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

> Briefs, arguments, decisions, and more.

URL: https://www.frixlaw.com/law-library/documents/fr%3A95-20051

## Record

- **Collection:** Federal Register
- **Document type:** Proposed Rule
- **Published:** August 11, 1995
- **Citation:** 60 FR 41314

## Text

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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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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87. 1989 SGR, p. 73.
88 DiFranza, J.R., and R.A. Lew, ``Effect of Maternal Cigarette
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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
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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 symbo

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A95-20051. Public record. Not legal advice.