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Testimony on Teenage Smoking by The Honorable Donna E. Shalala
U.S. Department of Health and Human Services

Before the Senate Committee on Labor and Human Resources
September 25, 1997

Mr. Chairman, Senator Kennedy, members of the Committee, thank you for inviting me to appear today to discuss one of the most vital public health issues affecting our nation: the need to protect our children from the death and disease caused by tobacco use. When the President last week called for a sweeping plan to provide American families with the support they need to prevent youth smoking, he made clear his strong desire to work with Congress in a bipartisan fashion to enact national tobacco legislation. I can think of no better place to begin this effort than with the committee whose bipartisan leadership on public health issues has helped to bring about so many major advances in the prevention and treatment of disease.

When the President announced his plan/ he was joined by a broad coalition of groups and individuals including former Surgeon General C. Everett Koop, former FDA Commissioner David Kessler, the American Medical Association, the American Heart Association, the American Cancer Society, the Campaign for Tobacco-Free Kids, and a bipartisan group of state Attorneys General. The President's plan builds on the Administration's own FDA rule and the efforts of many of the state Attorneys General, and offers a historic opportunity. Today, nearly 3,000 young people across our country will begin smoking regularly. Of these 3,000 young people, 1,000 will lose that gamble to the diseases caused by smoking. The net effect of this is that among children living in America today, 5 million will die an early preventable death because of a decision made as a child. We can change that if we are willing to take bold action necessary to protect our children and our grandchildren.

More than two years before his remarks last week, President Clinton and Vice President Gore began to lead the way on youth smoking with strong support from members of this Committee and others in the Congress. On August 10, 1995, they announced the proposed rule by the Food and Drug Administration to prevent young people from using tobacco products. One year later, they announced the final FDA rule. More recently, the President moved to protect hundreds of thousands of federal workers and public visitors by issuing an Executive Order to make federal buildings smoke-free.

As in all successful public health campaigns, many people helped bring us to this point - from the young child who speaks up at her town council meeting about how easy it is for her to buy cigarettes to the state Attorneys General who first challenged the tobacco industry in court and then took on the industry's lawyers at the negotiating table this past spring.

Building on that hard work, the President has challenged us all to go beyond the agreement reached this summer among many of the state Attorneys General, and the tobacco industry. To do so, we conducted an intensive analysis of their proposed settlement and other state suits using the knowledge and wisdom of scores of experts from inside and outside the Administration. Public health professionals, budgetary analysts, our best legal minds - all have reviewed the settlement. We reached out broadly to ensure that we had the benefit of the best thinking possible on how to protect the public health. The Vice President, White House Domestic Policy Advisor, Bruce Reed, and I listened to leaders of the public health and tobacco control groups (including those representing minority communities), tobacco farmers, and representatives of affected industries such as convenience and grocery stores and advertising agencies. We heard from the industry lawyers, state Attorneys General, plaintiffs' lawyers, as well as from tobacco industry "whistle blowers' and scientists and doctors nationally known for their research on nicotine addiction. We met with Senators and Members of Congress from both parties and from all regions of the country. As a result, our analysis and our thinking on this crucial public health question were invaluably enriched.

As the President said last week, we have moved from confrontation, denial and inertia to the brink of action on behalf of our children. Mr. Chairman, we must get national legislation right. First, we must strengthen those institutions that are flexible, strong and capable enough to meet the future challenges of protecting our children from tobacco. And second, we must demand accountability from the tobacco industry in helping us achieve our public health goal of reducing youth smoking.

Let me now briefly describe the five key elements that the President has laid out as the Administration's road map in working with Congress to craft legislation to protect our nation's children.

The President believes that such legislation must include:

  • A comprehensive plan to reduce teen smoking, including tough penalties if reduction targets are not met;

  • Full express authority for FDA to regulate tobacco products;

  • Changes in the way the tobacco industry does business;

  • Progress toward other public health goals; and

  • Protection for tobacco farmers and their communities.

As the President pointed out last week, one of the surest ways to help reduce youth smoking is to increase the price of cigarettes. Studies show that a 10 percent increase in cigarette prices leads to a 7 percent reduction in teen smoking. That is why the President has called for a combination of industry payments and penalties to increase cigarette prices by up to a dollar and fifty cents per pack over ten years, as needed, to help reach our youth reduction targets.

Tough Penalties and Price Increases Aimed at Youth Smokers Reducing teen smoking has always been America's bottom line. It must be the tobacco industry's bottom line as well. To achieve this important goal, the Administration believes tobacco legislation must include stiff penalties that give the tobacco industry the strongest possible incentive to stop targeting kids. Legislation should set ambitious targets to cut teen smoking by 30 percent in 5 years, 50 percent in 7 years, and 60 percent in 10 years, and impose severe financial penalties that hold tobacco companies accountable to meet those targets. The Administration supports penalties that are non-deductible, uncapped, and escalating - so that the penalties get stiffer and the price goes up the more that companies miss the targets. The penalties should be designed so that individual companies are accountable for their own actions.

