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Final Report
of
The Advisory Committee on
Tobacco Policy and Public Health

TABLE OF CONTENTS

Introduction by the Co-chairs

On May 22, 1997, a bipartisan group of Members of Congress asked us to convene a committee on national tobacco policy. In response to this request, we formed the panel that has met as the Advisory Committee on Tobacco Policy and Public Health. This Committee is composed of representatives of some of the major public health groups that have been leaders in the debate on tobacco control. The selection of organizations to be represented was an especially difficult task, inasmuch as so many highly qualified groups with great expertise are involved in tobacco control; nevertheless, in order to make the Committee of manageable size, we made hard choices to limit the number of members and urged them to consult with a wide range of other organizations and experts.

The Committee has as its mission the development of a comprehensive and rational public health policy toward tobacco, containing clear goals and principles, in order to provide a benchmark against which future public and private activities can be measured.

The Committee has met three times, each time in open session, on June 5, June 18, and June 25. To conduct its work, the Committee resolved itself into five task forces on overlapping topics:

• Regulation of Nicotine and Tobacco Products (Chair: American Cancer Society)
• Youth and Tobacco (Chair: American Academy of Pediatrics)
• Performance Objectives Subgroup (Chair: Partnership for Prevention)
• Current Users of Tobacco Products (Chair: American Medical Association)
• Environmental Tobacco Smoke (Chair: American Lung Association)
• Future of the Tobacco Industry and Tobacco Control Efforts (Chair: Advocacy Institute)

These task forces conferred independently and made their preliminary reports to the Committee. Each report was discussed in open session and amendments were made. Revised reports were developed and summarized.

We believe that this final report speaks loudly for itself, but it is perhaps appropriate for us to note here what this report does not speak to. This is not a report on past actions of the tobacco industry or on the harm that it has done. It is not intended to recommend how tobacco litigation or compensation programs for past injury should be handled. It is not a report on liability for the past.

Rather, in keeping with the Congressional charge, this is a blueprint for the future of tobacco policy and public health. It is neither incremental nor utopian. The plans outlined are ambitious but they can be achieved within a short time.

Most of all, this report is a document intended to look forward, and to move the Nation from its past injuries to future good health. Its recommendations are to ensure complete ability for the FDA to regulate nicotine and tobacco products, to prevent our children from starting to smoke, to treat those already addicted to tobacco, and to protect nonsmokers from involuntary exposure to smoke. These are the goals for which all new policy should aim. Any approach that fails these goals fails the Nation and fails the future.

We fully recognize that there are billions of dollars at stake here in hospital bills, compensation, and liability costs. While these are important issues, we believe that this debate about the past should not distract us from solid plans for the future. Not one of those compensatory dollars will be well spent if our children repeat their elders' mistakes, if adults continue their addiction, or if we all have smoke in our faces. As the national debate about tobacco continues, we urge all sides to keep their eyes clearly on this extraordinary opportunity for change.

What follows is a summary of the major recommendations of each of the task forces. An appendix has been included that contains the full final report of each of the task forces.

We want to thank and acknowledge our colleagues who have joined us for this daunting task in such a brief amount of time. We appreciate the expertise, commitment, and labor that have been contributed. We are confident that our work together will change the debate for the better.

Summary of Major Recommendations of the Task Force on the Regulation of Nicotine and Tobacco Products

BACKGROUND

"[N]icotine in cigarettes and smokeless tobacco has the same pharmacological effects as other drugs that FDA has traditionally regulated."¹ Indeed, it is acknowledged that nicotine is extremely addictive and that "the vast majority of people who use nicotine-containing cigarettes and smokeless tobacco do so to satisfy their craving for the pharmacological effects of nicotine; that is, to satisfy their drug-dependence or addiction."² Many would argue, therefore, that the regulation of nicotine and its delivery is itself the most essential element of tobacco control activities.

Other components of tobacco smoke are also toxic. The tar, carbon monoxide, and additives contained therein are dangerous to the health of those using tobacco and those around them.

RECOMMENDATIONS

Regulatory Policy

• FDA should continue to have authority to regulate all areas of nicotine, as well as other constituents and ingredients, and that authority should be made completely explicit.
  
  
• FDA should continue to have the authority to phase out nicotine and remove ingredients that contribute to the initiation of smoking and dependence on cigarettes and other tobacco products (including smokeless tobacco, pipes, cigars, and roll-your-own tobacco), and that authority should be made completely explicit.
  
