research about the smoking habits of
young people, questioning people in Iowa, including teen-agers as young
as 14.119 More specifically, research conducted for a Canadian
affiliate of one U.S. cigarette firm focused on the need to attract
young consumers, stating:
Ads for teenagers must be denoted by a lack of artificiality,
and a sense of honesty. Attempts at use of celebrities ***do not
seem to really click. If freedom from pressure and authority can
also be communicated, so much the better.120
Research conducted by an American cigarette firm, and confirmed by
other tobacco companies, revealed another significant behavior: most
smokers continue to purchase the brand they smoked when they became
regular smokers. Brand loyalty is seen in many consumer products (such
as toothpaste, coffee, and automobiles) but is particularly strong for
tobacco products. A 1989 ``Wall Street Journal''article showed
cigarettes as having the highest percentage of brand loyalty among
consumers of any consumer product, at 71 percent.121
Knowledge about brand loyalty among cigarette smokers, coupled with
the fact that most smokers began smoking before the age of 18, may
explain why cigarette manufacturers have focused advertising and
promotional efforts on younger people. R.J. Reynolds devised what it
called a ``Young Adult Smokers'' (``YAS'') program that was apparently
designed to appeal specifically to young smokers, 18 to 24 year olds,
and more narrowly to 18 to 20 year olds. An element of that program,
known as FUBYAS, an acronym for First Usual Brand Young Adult Smokers,
captured the concept that a smoker's first regular brand is the brand a
smoker will stay with for years. This program featured the use of
promotional items, such as hats and tee shirts bearing the Camel brand
name, the cartoon Joe Camel, and imagery, that appealed to young
people. Although these programs were ostensibly directed at people
between the ages of 18 and 24, company memoranda suggest that the
target population included high school students. For example, on
January 10, 1990, a manager in Sarasota, Florida, issued a memorandum
asking cigarette sales representatives to identify stores:
* * * that are heavily frequented by young adult shoppers. These
stores can be in close proximity to colleges [,] high schools or
areas where there are a large number of young adults [who] frequent
the store.122
On May 3, 1990, when the ``Wall Street Journal'' published this
memorandum, the cigarette firm stated that the memorandum was a
``mistake'' and violated company policy by targeting high
schools.123
Yet, on April 5, 1990, a manager in Moore, OK, issued a similar
memorandum regarding the YAS program asking sales and service
representatives to identify what was termed ``Retail Young Adult Smoker
Retailer Accounts.''One criterion for identifying a YAS account
included facilities ``located across from, adjacent to are [sic] in the
general vicinity of the High Schools or College Campus [sic].''
124 This second memorandum suggests that promotions aimed at high
school students were part of the company's marketing strategy.
Sales figures suggest that the YAS program was extremely effective.
Camel quickly became one of the most popular cigarette brands among
people under age 18. Prior to the introduction of the Joe Camel
campaign, Camel cigarettes commanded no more than 3 or 4 percent of the
youth market. One year into the campaign, the youth share rose to 8.1
percent and by 1991 it was at least 13 percent.125
While not all advertising campaigns are so blatantly directed at
juveniles, campaigns using more universal themes can be as effective
with young people. According to an advertising executive with the
advertising agency that created the Marlboro cowboy, ``The Marlboro
cowboy dispels the myth that in order to attract young people, you've
got to show young people.'' The cowboy theme of independence can be
translated into other venues that have appeal for young people and be
sold as an appropriate and desirable image. According to John Landry,
the Philip Morris executive credited with designing the Marlboro
campaign, the Marlboro theme sells because it fits young people's
desires. In 1973, Philip Morris sponsored the Marlboro Cup for the
first time. Landry recalls that ``Secretariat [the winning horse]
became a hero to young people. Youth were reaching out for something,
and someone they could identify with * * *
[[Page 41331]]
`Marlboro Country' fit these desires, this search people were going
through.'' ``Something young people could trust.''A candid appraisal of
the purpose of the Marlboro theme was provided by the marketing
director with Philip Morris in Argentina, ``Marlboro magic--people
using things with [the] Marlboro logo * * * was projected to other
products around it and when those kids who were playing with Marlboro
merchandise 5 to 10 years ago--when they start smoking they'll smoke
Marlboro.'' 126
With regard to smokeless tobacco products, the U.S. Tobacco Company
(UST) successfully revived a declining market by targeting young
people, especially young men, in its promotion and advertising. In
1970, the segment of the population with the highest use of these
products was men over age 50, and young males were among the lowest.
