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

SUMMARY: The Food and Drug Administration (FDA) is proposing new

regulations governing the sale and distribution of nicotine-containing

cigarettes and smokeless tobacco products to children and adolescents

in order to address the serious public health problems caused by the

use of and addiction to these products. The proposed rule would reduce

children's and adolescents' easy access to cigarettes and smokeless

tobacco as well as significantly decrease the amount of positive

imagery that makes these products so appealing to them. The proposed

rule would not restrict the use of tobacco products by adults.

Specifically, the proposed rule would establish 18 years of age as

the Federal minimum age of purchase and would prohibit cigarette

vending machines, free samples, mail-order sales, and self-service

displays. It would also require that retailers comply with certain

conditions regarding sales of tobacco, especially verification that the

purchaser is at least 18 years of age before a tobacco sale is made.

Finally, the proposed rule would limit advertising and labeling to

which children and adolescents are exposed to a text-only format; ban

the sale or distribution of branded non-tobacco items such as hats and

tee shirts; restrict sponsorship of events to the corporate name only;

and require manufacturers to establish and maintain a national public

education campaign aimed at children and adolescents to counter the

pervasive imagery and reduce the appeal created by decades of pro-

tobacco messages and thus to help reduce young people's use of tobacco

products.

The objective of the proposed rule is to meet the goal of the

report ``Healthy People 2000'' by reducing roughly by half children's

and adolescents' use of tobacco products. If this objective is not met

within seven years of the date of publication of the final rule, the

agency will take additional measures to help achieve the reduction in

the use of tobacco products by young people. FDA is requesting comment

regarding the type of additional measures that would be most effective.

DATES: Written comments and recommendations by November 9, 1995.

ADDRESSES: Submit written comments and recommendations to the Dockets

Management Branch (HFA-305), Food and Drug Administration, rm. 1-23,

12420 Parklawn Dr., Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Philip Chao, Office of Policy (HF-23),

Food and Drug Administration, 5600 Fishers Lane, Rockville, MD, 20857,

301-827-3380.

SUPPLEMENTARY INFORMATION:

I. Introduction

Approximately 50 million Americans currently smoke cigarettes and

another 6 million use smokeless tobacco products.1 These tobacco

products are responsible for more than 400,000 deaths each year due to

cancer, respiratory illnesses, heart disease, and other health

problems.2 Cigarettes kill more Americans each year than acquired

immune deficiency syndrome (AIDS), alcohol, car accidents, murders,

suicides, illegal drugs, and fires combined.3 On average, smokers

who die from a disease caused by smoking lose 12 to 15 years of life

because of tobacco use.4

In a separate document,5 FDA is addressing the issue of its

jurisdiction over nicotine-containing cigarettes and smokeless tobacco

products. The results of an extensive investigation and comprehensive

legal analysis support a finding at this time that the nicotine in

these products is a drug and that these products are nicotine-delivery

devices within the meaning of the Federal Food, Drug, and Cosmetic Act

(the act). FDA proposes to regulate cigarettes and smokeless tobacco

products by employing its restricted device authority, which affords

the most appropriate and flexible mechanism for regulating the sale,

distribution, and use of these products.

The primary objective of the proposed rule is to reduce the death

and disease caused by tobacco products. Rather than banning tobacco

products for the millions of Americans who are currently addicted to

them, this regulation focuses on preventing future generations from

developing an addiction to nicotine-containing tobacco products. In

addition, the scientific evidence strongly suggests that nicotine

addiction begins when most tobacco users are teenagers or younger and,

thus, is a pediatric disease. Therefore, reducing the number of young

people who regularly start to use tobacco products will help to prevent

future generations of individuals from becoming addicted to nicotine.

The goal of the proposed rule is to help the country achieve one of

the objectives of ``Healthy People 2000,'' which is to reduce the

number of children and adolescents who use tobacco products by roughly

one half by the year 2000. The agency has modified the goal to include

a different measurement tool and established 7 years after publication

of the final rule as the goal's endpoint. ``Healthy People 2000''

discussed national health promotion and disease prevention objectives

in this country. It was facilitated by the Institute of Medicine of the

National Academy of Sciences, with the help of the U.S. Public Health

Service, and included almost 300 national membership organizations and

all State health departments.6

To determine the most appropriate regulatory measures, the agency

reviewed the current patterns of use of tobacco products. According to

the 1994 Surgeon General's Report, ``Preventing Tobacco Use Among Young

People: A Report of the Surgeon General'' (the 1994 Surgeon General's

Report), more than 3 million American adolescents currently smoke

cigarettes and an additional 1 million adolescent males use smokeless

tobacco.7 Every day, another 3,000 young people become regular

smokers.8 U.S. data suggest that anyone who does not begin smoking

in childhood or adolescence is unlikely to ever begin.9 Eighty-two

percent of adults who ever smoked had their first cigarette before age

18, and more than half of them had already become regular smokers by

that age.10 Moreover, the younger one begins to smoke, the more

likely one is to become a heavy smoker.11

Many young tobacco users become addicted to nicotine, a chemical

substance in tobacco. Although they believe that they will not become

addicted to nicotine or become long-term users of tobacco products,

they often find themselves unable to quit smoking.12 In fact,

among smokers aged 12-17 years, 70 percent already regret their

decision to smoke and 66 percent state that they want to quit.13

Those who are able to quit experience relapse rates and withdrawal

symptoms similar to those reported in adults.14

Long-term addiction to nicotine can result in serious chronic

diseases and premature death. An adolescent whose cigarette use

continues into adulthood increases his or her risk of dying from

[[Page 41315]]

cancer, cardiovascular disease, or lung disease.15 In addition,

smokeless tobacco use has been linked to oral cancer and other adverse

effects.16

Although most segments of the American adult population have

decreased their use of cigarettes, the prevalence of smoking by young

people has failed to decline for more than a decade. Recently, smoking

among young people has begun to rise.17 Between 1991 and 1994, the

prevalence of smoking by eighth graders increased 30 percent, from 14.3

percent to 18.6 percent. Among 10th grade students, it increased from

20.8 percent to 25.4 percent and for 12th grade students, it rose from

28.3 percent to 31.2 percent.18 Between 1985 and 1994, smoking

among college freshmen increased from 9 percent to 12.5 percent.19

Millions of American children and adolescents can easily buy or

obtain cigarettes and smokeless tobacco products. The large number of

young people who use these products is especially noteworthy because

all States prohibit the sale of tobacco products to persons under the

age of 18, and a few States prohibit cigarette sales to persons under

the ages of 19 or 21.20 These State laws, however, are rarely

enforced. It is estimated that each year children and adolescents

consume between 516 million and 947 million cigarette packages and 26

million containers of smokeless tobacco products.21

In addition to easy access to tobacco products, advertising and

promotional activities can influence a young person's decision to smoke

or use smokeless tobacco products. Tobacco products are among the most

heavily advertised products in the United States.22 In 1993, the

tobacco industry spent a total of $6.2 billion on the advertising,

promotion, and marketing of cigarettes and smokeless tobacco. Of that

number, 31 percent ($1.9 billion) was spent on advertising and

promotional activities; 26 percent ($1.6 billion) was given to

retailers in the form of cash allowances or retailer items to

facilitate and enhance the sale of tobacco products, and finally, 43

percent ($2.6 billion) was in the form of financial incentives (e.g.

coupons, cents off, buy one/get one free, free samples) to

consumers.23

Tobacco product brand names, logos, and advertising messages are

pervasive, appearing on billboards, on buses and trains, in magazines

and newspapers, and on clothing and other goods. These ubiquitous

images and messages convey to young people that tobacco use is

desirable, socially acceptable, safe, healthy, and prevalent in

society. One study found that 30 percent of 3 years olds and 91 percent

of six year olds associate the ``Joe Camel'' cartoon figure with

cigarettes.24 Studies also show that most young people buy the

most heavily advertised cigarette brands, whereas many adults buy

generic or ``value category'' cigarette brands, which have little or no

image advertising.25

In proposing this regulation, FDA examined many domestic and

foreign tobacco control statutes, regulations, and legislation, as well

as numerous studies and reports. FDA also reviewed recommendations from

various public health organizations, including the World Health

Organization, the Office of the Surgeon General, the Centers for

Disease Control and Prevention (CDC), the National Cancer Institute

(NCI), and the Institute of Medicine (IOM). Two reports, the 1994

Surgeon General Report and the 1994 IOM Report ``Growing Up Tobacco

Free: Preventing Nicotine Addiction in Children and Youths,'' were

especially helpful and informative.

The agency has examined many options for reducing tobacco use by

children and adolescents, and believes that an effective program must

address the following two areas: (1) Restrictions on cigarette and

smokeless tobacco sales that will make these products less accessible

to young people; and (2) restrictions on labeling and advertising to

help reduce the appeal of tobacco products to young people along with

requirements for a manufacturer- funded national education campaign

aimed at those under 18 years of age to help reduce the products'

appeal to these young people. A brief description of the major

provisions of the proposed rule follows.

A. Sale and Distribution

The proposed rule would restrict the sale of cigarettes and

smokeless tobacco products to individuals age 18 and older. This age

restriction is based on the fact that most adult smokers became regular

smokers before age 18.

The proposed rule would require retailers to verify the age of

persons who wish to buy cigarettes or smokeless tobacco products and

would eliminate ``impersonal'' methods of sale that do not readily

allow age verification, such as mail orders, self-service displays, and

vending machines.

The proposed rule would make each manufacturer, distributor, and

retailer of tobacco products responsible for complying with the

proposed restrictions. Manufacturers would be required to remove all

manufacturer-supplied or manufacturer-owned self-service displays,

advertising, labeling, and other items that do not conform to the

requirements in the proposed rule.

The proposed rule would prohibit the distribution of free samples

and would allow the exchange of coupons and other non-cash certificates

only by individuals 18 or older and only in face-to-face transactions.

Currently, young people, including children in elementary school, are

often able to obtain free samples despite industry-imposed age

restrictions on such distributions.

The proposed rule would also prohibit the sale of single cigarettes

(``loosies'') and ``kiddie packs (less than 20 to a pack) which, due to

their relatively low price and easy concealment, have been shown to be

particularly appealing to children and adolescents.

Further, the proposed rule would prohibit manufacturers from using

a trade name or brand name of a non-tobacco product for a cigarette or

smokeless tobacco product. This will prevent a manufacturer from

transferring the images, good will, and appeal of a popular non-tobacco

product to a tobacco product.

B. Labeling, Advertising and Educational Programs

Advertising that reaches children would be in black and white,

text-only format. Studies indicate that children and adolescents are

very receptive to images and cartoons and less attentive to texts.

However, the proposed rule would not affect advertising in publications

with primarily adult readership--imagery and color would continue to be

permitted in such publications. Finally, outdoor advertising of tobacco

products located within 1,000 feet of schools and playgrounds would be

banned. Consequently, the proposed rule would help reduce the appeal of

advertising to children and adolescents without affecting informational

messages conveyed to adults.

The proposed rule would prohibit the sale or distribution of brand

identifiable non- tobacco items and services, proof-of-purchase sales,

games and contests, and sponsorship of events in the brand name, as

well as advertising for these items, services, and events.

The proposed rule would require manufacturers to establish and

maintain a national educational campaign in order to counter the

pervasive imagery and reduce the appeal created by decades of pro-

tobacco messages and, thus, help reduce young people's use of tobacco

products. Evidence exists that mass media antismoking campaigns

conducted nationally between 1967 and 1970, and more recently, in

Vermont and California, have had a sustained

[[Page 41316]]

effect on preventing teens from starting to smoke and on significantly

reducing per capita cigarette consumption.

C. Healthy People 2000 Objective

Seven years after publication of the final rule, the agency would

determine whether additional restrictions on tobacco products are

required by using outcome-based objectives modeled on the ``Healthy

People 2000'' report. One of the goals for tobacco use established by

that report is to reduce by roughly one half the percentage of young

people using tobacco products by the year 2000. If this objective is

not met within the time specified by the rule, FDA would take

additional measures to help achieve the reduction in young people's use

of tobacco products. The proposed rule requests comment on which

additional measures should be adopted.

The agency intends to adopt one or more additional provisions only

if the continued use of cigarettes and smokeless tobacco products by

children and adolescents indicates that the goal of reducing tobacco

use by young people by roughly half had not been met.

The remainder of this discussion of the proposed rule (hereinafter

``preamble'') is organized as follows: Chapter II examines the use of

cigarettes and smokeless tobacco products by children and adolescents,

and the health consequences of using nicotine- containing tobacco

products; Chapter III describes the provisions of the proposed rule and

provides the rationale for each of the requirements; Chapter IV reviews

the legal authority for these specific requirements, and Chapters V

through VIII provide analyses required by the Paperwork Reduction Act

of 1980, various Executive Orders, as well as provides analyses of

various economic and environmental impacts.

References

1. Substance Abuse and Mental Health Services Administration,

``National Household Survey on Drug Abuse: Population Estimate

1993,'' Rockville, MD: Department of Health and Human Services,

Public Health Service, Substances Abuse and Mental Health Services

Administration, Office of Applied Studies, DHHS Pub. No. (SMA) 94-

3017, 1994, pp. 89, 95; ``Cigarette Smoking Among Adults--United

States, 1993,'' in ``Morbidity and Mortality Weekly Report (MMWR),''

CDC, Department of Health and Human Services (DHHS), vol. 43, No.

50, pp. 925-930, 1994; ``Use of Smokeless Tobacco Among Adults--

United States, 1991,'' in ``MMWR,'' CDC, DDS, vol. 42, pp. 263-266,

1993; Unpublished data from the 1992 Youth Risk Behavior Survey,

National Health Interview Supplement, CDC.

2. ``Cigarette Smoking--Attributable Mortality and Years of

Potential Life Lost--United States, 1990,'' in ``MMWR,'' CDC, DHHS,

vol. 42, no. 33, pp. 645-649 (1993).

3. IOM, p. 3. Collectively, AIDS, alcohol, car accidents,

murders, suicides, illegal drugs and fire combined cause nearly

251,000 deaths a year.

4. ``Cigarette Smoking--Attributable Mortality and Years of

Potential Life Lost--United States, 1990, in ``MMWR,'' CDC, DHHS,

vol. 42, no. 33, pp. 645-649, 1993; Peto, R., et al., ``Mortality

from Tobacco in Developed Countries: Indirect Estimation from

National Vital Statistics,'' The Lancet, vol. 339, pp. 1268-1278,

1992.

5. ``Nicotine In Cigarettes and Smokeless Tobacco Products is a

Drug and These Products are Nicotine-Delivery Devices Under the

Federal Food, Drug, and Cosmetic Act,'' FDA, DHHS, August, 1995.

6. DHHS, ``Healthy People 2000, ``U.S. Department of Health and

Human Services, Public Health Service, Intro. pp. 1-8, September

1990.