This objective can also be achieved by increasing the base payments from the tobacco industry pro 'proposed in the settlement. Both increasing the base payments and strengthening the monetary penalties on the industry if youth smoking targets are not met would have the effect of raising the price of tobacco products, discouraging youths from smoking, and providing increased revenues for public health initiatives. The Administration looks forward to working with the Congress in deciding the best combination of the two policies.

Counter-Advertising and Education Campaigns

To succeed in reducing youth smoking, legislation must provide for a nationwide effort to deglamorize tobacco, warn young people of its addictive nature and deadly consequences, and help parents discourage their children from taking up the habit. Legislation should provide for a public education and counter-advertising campaign, as well as state and local prevention efforts. The Administration also supports stronger, more visible warning labels on tobacco products.

Today's teenagers already have been exposed to billions of dollars worth of image advertising for tobacco. That doesn't count other kinds of exposure that glamorize tobacco use in more subtle yet very powerful ways, like smoking in the movies. These influences create a "friendly familiarity" for tobacco products that is hard to change in the minds of young people. That's why we need a counter-advertising campaign that's every bit as pervasive and powerful. Unfortunately, government funding for media campaigns has been extremely limited and unimaginative. There are no powerful ongoing national prevention campaigns. To end this silence, we need to work with experts in the private marketing world. They can advise us on the best messages, the best ways to target and time those messages, and the best ways to tie in with local programing.

We already have data that show comprehensive, intensive media campaigns can work. When combined with school and community activities and advertising restrictions, media campaigns can reduce youth smoking. On a national level, the U.S. Fairness Doctrine campaign of the late 1960s taught us that tobacco counter-advertising can help reduce smoking - as long as we deliver repetitive creative messages to wide audiences over several years.

Tobacco marketing has shifted away from traditional mass media advertising toward targeted promotional activities. In the same way, our counter-marketing campaigns need to include a strong grassroots component. National campaigns are critical to get our messages on young people's radar screens, but we know their behavior is most influenced in their homes, neighborhoods, and communities. That is why every state and the District of Columbia has dedicated funding to this effort, and we should should build upon it with funds from any national tobacco legislation.

Studies show that research-based school curricula can reduce or delay tobacco use among our youth by teaching them the skills they need to resist social pressures to smoke. The effectiveness of school programs is boosted when they are coordinated with community programs. Unfortunately, most schools have not adopted effective programs. Local education and health agencies need additional funding through this legislation to work as our partners in moving research to the classroom.

Restrict Access and Limit Appeal

The current FDA rule includes significant measures to reduce youth access to tobacco products, such as requiring retailers to check photo identification of anyone under 27, and limiting the advertising of tobacco products to young people, by, for example, restricting such advertising near school buildings. The Administration supports legislation codifying these measures, imposing strong restrictions on youth access and advertising consistent with Constitutional provisions, and establishing an effective retail licensing scheme with tough penalties.


Mr. Chairman, the President's second principle for comprehensive tobacco legislation is that FDA must have full authority to regulate tobacco products. We emphasize this point in part because the proposed settlement weakens the regulatory flexibility that FDA now has and which is necessary to deal effectively with future public health challenges presented by growing tobacco use. In 1996, the Administration took the historic step of asserting FDA jurisdiction over tobacco products. Since that time, the Administration has said it would support federal legislation explicitly affirming the FDA's authority to regulate the manufacture, marketing, and sale of tobacco products. Under such legislation, the FDA's authority over tobacco products must be as effective as its authority over other drugs and devices, and must be sufficiently flexible to meet changing circumstances. The legislation should not impose any obligation on the FDA to make specific findings about such speculative matters as the creation of contraband markets; nor should it impose any special procedural hurdles or requirements, such as enhanced standards of proof or unusual evidentiary formalities.


Mr. Chairman, when we began to confront the tobacco industry's practice of marketing to teenagers, we faced a corporate culture that insisted on blocking access to information, on denying culpability and on sustaining unyielding attacks on opponents in courtrooms and in the media.

As we have progressed through the process of regulation and litigation, that culture may have begun to change. To foster that change and to make sure that the industry continues to face its responsibility for the problem of youth smoking, the President's third principle is to insist on measures to expose the industry's past misconduct, especially its efforts to market to children, and to change the way the industry does business.