Fifteen years later, there had been a 10-fold increase in the use of
smokeless tobacco products among young males, whose use was double that
of men over age 50.127
The increased use of smokeless tobacco products by young people was
precisely the objective of a marketing strategy of UST set in motion
almost 30 years ago. In 1968, officials at UST held a marketing meeting
where, according to the ``Wall Street Journal,'' the vice-president for
marketing said, ``We must sell the use of tobacco in the mouth and
appeal to young people * * * we hope to start a fad.'' 128 Another
official who attended the meeting was quoted as saying, ``We were
looking for new users--younger people who, by reputation, wouldn't try
the old products.'' 129 When a rival company developed a smokeless
tobacco product that 9-year-old children began using, a UST regional
sales manager reported to UST's national sales manager that the product
was mostly used by children and young adults ``from 9 years old and
up'' and noted that this age was ``four or five years earlier than we
have reached them in the past.'' 130
Responding to a question years later about why so many young males
were buying smokeless tobacco, Louis F. Bantle, then chairman of the
board of UST said, ``I think there are a lot of reasons, with one of
them being that it is very `macho'.'' 131 Playing to this
``macho'' perception of smokeless tobacco by young males,
advertisements for smokeless tobacco products have traditionally used a
rugged, masculine image and have been promoted by well-known
professional athletes. UST's successful penetration into the youth
market is indicated in a statement by Mr. Bantle: ``In Texas today, a
kid wouldn't dare to go to school, even if he doesn't use the product,
without a can in his Levis'.'' 132
UST distributes free samples of low nicotine-delivery brands of
moist snuff and instructs its representatives not to distribute free
samples of higher nicotine-delivery brands. The low nicotine-delivery
brands also have a disproportionate share of advertising relative to
their market share. For example, in 1983, Skoal Bandits, a starter
brand, accounted for 47 percent of UST's advertising dollars, but
accounted for only 2 percent of the market share by weight. In
contrast, Copenhagen, the highest nicotine-delivery brand, had only 1
percent of the advertising expenditures, but 50 percent of the market
share. This advertising focus is indicative of UST's ``graduation
process'' of starting new smokeless tobacco product users on low
nicotine-delivery brands and having them graduate to higher nicotine-
delivery brands as a method for recruiting new, younger users.133
Tobacco companies deny any youth-directed advertising and promotion
activities.134 Moreover, the industry claims that advertising
plays no role in a person's decision to start smoking; that tobacco
advertising is designed solely to capture brand share from competitors
and maintain product loyalty. The industry further claims that the
tobacco market is a ``mature'' market in which awareness of the product
is universal and overall demand is either stable or declining.135
In a mature market, the industry contends, advertising functions to
merely shift customers from one brand to another, but does not act as a
stimulus to new customers to enter the market.
One purpose of cigarette advertising may be to encourage or
discourage brand switching among current tobacco users. Some experts
believe, however, that this same advertising encourages new consumers
to begin using these products.136 Tobacco advertising, promotion,
and marketing, on which the industry spends over $6 billion each year,
may serve both purposes largely out of market necessity. Market
expansion, in the sense of new customers entering the market, must
occur to maintain total tobacco sales and avoid a significant market
decline. ``[T]he cigarette industry has been artfully maintaining that
cigarette advertising has nothing to do with total sales * * * [T]his
is complete and utter nonsense. The industry knows it is nonsense,''
wrote a former cigarette advertising executive.137
Evidence indicates that acquiring a portion of the ``starter''
market, overwhelmingly people in their teens, is regarded by the
industry as essential to a company's continuing economic viability. One
document acquired from Imperial Tobacco Limited (ITL) of Canada, a
sister company of the Brown & Williamson Company in the United States,
states:
If the last ten years have taught us anything, it is that the
industry is dominated by the companies who respond most effectively
to the needs of younger smokers.''138
To further this goal, ITL hired a consulting research company to
investigate attitudes about smoking among people aged 15 years and
older. The purpose of the research, i.e., how best to recruit new
smokers, is indicated in the following statement:
It is no exaggeration to suggest that the tobacco industry is
under siege. The smoker base is declining, primarily as a function
of successful quitting. And the characteristics of new smokers are
changing such that the future starting level may be in
question.139
Similar attitudinal research was done for R.J.R.-MacDonald, Inc.,
the Canadian subsidiary of R.J. Reynolds.140 A report entitled
YOUTH 1987 closely examined the lifestyles and value systems of ``young
men and women in the 15-24 age range.'' The report said the research
would:
provide marketers and policymakers with an enriched
understanding of the mores and motives of this important emerging
adult segment which can be applied to better decision making in
regard to products and programs directed at youth.141
A similar research objective was described in a 1969 research paper
presented to the Philip Morris Board of Directors.142 The paper
stated that one of its objectives was to probe ``[w]hy do 70 million
Americans * * * smoke despite parental admonition, doctors'' warnings,
governmental taxes, and health agency propaganda?'' 143 The paper
continues:
There is general agreement on the answer to the first
[question--why does one begin to smoke.] The 16 to 20-year old
begins smoking for psychosocial reasons. The act of smoking is
symbolic; it signifies adulthood, he smokes to enhance his image in
the eyes of his peers.144
Cigarette manufacturers are also aware of the difficulties young
people encounter when they try to quit smoking. Studies prepared for a
Canadian affiliate of a U.S. cigarette company state:
However intriguing smoking was at 11, 12, or 13, by the age of
16 or 17 many regretted their use of cigarettes for health reasons
and because they feel unable to stop smoking when they want
to.145
[[Page 41332]]
Another document declares:
[T]he desire to quit seems to come earlier now than before, even
prior to the end of high school. In fact, it often seems to take
hold as soon as the recent starter admits to himself that he is
hooked on smoking. However, the desire to quit, and actually
carrying it out, are two quite different things, as the would-be
quitter soon learns.146
Thus, these documents and reports suggest that cigarette
manufacturers know that young people are vital to their markets and
that they need to develop advertising and other promotional activities
that appeal to young people. They also suggest that cigarette
manufacturers know that once those young people become regular smokers,
that they, like adult smokers, find quitting smoking to be very
difficult, and most young people fail in their attempts to quit.
4. Empirical Research on the Effects of Cigarette Advertising
Activities on Young People
The 1994 Surgeon General's Report concluded that ``[a] substantial
and growing body of scientific literature has reported on young
people's awareness of, and attitudes about, cigarette advertising and
promotional activities.'' The report also found that ``[c]onsidered
together, these studies offer a compelling argument for the mediated
relationship of cigarette advertising and adolescent smoking.''