7. DHHS, ``Preventing Tobacco Use Among Young People: A Report

of the Surgeon General,'' Atlanta, Georgia: DHHS, PHS, CDC, NCCDPHP,

OSH, 1994 pp. 5 (hereinafter cited as ``1994 SGR'').

8. IOM Report p. 8.

9. 1994 SGR, pp. 5, 58, 65-67.

10. 1994 SGR, p. 65.

11. Taioli, E., E.L. Wynder, ``Effect of the Age at Which

Smoking Begins on Frequency of Smoking in Adulthood,'' The New

England Journal of Medicine, vol. 325, No. 13 pp. 968-969, 1991; and

L.G. Escobedo, et al., ``Sports Participation, Age of Smoking

Initiation, and the Risk of Smoking Among U.S. High School

Students,'' Journal of the American Medical Association, vol. 269,

No. 11, pp. 1391-1395, 1993.

12. IOM Report, pp. 51-52.

13. The George H. Gallup International Institute. ``Teenage

Attitudes and Behavior Concerning Tobacco,'' at p. 54, September

1992.

14. Reasons for Tobacco Use and Symptoms of Nicotine Withdrawal

Among Adolescent and Young Adult Tobacco Users--United States,

1993,'' in ``Morbidity and Mortality Weekly Report,'' CDC, DHHS,

vol. 43, No. 41, pp. 745-750, 1994; 1994 SGR, p. 78.

15. McGinnis, J.M., and W.H. Foege, ``Actual Causes of Death in

the United States,'' Journal of the American Medical Association,

vol. 270, No. 18, pp. 2207-2212, 1993; see generally DHHS,

``Reducing the Health Consequences of Smoking: 25 Years of Progress,

A Report of the Surgeon General.'' DHHS, PHS, CDC, NCCDPHP, OSH.

DHHS Publication No. (CDC) 89-8411, p. 5, 1989 (hereinafter cited as

``1989 SGR''); DHHS, ``The Health Consequences of Smoking Chronic

Obstructive Lung Disease: A Report of the Surgeon General, ``DHHS,

PHS, OSH, 1984 (hereinafter cited as ``1984 SGR''); DHHS, ``The

Health Consequences of Smoking: Cardiovascular Disease, A Report of

the Surgeon General,'' Public Health Service, OSH, DHHS, p. 76,

1983; DHHS, ``The Health Consequences of Smoking--Cancer--A Report

of the Surgeon General,'' DHHS, PHS, OSH, p. 8, 1982 (hereinafter

cited as ``1982 SGR'').

16. 1994 SGR, p. 39; DHHS, ``The Health Consequences of Using

Smokeless Tobacco: A Report of the Advisory Committee to the Surgeon

General,'' p. 32-47, Bethesda, Md., DHHS, PHS, NIH Publication No.

86-2874, April, 1986 (hereinafter cited as ``1986 SGR'').

17. ``Cigarette Smoking Among Adults--United States 1991, ``in

``MMWR,'' CDC, DHHS, Vol. 42, no. 12, pp. 230-233, 1993; Johnston,

L.D., P.M. O'Malley, and J.G. Bachman, ``National Survey Results on

Drug Use from The Monitoring the Future Study, 1975-1993, Volume I:

Secondary School Students,'' Rockville, MD: U.S. Department of

Health and Human Services, Public Health Service, National Institute

of Health, National Institute on Drug Abuse, NIH Pub. No. 94-3809,

pp. 9, 19, 1994; The University of Michigan, News and Information

Service, July 20, 1995, ``Smoking rates climb among American

teenagers, who find smoking increasingly acceptable and seriously

underestimate the risks.'' Table 1.

18. Johnston, L.D., P.M. O'Malley, and J.G. Bachman, ``National

Survey Results on Drug Use from the Monitoring the Future Study,

1975-1993, Volume I: Secondary School Students,'' Rockville, MD:

U.S. Department of Health and Human Services, Public Health Service,

National Institute of Health, National Institute on Drug Abuse, NIH

Pub. No. 94-3809, 1994; The University of Michigan, News and

Information Service, July 20, 1995, ``Smoking rates climb among

American teenagers, who find smoking increasingly acceptable and

seriously underestimate the risks.'' Table 1.

19. ``Washington Post,'' January 9, 1995, at p. A5, col. 3

(describing findings from a survey of approximately 238,000 freshman

conducted by the UCLA Higher Education Research Institute) and UCLA,

Health Education Research Institute, ``The American Freshman:

National Norms for Fall 1994.

20. Coalition on Smoking OR Health, ``State Legislated Actions

on Tobacco Issues,'' at Appendix G, 1993.

21. DiFranza, J.R., and J.B. Tye, ``Who Profits From Tobacco

Sales to Children?'' Journal of the American Medical Association,

vol. 263, No. 20, pp. 2784-2787, 1990; Cummings, K.M., T. Pechacek,

and D. Shopland, ``The Illegal Sale of Cigarettes to U.S. Minors:

Estimates by State,'' American Journal of Public Health, vol. 84,

No. 2, pp. 300-302, 1994 (conservative estimates of cigarette use by

teenagers in 1991 have teenagers smoking 516 million packs of

cigarettes and spending $962 million (of which the industry gained a

profit of $190 million); an estimated 255 million packs were sold

illegally to minors).

22. 1994 SGR, p. 160.

23. Federal Trade Commission, ``Report to Congress for 1993,

Pursuant to the Federal Cigarette Labeling and Advertising Act,''

Table 3D (1995) and Federal Trade Commission, ``Report to Congress,

Pursuant to the Comprehensive Smokeless Tobacco Health Education Act

of 1986,'' Table 4D (1995).

24. Pierce, J.P., et al., ``Does Tobacco Advertising Target

Young People to Start Smoking? Evidence from California,'' Journal

of the American Medical Association, vol. 266, No. 22, pp. 3154-

3158, 1991; See also Fischer, P.M. et al., ``Brand Logo Recognition

[[Page 41317]]

by Children Aged 3 to 6 Years, Mickey Mouse and Old Joe Camel,''

Journal of the American Medical Association, vol. 266, No. 22, pp.

3145-3148, 1991.

25. ``Changes in Cigarette Brand Preference of Adolescent

Smokers, United States, 1989-1993,'' in ``MMWR,'' DHHS, CDC, vol.

42, No. 32, pp. 577-581, 1994; Teinowitz, I., ``Add RJR to List of

Cigarette Price Cuts,'' Advertising Age, pp. 3, 46, April 26, 1993.

II. Cigarette and Smokeless Tobacco Product Use Among Children and

Adolescents

Each year, the cigarette industry loses about 1.7 million customers

in the United States; about 400,000 die from diseases caused by their

smoking and another 1.3 million quit smoking.\1\ To offset the sales

lost to smokers who die or quit smoking, cigarette manufacturers rely

on young people as the primary source of new customers. Each day,

approximately 3,000 young people become regular smokers,\2\ serving as

the industry's major domestic source of replacement smokers.

A. Epidemiology of Tobacco Use Among Children and Adolescents

In 1965, the year following the first Surgeon General's Report \3\

describing the relationship between smoking and diseases such as lung

cancer, chronic bronchitis, and emphysema, 42.4 percent of the overall

adult population in the United States smoked.\4\ By 1990, the

prevalence of smoking in the United States had declined to 25.5

percent.\5\ The greatest reduction in adult smoking occurred from 1987

to 1990, when the prevalence of smoking declined by 1.1 percentage

point annually, twice the rate of decline during the preceding 20

years.\6\ The prevalence of smoking among adults leveled off at 25.6

percent in 1991 and was 26.5 percent in 1992. This change was due to a

change in the definition of current smokers, rather than an increase in

prevalence. The new definition incorporates some day (i.e., less than

daily, occasional, or infrequent) smoking.\7\ The estimate for 1992

with the old definition was 25.6 percent--the same as in 1991. In 1993,

under the new definition, prevalence was 25.0 percent.\8\

The long-term downward trend in adult smoking contrasts with the

trends in smoking among young people. The Institute of Medicine noted

that the number of high school seniors who have smoked in the last 30

days remained ``basically unchanged since 1980,'' at approximately 30

percent, and further reported that 16.7 percent of 8th grade students

were current smokers (that is, had smoked within the past 30 days), and

8.3 percent smoked daily.\9\ The prevalence of cigarette smoking in

recent years among 8th and 10th grade students has risen significantly

and provides cause for great concern. For example, among 8th grade

students, 14.3 percent in 1991 and 18.6 percent in 1994 were current

smokers; among 10th grade students, 20.8 percent in 1991 and 25.4

percent in 1994 were current smokers.\10\

The 1994 Surgeon General's Report reviewed several different

surveys and found that the estimated percentage of adolescents who have

ever smoked cigarettes ranged from approximately 42 percent (as

reported by the 1991 National Household Survey on Drug Abuse) to 70

percent (as reported by the 1991 Youth Risk Behavior Survey).\11\ The

1994 Surgeon General's Report also found that 28 percent of high school

seniors were current smokers.\12\ (The most recent data reported by the

Monitoring the Future Project indicates that in 1994 the number of high

school seniors who were current smokers had risen to 31.2 percent.)\13\

Further, the 1994 Surgeon General's Report states that seven to 13

percent of adolescents were frequent or heavy smokers, consuming at

least one-half pack daily or smoking 20 days or more of the 30 days in

a survey period.\14\

Approximately 3 million children under the age of 18 are daily

smokers.\15\ One study found that children between the ages of 8 and 11

who are daily smokers consume an average of 4 cigarettes daily, and

those who are between the ages of 12 and 17 average nearly 14

cigarettes daily. The study also estimated that adolescents consume an

estimated 947 million packs of cigarettes and 26 million containers of

smokeless tobacco annually and account for annual tobacco sales of

$1.26 billion.\16\ Another study estimates that teenagers in 1991

smoked 516 million packs of cigarettes and spent $962 million

purchasing them.\17\ As stated previously, these figures are especially

significant given that all States prohibit the sale of tobacco to

persons under the age of 18 (with some States prohibiting sales to

persons under the age of 19 and one State, Pennsylvania, prohibiting

cigarette sales to persons under the age of 21).\18\ Unfortunately, few

States successfully enforce their laws restricting tobacco sales to

minors.\19\

Studies have also suggested that the age one begins smoking can

greatly influence the amount of smoking one will engage in as an adult

and will ultimately influence the smoker's risk of tobacco related

morbidity and mortality. Those who started smoking by early adolescence

were more likely to be heavy smokers than those who began smoking as

adults.\20\ Another study found that high school students who smoked

their first cigarette during childhood smoked more often and in greater

amount than those who first tried smoking during adolescence.\21\

The escalating use of smokeless tobacco products by underage

persons presents an additional and growing public health problem.

Smokeless tobacco products include chewing tobacco and snuff and are

also known as ``spit tobacco'' or ``spitting tobacco.'' In 1970, the

prevalence of snuff use among males was lowest in those 17 to 19 years

of age and the highest use was by men aged 50 or more. By 1985, a

dramatic shift had occurred, and males between 16 and 19 were twice as

likely to use snuff as men aged 50 and over.\22\ An estimated 3 million

users of smokeless tobacco products were under the age of 21 in

1986,\23\ when Congress enacted the Comprehensive Smokeless Tobacco

Health Education Act (the Smokeless Act) (15 U.S.C. 4401). The

Smokeless Act required the Secretary of Health and Human Services (the

Secretary) to inform the public of the health dangers associated with

smokeless tobacco use, required warning labels on packages, banned

advertising on electronic media subject to the Federal Communications

Commission's jurisdiction (such as television and radio), and

encouraged States to make 18 years the minimum age for purchasing

smokeless tobacco products. Despite the Smokeless Act and State laws

prohibiting sales to minors, a high percentage of persons under the age

of 18 use smokeless tobacco products. For example:

1991 school-based surveys estimated that 10.7 percent of

U.S. high school seniors and 19.2 percent of male 9th to 12th grade

students use smokeless tobacco.\24\

A 1992 national household-based survey of U.S. children

found that 11.9 percent of males 12-17 years of age were using

smokeless tobacco.\25\

Among high school seniors who had ever tried smokeless

tobacco, 73 percent did so by the ninth grade.\26\

In some parts of the United States the rates are especially high.

According to the 1990-91 Youth Risk Behavior Survey, the smokeless

tobacco product use rates among males in grades 9 through 12 were as

high as 34 percent in Tennessee, 33 percent in Montana, 32 percent in

Colorado, and 31 percent in Alabama and Wyoming.\27\

Native American youth are especially vulnerable to smokeless

tobacco product use. The rates for both males and females are extremely

high, ranging from 24 percent to 64 percent, and at rates that, in some

areas, are 10 times higher than those for non-Native

[[Page 41318]]

Americans.\28\ Studies also suggest that Native Americans begin using

smokeless tobacco products at much earlier ages than non-Native

Americans. A 1986 survey at the Rosebud Sioux Reservation in South

Dakota revealed that 21 percent of kindergarten children used smokeless

tobacco products,\29\ and a survey of Native Americans in the state of

Washington indicated that 33 percent of former users and 57 percent of

current users started using smokeless tobacco products before the age

of 10.\30\

The recent and very large increase in the use of smokeless tobacco

products by young people and the addictive nature of these products has

persuaded the agency that these products must be included in any

regulatory approach that is designed to help prevent future generations

of young people from becoming addicted to nicotine-containing tobacco

products.

B. The Health Effects Associated With Cigarettes and Smokeless Tobacco

Products

Over 400,000 Americans die each year from smoking-related

illnesses. This equates to more than one of every five deaths in the

United States.\31\ If an adolescent's tobacco use continues for a

lifetime, there is a 50 percent chance that the person will die

prematurely as a direct result of smoking.'' \32\ Moreover, the earlier

a young person's smoking habit begins, the more likely he or she will

become a heavy smoker and therefore suffer a greater risk of smoking

related diseases.\33\ Smoking is responsible for about 30 percent of

all cancer deaths,\34\ including 87 percent of all lung cancer deaths;

82 percent of deaths from chronic obstructive pulmonary disease (COPD);

\35\ 21 percent of deaths from coronary heart disease; \36\ and 18

percent of deaths from stroke.\37\ Further, a causal relationship

exists between cigarette smoking and cancers of the larynx, mouth,

esophagus, and bladder; and atherosclerotic peripheral vascular

disease, cerebrovascular disease (stroke), and low-birth weight

babies.\38\ Cigarette smoking is also a probable cause of infertility

and peptic ulcer disease and contributes to, or is associated with,

cancers of the pancreas, kidney, cervix, and stomach.\39\

Much of the following brief discussion is abstracted from several

Surgeon General's reports. The Surgeon General's reports summarize

thousands of peer-reviewed scientific studies and are themselves peer-

reviewed and subjected to significant scientific scrutiny.

