INTRODUCTION
Mr. Chairman and Members of the Committee, I am pleased to
testify today on behalf of the Food and Drug Administration (FDA)
about proposals for comprehensive tobacco legislation. We at FDA
and the Department of Health and Human Services (DHHS) appreciate
the leadership that you and Senator Kennedy have shown on this
issue, Mr. Chairman, and we look forward to working closely with
you. We do have some differences, including with some of the
details of the Discussion Draft that deal with FDA's authority.
But we are confident that we can resolve these issues because of
our mutual commitment to enact comprehensive legislation to
reduce teen smoking and the tremendous death and disease caused
by tobacco products. We should point out that our comments on
the Discussion Draft are based on a preliminary FDA review. The
Discussion Draft has not been fully reviewed by all of the other
Executive branch agencies affected by the proposed
legislation.
Everyone here is familiar with the statistics. Each year 400,000
persons in this country die from use of tobacco
products1, and most of these men and women started
using tobacco during childhood or adolescence.2 Every
day 3,000 children and adolescents begin smoking regularly
3, 1,000 of whom will die prematurely from tobacco-related diseases.4
I would like to discuss three issues in my remarks today: (1) the
Agency's tobacco program; (2) the Administration's position on
tobacco legislation; and (3) some of the issues raised by the
portion of the Discussion Draft that deals with FDA's authority.
1. FDA'S TOBACCO PROGRAM
FDA's tobacco regulation was announced in August 1996.
5 The Agency's decision to assert jurisdiction over
tobacco products and to issue its rule is grounded in two
important facts. First, most tobacco users begin during
childhood and adolescence. 6 More than 80 percent of
the people who smoke have their first cigarette before they are
18 years old, and by that age, half have become regular smokers.
And of the infants, children, and adolescents alive today, 5
million will become regular smokers and die because of their
smoking. 7 Unfortunately, the problem is getting
worse. Smoking rates among eighth and tenth graders have risen
by one-third since 1991. 8
Second, most tobacco users are addicted. In fact, studies
demonstrate that between 77 and 92 percent9 of the 50
million Americans who smoke and a large percentage of smokeless
tobacco users are addicted.
In response to these facts, FDA with the support of the President
and Secretary Shalala, established the Nation's first ever
comprehensive program to protect children from the dangers of
tobacco and a lifetime of nicotine addiction. The aim of the
program is to reduce tobacco use by children and adolescents by
50 percent in seven years, and it follows many of the
recommendations made by the American Medical Association and the
National Academy of Sciences' Institute of Medicine. Our program
will limit the availability of tobacco products to young people,
as well as the appeal that these products have to young people,
an appeal that is bolstered in large measure by the billions of
dollars in advertising and marketing spent by the tobacco
industry.
Each year, young people spend an estimated $1.26 billion
10 on tobacco products despite laws in all 50 states
that prohibit sales to minors. Numerous studies have confirmed
what we all have seen for ourselves, that adolescents have little
difficulty in purchasing tobacco products. 11 In
fact, studies of over-the-counter sales have determined that
nearly 70 percent of the time children or adolescents attempt to
buy cigarettes from retailers, they succeed.12 And if
these youngsters have any problem at the counter, they simply go
to a vending machine where studies show that they can
successfully purchase cigarettes almost 90 percent of the
time.13
The FDA rule is intended to change all that. The rule sets a
Federal minimum age of 18 to purchase tobacco products and
requires age verification. It eliminates free samples, sale of
single cigarettes and packages with fewer than 20 cigarettes. It
bans vending machines and self-service displays except in those
places where only adults are permitted, such as certain
nightclubs that are inaccessible to people under 18.
The second part of the rule is designed to reduce the appeal of
tobacco to children. Tobacco is among the most heavily
advertised and promoted products in the United States, with the
industry spending $5 billion annually. 14 And this
advertising is very effective with kids. The three most heavily
advertised brands are smoked by nearly 90 percent of all kids who
smoke. 15
The rule bans outdoor advertising within 1,000 feet of schools
and publicly-owned playgrounds. Outdoor advertising beyond these
areas is restricted to black-and-white text only. Advertising in
publications with a significant readership of people under 18 is
also limited to black-and-white text. The rule prohibits the
sale or free distribution of products, such as caps or gym bags,
that exhibit cigarette or smokeless tobacco products' brand names
or logos. Studies show that nearly half of all young people who
smoke own at least one of these items.16
Finally, the rule prohibits brand name sponsorship of sporting or
entertainment events, such as the use of the Virginia Slims
tournaments to attract healthy young women to a product that is
deadly and addictive. The rule, however, permits sponsorship in
the corporate name, as distinguished from brand name.