  
• There should be no limitations on or special exceptions to FDA authority to regulate nicotine, other constituents, and ingredients of tobacco products and such a no-limitations policy should be made completely explicit.
  
  
• The FDA should continue to have authority to regulate further nicotine, other constituents, and ingredients as the evidence suggests. The best science, information, and health policy (and not an arbitrary deadline) should drive FDA regulatory timing and that authority should be made completely explicit.
  
  
• The FDA should have the authority to test nicotine levels by brand, based on the best science and that authority should be made completely explicit.
  
  
• Regulation of non-tobacco nicotine delivery devices (e.g., nicotine patches, nicotine gum, nicotine inhalers, etc.) should be done in a manner that does not make the development and sale of less hazardous systems difficult and that encourages maximum overall reduction in disease.

Research Policy

• FDA should have the authority and funding to conduct research on nicotine and other components of tobacco products.
  
  
• International exchange and scientific conferences on nicotine and other components of tobacco products should be convened among private industry researchers and public researchers (such as those from the FDA, the CDC, the NIH, and the WHO).
  
  
• Research should be conducted on the effects of nicotine in children and adolescents.

Fiscal Policy

• FDA should be adequately funded to carry out its regulatory, enforcement, public education, and research activities.

Summary of Major Recommendations of the Task Force on
Youth and Tobacco

BACKGROUND

More than 90 percent of people who will ever smoke on a regular basis begin doing so prior to the age of 19. Each day, some 3,000 children take up the habit; the average age at which they begin is approximately 12-1/2, although many decide to smoke earlier if they are able. While these children start to use tobacco for a variety of reasons, very quickly they become addicted to the nicotine present in the product, and studies show clearly that children have just as difficult a time quitting as do adults.

There are a number of reasons why children begin to use tobacco. Among these are the remarkably effective advertising and promotion by the tobacco industry and, for many young people, perceived benefits from the use of tobacco, be they adult privileges, appealing images, or the opportunity for rebelliousness.

RECOMMENDATIONS

Regulatory Policy

• Sale and distribution of tobacco products to persons under age 18 should be prohibited.
  
  
• Specific and increasingly stringent targets for the reduction of tobacco use by children and adolescents (also known as "performance standards" should be established and become binding on the tobacco industry by brand within the next two years.³ Failure by the tobacco industry to meet these targets should result in predictable financial penalties sufficiently severe to act as a strong deterrent to continued failure.
  
  
• Included within this recommendation are such specific proposals as:
  
  
• Penalties should be structured so that failure to meet the targets directly reduces total revenue and affects total shareholder value.
• Such penalties should not be arbitrarily limited or capped.
• Additional non-financial penalties should be imposed if tobacco companies fail to meet such targets.
• Penalties should be assessed, to the maximum extent feasible, on a company-by-company basis.
• Similar goals and penalties should be established for smokeless tobacco and other tobacco products.
  
  
• Marketing, promotion, and advertising of all tobacco products directed at persons under age 18 should be banned.
  
  
• Included within this recommendation are such specific proposals as:
  
  
• Services, goods, and other items that carry tobacco brand names, logos, or imagery should be banned.
• Sponsorship of any athletic, social, or cultural events using the name of tobacco products present or future should be banned.
• Promotion in public entertainment, including product placement in movies and television should be banned.
  
  
• Sales and distribution of tobacco products through means that might make them available to underage users should be prohibited.
  
  
• Included within this recommendation are such specific proposals as:
  
  
• Sales of tobacco products through vending machines, mail order, Internet and other electronic systems, and self-serve displays should be banned.
• Sales of tobacco products near schools, playgrounds, and other areas where children congregate should be banned.
• Sales of tobacco products near health care facilities should be banned.
• The distribution of tobacco products through free samples or through individual or small sales should be banned.
• States should license all participants in tobacco sales (e.g., manufacturers, distributors, wholesalers, importers, etc.), and penalties for violations of sales to minors should be strict enough to ensure compliance with the law.
• Both State and Local governments should be allowed to enforce violations of such restrictions and licensing requirements.
  
  
• The warning and product content labeling on all tobacco products should be strengthened.
  
  
• Schools and other child-service institutions should adopt and enforce a "zero- tolerance" policy against tobacco use that applies to both minors and employees.
  
  
  
• Included within this recommendation are such specific proposals as:
  
  
• A zero-tolerance policy should apply not only at school or on-site, but also to all sponsored events and other sanctioned activities.
• A zero-tolerance policy should include the banning of the wearing and carrying of clothing and other items that include promotional material for tobacco products.