1. Health Effects of Cigarette Smoking

Epidemiologic studies provide overwhelming evidence that smoking

causes lung cancer.\40\ The risk of getting lung cancer may be more

than 20 times greater for heavy smokers than nonsmokers.\41\ The

relationship between smoking and lung cancer is due to the numerous

carcinogens in cigarette smoke.\42\ Cigarette smoking caused an

estimated 117,000 deaths from lung cancer in 1990.\43\

The risk of getting lung cancer increases with the number of

cigarettes smoked and the duration of smoking, and decreases after

cessation of smoking.\44\ Starting smoking at an earlier age increases

the potential years of smoking and increases the risk of lung

cancer.\45\ Studies have shown that lung cancer mortality is highest

among adults who began smoking before the age of 15.\46\

Cigarette smoking also causes cancer of the larynx, mouth, and

esophagus.47 According to current estimates, 82 percent of

laryngeal cancers are due to smoking and about 80 percent of the 10,200

deaths from esophageal cancer in 1993 can be attributed to

smoking.48 The risk of oral cancer among current smokers ranges

from 2.0 to 18.1 times the risk in people who have never smoked and can

be reduced more than 50 percent after quitting.49 The risk of

esophageal cancer among current smokers ranges from 1.7 to 6.4 times

the risk in people who have never smoked and can also be reduced by

about 50 percent after quitting.50

Epidemiologic studies demonstrate that cigarette smoking

contributes to the development of pancreatic cancer.51 The reason

for this relationship is unclear, but may be due to carcinogens or

metabolites present in the bile or blood.52 In 1985, the

proportion of pancreatic cancer deaths in the United States

attributable to smoking was estimated to be 29 percent in men and 34

percent in women.53

Cigarette smoking accounts for an estimated 30 to 40 percent of all

bladder cancers and is a contributing factor for kidney cancer.54

The increased risk of kidney and bladder cancer may be related to the

number of cigarettes smoked per day, and the risk decreases following

smoking cessation.55

Smoking appears to be a contributing factor for cancer of the

cervix. The association between cigarette smoking and cervical cancer

persists after control is made for risk factors, such as age at first

intercourse and the number of sexual partners, that predispose a woman

to developing sexually-transmitted diseases. The inclusion of these

risk factors, however, may not completely rule out confounding by

sexually-transmitted diseases. However, the findings that components of

tobacco smoke can be found in the cervical mucus of smokers, that the

mucus of smokers is mutagenic, and that former smokers have a lower

risk of getting cervical cancer than current smokers are consistent

with the hypothesis that smoking is a contributing cause of cervical

cancer.56

The 1982 Surgeon General's Report concluded that stomach cancer is

associated with cigarette smoking.57 Studies show a slight

increase in mortality from stomach cancer in smokers compared with

nonsmokers.58

Smoking is a leading cause of heart disease. The 1964 Surgeon

General's Report noted that male cigarette smokers had higher death

rates from coronary heart disease than nonsmokers.59 Subsequent

reports have concluded that cigarette smoking contributes to the risk

of heart attacks, chest pain, and even sudden death.60 Overall,

smokers have a 70 percent greater death rate from coronary heart

disease than nonsmokers.61

Ischemic heart disease resulting from cigarette smoking claimed

nearly 99,000 lives in 1990.62 One study estimates that 30 to 40

percent of all coronary heart disease deaths are attributable to

smoking.63 Smokers between the ages of 40 and 64, who smoked more

than one pack a day, were shown to have a risk of coronary heart

disease that is 3.2 times higher than people who do not smoke.64

Several processes that are likely to contribute to heart attacks

are influenced or caused by smoking: atherosclerosis, thrombosis,

coronary artery spasm, cardiac arrhythmia, and reduced capacity of the

blood to deliver oxygen. The nicotine and carbon monoxide in cigarette

smoke are believed to be responsible for heart disease, but other

components, such as cadmium, nitric oxide, hydrogen cyanide, and carbon

disulfide, have also been implicated.65 Female smokers who also

use oral contraceptives increase their risk of heart attacks

tenfold.66

Smoking also increases a person's risk of atherosclerotic

peripheral vascular disease, especially if the smoker is

diabetic.67 Complications of this disease include decreased blood

delivery to the peripheral tissues, gangrene, and ultimately loss of

the affected limb. Smoking cessation is the most important intervention

in the management of peripheral vascular disease.68

Smoking is a cause of stroke.69 Stroke is the third leading

cause of death in the United States.70 The association of

[[Page 41319]]

smoking with stroke is believed to be mediated by the mechanisms

responsible for atherosclerosis (narrowing and hardening of the

arteries), thrombosis, and decreased cerebral blood flow in

smokers.71 Female smokers who use oral contraceptives are at an

increased risk of having a stroke.72

Cigarette smoking is the leading cause of chronic obstructive

pulmonary disease (COPD) in the United States. Approximately 84 percent

of the COPD deaths in men and 79 percent of the COPD deaths in women

are attributable to cigarette smoking.73 The risk of death from

COPD may depend on how many cigarettes a person smokes daily, how

deeply the person inhales, and the age when the person began

smoking.74 The number of cigarettes smoked per day is a strong

indicator for the presence of the principal symptoms of chronic

respiratory illness, including chronic cough, phlegm production,

wheezing, and shortness of breath.75

Smoking's effects on lung structure and function appear within a

few years after cigarette smoking begins.76 Children who smoke

suffer from respiratory illnesses more than children who do not smoke.

Adolescents who smoke may experience inflammatory changes in the lung,

reduced lung growth, and may not achieve normal lung function as an

adult.77

Cigarette smoking is a probable cause of peptic ulcer

disease.78 Peptic ulcer disease is more likely to occur in smokers

than in nonsmokers, and the disease is less likely to heal, and more

likely to cause death in smokers than nonsmokers.79 Quitting

smoking reduces the chances of getting peptic ulcer disease and is an

important component of effective peptic ulcer treatment.80

Studies also show that women who smoke have reduced

fertility.81 One study showed that smokers were 3.4 times more

likely than nonsmokers to take more than 1 year to conceive.82

Smoking's severe detrimental effects during pregnancy are well

documented.83 Women who smoke are twice as likely to have low

birth weight infants as women who do not smoke. 84 Smoking also

causes intrauterine growth retardation of the fetus.85 Mothers who

smoke also have increased rates of premature delivery.86

Smoking may lead to premature infant death. Babies of mothers who

smoke are more likely to die than babies born to nonsmoking

mothers.87 A recent meta-analysis reported that use of tobacco

products by pregnant women results in 19,000 to 141,000 miscarriages

per year, and 3,100 to 7,000 infant deaths per year. In addition, the

meta-analysis attributed approximately two-thirds of deaths from sudden

infant death syndrome to maternal smoking during pregnancy.88 By

another estimate, if all pregnant women stopped smoking, there would be

4,000 fewer infant deaths per year in the United States.89

2. Health Effects of Smokeless Tobacco Products

Smokeless tobacco use can cause oral cancer.90 The risk of

oral cancer increases with increased exposure to smokeless tobacco

products, particularly in those areas of the mouth where smokeless

tobacco products are used.91 The risk of cheek and gum cancers is

nearly 50 times greater in long-term snuff users than in

nonusers.92 Snuff and chewing tobacco contain potent carcinogens,

including nitrosamines, polynuclear aromatic hydrocarbons, and

radioactive polonium.93

Smokeless tobacco use can cause oral leukoplakia, a precancerous

lesion of the soft tissue that consists of a white patch or plaque that

cannot be scraped off.94 One study of 117 high school students who

were smokeless tobacco users revealed that nearly 50 percent of these

students had oral tissue alterations.95 There is a 5 percent

chance that oral leukoplakias will transform into malignancies in 5

years.96 The leukoplakia appears to decrease or resolve upon

cessation of smokeless tobacco use.97

Smokeless tobacco use causes oral cancer and oral leukoplakia and

may be associated with an increased risk of cancer of the esophagus.

Smokeless tobacco use has been implicated in cancers of the gum, mouth,

pharynx, and larynx. Snuff use also causes gum recession and is

associated with discoloration of teeth and fillings, dental caries, and

abrasion of the teeth.98

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35. Id., p. 157.

36. Id., p. 97.

37. Id., p. 157.

38. Id., pp. 98-99; 1990 SGR, p. 10.

39. 1989 SGR, pp. 98-99.

40. See generally 1964 Surgeon General's Report.

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58. 1989 SGR, p. 57.

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81. Baird, D.C. and A.J. Wilcox, ``Cigarette Smoking Associated

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83. See generally, Surgeon General's Reports for the followings

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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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93. 1986 SGR, pp. 58-69.

94. 1994 SGR, p. 39; WHO Collaborating Centre for Oral

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Lesions: An Aid to Studies on Oral Precancer,'' Oral Surgery, Oral

Medicine Oral Pathology, vol. 46, No. 4, pp. 518-539, October 1978.

95. Greer, R.O., and T.C. Poulson, ``Oral Tissue Alterations

Associated With the Use of Smokeless Tobacco by Teen-Agers,'' Oral

Surgery, Oral Medicine, Oral Pathology, vol. 56, No. 3, pp. 275-284,

September 1983.

96. 1994 SGR. p. 39.

97. Id.

98. Id., pp. 39-40; see generally 1986 SGR.

III. Description of the Proposed Rule

The proposed rule would create a new part 897 of Title 21 of the

Code of Federal Regulations governing the labeling, advertising, sale,

and distribution of cigarettes and smokeless tobacco. The Commissioner

has proposed that nicotine-containing cigarettes and smokeless tobacco

products be regulated as restricted devices within the meaning of

section 520(e) of the act (21 U.S.C. 360j(e)). The regulations are

being proposed pursuant to the authority of section 520(e) of the act,

which authorizes the agency to regulate the sale, distribution, and use

of certain devices. Certain of the provisions in the regulation are

also being proposed pursuant to the authority of sections 201, 502,

510, 701, and 704 of the act.

In brief, the proposed rule is intended to support current State

laws regarding sales to minors by reducing the appeal of cigarettes and

smokeless tobacco to, and limiting access by, persons under 18 years of

age. The overall goal of the proposed rule is to decrease the rates of

death and disease caused by tobacco products by substantially reducing

the number of young people who begin using cigarettes or smokeless

tobacco products.

The proposed rule consists of five subparts. Subpart A, General

Provisions, would set forth scope and purpose provisions and provide

definitions. Subpart B, Sale and Distribution to Persons Under 18 Years

of Age, would describe the responsibilities of manufacturers,

distributors, and retailers concerning the manufacture, sale, and

distribution of cigarettes and smokeless tobacco products. Subpart C,

Labels and Educational Messages, would require each manufacturer to

establish and maintain a national public educational program, including

major reliance on television messages, in order to combat the pervasive

imagery and appeal created by decades of pro-tobacco messages, and,

thus, to discourage young people from using cigarettes and smokeless

tobacco products. Subpart D, Labeling and Advertising, would limit

advertising and labeling to which children and adolescents are exposed

to a text-only format; ban the sale or distribution of branded non-

tobacco items such as hats and tee shirts; and restrict sponsorship of

events to the corporate name only. Finally Subpart E, Miscellaneous

Requirements, would describe the records and reports that must be

submitted to FDA or made available for inspection, discuss the rule's

relationship to State and local laws or requirements, and require one

or more additional measures to be taken if the prevalence of tobacco

use is not significantly reduced within seven years of the publication

of the final rule.

A. Subpart A--General Provisions

Subpart A would contain three provisions that describe the rule's

scope and purpose and provide definitions that apply throughout part

897.

[[Page 41322]]

1. Section 897.1--Scope

Proposed Sec. 897.1(a) would state that part 897 is intended to

establish conditions under which nicotine-containing cigarettes and

smokeless tobacco products may be sold, distributed, or used. The

proposed rule would not apply to pipe tobacco or to cigars because the

agency does not currently have sufficient evidence that these products

are drug delivery devices under the act. FDA has focused its

investigation of its authority over tobacco products on cigarettes and

smokeless tobacco products, and not on pipe tobacco or cigars, because

young people predominantly use cigarettes and smokeless tobacco

products. Proposed Sec. 897.1(b) would note that all references to

regulatory sections in the Code of Federal Regulations are to Title 21

unless otherwise noted.

2. Section 897.2--Purpose

Proposed 897.2(a) would state that part 897 is intended to help

prevent persons younger than 18 years of age from becoming addicted to

nicotine, thereby avoiding the life-threatening consequences often

associated with tobacco use. The proposed rule would accomplish this

goal by reducing the appeal of and access to cigarettes and smokeless

tobacco products by persons under 18 years of age; it would preserve

access to cigarettes and smokeless tobacco products by persons 18 years

of age and older. Proposed Sec. 897.2(b) would add that the provisions

are intended to provide important information about product use to

users and potential users.

3. Section 897.3--Definitions

Proposed 897.3 would establish definitions of terms used in the

proposed rule, such as ``cigarette'' (897.3(a)) and ``distributor''

(897.3(c)). In drafting the definitions, FDA examined existing

definitions in Federal laws and regulations and paid special attention

to existing definitions in other FDA regulations. These definitions are

contained in the proposed codified language.

Proposed 897.3(e) contains the definition of ``nicotine,''which is

based, in part, on the chemical name and formula for nicotine in the

``Merck Index''(10th Edition). The agency also notes that, while the

proposed rule defines ``cigarette,'' in part, as a product that

``contains or delivers nicotine,'' it is aware that some companies are

trying to develop chemical substances that are pharmacologically active

or are as addictive as nicotine or that would be used to enhance

nicotine's pharmacological qualities. The agency's investigation has

focused primarily on cigarettes and smokeless tobacco products that

contain nicotine, and FDA would therefore consider a cigarette-like

product that contains a pharmacologically active or addictive substance

in place of nicotine to be a ``new'' drug delivery device that would be

outside the scope of this regulation. To be legally marketed, such a

product would require premarket approval.