The first phase of the rule went into effect on February 28,
1997. Since that date, retailers have not been allowed to sell
cigarettes or smokeless tobacco to anyone under the age of 18.
And since that same date, retailers have been required to check
photo ID for anyone under the age of 27.
The remainder of the regulations were scheduled to go into effect
on August 28, 1997, except the sponsorship provision, which was
scheduled to go into effect August 28, 1998.
In April 1997, the United States District Court for the Middle
District of North Carolina ruled that FDA has jurisdiction to
regulate nicotine-containing cigarettes and smokeless tobacco and
upheld all of the rule's access provisions. The Court also
delayed implementation of the August 28, 1997 access provisions,
pending further court action. Finally, the Court invalidated, on
statutory grounds, FDA's advertising restrictions. The
government is appealing the advertising portion of the ruling at
the same time that it is moving forward to enforce the age and ID
provisions. The case currently is before the U.S. Court of
Appeals for the Fourth Circuit.
FDA currently is enforcing the rule cooperatively with State and
local officials. Half a million retailers sell tobacco, and FDA
cannot possibly be in every store. Traditionally, when our
regulations need to be enforced at the community level, we have
adopted a cooperative model. This is how FDA regulations are
enforced for dairy farm and retail food inspections in
communities across the country -- by commissioning for the
services of State and local officials. We think this is a
particularly appropriate way to enforce our tobacco regulations.
Under our plan, a commissioned State or local official will
accompany an adolescent under the age of 18 into a retail
establishment on an unannounced visit. The adolescent will
attempt to purchase cigarettes or smokeless tobacco. Records
will be kept documenting each visit. Retailers who refuse to
sell to the minor will get a letter from FDA telling them that
they are in compliance. Retailers who do sell to the minor will
receive a warning letter from FDA informing them that they have
violated the rule, and that another unannounced visit will be
scheduled. If they sell to the minor during the second
unannounced visit, they will receive a letter stating that FDA
will seek a penalty of $250. The fines escalate for subsequent
violations.
Last year, we signed contracts with 10 states for enforcement of
the age and photo ID requirements. The unannounced visits began
last August. This year we expect to sign contracts with every
single State and territory that is willing to join us in
enforcing the rule. Under this program, we eventually will be
conducting tens of thousands of unannounced visits across the
country each month. In addition, we plan to educate retailers
and others about the FDA rule through a multi-media advertising
campaign.
2. THE ADMINISTRATION'S POSITION ON TOBACCO
LEGISLATION
As you know, on June 20, 1997, 40 State Attorneys General and the
major tobacco companies reached a tentative settlement,
contingent on enactment of Federal legislation. The
Administration spent the summer reviewing and analyzing the
proposed settlement. On September 19, 1997, the President called
for comprehensive tobacco legislation with a goal of reducing the
smoking rate among young people by 50 percent within seven years.
The President stressed that the following five key elements must
be at the heart of any national tobacco legislation:
1. A comprehensive plan to reduce teen smoking, including
a combination of penalties and price increases that
raise cigarette prices up to $1.50 per pack over the
next 10 years as necessary to meet youth smoking
targets;
2. Express reaffirmation that FDA has full authority to
regulate tobacco products;
3. Changes in the way the tobacco industry does business;
4. Progress toward other critical public health goals, such as
the expansion of smoking cessation and prevention programs
and the reduction of secondhand smoke; and,
5. Protection for tobacco farmers and their communities.
During his State of the Union address and in his recent budget
for fiscal year 1999, the President again forcefully emphasized
that his top priority is the reduction of underage smoking.
Reducing teen smoking is the most important step that Congress
and the Administration can take now to protect the Nation's
health in the next century and to minimize future health care
costs.
3. ISSUES RAISED BY THE DISCUSSION DRAFT
As the Committee is well aware, FDA's authority to adopt the
provisions of the regulation that I have just described is
grounded in the Agency's conclusion that tobacco products are
combination drug/device products under the Federal Food, Drug,
and Cosmetic Act. That Act provides a comprehensive set of tools
which allows the Agency to craft appropriate restrictions on
access to and the advertising of tobacco products. More
importantly, it gives FDA the flexibility to adapt its
restrictions to changing circumstances and new scientific
information. One of the President's key principles for tobacco
legislation is that it affirm the full authority of FDA to
regulate tobacco products, building on this statutory framework.
With this principle in mind, I would now like to turn to the
Chairman's Discussion Draft.
First, let me say once again, Mr. Chairman, that while we have
serious concerns about provisions of the draft, we look forward
to working with you in a cooperative fashion to resolve these
differences.
As an initial matter, it is significant that the Discussion Draft
would codify many of the advertising and access restrictions that
FDA adopted in its regulation. In addition, the Discussion Draft
would strengthen significantly the size and content of the
Surgeon General's warning currently required on tobacco
products.