147 The Surgeon General's Report and the Institute of Medicine's
report 148 find that there is sufficient evidence to conclude that
advertising and labeling play a significant and important contributory
role in a young person's decision to use cigarettes or smokeless
tobacco products.
a. Studies of advertising recall, approval of advertising, and
young people's response to advertising. Many studies have shown that
young people are aware of, respond favorably to, and are influenced by
cigarette advertising.149 Even relatively young children are aware
of cigarette advertisements and can recall salient portions. A recent
Gallup survey found that 87 percent of adolescents surveyed could
recall seeing one or more tobacco advertisements and that half could
identify the brand name associated with one of four popular cigarette
slogans.150 One study found that over 34 percent of 12- to 13-
year-old California children surveyed could name a brand of cigarettes
that was advertised, despite the fact that Federal law bans cigarette
and smokeless tobacco product advertising on both radio and television,
the usual medium of information for children and adolescents.151
Other studies show that children who smoke are more likely to
correctly identify cigarette advertisements and slogans in which the
product names have been removed than are non-smokers.152 One study
surveyed a group of U.S. high school students and found a positive
relationship between smoking level and cigarette advertisement
recognition. Regular smokers recognized 61.6 percent of the tobacco
advertisements while non-smokers recognized 33.2 percent.153
Another study measured cigarette advertising exposure among
adolescents by determining which magazines they read and the number of
cigarette advertisements in each magazine. The study found that two
factors, advertising exposure and whether a friend or friends smoked,
were predictive of smoking status or intention to smoke. The authors
contended that the findings are consistent with the theory that
cigarette advertising successfully represents, through attractive
imagery, that smoking is a facilitator for acquiring a desired
characteristic or goal.154
These studies raised the question of whether smoking causes a
person to recognize advertisements or whether a person's exposure to or
recognition of advertisements leads to smoking or increases the
likelihood that a person will smoke. One study designed specifically to
address this issue 155 showed that causality flowed in both
directions: experimentation with cigarettes prompted subjects to attend
to and retain information from cigarette advertisements (smoking status
determined whether the child attended to advertising) and the amount of
information retained by each subject from cigarette advertisements
predicted the subjects' experimentation with cigarettes
(causality).156
Another study attempted to address the issue of causality by
questioning Glasgow school children at two different times, 1 year
apart. The study asked 640 Glasgow children between the ages of 11 and
14 about their intention to smoke and their recognition of cigarette
advertising. Children who were more inclined to smoke between the time
when the two interviews were conducted tended to be more aware of
cigarette advertising at the first interview than children who were
less inclined to smoke. The study concluded that cigarette advertising
has predisposing, as well as reinforcing, effects on children's
attitudes towards smoking and their smoking intentions.157
Other studies relating children's misperceptions about the
prevalence of smoking to advertising exposure and smoking status have
found that overestimating smoking prevalence appears to be a very
strong predictor of smoking initiation and progression to regular
smoking.158 The 1994 Surgeon General's Report found that young
people overestimate the prevalence of cigarette smoking 159 and
that advertising's pervasiveness plays a role in this misconception.
One unpublished study cited in the Surgeon General's Report supports
this finding. The study found that children in Los Angeles (where
cigarette advertising and promotional campaigns are prevalent) were
nearly three times more likely to overestimate the prevalence of peer
smoking than were children in Helsinki, Finland (where there has been a
total ban on advertising since 1978).160 Moreover, adolescent
smokers are more likely to overestimate the prevalence than adolescent
non-smokers.161 Overestimating smoking prevalence, as well as
self-reported exposure to advertising, have both been positively
correlated with the intention to smoke.162
Additional evidence indicates that children smoke many fewer brands
than adults and that their choices, unlike adults, are directly related
to the amount and kind of advertising.163 CDC recently reported
that 86 percent of underage smokers who purchase their own cigarettes
purchase one of three brands: Marlboro (60 percent), Camel (13.3
percent) and Newport (12.7 percent).164 These three brands were
also the three most heavily advertised brands in 1993.165 While
Marlboro has long been the most popular brand among young people,
Camel's share of the youth market increased from around 3 percent to
13.3 percent as a result of the invigorated Joe Camel campaign.
Adult preferences, on the other hand, are more dispersed. The three
most commonly purchased brands among all smokers (as measured by market
share) accounted for only 35 percent of the overall market share.
(Camel had approximately 4 percent of the market and its market share
did not change as a result of the Joe Camel advertising.) Furthermore,
the most popular ``brand'' of cigarette among adult smokers was no
brand at all: 39 percent of all cigarettes sold in the first quarter of
1993 were from the ``price value market'' which includes private label,
generics, and plain-packaged products.166 These brands typically
rely on little or no advertising and little or no imagery on their
packaging.