B. Subpart B--Sale and Distribution to Persons Under 18 Years of Age

Subpart B would establish certain conditions or requirements for

the sale and distribution of cigarettes and smokeless tobacco pursuant

to section 520(e) of the act. These provisions are intended to reduce

access to cigarettes and smokeless tobacco products by children and

adolescents. Studies show that it is easy for most young people to

obtain tobacco products. The University of Michigan Monitoring the

Future Study in 1993 reported that 75 percent of 8th graders and nearly

90 percent of 10th graders said it would be fairly easy or very easy to

get cigarettes.1 According to a 1990 survey of 9th graders, 67

percent of current smokers said they usually buy their own

cigarettes.2 Further, interviews conducted by the Department of

Health and Human Services' (DHHS) Office of the Inspector General in

1986 found that 94 percent of junior and high school students said that

``it was either never or only rarely difficult'' to buy smokeless

tobacco products.3

Most children and adolescents who smoke purchase their own

cigarettes. A 1991 study showed that an estimated 516 million packs are

consumed by young people every year; almost half of these packs are

sold to minors.4 The 1994 Surgeon General's Report examined 13

studies of over-the-counter sales and determined that approximately 67

percent of minors are able to purchase tobacco illegally. Moreover,

successful cigarette purchases by children and adolescents averaged 88

percent in studies of vending machines.5

A significant percentage of young people can also easily purchase

smokeless tobacco products directly from retailers. Studies examining

smokeless tobacco product purchases by young people suggest that direct

successful underage purchases range from 30 percent (for junior high

school students) to 62 percent (for senior high school students).6

Interviews conducted by the DHHS' Office of the Inspector General in

1986 found that 90 percent of smokeless tobacco users in junior and

senior high schools said they purchased their own smokeless tobacco

products.7

Youth access restrictions have been found to be effective in

reducing illegal sales and some studies have demonstrated that efforts

to reduce access have led to a decrease in tobacco use by young people.

In Woodridge, IL, for example, a comprehensive community intervention

involving retailer licensing, regular compliance checks, and penalties

for merchant violations significantly reduced illegal sales from 70

percent to less than 5 percent almost 2 years later. Further, rates of

experimentation and regular smoking dropped by more than 50 percent

among seventh and eighth graders.8

In contrast, attempts to reduce sales to young people by relying

exclusively on educational programs for retailers were not nearly as

effective. For example, one study found that minors were able to buy

cigarettes in 73 percent of stores receiving informational packages on

preventing illegal sales to minors.9 After a comprehensive

retailer education program was conducted, illegal sales to minors

decreased to 68 percent of stores. However, after citations were issued

to violative establishments, over-the-counter illegal sales dropped to

31 percent.10

The proposed rule would prohibit the sale and distribution of

cigarettes and smokeless tobacco products to individuals younger than

18. This restriction parallels the age restrictions established by

almost all States. Moreover, it is based on the fact that most people

who become regular smokers do so at a young age. For instance, the IOM

reported that the average age when people become ``daily'' smokers is

17.7 years.11 According to the National Household Surveys on Drug

Abuse (1991), 53 percent of people who ever smoked became regular

smokers by the time they were 18 years old.12 Further, 82 percent

of those who had ever smoked daily first tried a cigarette before the

age of 18.13

Available data documenting the course of a young person's ability

to quit smoking after initiating smoking support the need for an age

restriction. A study tracking students from grades 6 to 12 in six

Minnesota communities noted a ``striking pattern'' that:

* * * once students become weekly smokers, they are unlikely to

give up cigarettes. Of the students who were current smokers, an

increasing percentage remained smokers over the years of follow-up;

they were either unable or unwilling to quit smoking. Of the self-

reported quitters, 13% to

[[Page 41323]]

46% returned to weekly smoking by the next year's measurement

period.14

The study found that ``students who smoke are increasingly unlikely to

quit as they get older.'' 15

Effectively prohibiting sales to people younger than 18 years of

age will therefore help reduce the number of adolescents and youths who

become daily smokers. FDA also selected the age limit of 18 to be

consistent with the 1992 Alcohol, Drug Abuse, and Mental Health

Administration (ADAMHA) Reorganization Act 16 that conditions

receipt of substance abuse grants on States adopting laws prohibiting

the sale and distribution of cigarette and smokeless tobacco products

to minors under age 18, and because the majority of States have set 18

as the age of purchase of these products.

1. Section 897.10--General Responsibilities of Manufacturers,

Distributors, and Retailers

Proposed 897.10 would describe the general responsibilities of

manufacturers, distributors, and retailers, and would make

manufacturers, distributors, and retailers responsible for ensuring

that the cigarettes and smokeless tobacco products they manufacture,

label, advertise, package, sell, distribute, or otherwise hold for sale

comply with all the applicable regulations under proposed Part 897.

2. Section 897.12--Additional Responsibilities of Manufacturers

Proposed 897.12 would provide that, in addition to its other

responsibilities, each manufacturer would be responsible for removing

all self-service displays, violative advertising, labeling, and other

manufacturer- or distributor-supplied items from each point of sale.

Proposed Sec. 897.12(b) would require each manufacturer to monitor,

through visual inspection on each visit to a point of sale (carried out

in the normal course of the manufacturer's business), to assure the

proper labeling, advertising, and distribution of its products. This

provision would not create a new responsibility or burden for companies

(typically the smaller ones) who do not visit retail locations as part

of their usual business practice. The obligation to inspect exists only

for those companies (typically the larger ones) for whom visits are

part of their usual business practice.

Further, because there are detailed contracts between the larger

cigarette manufacturers and retailers, proposed 897.12 should not

impose a significant burden on these manufacturers. For example, a Non-

Self-Service Carton Shelf Plan for the R.J. Reynolds Tobacco Co.

specified that `` [t]he height of the top shelf cannot exceed 72 inches

and must have a height capacity of seven cartons * * * '' and that the

cigarette display or shelves `` * * * must be in total view of the

consumer * * * '' and `` * * * may not be placed more than 10 feet from

point-of-purchase.'' 17 Another plan, titled ``R.J. Reynolds

Tobacco USA Savings Center Display Plan,'' created six different pay

scales for retailers; the retailers would receive more money if they

sold a large volume of cigarettes. Under this plan, R.J. Reynolds would

also provide a ``merchandiser'' to display its products, and the

retailer would agree to stock the ``designated RJR shelf rows'' ``no

less than five cartons high,'' and not alter the shelves or reduce the

amount allocated to R.J. Reynolds products.18 In both plans, the

retailer also agreed to permit R.J. Reynolds representatives to ``plan-

o-gram, adjust, and divide its allocated space as deemed necessary''

and to ``make reasonable audits of performance and to inspect and

rotate R.J.R's products in stores under contract.'' 19

Former sales representatives and managers interviewed by FDA stated

that manufacturers keep extremely detailed records about each retailer.

Some records noted whether the retailer should be visited weekly,

biweekly, monthly, etc.; other entries included the types of displays

in the retailer's establishment. At least one company also gave

portable computers to its representatives; the data entered into these

computers were downloaded nightly and sent to company headquarters.

These detailed contracts and records demonstrate that the manufacturers

are heavily involved in establishing and maintaining retailers'

displays and that the proposed rule's requirements that each

manufacturer be responsible for removing violative advertising,

labeling, and self-service displays, and for performing a visual

inspection on each subsequent business call are both feasible and

reasonable.

3. Section 897.14--Additional Responsibilities of Retailers

Proposed 897.14 would establish additional responsibilities for

retailers. Proposed 897.14(a) would require the retailer or the

retailer's employees to verify that people who intend to purchase

cigarettes or smokeless tobacco products are legally entitled to do so.

Verification would be by direct visual inspection of each prospective

purchaser and, if necessary, would include the use of a photographic

identification card with a birth date. Examples of documents that would

be acceptable are a driver's license or a college identification card.

The proposal would require an identification card with a picture and a

birth date because such identification cards are more reliable than

other forms of identification. FDA invites comment on whether the final

rule should contain more specific requirements concerning the types of

identification that would comply with this provision.

The agency has found strong support for the additional retailer

responsibilities that this section would impose. According to a recent

report endorsed by 26 State attorneys general, industry training films

and programs used by retailers regarding tobacco sales had little or no

impact on preventing illegal sales to minors and, in some retail

sectors, high employee turnover rates complicated training efforts.

Moreover, determining a young customer's age through visual examination

alone proved to be difficult. Thus, the attorneys general recommended

requiring proof of age of anyone who does not appear to be at least 26

years old.20

Additionally, studies indicate that minors who are able to purchase

cigarettes and other tobacco products from stores are rarely asked to

verify their age. For example, in one study, 67 percent of minors (mean

age: 15 years) were asked no questions when they attempted to purchase

cigarettes.21 Store cashiers tried discouraging the minors from

buying cigarettes in only 7 percent of the spot checks conducted by the

authors. In 14 percent of the cases, the cashiers actually ``encouraged

the minor's purchase by offering matches, suggesting a cheaper brand,

or offering to make up the difference if the minor was `short on

cash'.'' 22

In another report, five minors between the ages of 13 and 16 were

sent to various locations to buy cigarettes. Despite signs at some

locations that prohibited entry by persons under the age of 21, the

minors were able to buy cigarettes, even when they admitted they were

under 21. For smokeless tobacco products, studies show that half of the

stores examined were willing to sell smokeless tobacco products to

minors.23 In contrast, in Everett, WA, where a local ordinance

required proof of age if the prospective buyer did not appear to be of

legal age to purchase cigarettes, over 60 percent of students between

the ages of 14 and 17 reported being asked for proof of age when they

attempted to buy cigarettes, and tobacco use, among 14 to 17-year-olds,

declined from 25.3 percent to 19.7 percent overall.24

[[Page 41324]]

Proposed Sec. 897.14(b) would prevent the retailer or an employee

of the retailer from using any electronic or mechanical device in

providing cigarettes or smokeless tobacco products to the purchaser.

Requiring the retailer's employees to hand cigarettes or smokeless

tobacco products to customers, after checking identification, has the

practical effect of making access to such products more difficult for

young people.

Proposed Sec. 897.14(c) would prohibit the retailer or an employee

of the retailer from opening a cigarette, cigarette tobacco, or

smokeless tobacco product package to sell or distribute a cigarette, or

cigarettes (often referred to as ``singles'' or ``loosies'') or any

quantity of cigarette tobacco or of a smokeless tobacco product from

that package. The agency is proposing this restriction because the

primary market for ``loosies'' is children and adolescents. One

California study found that 101 of 206 stores sold single cigarettes to

minors and adults, and more stores sold single cigarettes to minors

than to adults.25 A survey in Nashville, TN, found that one-

quarter of the stores sold single cigarettes.26

Additionally, the IOM noted that the sale of single cigarettes is

attractive to children due to the low costs, could make children more

willing to experiment with tobacco products, and that single cigarettes

may be easier for children to shoplift.27 Consequently, the IOM

advocated banning the sale of single cigarettes.28 Several States,

including Mississippi, Oklahoma, South Dakota, Tennessee, and

Washington, already restrict the sale of unpackaged tobacco products,

and a working group of State attorneys general recently recommended

that single cigarette sales be prohibited.29

4. Section 897.16--Conditions of Manufacture, Sale and Distribution

a. Restrictions on product names. Proposed 897.16(a) would prohibit

prospectively the use of a trade or brand name for a non-tobacco

product as the trade or brand name for a cigarette or smokeless tobacco

product. The agency is aware of three brands of cigarettes that have

used this strategy: Harley-Davidson, Cartier, and Yves St. Laurent's

Ritz cigarettes. In the final rule, the agency intends to exempt those

brands that already use the trade or brand name of a non-tobacco

product.

This provision would complement the requirements in proposed

subpart D (regarding labeling and advertising) that would reduce the

appeal of cigarettes and smokeless tobacco products to people younger

than 18. FDA believes that this provision is necessary to prevent

manufacturers from circumventing the purpose of this proposed rule. As

discussed elsewhere, the imagery associated with tobacco products is an

important factor in why young people smoke. This provision would

prevent tobacco manufacturers from capitalizing on the imagery of other

consumer products by using the brand name of those products for tobacco

products.

b. Minimum package size. Proposed Sec. 897.16(b) would make 20

cigarettes the minimum package size for cigarettes. FDA selected 20

because the vast majority of cigarette packs in the United States

contain 20 cigarettes. The proposal is intended to preclude firms from

manufacturing packages that contain fewer than 20 cigarettes; these

packs, sometimes referred to as ``kiddie'' packs, usually contain a

small number of cigarettes, are easier to conceal, and are less

expensive than full-size packs. (Young people, who generally have

little disposable income, can be particularly sensitive to the price of

cigarettes and may choose not to smoke as the price increases.30)

Further, FDA is aware that Lorrilard Tobacco Company is offering a pack

containing only 10 cigarettes of its Newport brand for sale and that

another firm is experimenting with single cigarettes packed in

individual tubes.31

One study showed that 56.3 percent of all 14 to 15 year old

adolescent smokers surveyed in one urban area of Australia had

purchased kiddie packs in the month prior to the survey, compared with

only 8.8 percent of adult smokers. The study concluded, ``If we fail to

take strong action against the well targeted marketing methods of

tobacco companies then the adolescent smoking rates recorded in this

study are likely to remain high.'' 32

The Nova Scotia Council on Smoking and Health reported that 49

percent of tobacco users in the sixth grade purchased kiddie packs of

15 cigarettes.33 Another study of Australian schoolchildren

reported that 30 percent of the 12-year olds preferred packages

containing 15 cigarettes compared to 11 percent of the 17-year

olds.34 The Australian study, however, also reported that older

children preferred cigarette packages that contained 25 cigarettes.

Consequently, even though FDA has no evidence that firms intend to

market cigarette packages that contain more than 20 cigarettes, the

agency invites comment as to whether proposed Sec. 897.16(b) should

also state the maximum package size for cigarettes.

c. Impersonal modes of sale. Proposed Sec. 897.16(c) would permit

cigarettes and smokeless tobacco products to be sold only in a direct,

face-to-face exchange between the retailer or the retailer's employees

and the consumer. The proposal would prohibit specifically cigarette

vending machines, self-service displays, mail-order sales, and mail-

order redemption of coupons.

i. Vending Machines. Studies indicate that a significant percentage

of adolescents are able to obtain their cigarettes from vending

machines and that such purchases occur regardless of locks, warning

signs, and other restrictions. In 1994, CDC examined 15 recent tobacco

inspection surveys to investigate underage sales to minors. While 73

percent of over-the-counter outlets made illegal sales to children and

adolescents, 96 percent of vending machine sales were

successful.35

A 1989 survey of 10th grade students in Minnesota indicated that 71

percent had purchased tobacco from vending machines.36 Another

1989 report found that, in California, minors between the ages of 14

and 16 were able to purchase cigarettes from vending machines 100

percent of the time.37 A 1992 study in Minnesota involving minors

between the ages of 12 and 15 reported a 79 percent success rate in

purchasing cigarettes from vending machines.38 Children in the

Washington, D.C. area, New York, Colorado, and New Jersey who were sent

to purchase cigarettes from vending machines achieved 100 percent

success rates.39 The 1994 Surgeon General's Report examined nine

studies on cigarette purchases from vending machines and found that

underage persons were able to purchase cigarettes 82 to 100 percent of

the time, with a weighted-average rate of 88 percent.40

Moreover, younger children use vending machines to purchase

cigarettes more often than older adolescents. A study commissioned by

the vending machine industry revealed that 22 percent of 13-year olds

who smoke reported purchasing cigarettes from vending machines

``often'' compared with only 2 percent of 17-year olds. Twenty-two

percent of 13- to 17-year- olds who smoke report purchasing cigarettes

from vending machines ``often''or ``occasionally.''41

FDA is aware that some jurisdictions have attempted to place locks,

post warning signs, or restrict placement of vending machines to

curtail access by young people. These efforts have had only limited

success. A 1992 report examining vending machines in St. Paul, MN,

indicates the limitations of requiring locking devices on vending

machines. Despite a 1990 city ordinance requiring locking devices on

vending machines, the rate of noncompliance by

[[Page 41325]]

merchants was 34 percent after 3 months and 30 percent after 1

year.42 Underage buying increased from 30 percent 3 months after

the ordinance had been enacted to 48 percent after 1 year.43

Further, in those locations where locking devices were not placed on

vending machines, underage buying was successful 91 percent of the

time.44 The study concluded that the use of locking devices on

vending machines was less effective than a vending machine ban.