Public Education and Other Public Health Policy

• Broad programs of counter-advertising should be required in all media markets and should be funded or supported by the tobacco industry.
  
  
• Schools should implement the Centers for Disease Control and Prevention guidelines to prevent tobacco use and addiction.
  
  
• Schools should institute comprehensive tobacco prevention programs from pre-kindergarten through 12th grade, and such programs should be funded or supported by the tobacco industry.
  
  
• IMPACT and ASSIST grants⁴ programs should be continued and strengthened.
  
  
• Partnerships between public entities (such as schools) and businesses should be instituted to help achieve continued reduction in underage use of tobacco products.
  
  
• Health care providers should be educated about effective means to prevent children from beginning tobacco use.
  
  
• Tobacco use by children and adolescents should be included as an outcome measure in assessing the quality of health care services (e.g., in HEDIS and other NCQA reviews).

Research Policy

• Research should be conducted on the reduction of underage tobacco use.
  
  
• Included within this recommendation are such specific proposals as research on:
  
  
• Methods of identifying children who are likely to begin (or increase) use of tobacco products.
• The effectiveness of current prevention and education efforts on youth consumption.
• Children's and parents' attitudes and beliefs about tobacco use and the perception of risk, understanding of addiction, and the long-term consequences of tobacco use by children.

Fiscal Policy

• Excise taxes on tobacco products should be dramatically increased and should be indexed to inflation.⁵
  
  
• Fines from performance standards violations should not be tax-deductible.
  
  
• Fines from performance standards violations should be used to support activities to reduce tobacco consumption, with emphasis on activities designed to reduce consumption by children and adolescents.
  
  
• The enforcement of regulations and the initiation of public education, public health, and research efforts should be funded by these excise taxes, fines from performance standards violations, and by other funds from the tobacco industry.
  
  
• A new non-profit corporation to support tobacco prevention and control programs should be established in the private sector and should be funded by the tobacco industry, by excise taxes, and by fines from performance standard violations. The start-up of the non-profit corporation and its educational activities should begin at the earliest possible time.

Summary of Major Recommendations of the Task Force on
Current Users of Tobacco Products

BACKGROUND

Some 50 million Americans are now addicted to tobacco. One of every three long-term users of tobacco will die from a disease related to their tobacco use⁶ Nicotine, a major constituent of tobacco, is highly addictive and "cigarettes and other forms of tobacco are just as addicting as heroin and cocaine. . . ."⁷ Similarly, withdrawal from this addiction is like withdrawal from other highly addictive substances. About 70 percent of smokers want to quit, but less than one-quarter are successful in doing so.

The Agency for Health Care Research and Policy has issued smoking cessation clinical practice guidelines⁸ that lay out recommendations for primary care clinicians, smoking cessation specialists, and health care administrators, insurers, and purchasers. These guidelines are often cited as the framework for providing and evaluating smoking cessation services.

In a separate but related area, it should be noted that cigarette-caused fires are the leading cause of deaths from residential fires. It is argued that many such fires could be prevented by changes that would reduce the burn characteristics of cigarettes.

RECOMMENDATIONS

Regulatory Policy

• Coverage for tobacco use cessation programs and services should be required under all health insurance, managed care, and employee benefit plans, as well as all Federal health financing programs (e.g., Medicare and Medicaid). Such coverage should be provided as a lifetime benefit rather than as a one-time opportunity to "kick the habit."
  
  
• Tobacco use cessation programs and services should be available to adults, adolescents, and children who are addicted to tobacco products, regardless of their insurance status or ability to pay.

Public Education and Other Public Health Policy

• The smoking cessation guidelines issued by the Agency for Health Care Policy and Research⁹ should serve as the cornerstone for health care providers engaged in clinical practice.
  
  
• Courses on the prevention, treatment, and control of tobacco use, including cessation, should be made a part of the core curriculum in the education of health professionals.
  
  
• Tobacco use cessation programs and services should be made widely available. Specific cessation programs and services should be developed for specific populations, including children, women, racial and ethnic minorities, and individuals with limited literacy.
  
  
• Substantial public education efforts designed to inform tobacco users about both the health hazards of tobacco and the availability of tobacco use cessation programs and services should be undertaken.
  
  
• Policies designed to reduce the number of fires caused by tobacco products should be developed and implemented.

Research Policy

• Research efforts designed to evaluate the effectiveness of tobacco use cessation programs, services and therapeutics should be undertaken.
  
  
• Research projects should include work on smokeless tobacco and cigar use as well as cigarette smoking.
  