Nevertheless, I also must emphasize that the Discussion Draft
would place unacceptable limits on FDA's authority and future
flexibility to regulate tobacco products. First and foremost,
the Discussion Draft fails to provide the flexibility that the
Agency currently has under its drug and device authorities;
instead, the Discussion Draft would severely limit FDA's
authority to make future adjustments in regulating tobacco
products. The Discussion Draft also limits the Agency's ability
to take into account new scientific developments.
No one today can predict how tobacco products should be regulated
in the future. Will the scientific understanding of nicotine
lead to regulating it in some way? Will new scientific knowledge
support redesigning tobacco products to make them less harmful?
Fortunately the current law would allow FDA, after a thorough
public process, to require improvements in tobacco products. But
the Discussion Draft would hamper the Agency's authority and its
ability to improve public health in the future by imposing new
requirements and new standards -- such as findings about
potential black markets -- that might be impossible to meet. The
Discussion Draft accomplishes this by imposing onerous procedural
obstacles and, in some cases, requiring that new requirements
applicable to the product be approved in advance by both Houses
of Congress.
In addition, the Discussion Draft would limit FDA's authority to
regulate the marketing practices of tobacco companies. We
believe the regulations FDA has adopted are an extremely
effective approach to regulating tobacco products at the current
time. We should anticipate, however, that the tobacco companies
will adjust their marketing practices such that it will be
necessary to make adjustments in the regulatory approach in order
to maintain an effective program in reducing youth use of tobacco
products.
We do not know what those future promotion strategies will be.
For example, will methods be devised to make text-only
advertising extremely appealing to children? Will some approach
that we cannot even imagine be used? After all, who would have
predicted after the 1971 TV ad ban on tobacco advertising that
the companies would have designed a marketing strategy that
resulted in 91 percent of 6 year olds being able to identify Joe
Camel 17 and that over 25 percent of all adolescents,
whether they smoked or not, would own a tobacco T-shirt, gym bag
or similar item. 18
Unfortunately, we believe the Discussion Draft would prevent the
Agency from responding appropriately to future developments.
This limitation on the flexibility afforded by the current
Federal Food, Drug, and Cosmetic Act is a very serious
concern.
Finally, the Discussion Draft abolishes FDA's authority to
enforce youth access restrictions. Instead, this power would be
transferred to the Office of Smoking and Health in the Centers
for Disease Control (CDC). This approach is flawed because CDC
does not have any experience in directing a nation-wide
inspection program, in training inspectors, in bringing
enforcement actions against violators, and it does not have a
field inspection force to deploy in states that choose not to
enter into contracts with the federal authority. Moreover,
dividing the responsibility for enforcing tobacco advertising and
access restrictions will significantly weaken the program to
reduce tobacco use by children.
This is by no means an exhaustive list of our concerns. But it
provides an indication of the manner in which we believe the
Discussion Draft would inappropriately limit FDA's existing
authority and thus fail to satisfy the principles espoused by the
President last September relative to FDA.
CONCLUSION
In closing, FDA and the Administration strongly support
comprehensive tobacco legislation to significantly reduce young
people's tobacco use and meet the other goals announced by the
President. We look forward to working closely with you, Mr.
Chairman, and other members of the Committee to meet the
challenge of enacting the kind of comprehensive legislation that
enables us to meet our public health objectives. We stand ready
to work with you to address the concerns we have raised today.
Thank you for giving me this opportunity to share the view of the
Food and Drug Administration on this important legislative
initiative. I would be pleased to answer any questions you may
have.
161 FR 44396 at 44398
261 FR 44396 at 44398
361 FR 44396 at 44422
461 FR 44396 at 44399
560 FR 41314
661 FR 44396 at 44398
7"Projected Smoking - Related Deaths Among Youth--U.S., 5 million," MMWR, November 8, 1996, Vol.45, No. 44.
8"Results from the 1995 Monitoring the Future Survey,"
National Institute on Drug Abuse Briefing for Donna E. Shalala,
Ph.D., Secretary of Health and Human Services, December 13, 1995.
961 FR 44396 at 44398
10Difranza JR, Tye, "Who profits from tobacco sales to
children?," JAMA, 1990, Vol. 263, pp. 2784-7.
11Department of Health and Human Services; "Preventing
Tobacco Use Among Young People: A Report of the Surgeon General,"
Washington, DC: Government Printing Office, 1994, p. 249 (S/N-0017-001-00491-0).
12Id.
13Id.
14FTC Report to Congress, 1994.
1561 FR 44396 at 44482
1661 FR 44396 at 44525
1761 FR 44396 at 44477
1861 FR 44396 at 44525
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