In 1994, CDC examined minors' access to cigarette vending machines

in Texas. CDC noted that Texas law requires cigarette vending machine

owners to post signs on their machines stating that sales to persons

under the age of 18 are illegal. Despite these laws, minors between the

ages of 15 and 17 successfully bought cigarettes from vending machines

98 percent of the time.45

Laws restricting placement of vending machines also appear to be

ineffective. In one study, 14-year-old children were able to purchase

cigarettes from vending machines 77 percent of the time despite State

laws requiring the machines to be ``in the immediate vicinity, plain

view and control of an employee'' and to bear signs concerning illegal

purchases by minors.46 Six surveys conducted in bars, taverns,

private clubs, and liquor stores in five states found that minors were

able to successfully purchase cigarettes in vending machines between 70

percent and 100 percent of the time, about the same rate as

elsewhere.47 In these surveys, the sales rates for ``adult only''

locations were similar to the rates for vending machine cigarette sales

located elsewhere in the communities, indicating that restricting

cigarette vending machines to places such as bars and liquor stores

does not serve as an impediment to young people buying cigarettes.

Additionally, according to the vending machine industry's research,

77.5 percent of all cigarette vending machines are already in ``adult''

areas such as bars, lounges, offices, college campuses, and industrial

plants.48 Therefore, it is likely that restricting cigarette

vending machines to these areas would have a minimal effect on reducing

sales to young people.

Studies also have shown that the use of vending machines by young

people appears to be highest in those areas with strong access

restrictions. In Santa Fe, New Mexico, where selling to minors was not

against the law, vending machines were used 18 percent of the time by

teen smokers.49 By contrast, in Vallejo, California, where local

merchants were actively requiring photographic identification, a survey

found that teen smokers used vending machines 56 percent of the time

(thereby making vending machines the most common source of cigarettes

for young people.50) Therefore, if access restrictions are imposed

such as requiring retailers to verify age, it is likely that vending

machines may become an even more important source of cigarettes for

young people.

Because minors, especially very young children who try smoking,

rely on vending machines to purchase tobacco products, and because

State and local laws restricting placement of, or requiring locking

devices on, vending machines appear to be ineffective, the agency

believes that the only practical approach to curtailing young people's

access to such products is to eliminate vending machines and other

impersonal modes of sale. Moreover, government enforcement of vending

machine locking devices would entail a greater regulatory burden than

enforcing a complete ban because authorities would need to ensure the

devices were installed and operating properly, and that store employees

were using them correctly.51

Consequently, proposed Sec. 897.16(c) would require retailers to

hand the product to the consumer. This proposed requirement would have

the added effect of preventing persons younger than 18 from evading the

proposed rule's age requirement by shifting their purchasing patterns

from stores to vending machines or mail orders. Further, the agency

notes that this aspect of the proposed rule is consistent with

recommendations from the IOM,52 the Public Health Service,53

a working group of State attorneys general,54 and findings by the

Office of the Inspector General, DHHS.55

Finally, data from the vending machine industry show that

cigarettes account for a small and declining portion of total vending

machine revenues.56 Using industry data from 1993, calculations

indicate that daily sales from cigarette vending machines average

approximately $10 per machine/per day.57 In 1993, cigarettes

comprised 4.7 percent of total vending machine revenues compared to

45.5 percent in 1960.58 Between 1992 and 1993, vending machine

revenues from cigarettes dropped 25 percent.59 While total

revenues from cigarette vending machines have been decreasing, revenues

from most other product categories sold in vending machines, such as

juice and other cold drinks, rose dramatically.60 Further, the

number of cigarette vending machines decreased significantly from

373,800 to 181,755 between 1988 and 1993.61 Recognizing that more

and more states and localities have enacted restrictions or bans on

cigarette vending machines, machines are being produced that can be

converted to dispense other products.62 Furthermore, according to

the National Automatic Merchandising Association, the association

representing the vending machine industry, virtually no new shipments

of cigarette vending machines have been made since 1990, compared with

32,065 shipments in 1976.63

ii. Self-service displays. Proposed Sec. 897.16(c) would also

prohibit self-service displays. Self-service displays enable young

people to quickly, easily, and independently obtain tobacco products.

This restriction is intended to prevent young people from helping

themselves to tobacco products and to increase the direct interaction

between the sales clerk and the underage customer. This restriction is

also consistent with the 1994 IOM Report's recommendation. IOM reviewed

surveys of grade school students in New York, and Wisconsin, and noted

that many students--over 40 percent of daily smokers in Erie County, NY

and Fond du Lac, WI--shoplifted cigarettes from self-service

displays.64 IOM found that eliminating self-service displays would

make it more difficult for children to obtain cigarettes, especially if

the children had to purchase the cigarettes from a store clerk (as

would be required under this proposal). IOM further noted that

``placing the products out of reach reinforces the message that tobacco

products are not in the same class as candy or potato chips.'' 65

A California study compared smoking prevalence among minors in five

counties before and after the institution of ordinances prohibiting

self-service merchandising (display and sale) and requiring only

vender-assisted sales. The rate of tobacco sales to minors in the five

counties dropped 40 to 80 percent and the decrease was still in

evidence 2 years after the survey. Moreover, the study found that the

ban on self-service significantly increased the checking of young

purchasers' identification by retail clerks and, in particular,

discouraged younger adolescents from attempting to buy tobacco.66

iii. Mail-order sales. In addition to prohibiting the sale of

tobacco products in vending machines and the use of self-service

displays, proposed Sec. 897.16(c) would prohibit mail-order sales and

redemption of mail-order coupons. Mail-order sales provide no face-to-

face interaction to verify the age of the consumer. The current

industry practice merely requires that the customer provide a birth

date or check a box on

[[Page 41326]]

the mail-order card to verify, for example, that he/she is 21. The

agency concludes that proposed Sec. 897.16(c) would significantly

reduce access to cigarettes and smokeless tobacco products by persons

younger than 18. The ban of mail-order sales is recommended by the IOM

67 and Philip Morris recently announced that it would discontinue

mail-order sales in order to reduce access to young people.68

d. Free samples. Proposed Sec. 897.16(d) would prohibit

manufacturers, distributors, and retailers from distributing free

samples of tobacco products. The agency is proposing this restriction

because many young people, including elementary school children,

receive free samples.69 Free samples are often distributed at

``mass intercept locations'' such as street corners and shopping malls,

and events such as music festivals, rock concerts, and baseball games.

They have been distributed at zoos, at bars and restaurants where

entertainers perform and promote the product, and through the

mail.70 Free samples give young people a ``risk-free and cost-free

way to satisfy their curiosity'' about tobacco products and, when

distributed at cultural or social events, may increase social pressure

on young people to accept and use the free samples.71

For smokeless tobacco products, distribution of free samples to

young people has been a foundation of the growth strategy of the UST

(makers of Skoal, Copenhagen, Happy Days, and other smokeless tobacco

products).72 In 1992 and 1993, the smokeless tobacco industry

spent nearly $16 million annually on the distribution of free samples.

The industry's largest expenditure in 1993 was on coupons and retail

value-added articles to encourage trial use ($32 million).73

Despite industry-imposed age restrictions on the distribution of

samples, underage persons are able to obtain samples either by lying

about their age or by enlisting older friends and relatives to obtain

samples for them.74 The lure of free samples can also be quite

attractive; one advertising campaign offering a sample pack of Skoal

Bandits reportedly generated 400,000 responses in a 3-month

period.75

Even elementary school children are able to obtain free cigarette

samples easily. One survey examined five schools in Chicago and a

sample of students at DePaul University. Four percent of the elementary

school students reported receiving free samples of cigarettes

themselves. Nearly half of the elementary and high school students and

one-quarter of the college students ``* * * reported having seen free

cigarettes given to children and adolescents.'' 76 In another

survey, one-third of approximately 500 New Jersey high school students

who were current or former smokers reported receiving free cigarette

samples before the age of 16.77

The distribution of free samples to minors occurs despite the

industry's voluntary code against distributing cigarettes to persons

under the age of 21. The recent IOM report noted several problems with

the industry's voluntary code, stating that ``distribution to minors

appears to be nearly inevitable.'' 78 While the voluntary code

instructs employees distributing samples to ask for identification and

ask other questions if they suspect a potential recipient to be under

age, distribution of samples to minors occurs anyway because the

samplers are often placed in crowded places and constrained by time:

There is a significant time constraint in asking for proof of

age from all young-looking individuals who solicit samples, not to

mention the time required for the myriad of other questions which

samplers are instructed to ask. Samplers are often surrounded on all

sides by those soliciting samples and a dozen or more outstretched

arms waiting (or grabbing) for samples * * * those passing out

samples are usually quite young themselves. These youthful

distributors may lack the psychological wherewithal to request proof

of age and refuse solicitations from those in their own peer

group.79

Consequently, the ineffectiveness of the industry's voluntary code and

the fact that State laws that ban or restrict the distribution of free

samples are rarely enforced led IOM to recommend prohibiting

distribution of free samples in public places and through the

mail.80 The National Cancer Institute reached a similar conclusion

in 1991, and stated, ``The offer of free cigarettes and smokeless

tobacco products is reminiscent of the drug pusher who gives the first

sample free to get his customer hooked.'' 81 The proposed rule is

consistent with IOM's and NCI's recommendations.

C. Subpart C--Labels and Educational Programs

Proposed subpart C would provide the established name for

cigarettes and smokeless tobacco products that is required by sections

502 of the act. In addition, it would require that cigarette and

smokeless tobacco manufacturers fund a national program including

educational messages in order to undo the effects of young people's

near constant exposure to pro-tobacco messages and, thus, to discourage

young people from using cigarettes and smokeless tobacco products,

pursuant to sections 201, 502, and 520(e) of the act.

1. Section 897.24--Established Names for Cigarettes and Smokeless

Tobacco Products

Proposed Sec. 897.24 would provide the ``established name'' for

cigarettes, cigarette tobacco, and smokeless tobacco products. This

provision is intended to implement section 502(e)(2) of the act, which

states that a device shall be deemed misbranded if its label fails to

display the established name for the device ``in type at least half as

large as that used thereon for any proprietary name or designation for

such device.'' Section 502(e)(4) of the act, in turn, explains that the

``established name'' for a device is the applicable official name of

the device designated under section 508 of the act (21 U.S.C. 358), the

official title in a compendium if the device is recognized in an

official compendium but has no official name, or ``any common or usual

name of such device.''

In this case, no official names have been designated under section

508 of the act, and no compendium provides an established name for

these products. Consequently, proposed Sec. 897.24 would consider

``cigarettes,'' ``cigarette tobacco,'' and the common or usual names

for smokeless tobacco products (such as ``moist snuff'' or ``loose leaf

chewing tobacco'') as established names.

2. Section 897.29-Educational Programs Concerning Cigarettes and

Smokeless Tobacco Products

The Surgeon General's 1994 Report suggested that ``a nationwide,

well-funded antismoking campaign could effectively counter the effects

of cigarette advertising in its currently permitted media forms.''

82 IOM also recommended that ``counter-tobacco advertisements

should be intensified to reverse the image appeal of pro-tobacco

messages, especially those that appeal to children and youths.''

83

FDA's proposal is consistent with the Surgeon General's and IOM's

findings. Proposed 897.29 would require each manufacturer to establish

and maintain a national public educational program, including major

reliance on television messages, to combat the effects of the pervasive

and positive imagery that has for decades helped to foster a youth

market for tobacco products.

FDA based proposed 897.29, in part, on historical experience. From

July 1, 1967 to December 31, 1970, the Federal Communications

Commission, as part of

[[Page 41327]]

the ``Fairness Doctrine,'' required broadcasters to provide a

significant amount of time for antismoking messages on television and

radio. Thus, one antismoking message appeared for every three or four

industry-sponsored, prosmoking advertisements. This amounted to

approximately $75 million (in 1970 dollars) in commercial air time for

antismoking messages annually, until a ban on prosmoking advertisements

on television and radio became effective on January 1, 1971. Thus, for

several years, the American public was exposed to both pro- and

antismoking messages.

During this time, per capita cigarette consumption declined 7

percent, from 4,280 in 1967 to 3,985 in 1970. Most of the 7 percent

decline (6.2 percent) was attributable to the anti-smoking

messages.84 This was the first time since the early 1930's that

per capita consumption declined consecutively for 3 years and was one

of the largest declines ever recorded. Additionally, a study of nearly

7,000 adolescents found that adolescent smoking rates declined during

this period.85 The greatest decline occurred in the first year

that the antismoking messages appeared. A 1972 econometric analysis

confirmed that the antismoking messages had up to a 5.6 times greater

effect on cigarette consumption than promotional cigarette

advertising.86 When the antismoking messages ended on television

and radio (due to the Federally-mandated ban on advertising on

television and radio, thereby ending the application of the Fairness

Doctrine), per capita cigarette consumption began to rise.

A similar experience occurred in Greece during the late

1970's.87 In an effort to reduce cigarette consumption, the Greek

government launched an antismoking campaign and, in 1978, banned

cigarette advertising on television and radio. In 1979, the Greek

Government intensified its antismoking effort by adding television and

radio counter-advertising as well as a community-based print education

campaign. This enhanced campaign lasted 2 years but was discontinued

following a change in government, with the ban on television and radio

advertising remaining. Evaluation of this experience revealed that,

during the counter-advertising phase, the annual increase in per capita

tobacco consumption dropped to zero, compared to the pre-campaign

advertising ban rate of 6 percent increase in consumption. When the

campaign ended, the annual rate of increase in tobacco consumption

quickly increased to earlier levels. This experience suggests that

intensive health education and counter-advertising campaigns can be

effective.

There have been numerous research and demonstration projects

evaluating the effectiveness of counter-advertising and mass-media

smoking cessation programs.88 As the research designs have

evolved, more has been learned about which types of programs are

effective and under what conditions. Most recently, well-evaluated

studies of programs in Vermont, California, and elsewhere suggest that

mass-media and counter-advertising campaigns can have a sustained

effect on both preventing teens from starting to smoke and in helping

smokers quit.