  
• Research projects should focus on the development of tobacco use cessation programs and services for pregnant women, children, and adolescents.
  
  
• Research efforts designed to evaluate the effectiveness of public education and public health policies in successfully encouraging current users of tobacco products to attempt cessation efforts should be undertaken.

Fiscal Policy

• Tobacco use cessation programs and services should be funded or supported by the tobacco industry at a level sufficient to ensure that they are provided universally and in a manner most likely to prove effective.
  
  
• Research efforts related to the development of effective tobacco use cessation programs and services should be funded or supported by the tobacco industry.

Summary of Major Recommendations of the Task Force on
Environmental Tobacco Smoke

BACKGROUND

Second-hand or environmental tobacco smoke (ETS) is no longer considered just an unpleasant side effect of cigarette smoking. Scientific evidence now indicates that nonsmokers become seriously ill or die because of exposure to the toxic smoke produced by other people's active smoking and the U.S. Environmental Protection Agency has classified ETS as an agent known to cause cancer in humans.¹⁰ ETS is believed to cause tens of thousands of deaths each year and to cause or exacerbate cardiovascular and pulmonary illnesses in hundreds of thousands additional individuals.

ETS is of particular concern with regard to children. Children are powerless to control their exposure to ETS and yet, because of their young age, are most adversely affected by exposure to this agent. The EPA estimates that exposure to ETS from parental smoking alone causes as many as 300,000 lower respiratory infections per year in infants under the age of 18 months.¹¹

Efforts to control second-hand smoke have been undertaken at Federal, State, and Local levels of government. The Federal government has banned smoking in federally- assisted programs for children and on domestic airline flights. Forty-eight States and the District of Columbia have enacted laws that, in some way, restrict smoking in public places. Local governments have usually led the way in these efforts; over 800 local communities have adopted significant restrictions on smoking in public places and workplaces.

RECOMMENDATIONS

Regulatory Policy

• Legislation or regulations should be enacted and enforced by Local, State, and Federal governments to eliminate exposure to second-hand smoke.
  
  
• Included within this recommendation are such specific proposals as:
  
  
• Smoking should be banned in all work sites and in all places of public assembly, especially those in places in which children are present.
• Smoking should be banned in outdoor areas where people assemble, such as service lines, seating areas of sports stadiums and arenas, etc.
• Schools should be required to be 100 percent smoke-free in all areas of their campuses.
  
  
• Smoking should be banned on all forms of public transportation, including bus, train, commuter services, and flights originating in or arriving at the U.S.
  
  
• Smoking should be banned at all Federal workplaces, including branches of the military and the Department of Veterans' Affairs and its hospitals.

Public Education and Other Public Health Policy

• A comprehensive public education and public awareness program about the dangers of ETS should be funded and implemented by Local, State, and Federal levels of government.
  
  
• State and local school boards should revise school health education programs to include information on ETS and its health effects.

Research Policy

• Federal health agencies should complete a risk assessment of the cardiovascular effects of ETS.

Fiscal Policy

• Economic incentives for smoke-free workplaces should be developed.
  
  
• Included within this recommendation are such specific proposals as:
  
  
• Insurers should be encouraged to take into account worksite smoke-free policies in assessing appropriate premiums for health insurance, business insurance, and workers' compensation coverage.

Summary of Major Recommendations of the Task Force on the
Future of the Tobacco Industry and Tobacco Control Efforts

BACKGROUND

This task force reviewed three basic areas and made recommendations regarding each one. The three areas were: (1) common threads of domestic tobacco control efforts that cut across all other task force recommendations; (2) activities to aid those Americans who will be disadvantaged through no fault of their own by tobacco control policies; and (3) U.S. activities that can assist in tobacco control internationally.

In the first area, it is clear that many of the problems identified by the other four task forces have common sources and potentially common solutions. Most of these task forces made recommendations, for example, opposing peremption of State and local standards. Rather than repeating these proposals in each task force summary, these suggested actions are consolidated here: They should be read to be a part of each task force, unless specific circumstances dictate a narrower approach as reflected in the respective task force summary.

In the second area, this task force reports that tobacco farmers and farm communities are at severe economic risk as comprehensive tobacco control policies take effect. Most Americans consider the tobacco farmer to be as much an economic victim as a participant in the manufacture of tobacco products and support government efforts to help tobacco farmers find other means of making a living.