These studies present evidence that advertising plays a significant
role in children's smoking behavior. There are, in addition, individual
case studies that
[[Page 41333]]
illustrate the profound effect that certain cigarette advertising
campaigns can have on the youth market.
b. The effect of selected advertising campaigns, which were
effective with children. Two American studies and one British study
analyzed alleged youth-oriented campaigns to determine what effect they
had on the underage market. One U.S. study examined the effect on the
youth market of R.J. Reynolds' advertising campaign for Camel brand
cigarettes. In the mid 1980's, R.J. Reynolds sought to revitalize its
Camel brand cigarettes. It gave its symbol, the Camel, a new, more hip
personality. It transformed the symbol into ``Joe Camel,'' an
anthropomorphic ``spokescamel.'' The campaign featured Joe as a
humorous figure in history, as an advisor to young adults with ``smooth
moves'' and eventually as one of a gang of hip camels (``the hard
pack'' band and the gang at the watering hole bar). The study analyzed
1990 data from the California Tobacco Survey which consisted of a
telephone survey of 24,296 adults and 5,040 children under the age of
18. The study found that teenagers were twice as likely as adults to
identify Camel cigarettes as one of the two most advertised
brands.\167\
One study explored the power of the Joe Camel campaign to penetrate
the youth market. The study found that children as young as 3 years old
could identify Joe Camel as a symbol for smoking. This recognition
ranged from 30 percent of 3 year olds, to 91 percent of 6 year olds. In
fact, the recognition rates for Joe Camel surpassed the rates for
certain children's products, cereals, computers, and network television
symbols.\168\ A similar study funded by R.J. Reynolds found that 72
percent of 6 year olds and 52 percent of children between the ages of 3
and 6 could identify Joe Camel. These rates exceeded the recognition
rates for Ronald McDonald, which were 62 percent of the 6 year olds and
51 percent of children between the ages of 3 and 6.\169\ The higher
recognition rates for Joe Camel are remarkable because, unlike Ronald
McDonald who appears in television commercials during children's
viewing hours, Federal law prohibits cigarette advertisements on
television.
Data collected by researchers for the State of California found
that in 1990, 23.1 percent of the under age 18 market in California
purchased Camel as their brand. This represented a 230 percent increase
over its pre-``Joe Camel'' 1986 rate. The same growth rate did not
occur for adults.\170\ Nationally, Camel had less than 3 percent of the
youth market before the brand was repositioned in 1988 and Joe Camel
was introduced.\171\ By 1989, Camel's share of the youth market had
risen to 8.1 percent,\172\ and by 1992, 13 to 16 percent.\173\ During
this same period, Camel's share of the adult market barely moved from
its 4 percent level.\174\
The other American study used data from the National Health
Interview Survey to study trends in smoking initiation among 10- to 20-
year-olds from 1944 through 1980. The study found that initiation rates
for 18- to 20-year-old women peaked in the early 1960's and steadily
declined thereafter. Initiation rates for girls under 18, however,
increased abruptly around 1967. This was the same period when brands
specifically intended for women were introduced and heavily advertised.
The initiation rate was particularly steep for women who did not attend
college. The initiation rate for girls under the age of 18 peaked in
1973--about the same time that sales for these brands (Virginia Slims,
Silva Thins, and Eve) peaked. Between 1967 and 1973, smoking initiation
rates increased around 110 percent for 12-year-old girls, 55 percent
for 13-year-olds, 70 percent for 14-year-olds, 75 percent for 15-year-
olds, 55 percent for 16-year- olds, and 35 percent for 17-year-
olds.\175\
In contrast, initiation rates for men declined from 1944 to 1949
and did not decline again until the middle to late 1960's. Initiation
rates for boys under 16 showed little change during the entire study
period. The study concluded that advertising for women's brands during
this period was positively associated with increased smoking uptake in
girls under 18 years of age.\176\
The British study looked at a campaign featuring a flippant and
humorous character named ``Reg.'' The study found that 91 percent of
11- to 15-year-olds recognized the ads, compared with 52 percent of 33-
to 55-year-olds. Teenagers who liked the advertisements were more
likely to smoke. In fact, it was one of the two brands that most
children smoked. During the period in which Reg was advertised, smoking
by 11- to 15-years-olds in northern England increased from 8 percent to
10 percent, but the rate for this same age group in southern England,
where the advertisements did not appear, remained stable at 7
percent.\177\ The government, pursuant to the industry's voluntary
code, later requested that the company discontinue the advertising
campaign because of its disproportionate appeal to children.
These studies provide compelling evidence that promotional
campaigns can be extremely effective with young people.
c. Direct quantitative studies. There are many direct quantitative
studies of the relationship between advertising and tobacco use and of
the effects of advertising restrictions and bans on consumption. These
studies provide insight into the effects of advertising on the general
appeal of and demand for cigarettes and smokeless tobacco products.
They also provide evidence confirming advertising's effects on
consumption and the effectiveness of advertising restrictions on
reducing youth smoking.