In Vermont, researchers tested the effect of mass-media and school

health education programs.89 Students exposed to both school and

media interventions were 35 percent less likely to have smoked in the

past week than students exposed only to the school program, and this

preventive effect persisted for at least 2 years following the

completion of the intervention program. The decrease occurred even in

students who were considered to be at slightly higher risk of becoming

smokers because of demographic considerations (lower family income).

There have been similar results in helping smokers interested in

quitting. In California, the Department of Health Services has been

conducting a $26 million multi-year media campaign to prevent teens

from starting to smoke and help adult smokers quit. In a preliminary

study of the campaign's effectiveness, researchers found that the state

media campaign ``had a negative impact on cigarette consumption, while

industry advertising had a positive impact on cigarette consumption.''

The authors concluded that ``[t]his suggests, as one would expect, that

increasing state media expenditures and decreasing industry advertising

are both effective ways to deter smoking.'' 90 According to a

recent evaluation, the media campaign's advertisements directly

influenced 7 percent (33,000) of Californians who quit smoking in 1990

to 1991, and contributed to the quitting of another 173,000.91 The

California media program has also resulted in high levels of awareness

among young people,92 and may have contributed to stopping the

rise in teen smoking that had been occurring in California prior to the

campaign.93

FDA has proposed general criteria in the codified language. The

following describes one set of requirements for such a program that the

agency is considering requiring in a final rule. FDA is soliciting

comments on whether the described program would accomplish the goal of

creating an effective national program that would correct and combat

the effects of the pervasive positive imagery in advertising and, thus,

help reduce young people's use of tobacco products or whether

additional or different requirements would be preferable. The program

would be national in scope and could require that the companies

purchase certain times and places on television programming (referred

to in the industry as a ``buy''). For example, a television buy could:

(1) Devote at least 80 percent of its resources to television messages,

both on network and on cable television, during prime time hours

(between the hours of 8 p.m. and 11 p.m.), early fringe time (between

the hours of 4 p.m. and 6 p.m.), and access time (time that is

allocated to local broadcasting stations); (2) be directed to persons

between the ages of 12 and 17 years; and (3) be national in scope.

Moreover, the buy could include advertising time in at least 50 percent

of television programs rated by a national rating service as being in

the top 20 for persons between the ages of 12 and 17 and corresponding

to the demographic profile of underage tobacco users by gender, racial,

and ethnic characteristics, and the remaining percentage in programs

with either high concentration or high coverage to young people. The

buy could ensure that the manufacturer reach an average of 70 to 90

percent of all persons between the ages of 12 and 17 years five to

seven times per 4-week period. (The 4-week period is often referred to

as a ``flight.'') Such requirements would help to ensure that the

educational messages reach large numbers of young people and are

consistent with the way in which advertising is typically purchased. In

addition, to ensure that the messages change over time and remain novel

and of interest to young people, each message could be limited in use

so that each message would be presented no more than 15 times per

quarter to the top two-fifths (referred to as top two quintiles) of

television viewers between the ages of 12 and 17 and who watch the most

television.

The industry members could select from a variety of messages

maintained by FDA. FDA could collect and maintain a file of messages

developed by states with active tobacco control programs (such as

California and Massachusetts), from voluntary health organizations (as

was done by broadcasters during the Fairness Doctrine period), and from

other appropriate sources, including messages developed and submitted

by the tobacco

[[Page 41328]]

companies. FDA could determine which messages would be appropriate in

consultation with other entities and offices within the Department of

Health and Human Services, such as CDC's Office on Smoking and Health;

with other federal agencies with expertise in consumer behavior and

marketing, such as the Federal Trade Commission; and with consultants

and contractors who are expert in communications theory and practice.

FDA, in consultation with other federal agencies and other experts,

could review the messages to ensure that their language and imagery are

effective with 12- to 17-year olds. Each message would be evaluated to

determine if it were designed to influence those beliefs and attitudes

of 12- to 17- year olds that are most likely to affect the initial

decision to smoke (or to start using smokeless tobacco products), the

decision to continue smoking (or continue to use smokeless tobacco

products), and/or the decision to quit. Examples of appropriate

messages include those addressing addiction, weight control, effective

ways to refuse a cigarette and other social influences that are related

to youth smoking.

Moreover, an appropriate educational program could require each

manufacturer to submit, on a quarterly basis, analyses of every

television buy by time period on network television (referred to as

``day part''), cable, and other media, prepared and executed by the

party or parties responsible for the advertising. This requirement

could fulfill the manufacturer's responsibility to report on the

effectiveness of the program.

In addition, each manufacturer could conduct tracking studies of

persons between the ages of 12 and 17. This would enable the

manufacturers to determine how effective their educational programs and

buys were. The studies could be performed twice per year and would need

to meet recognized industry standards for tracking studies, such as

measuring recall and recognition of the televised messages. These

studies could be given to FDA, which could review the results of the

industry's testing in consultation with other experts as needed, in

order to help the agency refine its selection criteria for messages.

Finally, the remaining 20 percent of the messages could be placed

in other media, with emphasis on radio and outdoor advertising.

Consideration should be given to ensuring that these messages appear in

media that are heavily used by young people.

Under proposed Sec. 897.29, each manufacturer would devote an

amount of money to the corrective educational program proportionate to

its share of the total advertising and promotional expenditures of the

cigarette and smokeless tobacco industry. Thus, a company whose

expenditures equal 40 percent of total industry expenditures would be

required to allocate an amount equal to 40 percent of the total monies

required. The agency calculated the amount of money that would be

allocated to the initial corrective educational program by looking at

the period of time when the Fairness Doctrine was in effect. It was

estimated that, at that time, approximately $75 million a year in air

time was provided by broadcasters for anti-smoking messages, which

translates to $290 million in 1994 dollars. In order to ensure an

effective program, the agency is proposing that approximately half that

amount, or $150 million a year, be allocated initially. Under this

proposal, the agency could determine each manufacturer's proportionate

share of the overall advertising and promotional expenditures of the

cigarette or smokeless tobacco industry by referring to the most recent

figures reported to the FTC under the Cigarette Act or the Smokeless

Act. This provision is intended to ensure that the corrective

educational programs are adequately funded in proportion to each

manufacturer's overall reported advertising and promotion expenses.

D. Subpart D--Labeling and Advertising

1. Introduction

Proposed subpart D would establish certain requirements for

cigarette and smokeless tobacco product labeling (excluding product

labels) and advertising pursuant to sections 520(e), 502(q), and 502(r)

of the act. The proposal would apply similar requirements to labeling

and advertising in print media because both are used to convey

information about the product; to promote consumer awareness, interest,

and desire; to change or shape consumer attitudes and images about the

product; and/or to promote good will for the product. Therefore, FDA

has decided to place the labeling provisions with the advertising

requirements rather than place the labeling provisions with those

pertaining to product labels.

Regulating cigarette and smokeless tobacco product labeling and

advertising is essential to decrease young people's use of tobacco

products. Proposed subpart D would preserve the informational component

of labeling and advertising while decreasing their appeal to children

and adolescents.

Briefly, the proposed regulations would require that advertising in

any publication with a youth readership of more than 15 percent (youth

being defined as under 18) or more than 2 million children and

adolescents under 18 be limited to a text-only format in black and

white. Advertising in any publication that is read primarily by adults

would be permitted to continue to use imagery and color. Pursuant to

section 502(r), the proposed regulations would require that cigarette

advertising contain a statement of the product's established name,

intended use, and a brief statement regarding relevant warnings,

precautions, side effects, and contradictions. In addition, brand

identifiable non-tobacco items, such as hats and tee shirts, and brand

identifiable sponsorship of events, such as the Virginia Slims Tennis

Tournament or a sponsored event using a tobacco product logo or symbol,

would be prohibited.

Section 201(m) of the act (21 U.S.C. 321(m)) defines ``labeling''

as ``all labels and other written, printed, or graphic matter'' that

are on an article or its containers or wrappers, or ``accompanying such

article.'' In interpreting the phrase ``accompanying such article,''

the Supreme Court has held that it is not necessary for the labeling to

physically accompany the product (see Kordel v. United States, 338 U.S.

345, 350 (1948)). Thus, labeling includes traditional promotional

items, such as booklets, calendars, movies, etc., and also less obvious

types of labeling, such as clocks, coffee mugs, desktop toys, and even

tee shirts.94 FDA would, therefore, consider non-tobacco items

distributed by cigarette and smokeless tobacco companies with the

product's brand name or product identification printed on them (e.g.,

tee shirts, hats, pens, golf tees) to be ``labeling,'' and these would

be prohibited.

Subpart D is based, in part, on the recommendations of major U.S.

and world health organizations and on current efforts by other

countries to reduce tobacco use. These organizations and countries

support advertising restrictions as an essential part of any

comprehensive program to reduce or eliminate smoking by young people.

The American Medical Association, American Heart Association, American

Cancer Society, American Lung Association, American Academy of Family

Physicians, the World Health Assembly, and the World Health

Organization have recommended restrictions on advertising and promotion

including a total ban of all promotional and advertising

activities.95

[[Page 41329]]

Additionally, the recent IOM report recommended that, to ensure

that one clear message about the health risks of tobacco use is

disseminated, the government should see to it that the ``contradictory

message [minimizing the risk] now conveyed by the tobacco industry''is

stopped.96 The report recommended many restrictions that are

similar to those in the proposed rule. For example, the report

recommended that advertising either be banned entirely or restricted to

a text-only format.97 The IOM said that such an approach would

``eliminate all the images that imply that tobacco use is beneficial

and make it attractive, and that encourage young people to use tobacco

products.'' 98

The proposed labeling and advertising regulations are also based

upon numerous studies and reports. The first and most compelling piece

of evidence supporting restrictions on cigarette and smokeless tobacco

product labeling, advertising, and promotion is that these products are

among the most heavily advertised products in America. Between 1970 (1

year before Federal law prohibited cigarette advertisements on

television and radio) and 1993, cigarette advertising and promotional

expenditures increased from $361 million to $6 billion, a 1,562 percent

increase.99 These messages were disseminated in print media, on

billboards, at point of sale, by direct mail, on specialty items (hats,

tee shirts, lighters), at concerts and sporting events, in direct mail

solicitations, as sponsorships on television, and in other media. FDA

is concerned that the amount of advertising, its attractive imagery,

and the fact that it appears in so many forums, overwhelms the

government's health messages.

Advertising and promotion of smokeless tobacco products, although a

much smaller market than cigarettes, also increased over the years. The

largest increase in advertising expenditures for smokeless tobacco

products occurred for moist snuff. U.S.Tobacco (UST), the market leader

in moist snuff, increased its television advertising expenditures from

$800,000 in 1972 to $4.6 million in 1984,100 an increase of 485

percent. By 1993, total advertising and promotional expenditures for

smokeless tobacco products exceeded $119 million. This increase was

largely attributable to the advertising of moist snuff ($71.4

million).101 This increase in expenditures corresponds to the

growth of the moist snuff portion of the smokeless tobacco market, from

36 million pounds in 1986 to 50 million pounds in 1993. All other

segments of the smokeless tobacco market declined during that

period.102

In addition to spending large amounts on advertising, the cigarette

and smokeless tobacco product industries have disseminated a variety of

advertising and promotional messages that have had an enormous impact

upon young people's attitudes towards smoking. In summarizing its

analysis of the industry's advertising practices, IOM stated:

The images typically associated with advertising and promotion

convey the message that tobacco use is a desirable, socially

approved, safe and healthful, and widely practiced behavior among

young adults, whom children and youths want to emulate. As a result,

tobacco advertising and promotion undoubtedly contribute to the

multiple and convergent psychosocial influences that lead children

and youths to begin using these products and become addicted to

them.103

The pervasiveness and magnitude of the labeling and advertising for

these products create an atmosphere of ``friendly familiarity''

104 that affects and shapes a young person's views towards tobacco

products. Thus, FDA's decision to propose stringent regulations for

labeling and advertising is based upon compelling evidence that

advertising and labeling play an important role in shaping a young

person's attitude towards, and willingness to experiment with,

cigarettes and smokeless tobacco products.

2. Advertising, Labeling, and Adolescents

Products may be advertised and promoted for their symbolic or

fanciful attributes. Advertising utilizing this technique tries to

convey that consumption of the product will enhance the user's self

image 105 or image in the community. Consumers purchasing products

for these symbolic attributes hope to acquire the image as well as the

product itself.106 This psychosocial consumer phenomenon is

particularly descriptive of adolescent consumer behavior. As one

consumer psychologist remarked:

[adolescence] create[s] a lot of uncertainty about the self, and

the need to belong and to find one's unique identity as a person

becomes extremely important. At this age, choices of activities,

friends, and ``looks''often are crucial to social acceptance. Teens

actively search for cues from their peers and from advertising for

the ``right''way to look and behave.* * * Teens use products to

express their identities, to explore the world and their new-found

freedoms in it, and also to rebel against the authority of their

parents and other socializing agents. Consumers in this age sub-

culture have a number of needs, including experimentation,

belonging, independence, responsibility, and approval from others.

Product usage is a significant medium to express these

needs.107

For example, adolescent males often use ``such 'macho' products as

cars, clothing, and cologne to bolster developing and fragile masculine

self-concepts.'' 108

Adolescents view cigarettes as a symbol to be used in helping to

create a desired self image and to communicate that image to others.

Cigarette advertising reinforces this symbolism and links smoking to

success, social acceptance, sophistication, and a desirable lifestyle.

The rugged and masculine Marlboro Man conveying, in the words of the

Chief Executive Officer and President of Philip Morris, ``elements of

adventure, freedom, being in charge of your own destiny,'' 109 and

the cool Joe Camel, giving humorous dating tips, provide imagery that

adolescents can accept as identifying badges. Not surprisingly, these

brands are among the most popular with young people. One Canadian

tobacco company described its ``masculine''targeting in these words:

Since 1971, [the company's] marketing strategy has been to

position [a cigarette brand] as a ``masculine trademark for young

males.'' It has been our belief that lifestyle imagery conveying a

feeling of independence/freedom should be used to trigger the desire

for individuality usually felt by maturing young males.110

Advertising for cigarette brands targeted to women have proven

successful in attracting young female smokers. One study correlated

trends in rising smoking initiation rates among girls with the

introduction of several brands targeted at women. Some of these

campaigns utilized themes thought to be appealing to women (e.g.

liberation and feminism, images of slimness and sophistication). The

advertising campaigns preceded a rapid increase in smoking initiation

rates among girls under 18 that was not accompanied by any increase in

smoking rates for women, boys, or men.