Ending the Marketing Aimed at Children

Sincere and comprehensive commitments by the industry, such as agreements to limit advertising to children, can serve to recognize the need for increased corporate responsibility. That is why the President reiterated his call to the tobacco industry to end the marketing and promoting of tobacco to children.

Document Disclosure

To ensure that patterns of corporate malfeasance are disclosed and effectively checked in the future, national tobacco legislation must provide for broad disclosure of industry documents, especially those containing scientific and health information or relating to the industry's attempts to market tobacco to children. This legislation should respect essential principles of attorney-client privilege. But the legislation should establish effective mechanisms to turn over to the public all non-privileged documents, including documents that the industry has inappropriately claimed to be privileged, as well as to disclose scientific and health-related information even in privileged documents.

Corporate Compliance

Tobacco companies should set up comprehensive corporate compliance programs that will reinforce the real economic incentives provided by the youth smoking penalties to discourage companies from marketing to children. The legislation should establish oversight mechanisms to investigate and monitor corporate compliance and to make recommendations to Congress on appropriate future legislation.


Federal tobacco legislation provides an opportunity not only to reduce youth smoking, but to meet other public health goals: the reduction of environmental (second-hand) tobacco smoke, the expansion of smoking cessation programs, the strengthening of international efforts to control tobacco, and the provision of funds for health research and other health objectives. Only a comprehensive approach will permit us to achieve our objective of reducing teen smoking.

I have already mentioned that we need a well financed nationwide media campaign lo strip tobacco use of its glamour and appeal. We need ongoing state and community interventions to reach young people where they live and work; and we need well designed, research-based school programs to equip them with knowledge and resistance skills. We need surveillance and evaluation to help us gauge our success and retool our approaches; and we need prevention research to help us better understand why young people smoke and what we can do about it. And I cannot stress strongly enough that we must fund all of these activities at levels commensurate with the harm that tobacco causes our youth and our nation.

Second-Hand Smoke

Over the past few years, we have learned more and more about the adverse effects of second-hand smoke - or environmental tobacco smoke (ETS) - particularly on children. The U.S. Environmental Protection Agency estimates that ETS causes about 3,000 lung cancer deaths each year in nonsmoking adults. It has been linked with other health problems such as heart disease. ETS threatens the health of hundreds of thousands of children with asthma and other respiratory illnesses. It was for these reasons the President issued his Executive Order last month to make federal buildings smoke-free. Congress should take the next step. Comprehensive tobacco legislation should include provisions of the kind found in the President's Executive Order, to restrict smoking in workplaces and other public facilities.

Cessation Research and Services

Some 50 million Americans are current tobacco users and most of them want help to break their addiction. Motivation for these smokers doesn't seem to be the major obstacle. As I previously noted, about 70 percent of adult smokers say they would like to quit completely. However, only about 2.5 percent of all smokers permanently quit each year.

The good news is that there are methods that work. Simple advice from a health provider can boost cessation rates by as much as 30 percent, while more intensive counseling or nicotine replacement therapy can double this level. The more comprehensive and intensive the service, the higher the success rates can be. Details are spelled out in clinical guidelines available from the Agency for Health Care Policy and Research (AHCPR).

Smoking cessation is not just an adult issue. About 3 million teenagers are regular cigarette smokers. Unfortunately, teens who smoke like adults become addicted like adults. Young people vastly underestimate the addictiveness of nicotine. Of those who thought they would not be smoking in 5 years, 75 percent still are. Many teenagers also have the same intense interest in quitting as do adult smokers. But at present we know precious little about effective ways to help these young people quit. Developing these approaches should be a high priority of tobacco-related research. just last week, the nation's leading researchers in cessation of tobacco use by teens met in Atlanta to discuss what we do know and what are the most promising leads for research. Comprehensive tobacco legislation should ensure that such research receives strong support. Legislation should also help enable smoking cessation services to reach and assist the millions of smokers who want to break their addiction to tobacco products.

International Leadership

As President Clinton said last week, federal tobacco legislation must aim not only to reduce youth smoking, but-to meet other health goals as well, including strengthening of international prevention and cessation programs and strengthening of international efforts to control tobacco. We recently heard from the world's health experts in Beijing about how tobacco will become the leading preventable cause of death in the world by the year 2020. By 2025, tobacco will claim 10 million lives each year. Seventy percent of these deaths will occur in developing countries, countries which truly cannot afford the high social, economic and medical costs incurred as a consequence of tobacco use. But the opportunities for prevention are real - people in developing countries have not yet taken up the habit to the degree that we have in the United States and in other developed countries.