A large, multinational study commissioned by the New Zealand
Government examined consumption trends in 33 countries between 1970 and
1986.\178\ Controlling for income, price, and health education, the
study found that the greater a government's degree of control over
tobacco promotion, the greater the annual average fall in tobacco
consumption and in the rate of decrease of smoking among young
people.\179\ One of the report's most relevant conclusions was that,
among the 18 countries with data on youth smoking, there is evidence of
a relationship between stringent government restrictions on tobacco
promotion and reduced uptake of smoking among young people. The report
concluded that there appeared to be a greater decrease in smoking
uptake in those countries with the most stringent measures compared
with those countries where advertising had not been affected.\180\
Other studies that have looked at populations in general provide
evidence that restrictions can have an important effect on total
consumption and provide inferential evidence of similar positive
effects on youth smoking. One such study conducted by the Chief
Economic Advisor of the Department of Health of the Government of Great
Britain found that advertising tends to increase consumption of tobacco
products and that restrictions on advertising tend to decrease tobacco
use beyond what would have occurred in the absence of regulation.\181\
After performing an in-depth analysis of data from the four countries
(Norway, Finland, Canada, and New Zealand) which had varying degrees of
tobacco advertising restrictions and for which data exist, the study
concluded that restrictions, including bans on some forms of
advertising or on all advertising, resulted in an overall decrease in
consumption. The study suggests that Norway's restrictions on all
advertising, sponsorship, and indirect advertising produces a 9 to 16
percent reduction in consumption over the long run.\182\ Finland's ban
on advertising and
[[Page 41334]]
restrictions on other nonadvertising measures reduced cigarette smoking
by 6.7 percent.\183\
Canada's Tobacco Products Control Act, which became effective on
January 1, 1989, banned most print advertising, restricted sponsorship,
and forbade indirect advertising (e.g., use of trade names on non-
tobacco items). Although advertising restrictions often take time to be
fully effective, the study found that in only 2 years following the
institution of government regulation, consumption was reduced 2.8
percent more than would have been expected had there been no
advertising restrictions.\184\
Another study looked at tobacco consumption per adult in the 22
countries of the Organization for Economic Cooperation and Development
between 1960 and 1986.\185\ The report reaffirmed the New Zealand
Board's conclusion that, as a group, countries prohibiting tobacco
advertising in most or all media experienced more rapid percentage
falls in consumption than the group of countries which permitted
promotion.\186\
Other studies try to measure the effect that advertising has on the
general level of consumption in a country. Advertising can have an
increased effect on consumption, even in those countries where the
smoking rate has been falling. The analyses are able to determine
whether consumption would have fallen at a greater rate but for the
advertising, and ascribe that difference (the slowed rate of decline)
to advertising.
One New Zealand study provides evidence that changes in advertising
expenditures can have an effect on youth smoking behavior. The study
analyzed the total sales of cigarettes sold by New Zealand supermarkets
over a 42 week period. The study design included advertising that had
recently been modified to contain newly-mandated, strong, varied
disease warnings that occupied 15 percent of the advertisement.
Moreover, no human form could be displayed in the advertising except a
hand and forearm, and one color apart from black was usually used. The
results indicated that advertising for upscale brands of cigarettes did
not raise cigarette consumption, but that consumption of an inexpensive
brand with a heavy youth appeal did increase with increased
advertising. Moreover, the study found that the advertising for the
new, inexpensive brand had the additional effect of recruiting young
smokers and increasing the market base.\187\
Studies that assessed the response of large population groups to
changes in advertising generally confirm a finding that advertising has
a positive effect on consumption. The most recent comprehensive
analysis of existing studies on the effect of advertising expenditures
on consumption rates was done in the English study, discussed above.
Among other things, the study looked at the effect of yearly
fluctuations in advertising expenditures within several countries, but
principally within the United States and United Kingdom. The result was
that the ``preponderance of positive results points to the conclusion
that advertising does have a positive effect on consumption.'' \188\
Individual, smaller studies \189\ have examined the same question and
confirmed a finding of effect of advertising on consumption.\190\
5. Summary of Evidence
The agency concludes that the preponderance of quantitative and
qualitative studies of cigarette advertising suggests: (1) A causal
relationship between advertising and youth smoking behavior, and (2) a
positive effect of stringent advertising measures on smoking rates and
on youth smoking. Moreover, industry statements indicate the importance
of the youth market segment to the industry's continued success.
Actions taken by industry members to attract young smokers have also
resulted in attracting children and adolescents. Finally, examples of
specific campaigns directed at young people support the hypothesis that
cigarette advertising and promotion play an important role in
encouraging young people to start smoking, to sustain their smoking
habit, and to increase consumption. Therefore, the agency finds that
stringent restrictions on advertising are essential if smoking by
adolescents is to be reduced.
6. Proposed Subpart D--Labeling and Advertising
a. General overview. Proposed subpart D would establish regulations
on the labeling and advertising of cigarettes and smokeless tobacco
products. Proposed subpart D consists of four sections. Proposed
Sec. 897.30 would establish the scope of permissible forms of labeling
and advertising. Proposed Sec. 897.32 would set forth the format and
content requirements. Proposed Sec. 897.34(a) would prohibit the sale
and distribution of non-tobacco items and services that are identified
with a cigarette or smokeless tobacco product brand name or other
identifying characteristics; proposed Sec. 897.34(b) would prohibit
proof of purchase gifts and games of chance and contests; and
Sec. 897.34(c) would prohibit sponsorship of events that are identified
with a cigarette or smokeless tobacco product brand name or other
identifying characteristics. Proposed Sec. 897.36 would address false
and misleading labeling and advertising. These sections are discussed
more fully below.
The proposed rule would establish different labeling and
advertising requirements for cigarettes and smokeless tobacco products.
These differences result from different Federal preemption provisions
contained in the two Federal laws requiring warning labels on those
products. Briefly, FDA believes that the Cigarette Act only preempts
FDA's authority to require additional statements about smoking and
health on cigarette packages, while the Smokeless Act prohibits FDA
from requiring additional information about health and tobacco use in
advertising as well as on the package of smokeless tobacco products.
For a more complete discussion, see section IV.C. below.
b. Proposed Sec. 897.30--permissible forms of labeling and
advertising. Proposed Sec. 897.30 would set forth the permissible forms
of labeling and advertising for cigarettes and smokeless tobacco
products. Labeling and advertising are used throughout this subpart to
include all commercial uses of the brand name of a product (alone or in
conjunction with other words), logo, symbol, motto, selling message, or
any other indicia of product identification similar or identical to
that used for any brand of cigarette or smokeless tobacco product.
However, labeling and advertising would exclude package labels, which
would be covered under proposed subpart C. In brief, Sec. 897.30(a) of
the proposed rule would define permissible outlets for labeling and
advertising as newspapers, magazines, periodicals, billboards, posters,
placards, entries and teams in sponsored events, promotional materials,
audio and/or video formats, and delivered at the point of sale.