Thus, advertising can play an important role in a youth's decision

to use tobacco. Many researchers, including those within the cigarette

industry, have advanced a stage-based model of smoking uptake.111

The first, preparatory stage is when a child or adolescent starts

forming his or her attitudes and beliefs about smoking, and sees

smoking as a coping mechanism, as a badge of maturity, as a way to

enter a new peer group, or as a means to display independence.112

During this stage, pervasive advertising imagery that glamorizes

tobacco use may be an important factor in shaping beliefs. The

[[Page 41330]]

middle, trying and experimenting stages occur when the first cigarette

is smoked, often at the urging of a peer, and becomes repeated but

irregular. It is important to note that those who experiment often, or

begin smoking at an early age, are much more likely to become regular

smokers.113 Therefore, age of initiation is important.

The final stage, nicotine dependence and addiction, is

characterized by a physiological need for nicotine. At this stage, the

adolescent develops a tolerance for nicotine and can experience

withdrawal symptoms (such as dysphoric or depressed mood, insomnia,

irritability, frustration or anger, anxiety, and difficulty

concentrating) if he or she attempts to quit. However, of those who try

to quit, few succeed without help, and there is a high probability of

relapse.114

In the early stages of smoking, i.e., at initiation, psychosocial

factors are decisive, and those factors are most often capitalized on

in the themes used in tobacco product advertising. In the final stage,

as smoking takes hold, physiological factors (and even health concerns)

dominate. A document prepared by Imperial Tobacco Ltd. stated:

At a younger age, taste requirements and satisfaction in a

cigarette are thought to play a secondary role to the social

requirements. Therefore taste, until a certain nicotine dependence

has been developed, is somewhat less important than other

things.115

Many behavioral and personal characteristics influence an

adolescent's decision to use cigarettes or smokeless tobacco products,

including: rebelliousness; risk-taking personality; use of other legal

or illegal drugs; belief in the perceived utility of smoking (to cope

with stress, control weight, or improve one's self-image); low self-

esteem or depression; disbelief of or discounting health risks; and

poor academic achievement.116 Cognitive factors specific to

children and adolescents also play a role in the early decision to

smoke. Children and adolescents often focus on present needs and

concerns, and ignore risks that might exist in the future. They exhibit

a sense of personal invulnerability that permits them to act as if they

were immortal.117 Tobacco advertising plays on these feelings and

exploits these adolescent vulnerabilities. As one report, created for a

Canadian cigarette company, stated:

Starters no longer disbelieve the dangers of smoking, but they

almost universally assume these risks will not apply to themselves

because they will not become addicted. Once addiction does take

place, it becomes necessary for the smoker to make peace with the

accepted hazards. This is done by a wide range of

rationalizations.118

3. Industry's Marketing Practices

Industry documents indicate that cigarette manufacturers have

conducted extensive research on smoking behavior and attitudes in young

people and how advertisements should be made to appeal to young people.

Documents from Philip Morris' files indicate that the company did, at

least on one occasion, conduct research about the smoking habits of

young people, questioning people in Iowa, including teen-agers as young

as 14.119 More specifically, research conducted for a Canadian

affiliate of one U.S. cigarette firm focused on the need to attract

young consumers, stating:

Ads for teenagers must be denoted by a lack of artificiality,

and a sense of honesty. Attempts at use of celebrities ***do not

seem to really click. If freedom from pressure and authority can

also be communicated, so much the better.120

Research conducted by an American cigarette firm, and confirmed by

other tobacco companies, revealed another significant behavior: most

smokers continue to purchase the brand they smoked when they became

regular smokers. Brand loyalty is seen in many consumer products (such

as toothpaste, coffee, and automobiles) but is particularly strong for

tobacco products. A 1989 ``Wall Street Journal''article showed

cigarettes as having the highest percentage of brand loyalty among

consumers of any consumer product, at 71 percent.121

Knowledge about brand loyalty among cigarette smokers, coupled with

the fact that most smokers began smoking before the age of 18, may

explain why cigarette manufacturers have focused advertising and

promotional efforts on younger people. R.J. Reynolds devised what it

called a ``Young Adult Smokers'' (``YAS'') program that was apparently

designed to appeal specifically to young smokers, 18 to 24 year olds,

and more narrowly to 18 to 20 year olds. An element of that program,

known as FUBYAS, an acronym for First Usual Brand Young Adult Smokers,

captured the concept that a smoker's first regular brand is the brand a

smoker will stay with for years. This program featured the use of

promotional items, such as hats and tee shirts bearing the Camel brand

name, the cartoon Joe Camel, and imagery, that appealed to young

people. Although these programs were ostensibly directed at people

between the ages of 18 and 24, company memoranda suggest that the

target population included high school students. For example, on

January 10, 1990, a manager in Sarasota, Florida, issued a memorandum

asking cigarette sales representatives to identify stores:

* * * that are heavily frequented by young adult shoppers. These

stores can be in close proximity to colleges [,] high schools or

areas where there are a large number of young adults [who] frequent

the store.122

On May 3, 1990, when the ``Wall Street Journal'' published this

memorandum, the cigarette firm stated that the memorandum was a

``mistake'' and violated company policy by targeting high

schools.123

Yet, on April 5, 1990, a manager in Moore, OK, issued a similar

memorandum regarding the YAS program asking sales and service

representatives to identify what was termed ``Retail Young Adult Smoker

Retailer Accounts.''One criterion for identifying a YAS account

included facilities ``located across from, adjacent to are [sic] in the

general vicinity of the High Schools or College Campus [sic].''

124 This second memorandum suggests that promotions aimed at high

school students were part of the company's marketing strategy.

Sales figures suggest that the YAS program was extremely effective.

Camel quickly became one of the most popular cigarette brands among

people under age 18. Prior to the introduction of the Joe Camel

campaign, Camel cigarettes commanded no more than 3 or 4 percent of the

youth market. One year into the campaign, the youth share rose to 8.1

percent and by 1991 it was at least 13 percent.125

While not all advertising campaigns are so blatantly directed at

juveniles, campaigns using more universal themes can be as effective

with young people. According to an advertising executive with the

advertising agency that created the Marlboro cowboy, ``The Marlboro

cowboy dispels the myth that in order to attract young people, you've

got to show young people.'' The cowboy theme of independence can be

translated into other venues that have appeal for young people and be

sold as an appropriate and desirable image. According to John Landry,

the Philip Morris executive credited with designing the Marlboro

campaign, the Marlboro theme sells because it fits young people's

desires. In 1973, Philip Morris sponsored the Marlboro Cup for the

first time. Landry recalls that ``Secretariat [the winning horse]

became a hero to young people. Youth were reaching out for something,

and someone they could identify with * * *

[[Page 41331]]

`Marlboro Country' fit these desires, this search people were going

through.'' ``Something young people could trust.''A candid appraisal of

the purpose of the Marlboro theme was provided by the marketing

director with Philip Morris in Argentina, ``Marlboro magic--people

using things with [the] Marlboro logo * * * was projected to other

products around it and when those kids who were playing with Marlboro

merchandise 5 to 10 years ago--when they start smoking they'll smoke

Marlboro.'' 126

With regard to smokeless tobacco products, the U.S. Tobacco Company

(UST) successfully revived a declining market by targeting young

people, especially young men, in its promotion and advertising. In

1970, the segment of the population with the highest use of these

products was men over age 50, and young males were among the lowest.

Fifteen years later, there had been a 10-fold increase in the use of

smokeless tobacco products among young males, whose use was double that

of men over age 50.127

The increased use of smokeless tobacco products by young people was

precisely the objective of a marketing strategy of UST set in motion

almost 30 years ago. In 1968, officials at UST held a marketing meeting

where, according to the ``Wall Street Journal,'' the vice-president for

marketing said, ``We must sell the use of tobacco in the mouth and

appeal to young people * * * we hope to start a fad.'' 128 Another

official who attended the meeting was quoted as saying, ``We were

looking for new users--younger people who, by reputation, wouldn't try

the old products.'' 129 When a rival company developed a smokeless

tobacco product that 9-year-old children began using, a UST regional

sales manager reported to UST's national sales manager that the product

was mostly used by children and young adults ``from 9 years old and

up'' and noted that this age was ``four or five years earlier than we

have reached them in the past.'' 130

Responding to a question years later about why so many young males

were buying smokeless tobacco, Louis F. Bantle, then chairman of the

board of UST said, ``I think there are a lot of reasons, with one of

them being that it is very `macho'.'' 131 Playing to this

``macho'' perception of smokeless tobacco by young males,

advertisements for smokeless tobacco products have traditionally used a

rugged, masculine image and have been promoted by well-known

professional athletes. UST's successful penetration into the youth

market is indicated in a statement by Mr. Bantle: ``In Texas today, a

kid wouldn't dare to go to school, even if he doesn't use the product,

without a can in his Levis'.'' 132

UST distributes free samples of low nicotine-delivery brands of

moist snuff and instructs its representatives not to distribute free

samples of higher nicotine-delivery brands. The low nicotine-delivery

brands also have a disproportionate share of advertising relative to

their market share. For example, in 1983, Skoal Bandits, a starter

brand, accounted for 47 percent of UST's advertising dollars, but

accounted for only 2 percent of the market share by weight. In

contrast, Copenhagen, the highest nicotine-delivery brand, had only 1

percent of the advertising expenditures, but 50 percent of the market

share. This advertising focus is indicative of UST's ``graduation

process'' of starting new smokeless tobacco product users on low

nicotine-delivery brands and having them graduate to higher nicotine-

delivery brands as a method for recruiting new, younger users.133

Tobacco companies deny any youth-directed advertising and promotion

activities.134 Moreover, the industry claims that advertising

plays no role in a person's decision to start smoking; that tobacco

advertising is designed solely to capture brand share from competitors

and maintain product loyalty. The industry further claims that the

tobacco market is a ``mature'' market in which awareness of the product

is universal and overall demand is either stable or declining.135

In a mature market, the industry contends, advertising functions to

merely shift customers from one brand to another, but does not act as a

stimulus to new customers to enter the market.

One purpose of cigarette advertising may be to encourage or

discourage brand switching among current tobacco users. Some experts

believe, however, that this same advertising encourages new consumers

to begin using these products.136 Tobacco advertising, promotion,

and marketing, on which the industry spends over $6 billion each year,

may serve both purposes largely out of market necessity. Market

expansion, in the sense of new customers entering the market, must

occur to maintain total tobacco sales and avoid a significant market

decline. ``[T]he cigarette industry has been artfully maintaining that

cigarette advertising has nothing to do with total sales * * * [T]his

is complete and utter nonsense. The industry knows it is nonsense,''

wrote a former cigarette advertising executive.137

Evidence indicates that acquiring a portion of the ``starter''

market, overwhelmingly people in their teens, is regarded by the

industry as essential to a company's continuing economic viability. One

document acquired from Imperial Tobacco Limited (ITL) of Canada, a

sister company of the Brown & Williamson Company in the United States,

states:

If the last ten years have taught us anything, it is that the

industry is dominated by the companies who respond most effectively

to the needs of younger smokers.''138

To further this goal, ITL hired a consulting research company to

investigate attitudes about smoking among people aged 15 years and

older. The purpose of the research, i.e., how best to recruit new

smokers, is indicated in the following statement:

It is no exaggeration to suggest that the tobacco industry is

under siege. The smoker base is declining, primarily as a function

of successful quitting. And the characteristics of new smokers are

changing such that the future starting level may be in

question.139

Similar attitudinal research was done for R.J.R.-MacDonald, Inc.,

the Canadian subsidiary of R.J. Reynolds.140 A report entitled

YOUTH 1987 closely examined the lifestyles and value systems of ``young

men and women in the 15-24 age range.'' The report said the research

would:

provide marketers and policymakers with an enriched

understanding of the mores and motives of this important emerging

adult segment which can be applied to better decision making in

regard to products and programs directed at youth.141

A similar research objective was described in a 1969 research paper

presented to the Philip Morris Board of Directors.142 The paper

stated that one of its objectives was to probe ``[w]hy do 70 million

Americans * * * smoke despite parental admonition, doctors'' warnings,

governmental taxes, and health agency propaganda?'' 143 The paper

continues:

There is general agreement on the answer to the first

[question--why does one begin to smoke.] The 16 to 20-year old

begins smoking for psychosocial reasons. The act of smoking is

symbolic; it signifies adulthood, he smokes to enhance his image in

the eyes of his peers.144

Cigarette manufacturers are also aware of the difficulties young

people encounter when they try to quit smoking. Studies prepared for a

Canadian affiliate of a U.S. cigarette company state:

However intriguing smoking was at 11, 12, or 13, by the age of

16 or 17 many regretted their use of cigarettes for health reasons

and because they feel unable to stop smoking when they want

to.145

[[Page 41332]]

Another document declares:

[T]he desire to quit seems to come earlier now than before, even

prior to the end of high school. In fact, it often seems to take

hold as soon as the recent starter admits to himself that he is

hooked on smoking. However, the desire to quit, and actually

carrying it out, are two quite different things, as the would-be

quitter soon learns.146

Thus, these documents and reports suggest that cigarette

manufacturers know that young people are vital to their markets and

that they need to develop advertising and other promotional activities

that appeal to young people. They also suggest that cigarette

manufacturers know that once those young people become regular smokers,

that they, like adult smokers, find quitting smoking to be very

difficult, and most young people fail in their attempts to quit.

4. Empirical Research on the Effects of Cigarette Advertising

Activities on Young People

The 1994 Surgeon General's Report concluded that ``[a] substantial

and growing body of scientific literature has reported on young

people's awareness of, and attitudes about, cigarette advertising and

promotional activities.'' The report also found that ``[c]onsidered

together, these studies offer a compelling argument for the mediated

relationship of cigarette advertising and adolescent smoking.''