In the third area, this task force focused on the need for international tobacco policy to which the U.S. could make a substantial contribution. According to the World Health Organization, in the early 1990's, tobacco use caused three million deaths a year worldwide; WHO goes on to project that within the next twenty to thirty years, this number will rise to ten million deaths a year, with 70 percent of those deaths occurring in developing countries. Many of these deaths and projected deaths can be attributed to the increasingly aggressive marketing efforts of U.S.-based transnational tobacco companies.

RECOMMENDATIONS

Tobacco Control Efforts

Regulatory Policy

• Any Federal or State regulation of tobacco products should contain unambiguous non-preemption provisions, expressly clarifying that higher standards of public health protection imposed by State and Local governments are preserved.
  
  
• Federal, State, and Local tobacco control regulations should be aggressively enforced and such enforcement activities should be fully funded and supported.
  
  
• All currently available avenues of litigation, both civil and criminal, must be fully preserved.
  
  
• All elements of Federal, State, and Local tobacco control policies should be enforceable through lawsuits sought by individual citizens.
  
  
• All internal tobacco company documents that bear upon the public health must be disclosed.
  
  
• Included within this recommendation are such specific proposals as:
  
  
• Disclosure of the companies' and their affiliates' public relations, advertising, promotion, marketing, and political activities.
• Disclosure of all information inappropriately shielded by an assertion of attorney-client privilege.
• Disclosure of all technical and health/safety data (with a possible exception for those true trade secrets that the companies can clearly establish have no health implications).
• Disclosure of all information related to marketing, including opinion and behavioral research; and the targeting of children, women, and racial and ethnic minorities.
• Disclosure of all documents relating to the effects of second- hand smoke.
  
  
• A Federal oversight board should be established to investigate all matters relating to public health and tobacco products and the tobacco industry.
  
  
• Included within this recommendation are such specific proposals as:
  
  
• The board should have investigative authorities, including subpoena power, necessary to investigate all matters regarding tobacco policy and public health.

Research Policy

• The collection and analysis of comprehensive data on tobacco use, behavior, attitudes (at national, regional, state, and local levels) should be funded or supported.
  
  
• Federal agencies and their partners should support programs to research, develop, and disseminate information regarding innovative interventions, including demonstration projects for implementing effective interventions.

Fiscal Policy

• Significant excise taxes (indexed to inflation) should be imposed upon tobacco products, both as a means of reducing consumption¹² and as a means of raising revenues as one source of support for tobacco control activities.
  
  
• All tobacco control activities (including education, counter- advertising, smoking cessation, etc.) funded or supported in whole or in part by the tobacco industry should be developed and implemented in a manner entirely independent of the industry.
  
  
• Fines, punitive damages, and other forms of financial punishment imposed on the tobacco industry and its affiliates should not be recognized as an ordinary business expense and should not be tax- deductible or given other special tax treatment.
  
  
• Fines collected for failure to meet performance standards or violations of sales and promotion restrictions should be used for tobacco control activities.
  
  
• Funding for Federal, State, and Local tobacco control activities (including regulation and enforcement activities) should be sufficient to allow the effective conduct of such efforts.
  
  
• Funding for nongovernmental tobacco control activities should be sufficient to allow the effective conduct of such efforts. Particular emphasis should be placed on community programs for racial and ethnic minorities.
  
  
• Future smoking cessation programs and services should be entirely financed by the tobacco industry, regardless of location of service delivery or initial source of payment. Individuals and third-party payors (both public and private) should receive full reimbursement (or subrogation, as appropriate) for the costs of all future smoking cessation programs or services, without restriction on extrapolation, aggregation, or other means of consolidation.

Tobacco Farms and Farm Communities

Public Education and Other Public Health Policy

• A blue-ribbon panel should be established to oversee tobacco growing, manufacturing, and marketing policy, including the history of domestic and foreign tobacco purchases. This panel should provide both short- and long-term strategies for reducing the dependence of tobacco-growing States and communities on tobacco, including recommendations for the provision of economic development assistance.

Fiscal Policy

• An economic assistance and development fund should be established (and funded by the tobacco industry) to assist tobacco farmers and their communities in developing alternatives to tobacco farming. Economic conversion funds should also be provided to assist tobacco manufacturing workers and related non- farm workers.
  
  
• Federal price support programs for tobacco should be eliminated.

International Tobacco Policy

Regulatory Policy

• The U.S. should actively promote tobacco control worldwide.
  