Proposed Sec. 897.30(b) would prohibit outdoor advertising of tobacco
products from appearing outside of buildings within 1,000 feet of an
elementary or secondary school or playground. These are places where
children and adolescents spend a great deal of time and should
therefore be free of advertising for these products. The agency
believes that this a reasonable restriction and notes that the
cigarette industry's voluntary ``Cigarette Advertising and Promotion
Code,'' revised in 1990, contains a similar
[[Page 41335]]
provision concerning schools and playgrounds.
These labeling and advertising requirements are an effort to
control the proliferation of promotional messages that attract young
people. As discussed above, advertising and promotion can play a
significant role in young people's smoking behavior. The agency finds
that restricting the permissible forms of media would help prevent
young people from starting to use cigarettes and smokeless tobacco
products and becoming addicted to those products. Proposed Sec. 897.30
(a) would describe the range of known labeling and advertising media
currently used by cigarette and smokeless tobacco product companies.
It is important to note that the proposal would not affect any
other limitations on labeling or advertising, such as the radio and
television advertising bans placed on cigarette and smokeless tobacco
product advertising (the Cigarette Act, 15 U.S.C. 1331, 1334 and the
Smokeless Act, 15 U.S.C. 4401, 4402(f)) nor any other actions taken by
Federal agencies (e.g., FTC's ``Regulations Under the Comprehensive
Smokeless Tobacco Health Education Act of 1986,'' 16 CFR Part 307
(1994)).
c. Proposed Sec. 897.32--format and content requirements for
labeling and advertising. Proposed Sec. 897.32 would describe the
format and content requirements for cigarette and smokeless tobacco
product labeling and advertising. This section would establish
requirements in three principal areas: text-only format, the product's
established name, and a brief statement of the risks of using
cigarettes.
i. Text-only advertising. The agency considered various options
available to control advertising's influence on young people, from a
full ban on all advertising and promotion, to restrictions on
advertising and promotional practices that children actually view.
FDA's proposed rule would address the need to eliminate advertising's
influence on young people and, at the same time, preserve advertising's
informative aspects--that is, to provide useful information to
consumers legally able to purchase these products. Therefore, the
agency agrees with the IOM's recommendation that advertising and
labeling should appear in text-only format because this format would
reduce the attraction and appeal that cigarette and smokeless tobacco
product advertising have for young people. Recognizing that it is
difficult to draw the line between advertising that should be
restricted or regulated and advertising that does not pose an
unreasonable risk of influencing young people, the agency requests
comment on the appropriateness of the proposed regulations and whether
other alternatives would be more appropriate or effective.
Under proposed Sec. 897.32(a), cigarette and smokeless tobacco
product labeling and advertising, as described in Sec. 897.30 (a), and
(b), would be required to use black text on a white background and
nothing else. This text-only requirement is intended to reduce the
appeal of cigarette and smokeless tobacco product labeling and
advertising to persons younger than 18 without affecting the
informational message conveyed to adults.
However, FDA believes that advertising in publications that are
read primarily by adults should be allowed to use imagery and color
because the effect of such advertising on young people would be
nominal. Therefore, advertisements in publications with primarily adult
readership would not be restricted to a text-only format. The agency
proposes to define such publications as those: (a) Whose readers age 18
or older constitute 85 percent or more of the publication's total
readership, or (b) that is read by two million or fewer people under
age 18, whichever method results in the lower number of young people.
The readership of a publication is the total number of people that read
any given copy of that publication. It should be measured according to
industry standards and at a minimum by asking a nationally projectable
survey of people what publications they read or looked at during any
given time. A reader is one who said that he/she read the last issue of
a publication. Prior to disseminating advertising containing images and
colors, it would be the company's obligation to establish that the
publication meets the criteria for a primarily adult readership.
The concept of text-only advertising requirements is not new. The
cigarette industry has employed text-only advertisements in the past,
particularly when it sought to inform or educate consumers about
company policies or important issues. See, e.g., ``In the Matter of
R.J. Reynolds Tobacco Co.,'' 111 F.T.C. 539 (D. 9206) (1988) (a text-
only advertisement that disputed that cigarette smoking was related to
coronary heart disease); ``Washington Post,'' October 18, 1994, at p.
A11; ``Washington Post,'' October 20, 1994, at p. A17; ``Time,''
144(19): 42(1994) (Philip Morris text-only advertisement which
discussed environmental tobacco smoke); ``Tobacco Control and
Marketing: Hearings Before the Subcommittee on Health and the
Environment of the House Committee on Energy and Commerce,'' R.J.
Reynolds, to the Honorable Edolphus Towns (Reynolds' text-only
advertisement about youth smoking).
Several studies show how strongly images appeal to young people.