147 The Surgeon General's Report and the Institute of Medicine's

report 148 find that there is sufficient evidence to conclude that

advertising and labeling play a significant and important contributory

role in a young person's decision to use cigarettes or smokeless

tobacco products.

a. Studies of advertising recall, approval of advertising, and

young people's response to advertising. Many studies have shown that

young people are aware of, respond favorably to, and are influenced by

cigarette advertising.149 Even relatively young children are aware

of cigarette advertisements and can recall salient portions. A recent

Gallup survey found that 87 percent of adolescents surveyed could

recall seeing one or more tobacco advertisements and that half could

identify the brand name associated with one of four popular cigarette

slogans.150 One study found that over 34 percent of 12- to 13-

year-old California children surveyed could name a brand of cigarettes

that was advertised, despite the fact that Federal law bans cigarette

and smokeless tobacco product advertising on both radio and television,

the usual medium of information for children and adolescents.151

Other studies show that children who smoke are more likely to

correctly identify cigarette advertisements and slogans in which the

product names have been removed than are non-smokers.152 One study

surveyed a group of U.S. high school students and found a positive

relationship between smoking level and cigarette advertisement

recognition. Regular smokers recognized 61.6 percent of the tobacco

advertisements while non-smokers recognized 33.2 percent.153

Another study measured cigarette advertising exposure among

adolescents by determining which magazines they read and the number of

cigarette advertisements in each magazine. The study found that two

factors, advertising exposure and whether a friend or friends smoked,

were predictive of smoking status or intention to smoke. The authors

contended that the findings are consistent with the theory that

cigarette advertising successfully represents, through attractive

imagery, that smoking is a facilitator for acquiring a desired

characteristic or goal.154

These studies raised the question of whether smoking causes a

person to recognize advertisements or whether a person's exposure to or

recognition of advertisements leads to smoking or increases the

likelihood that a person will smoke. One study designed specifically to

address this issue 155 showed that causality flowed in both

directions: experimentation with cigarettes prompted subjects to attend

to and retain information from cigarette advertisements (smoking status

determined whether the child attended to advertising) and the amount of

information retained by each subject from cigarette advertisements

predicted the subjects' experimentation with cigarettes

(causality).156

Another study attempted to address the issue of causality by

questioning Glasgow school children at two different times, 1 year

apart. The study asked 640 Glasgow children between the ages of 11 and

14 about their intention to smoke and their recognition of cigarette

advertising. Children who were more inclined to smoke between the time

when the two interviews were conducted tended to be more aware of

cigarette advertising at the first interview than children who were

less inclined to smoke. The study concluded that cigarette advertising

has predisposing, as well as reinforcing, effects on children's

attitudes towards smoking and their smoking intentions.157

Other studies relating children's misperceptions about the

prevalence of smoking to advertising exposure and smoking status have

found that overestimating smoking prevalence appears to be a very

strong predictor of smoking initiation and progression to regular

smoking.158 The 1994 Surgeon General's Report found that young

people overestimate the prevalence of cigarette smoking 159 and

that advertising's pervasiveness plays a role in this misconception.

One unpublished study cited in the Surgeon General's Report supports

this finding. The study found that children in Los Angeles (where

cigarette advertising and promotional campaigns are prevalent) were

nearly three times more likely to overestimate the prevalence of peer

smoking than were children in Helsinki, Finland (where there has been a

total ban on advertising since 1978).160 Moreover, adolescent

smokers are more likely to overestimate the prevalence than adolescent

non-smokers.161 Overestimating smoking prevalence, as well as

self-reported exposure to advertising, have both been positively

correlated with the intention to smoke.162

Additional evidence indicates that children smoke many fewer brands

than adults and that their choices, unlike adults, are directly related

to the amount and kind of advertising.163 CDC recently reported

that 86 percent of underage smokers who purchase their own cigarettes

purchase one of three brands: Marlboro (60 percent), Camel (13.3

percent) and Newport (12.7 percent).164 These three brands were

also the three most heavily advertised brands in 1993.165 While

Marlboro has long been the most popular brand among young people,

Camel's share of the youth market increased from around 3 percent to

13.3 percent as a result of the invigorated Joe Camel campaign.

Adult preferences, on the other hand, are more dispersed. The three

most commonly purchased brands among all smokers (as measured by market

share) accounted for only 35 percent of the overall market share.

(Camel had approximately 4 percent of the market and its market share

did not change as a result of the Joe Camel advertising.) Furthermore,

the most popular ``brand'' of cigarette among adult smokers was no

brand at all: 39 percent of all cigarettes sold in the first quarter of

1993 were from the ``price value market'' which includes private label,

generics, and plain-packaged products.166 These brands typically

rely on little or no advertising and little or no imagery on their

packaging.

These studies present evidence that advertising plays a significant

role in children's smoking behavior. There are, in addition, individual

case studies that

[[Page 41333]]

illustrate the profound effect that certain cigarette advertising

campaigns can have on the youth market.

b. The effect of selected advertising campaigns, which were

effective with children. Two American studies and one British study

analyzed alleged youth-oriented campaigns to determine what effect they

had on the underage market. One U.S. study examined the effect on the

youth market of R.J. Reynolds' advertising campaign for Camel brand

cigarettes. In the mid 1980's, R.J. Reynolds sought to revitalize its

Camel brand cigarettes. It gave its symbol, the Camel, a new, more hip

personality. It transformed the symbol into ``Joe Camel,'' an

anthropomorphic ``spokescamel.'' The campaign featured Joe as a

humorous figure in history, as an advisor to young adults with ``smooth

moves'' and eventually as one of a gang of hip camels (``the hard

pack'' band and the gang at the watering hole bar). The study analyzed

1990 data from the California Tobacco Survey which consisted of a

telephone survey of 24,296 adults and 5,040 children under the age of

18. The study found that teenagers were twice as likely as adults to

identify Camel cigarettes as one of the two most advertised

brands.\167\

One study explored the power of the Joe Camel campaign to penetrate

the youth market. The study found that children as young as 3 years old

could identify Joe Camel as a symbol for smoking. This recognition

ranged from 30 percent of 3 year olds, to 91 percent of 6 year olds. In

fact, the recognition rates for Joe Camel surpassed the rates for

certain children's products, cereals, computers, and network television

symbols.\168\ A similar study funded by R.J. Reynolds found that 72

percent of 6 year olds and 52 percent of children between the ages of 3

and 6 could identify Joe Camel. These rates exceeded the recognition

rates for Ronald McDonald, which were 62 percent of the 6 year olds and

51 percent of children between the ages of 3 and 6.\169\ The higher

recognition rates for Joe Camel are remarkable because, unlike Ronald

McDonald who appears in television commercials during children's

viewing hours, Federal law prohibits cigarette advertisements on

television.

Data collected by researchers for the State of California found

that in 1990, 23.1 percent of the under age 18 market in California

purchased Camel as their brand. This represented a 230 percent increase

over its pre-``Joe Camel'' 1986 rate. The same growth rate did not

occur for adults.\170\ Nationally, Camel had less than 3 percent of the

youth market before the brand was repositioned in 1988 and Joe Camel

was introduced.\171\ By 1989, Camel's share of the youth market had

risen to 8.1 percent,\172\ and by 1992, 13 to 16 percent.\173\ During

this same period, Camel's share of the adult market barely moved from

its 4 percent level.\174\

The other American study used data from the National Health

Interview Survey to study trends in smoking initiation among 10- to 20-

year-olds from 1944 through 1980. The study found that initiation rates

for 18- to 20-year-old women peaked in the early 1960's and steadily

declined thereafter. Initiation rates for girls under 18, however,

increased abruptly around 1967. This was the same period when brands

specifically intended for women were introduced and heavily advertised.

The initiation rate was particularly steep for women who did not attend

college. The initiation rate for girls under the age of 18 peaked in

1973--about the same time that sales for these brands (Virginia Slims,

Silva Thins, and Eve) peaked. Between 1967 and 1973, smoking initiation

rates increased around 110 percent for 12-year-old girls, 55 percent

for 13-year-olds, 70 percent for 14-year-olds, 75 percent for 15-year-

olds, 55 percent for 16-year- olds, and 35 percent for 17-year-

olds.\175\

In contrast, initiation rates for men declined from 1944 to 1949

and did not decline again until the middle to late 1960's. Initiation

rates for boys under 16 showed little change during the entire study

period. The study concluded that advertising for women's brands during

this period was positively associated with increased smoking uptake in

girls under 18 years of age.\176\

The British study looked at a campaign featuring a flippant and

humorous character named ``Reg.'' The study found that 91 percent of

11- to 15-year-olds recognized the ads, compared with 52 percent of 33-

to 55-year-olds. Teenagers who liked the advertisements were more

likely to smoke. In fact, it was one of the two brands that most

children smoked. During the period in which Reg was advertised, smoking

by 11- to 15-years-olds in northern England increased from 8 percent to

10 percent, but the rate for this same age group in southern England,

where the advertisements did not appear, remained stable at 7

percent.\177\ The government, pursuant to the industry's voluntary

code, later requested that the company discontinue the advertising

campaign because of its disproportionate appeal to children.

These studies provide compelling evidence that promotional

campaigns can be extremely effective with young people.

c. Direct quantitative studies. There are many direct quantitative

studies of the relationship between advertising and tobacco use and of

the effects of advertising restrictions and bans on consumption. These

studies provide insight into the effects of advertising on the general

appeal of and demand for cigarettes and smokeless tobacco products.

They also provide evidence confirming advertising's effects on

consumption and the effectiveness of advertising restrictions on

reducing youth smoking.

A large, multinational study commissioned by the New Zealand

Government examined consumption trends in 33 countries between 1970 and

1986.\178\ Controlling for income, price, and health education, the

study found that the greater a government's degree of control over

tobacco promotion, the greater the annual average fall in tobacco

consumption and in the rate of decrease of smoking among young

people.\179\ One of the report's most relevant conclusions was that,

among the 18 countries with data on youth smoking, there is evidence of

a relationship between stringent government restrictions on tobacco

promotion and reduced uptake of smoking among young people. The report

concluded that there appeared to be a greater decrease in smoking

uptake in those countries with the most stringent measures compared

with those countries where advertising had not been affected.\180\

Other studies that have looked at populations in general provide

evidence that restrictions can have an important effect on total

consumption and provide inferential evidence of similar positive

effects on youth smoking. One such study conducted by the Chief

Economic Advisor of the Department of Health of the Government of Great

Britain found that advertising tends to increase consumption of tobacco

products and that restrictions on advertising tend to decrease tobacco

use beyond what would have occurred in the absence of regulation.\181\

After performing an in-depth analysis of data from the four countries

(Norway, Finland, Canada, and New Zealand) which had varying degrees of

tobacco advertising restrictions and for which data exist, the study

concluded that restrictions, including bans on some forms of

advertising or on all advertising, resulted in an overall decrease in

consumption. The study suggests that Norway's restrictions on all

advertising, sponsorship, and indirect advertising produces a 9 to 16

percent reduction in consumption over the long run.\182\ Finland's ban

on advertising and

[[Page 41334]]

restrictions on other nonadvertising measures reduced cigarette smoking

by 6.7 percent.\183\

Canada's Tobacco Products Control Act, which became effective on

January 1, 1989, banned most print advertising, restricted sponsorship,

and forbade indirect advertising (e.g., use of trade names on non-

tobacco items). Although advertising restrictions often take time to be

fully effective, the study found that in only 2 years following the

institution of government regulation, consumption was reduced 2.8

percent more than would have been expected had there been no

advertising restrictions.\184\

Another study looked at tobacco consumption per adult in the 22

countries of the Organization for Economic Cooperation and Development

between 1960 and 1986.\185\ The report reaffirmed the New Zealand

Board's conclusion that, as a group, countries prohibiting tobacco

advertising in most or all media experienced more rapid percentage

falls in consumption than the group of countries which permitted

promotion.\186\

Other studies try to measure the effect that advertising has on the

general level of consumption in a country. Advertising can have an

increased effect on consumption, even in those countries where the

smoking rate has been falling. The analyses are able to determine

whether consumption would have fallen at a greater rate but for the

advertising, and ascribe that difference (the slowed rate of decline)

to advertising.

One New Zealand study provides evidence that changes in advertising

expenditures can have an effect on youth smoking behavior. The study

analyzed the total sales of cigarettes sold by New Zealand supermarkets

over a 42 week period. The study design included advertising that had

recently been modified to contain newly-mandated, strong, varied

disease warnings that occupied 15 percent of the advertisement.

Moreover, no human form could be displayed in the advertising except a

hand and forearm, and one color apart from black was usually used. The

results indicated that advertising for upscale brands of cigarettes did

not raise cigarette consumption, but that consumption of an inexpensive

brand with a heavy youth appeal did increase with increased

advertising. Moreover, the study found that the advertising for the

new, inexpensive brand had the additional effect of recruiting young

smokers and increasing the market base.\187\

Studies that assessed the response of large population groups to

changes in advertising generally confirm a finding that advertising has

a positive effect on consumption. The most recent comprehensive

analysis of existing studies on the effect of advertising expenditures

on consumption rates was done in the English study, discussed above.

Among other things, the study looked at the effect of yearly

fluctuations in advertising expenditures within several countries, but

principally within the United States and United Kingdom. The result was

that the ``preponderance of positive results points to the conclusion

that advertising does have a positive effect on consumption.'' \188\

Individual, smaller studies \189\ have examined the same question and

confirmed a finding of effect of advertising on consumption.\190\

5. Summary of Evidence

The agency concludes that the preponderance of quantitative and

qualitative studies of cigarette advertising suggests: (1) A causal

relationship between advertising and youth smoking behavior, and (2) a

positive effect of stringent advertising measures on smoking rates and

on youth smoking. Moreover, industry statements indicate the importance

of the youth market segment to the industry's continued success.

Actions taken by industry members to attract young smokers have also

resulted in attracting children and adolescents. Finally, examples of

specific campaigns directed at young people support the hypothesis that

cigarette advertising and promotion play an important role in

encouraging young people to start smoking, to sustain their smoking

habit, and to increase consumption. Therefore, the agency finds that

stringent restrictions on advertising are essential if smoking by

adolescents is to be reduced.

6. Proposed Subpart D--Labeling and Advertising

a. General overview. Proposed subpart D would establish regulations

on the labeling and advertising of cigarettes and smokeless tobacco

products. Proposed subpart D consists of four sections. Proposed

Sec. 897.30 would establish the scope of permissible forms of labeling

and advertising. Proposed Sec. 897.32 would set forth the format and

content requirements. Proposed Sec. 897.34(a) would prohibit the sale

and distribution of non-tobacco items and services that are identified

with a cigarette or smokeless tobacco product brand name or other

identifying characteristics; proposed Sec. 897.34(b) would prohibit

proof of purchase gifts and games of chance and contests; and

Sec. 897.34(c) would prohibit sponsorship of events that are identified

with a cigarette or smokeless tobacco product brand name or other

identifying characteristics. Proposed Sec. 897.36 would address false

and misleading labeling and advertising. These sections are discussed

more fully below.

The proposed rule would establish different labeling and

advertising requirements for cigarettes and smokeless tobacco products.

These differences result from different Federal preemption provisions

contained in the two Federal laws requiring warning labels on those

products. Briefly, FDA believes that the Cigarette Act only preempts

FDA's authority to require additional statements about smoking and

health on cigarette packages, while the Smokeless Act prohibits FDA

from requiring additional information about health and tobacco use in

advertising as well as on the package of smokeless tobacco products.

For a more complete discussion, see section IV.C. below.

b. Proposed Sec. 897.30--permissible forms of labeling and

advertising. Proposed Sec. 897.30 would set forth the permissible forms

of labeling and advertising for cigarettes and smokeless tobacco

products. Labeling and advertising are used throughout this subpart to

include all commercial uses of the brand name of a product (alone or in

conjunction with other words), logo, symbol, motto, selling message, or

any other indicia of product identification similar or identical to

that used for any brand of cig

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