  
• Included within this recommendation are such specific proposals as:
  
  
• The U.S. should actively promote the global adoption of U.S. domestic tobacco control policies through all appropriate international activities.
• The U.S. should support the development and implementation of tobacco control activities by multilateral organizations, including the Pan-American Health Organization, the World Health Organization, UNICEF, and the Framework Tobacco Control Convention.
• The U.S. should support the development and implementation of tobacco control activities by non-governmental organizations.
• The U.S. should support bilateral and multilateral treaties making the Framework Convention legally binding on all countries.
• The U.S. should remove tobacco products from Section 301 of the 1974 Trade Act and should prohibit U.S. government interference in international activities or the national tobacco control activities of other countries.
• The U.S. should support the development of a non- governmental International Tobacco Control Commission, governed by public health leaders. Such a commission would (1) monitor international control efforts; (2) develop uniform standards, review procedures, and provide support for non- governmental organizations advocating tobacco control; and (3) administer an international information exchange of all available tobacco industry documents.

Research Policy

• The U.S. should support international research efforts to determine the most effective means of preventing the initiation of tobacco use and of smoking cessation.

Fiscal Policy

• The U.S. should provide financial support for international governmental and non-governmental efforts to control tobacco use.

Footnotes

¹ 61 Fed. Reg. 168, 44661 (1996).

²Id. at 44636 (comments of the American Heart Association, the American Lung Association, and the American Cancer Society).

³In its deliberations, the Advisory Committee recommended that a ten-year plan be established that is at least as strong as the following:

	At the end of	Reduction target
	Year 2	15%
	Year 3	20%
	Year 4	25%
	Year 5	30%
	Year 6	40%
	Year 7	50%
	Year 8	55%
	Year 9	60%
	Year 10	65%

⁴ IMPACT grants are administered by the Centers for Disease Control and Prevention. ASSIST grants are administered by the National Institutes of Health.

⁵Economic analyses suggest that children's use of tobacco is significantly affected by price increases of $2 per pack or more.

⁶Coalition on Smoking OR Health, Protecting Our Families and Children from Tobacco: Public Policy Activities of the Coalition on Smoking or Health for 1995 and 1996, 2 (1996).

⁷Addiction Research Foundation, Facts About Tobacco, 2 (undated)(citing the United States Surgeon General's 1988 Report on Smoking).

⁸Agency for Health Care Policy and Research, Smoking Cessation (Clinical Practice Guideline, Number 18) (1996) (reprinted in 275 J.A.M.A. 16 (April, 24, 1996)).

⁹Agency for Health Care Policy and Research, Smoking Cessation (Clinical Practice Guideline, Number 18) (1996) (reprinted in 275 J.A.M.A. 16 (April, 24, 1996)).

¹⁰ U.S. Environmental Protection Agency, Respitory Health Effects of Passive Smoking: Lung Cancer and Other Disorders, (Dec. 1992)(EPA /600/6-90/006F).

¹¹Id.

¹²Economic analyses suggest that children's use of tobacco is significantly affected by price increases of $2 per pack or more.

Appendix 1

Mr. John Garrison
Managing Director, American Lung Association
1740 Broadway
New York, NY 10019

Dear Mr. Garrison:

We are writing as Members of Congress to ask that you serve on an Advisory Committee on Tobacco Policy and Public Health to be chaired by Dr. C. Everett Koop and Dr. David Kessler. The Advisory Committee will advise us on any tobacco settlement that may be proposed and will work with us to develop a comprehensive and united approach to any tobacco legislation that Congress may consider.

In the talks that are now underway, the tobacco industry is seeking a "global settlement" that would provide the industry with limitations on liability, public legitimacy, and sustained economic health. We are concerned that no one has adequately analyzed the ramifications of the tobacco companies' proposals. Before Congress considers any "global settlement" with the tobacco companies, we believe that it is essential that we obtain input from a public health perspective.

We seek your help in this effort. We must not limit our focus to only one part of the tobacco control agenda. In fact, given the unprecedented nature of the relief being discussed by the negotiators for the tobacco industry, the class-action lawyers, and the attorneys general, we believe we should not necessarily limit our focus top provisions tobacco control advocates have proposed in the past. Instead, with your help, we want to ask fundamental questions about what - - from the public health perspective -- the future of the industry should be like.

We will fail our responsibilities if we limit our agenda to the issues currently on the table in the so-called "global settlement" talks. We should look at issues such as reducing tobacco exports, significantly raising tobacco taxes, ensuring actual reductions in youth smoking rates, imposing special corporate responsibilities on the industry, and other important public health policies. We ask for your help in identifying the broad range of provisions that should be encompassed in any "global settlement" with the tobacco industry.