Photographs, pictures, cartoons, and other graphics allow the
advertiser to encode its sales message in a way that makes the
advertisement more compelling and memorable.\191\ Imagery ties the
products to a positive visual image that can be used consistently in
all advertising media as well as on the product package itself.\192\
Adding visual images to a text advertisement can produce greater
recall and a more positive product rating.\193\ Not surprisingly,
studies have shown that children and adolescents react more positively
to advertising with pictures and other depictions than to advertising
(or packaging) that contains only print or text.\194\
One study examined 243 seventh and eighth grade students in Chicago
to determine the appeal (likability) of different types of cigarette
advertising. The study compared a Joe Camel advertisement, an
advertisement with a model, and a text-only advertisement. The results
indicated that adolescents found advertisements containing pictures and
cartoons to be significantly more appealing than advertisements with
human models; advertisements with any imagery were more appealing than
text-only advertisements. These results are particularly compelling
because a study by the Advertising Research Foundation found that an
advertisement's ``likability'' is the best predictor of product
sales.\195\
In arriving at its proposal, FDA considered other options,
including banning all advertising or restricting the type of imagery
used.\196\ FDA believes that the evidence detailed above would justify
a ban on all or most advertising and promotion of tobacco products. The
studies cited and industry statements and actions already discussed in
this proposal indicate the positive effect that advertising can have on
young people's smoking behavior, while other studies establish that
bans on cigarette advertising can help reduce overall consumption and
youth initiation. Given the extremely grave health consequences of a
lifetime of smoking, actions taken that would help achieve a lower
initiation rate among young people would be authorized as a matter of
law and justified as a matter of public health policy.
Moreover, young people are currently exposed to billions of dollars
worth of tobacco advertising and promotion that
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use attractive imagery and do not rely on objective product claims. The
industry's claims that this advertising exists solely to maintain brand
loyalty or induce smokers to switch. However, as noted previously,
tobacco advertising and promotion appear to have a more profound effect
on brand choices by young people (86 percent of young people smoke the
three most advertised brands) than on adults, whose choice is more
often based on price (39 percent of the market is comprised of generic
and discount products.) Furthermore, brand loyalty runs higher for
cigarettes than for any other product. Thus, significant expenditures
would not appear to be necessary to retain loyal consumers and would
appear to be excessive and wasteful if they are expended merely to get
people to switch brands.
While a total ban on advertising, therefore, would likely be
justified, FDA believes that limiting advertisements and labeling to
which children are exposed to a text-only format is less burdensome and
would effectively reduce the appeal of tobacco products to children and
adolescents. Further, while some have suggested prohibiting only youth-
oriented images, the agency has been unable to define the subset of
advertising and labeling directed to young people based upon the media
selected or the location of the advertising. For example, billboards
are always visible to young people, and there are few, if any,
publications that children and adolescents cannot see. Thus, the
proposed text-only requirement would offer the most protection for
children and adolescents while still enabling informative advertising
to reach persons aged 18 and older. Given the complexities of this
subject, however, FDA invites comment on other potential methods that
may exist for curtailing advertising's appeal to young people.
ii. Non-tobacco items and sponsorship. Proposed Sec. 897.34(a)
would prohibit the sale or distribution of all non-tobacco items that
are identified with a cigarette or smokeless tobacco product brand name
or other identifying characteristic. As noted above, advertising
expenditures have risen dramatically in the past two decades, and the
distribution of the marketing expenditures represents a major shift in
marketing trends. In 1970, the amounts spent on traditional advertising
represented 82 percent of total spending, but, by 1991, this figure had
fallen to approximately 17 percent.\197\ The remaining funds devoted to
marketing cigarettes are spent on a variety of promotional activities
designed to assure advantageous placement of products in retail
outlets, get products into a prospective consumer's hand through the
use of coupons and samples, and provide gifts, contests, and other non-
tobacco items and gifts to create special appeal and reduce real
price.\198\
Proposed Sec. 897.34(a) would pertain to non-tobacco items and
services (other than cigarettes or smokeless tobacco products) that the
tobacco companies market, license, distribute, or sell. Manufacturers
often provide branded, non-tobacco items as an inducement to purchase
cigarettes or generate purchases through the use of proof-of-purchase
coupons. Both R.J. Reynolds and Philip Morris utilize this popular
technique by providing either a coupon with each package (Camel cash)
or indicating that each package was worth a number of credits towards a
purchase (Marlboro miles). Each company also printed glossy catalogues
with items and gifts that could be purchased using ``cash'' or credits.
Either method creates an incentive to purchase the tobacco product by
reducing the product's real price; the consumer gets the product and
the non-tobacco ``gift.''
The IOM found that this form of advertising is particularly
effective with young people.\199\ Young people have relatively little
disposable income, so promotions are appealing because they represent a
means of ``getting something for nothing.'' In many cases, the items--
tee shirts, caps, and sporting goods--are particularly attractive to
young people. Some items, when used or worn by young people, also
create a new advertising medium--the ``walking billboard''--which can
come into schools or other locations where advertising is usually
prohibited. A 1992 Gallup survey found that about half of adolescent
smokers and one quarter of non-smokers owned at least one of these
items.\200\ Similar data were reported for a group of ninth graders
from New York State. Among these ninth-graders, 48 percent of
occasional smokers and 28 percent of non-smokers reported owning
branded clothing.\201\
A recent report found that tobacco companies spent $600 million on
programs that provide promotional items in exchange for proofs-of-
purchase (usually by catalogue). Although the tobacco industry states
that these items are meant for individuals over the age of 20, many
teens report participating in promotional activities, with
participation ranging from 25.6 percent of 12- to 13-year-olds and 42.7
percent of 16- to 17-year-olds owning a promotional item. The report
found that 68.2 percent of current smokers participated, and 28.4
percent of non-smokers participated. The report concluded that there is
an association between participating in promotions and a person's
susceptibility to tobacco use. It also noted that participation in
promotions has the same ability to predict susceptibility to tobacco
use as does use by a household member.\202\ These proposed provisions
would eliminate these items and therefore would prevent young people
from wearing such items and becoming ``walking advertisements.'' \203\
Proposed Sec. 897.34(b) would prohibit all proof of purchase sales
or gifts of non-tobacco items as well as all contests, lotteries, or
games of chance that are linked to the purchase of, or in consideration
for the purchase of a tobacco product. Because contests and lotteries
are usually conducted through the mail, the agency has not been able to
devise regulations that would reduce a young person's access to
contests or lotteries.