There is much that we can do to assist other countries interested in our help, bilaterally and multilaterally, through official channels and international institutions as well as through non-governmental organizations. At a minimum, we should give greater priority to preventing global tobacco use by increasing our investments in this area and taking a leadership role in mobilizing the international health community to discourage young people from starting to smoke and to encourage those that have the habit to quit.

Because tobacco is global issue, our international priorities should be consistent with our domestic priorities, and they are. Consistent with domestic policy and international trade rules, it is the policy of the Clinton Administration not to interfere with a foreign country's non-discriminatory health-based efforts to control the use of tobacco. The Department of Health and Human Services will continue to work with the U.S. Trade Representative to ensure that U.S. tobacco trade policy incorporates the health policy perspective. This includes having HHS at the table for trade negotiations. HHS also will work with the Departments of State, Commerce and Agriculture in dealing with tobacco issues overseas. While we are committed to ensuring that American business interests receive fair and equal treatment abroad, our trade and commercial actions should do no more than seek to ensure equal access to a shrinking global tobacco market. Our U.S. embassies and missions should not be engaged in activities that are likely to stimulate the demand for tobacco products, or increase tobacco use, especially among young people.

Resources for Health Research and Other Health Care Requirements The Administration believes that the primary objective of tobacco legislation is to reduce youth smoking, not to raise money. But comprehensive tobacco legislation also should take into account the health costs associated with smoking and the resulting need for public health investments. The legislation should generate sufficient resources to increase funding for smoking-related health research and contribute significantly to other important health objectives.

It is important to remember that tobacco use is responsible for 30 percent of the prevalence of cancer, one-third of cardiovascular disease deaths and 90 percent of chronic obstructive pulmonary disease. Smoking is the leading preventable cause of premature death in the United States. - And research continues to identify additional diseases and conditions - like SIDS, low-birth weight babies, respiratory illness in children, miscarriage, and birth defects such as cleft lip and palate - in which tobacco use is implicated.

Any national tobacco legislation must provide for a robust, comprehensive, and well funded tobacco research program that examines tobacco's impact on health, disease and quality of life. Research also must address issues at the national, state, local, and individual levels, informing the development of new federal and state policies, regulations and programs. The research should be broad-based, focusing on the biomedical, clinical, behavioral, health service, public health, and surveillance and epidemiological aspects of tobacco-related research.

This research program should include studies of tobacco use among youth. That seems obvious, but despite the fact that there are currently about 3 million young people under age 18 who are regular cigarette smokers, there are major gaps in research, surveillance, and evaluation data on youth smoking. We do not even have any state-level data on smoking among youth or consistent data on which brands are smoked by young people. Furthermore, little is known about effective strategies to help adolescents to quit smoking. Developing such approaches should be a high priority of tobacco-related research.

Let me make one more very important point with regard to a possible financing structure and funding. Comprehensive tobacco legislation affords us a unique opportunity to protect the public health; but that opportunity easily could be undermined if new funds simply displace current obligations. Specific protections are needed to prevent funds provided under any legislation from supplanting Congress's current appropriations to agencies engaged in tobacco-related research, as well as cessation and education activities. In other words, funding provided by this legislation must not replace any federal agencies' existing commitments to tobacco-related activities or other health commitments.


The President's fifth principle is to protect the thousands of farmers whose livelihoods depend on reliable markets, and whose communities are built on the foundation of a tobacco-growing economy. We have a responsibility to these people. They have not done anything wrong. As the President said last week: "They're good, hard-working, tax-paying citizens, and they have not caused this problem. And we cannot let them, their families or their communities just be crippled and broken by this."

Mr. Chairman, we are trying to change America and make everybody whole. Farmers and their communities deserve a chance to have their lives and be made whole and go on with the future as well, and I can say I speak for the President and his entire Administration when I say we are determined to see that they are part of this.

Several possible solutions -- from enhanced assurance of quota stability and price protection, to the purchase on a voluntary basis of the quotas, to a comprehensive plan of rural and economic development in tobacco growing areas - all of these options and others have been discussed. Whatever the best solutions, the President has made it abundantly clear that these protections must be included in any tobacco legislation.


Mr. Chairman and Members of this Committee, the President's plan offers us a unique opportunity to help prevent young people from using tobacco, to reduce environmental tobacco smoke, and to help tobacco farmers and their local communities build a better economic future. We are eager to work with members of Congress in both parties, especially the members of this committee.

Congress has a formidable task. Several committees in each House must evaluate at least a part of this complicated policy area, and after an open, public review, write national legislation that the President and the American people can support. I can assure you that we in the Administration are eager to work with you and others in Congress to meet this responsibility and to make major progress on one of the most significant public health challenges facing our nation.

As an indication of how important we believe this opportunity is, the President has asked the Vice President to take the lead in building bipartisan support for our plan

Thank you.

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