If any agreement is reached in the tobacco settlement talks currently underway, it will undoubtably be closely reviewed and substantially revised by Congress. Indeed, no proposal from outside groups of such a far-reaching nature has ever passed Congress without a great deal of debate and modification. A unified public health position developed by the Advisory Committee will allow us to respond to any weakening amendments effectively -- and to insist on public health amendments to strengthen the legislation.

We are at a turning point in our nation's relationship with the tobacco industry. We hope you will agree to serve on the Advisory Committee on Tobacco Policy and Public Health -- and help us to ensure that any tobacco legislation is in the public health interest of our nation.

Congressman Henry A. Waxman
Congressman James V. Hanson
Congressman Marty Meehan
Senator Dick Durbin
Senator Frank R. Lautenberg
Senator Ron Wyden
Senator Paul Wellstone
Congressman Sherrod Brown

Appendix 2

The Advisory Committee on
Tobacco Policy and Public Health

Co-Chairs: C. Everett Koop, M.D., Sc.D. and David A. Kessler, M.D.

Panel Members

Action on Smoking and Health
John F. Banzhaf III, Executive Director

Advocacy Institute
Michael Pertschuk, J.D., Co-Director

American Academy of Family Physicians
Robert Graham, M.D., Executive Vice President

American Academy of Pediatrics
Richard B. Heyman, M.D., Chair, Committee on Substance Abuse
George D. Comerci, M.D., Past President, AAP

American Cancer Society
John R. Seffrin, Ph.D., Chief Executive Officer

American College of Chest Physicians
D. Robert McCaffree, M.D., F.C.C.P., President-Elect

American College of Preventive Medicine
George K. Anderson, M.D., M.P.H., President-Elect

American Heart Association
Dudley H. Hafner, Chief Staff Executive Officer

American Lung Association
John R. Garrison, Chief Executive Officer

American Medical Association
Nancy Dickey, M.D., President-Elect
Randolph Smoak, Jr., M.D., Vice-Chair, Board of Trustees

American Medical Women's Association
Eileen McGrath, J.D., C.A.E., Executive Director

American Public Health Association
Mohammad N. Akhter, M.D., M.P.H., Executive Director

Americans for Nonsmokers' Rights
Julia Carol, Co-Director

Association of State and Territorial Health Officials
Donald E. Williamson, M.D., President-Elect
Martin Wasserman, M.D., Maryland Secretary of Health

Maine Department of Human Services, Bureau of Health
Randy H. Schwartz, M.S.P.H., Director, Division of Community and Family Health

National Center for Tobacco-Free Kids
William D. Novelli, President
Matthew L. Myers, J.D., Executive Vice President

National Medical Association
Randall C. Morgan, M.D., President
Yvonnechris Smith Veal, M.D., Past President

The Onyx Group
Rev. Jesse W. Brown, Jr., M. Div., Vice President

Partnership for Prevention
Jonathan E. Fielding, M.D., M.P.H., M.B.A., Vice-Chair

Science and Public Policy Institute
Jeff Nesbit, President

Smokeless States National Program
Thomas P. Houston, M.D., Director of Smokeless States National Program Office

Stop Teenage Addiction to Tobacco
Judy Sopenski, M.Ed., Executive Director

Tobacco Products Liability Project
Richard A. Daynard, J.D., Ph.D., President, Tobacco Control Resource Center;
Chairman, Tobacco Products Liability Project

The Advisory Committee on
Tobacco Policy and Public Health

Task Force Members

Task Force on the Regulation of Nicotine and Tobacco Products:

1. American Cancer Society (John Seffrin—Chair)
2. National Center for Tobacco-Free Kids (William Novelli/Matthew Myers)
3. Stop Teenage Addition to Tobacco (Judy Sopenski)
4. Tobacco Products Liability Project (Richard Daynard)

Task Force on Youth and Tobacco:

1. American Academy of Pediatrics (Richard Heyman—Chair)
2. American Academy of Family Physicians (Robert Graham)
3. American Cancer Society (John Seffrin)
4. American College of Chest Physicians (Robert McCaffree)
5. American Public Health Association (Katherine McCarter for Mohammed Akhter)
6. Association of State and Territorial Health Officials (Donald Williamson)
7. National Center for Tobacco-Free Kids (William Novelli)
8. National Medical Association (Yvonnechris Veal for Randall Morgan)
9. Partnership for Prevention (Jonathan Fielding)
10. Smokeless States National Program (Thomas Houston)
11. Stop Teenage Addition to Tobacco (Judy Sopenski)