Proposed 897.34(c) would also prohibit a sponsored event from being
identified with a cigarette or smokeless tobacco product brand name or
any other brand identifying characteristic. Entries and teams in
sponsored events are to be treated as labeling under Sec. 897.30 and
Sec. 897.32 and would be required to be in text-only, black and white
format. Any other athletic, musical, artistic, or other social or
cultural event would be permitted to be sponsored in the name of the
tobacco company. However, the event would not be permitted to include
any brand name (alone or in conjunction with any other words), logo,
symbols, motto, selling message, or any other indicia of product
identification similar or identical to those used for any brand of
cigarettes or smokeless tobacco products. The corporation in whose name
the sponsorship would be permitted, would be required to have been in
existence on January 1, 1995. This latter provision is intended to
prevent manufacturers from circumventing this restriction by
incorporating separately each brand that they manufacture for use in
sponsorship.
Sponsorship by cigarette and smokeless tobacco companies associates
tobacco use with exciting, glamorous, or fun events, such as car racing
and rodeos. It provides an opportunity for what sponsorship experts
call ``embedded advertising''\204\ that actively creates a ``friendly
familiarity'' between tobacco and sports enthusiasts, many of whom are
children and adolescents. Those watching a sponsored event, including
children and adolescents, repeatedly see the sponsor's brand or
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corporate name linked with an event they enjoy. For example, sponsoring
a race car, motorcycle, or boat enables manufacturers to place
cigarette brand names and logos on the vehicles and drivers' uniforms;
by sponsoring the event itself, the manufacturers may also place
cigarette brand names and logos on the event and on official's
clothing.
IEG, the leading source in the United States for sponsorship
information and consulting services, is also the only company that
tracks and analyzes sponsorship of sporting and other events and
causes. It publishes the IEG Sponsorship Report, an international
biweekly newsletter on sponsorship, as well as an industry report
titled, ``IEG's Complete Guide to Sponsorship: Everything you need to
know about sports, arts, event, entertainment and cause
marketing.''\205\ In this primer for companies considering sponsorship,
it defines sponsorship as ``a cash and/or in-kind fee paid to a
property (typically in sports, arts, entertainment, or causes) in
return for access to the exploitable commercial potential associated
with that property.''\206\ According to the IEG, ``[s]ponsorship, the
fastest growing form of marketing, is unregulated in the U.S.''\207\ In
North America, total sponsorship grew from $850 million in 1985 to more
than $4.2 billion in 1994 and is done by thousands of companies.\208\
The IEG further notes that for the cost of a 30-second spot on the
Super Bowl telecast, a company can sponsor a NASCAR Winston Cup car and
receive more than 30 hours of television coverage.\209\
The report states that companies can link sponsorship directly to
product usage or sales.\210\ The Chairman and CEO of R.J. Reynolds
summed up the underlying purpose of sponsorship for his company by
saying, ``We made it clear from the day we announced our sponsorship of
the Grand National Division that we were in the business of selling
cigarettes, not the racing business.''\211\
The cigarette \212\ and smokeless tobacco industry \213\ has been
involved in sponsorships for many years and was at one time one of the
dominant sponsors of events. More recently other industries have become
increasingly involved in sponsoring events and causes and today the
packaged goods, retail, and financial service industries are the
leading sponsors of events. Although the tobacco industry accounts for
only 4 percent of all sponsored events,\214\ FDA has concluded that
sponsored events are a significant part of the successful marketing of
tobacco products and that sponsorship should be regulated under this
proposal.
Companies often choose to sponsor events in order to heighten their
visibility, shape consumer attitudes, communicate commitment to a
particular lifestyle, and to drive sales.\215\ The IEG reports that
sponsorship offers several advantages over traditional advertising.
According to the IEG, sponsorship is generally more effective in
``establishing qualitative attributes, such as shaping consumers' image
of a brand, increasing favorability ratings and generating
awareness.''\216\ IEG also states that companies with huge advertising
budgets and high consumer awareness (such as tobacco companies), ``are
looking to the event to have a rub-off effect on their image and
ultimately their sales.''\217\ One marketing executive of a company
that sponsors professional beach volleyball said, ``Consumer attitudes
are the hardest thing to change * * * the more our brand is part of
events that are part of a consumer's lifestyle, the more we can affect
his or her attitude toward the product.''\218\
Image compatibility is listed by IEG as the number one factor in
determining which events to sponsor. IEG encourages companies to
consider whether the event offers the imagery it is trying to establish
and whether it depicts a lifestyle with which the company wants to be
associated.\219\ A senior Philip Morris executive explained how the
sponsorship of racing car events by Marlboro is consistent with the
cowboy imagery associated with Marlboro: ``We perceive Formula One and
Indy car racing as adding, if you will, a modern-day dimension to the
Marlboro Man. The image of Marlboro is very rugged, individualistic,
heroic. And so is this style of auto racing. From an image standpoint,
the fit is good.''\220\
The tobacco industry's sponsorship of events also can lead to
associations (often referred to as ``tie-ins'') with youth-oriented
items that extend the imagery. A sponsored event ``can bring
excitement, color, and uniqueness to a [point-of-purchase] display and
can be merchandised weeks or months in advance.''