Task Force on Current Users of Tobacco Products:

1. American Medical Association (Randolph Smoak for Nancy Dickey—Chair)
2. American Academy of Family Physicians (Robert Graham)
3. American Academy of Pediatrics (Richard Heyman)
4. American College of Chest Physicians (Robert McCaffree)
5. American College of Preventive Medicine (George Anderson)
6. National Medical Association (Yvonnechris Veal for Randall Morgan)
7. The Onyx Group (Jesse Brown)
8. Smokeless States National Program (Thomas Houston)

Task Force on Environmental Tobacco Smoke:

1. American Lung Association (John Garrison—Chair)
2. Action on Smoking and Health (John Banzhaf)
3. American College of Preventive Medicine (George Anderson)
4. American Heart Association (Dudley Hafner)
5. American Public Health Association (Katherine McCarter for Mohammed Akhter)
6. Americans for Non-smokers Rights (Julia Carol)
7. Association of State and Territorial Health Officials (Donald Williamson)

Task Force on the Future of the Tobacco Industry and Tobacco Control Efforts:

1. Advocacy Institute (Michael Pertschuk—Chair)
2. American Heart Association (Dudley Hafner)
3. American Lung Association (John Garrison)
4. American Medical Association (Randolph Smoak for Nancy Dickey)
5. Americans for Non-smokers Rights (Julia Carol)
6. National Center for Tobacco Free Kids (Matthew Myers)
7. The Onyx Group (Jesse Brown)
8. Partnership for Prevention (Jonathan Fielding)
9. Tobacco Products Liability Project (Richard Daynard)

The Advisory Committee on
Tobacco Policy and Public Health

Staff to the Committee

Jeff Nesbit, Staff Director
Timothy M. Westmoreland, J.D., Counsel
Ruth J. Katz, J.D., M.P.H., Counsel


Michael D. Beauvais, Legal Associate
R. Scott Foster, J.D., Legal Associate
Susan E. O'Donnell, M.A., Public Affairs
Martha Ross, Senior Program Associate
Mary Supley, Public Affairs

Appendix 3A

Report of the Task Force on
the Regulation of Nicotine and Tobacco Products

This report establishes public health benchmarks developed by the Subcommittee on Nicotine and Product Regulation. This compilation is not all inclusive, but rather a summary of the most serious concerns expressed by committee members to date with the advice and consent of nationally recognized experts:

I. Health Consequences of Nicotine Addiction, Withdrawal, Treatment, and Cessation Issues

With 50 million addicted tobacco users and other Americans who are impacted by smoking, the health policy developed through legislation, settlement, or regulation must address the needs of this population. Aside from compensation issues, these people will need help and funds from the industry should pay for their treatment. The FDA must have the authority to regulate nicotine, but not just in the context of future addicts. Any solution that does not address the needs of current users is inadequate. The costs and administration of a program to assist with this population must be coordinated with Federal, State, and Local agencies. It must be systematic and available throughout the country. Principles of a cessation program include:

• Multi-component program, utilizing all treatment options within the existing framework of nicotine replacement.
  
  
• A standard list of approved modalities, with reimbursement guidelines.
  
  
• A lifetime benefit, rather than a single or one time opportunity for help. Addiction to nicotine is a chronic disease, many individuals will need treatment more than once. A few will benefit from extensive help. There must be no arbitrary cap on number or cost of treatment that an individual may receive.
  
  
• An assessment of existing programs throughout the US, in order to maximize funds for coordinated effort.
  
  
• Quality control to ensure high standards.
  
  
• Adequate funding for research, particularly for children and special populations.
  
  
• Agency for Health Care Policy and Research guidelines provide a sound basis for describing for the range of services that should be actively supported initially, but additional modalities and interventions should be explored through clinical research.
  
  
• Both treatment and prevention services should be made available through state contracts.

II. Extent of Jurisdiction Over Nicotine, Other Constituents, and Ingredients

Much has been documented about the addictive qualities of nicotine, and the focus on the drug and its delivery device is the basis for FDA assertion of jurisdiction. Yet regulation of the myriad other constituents and ingredients has been less prevalent in the discussion of FDA authority. Full FDA authority in the regulation of nicotine is not sufficient. The authority to regulate, disclose, and if necessary prohibit other constituents and ingredients must be addressed in any public health policy. Tobacco additives, carcinogens, dyes, product enhancers, and preservatives all play a key role in the cigarette as a delivery device and must be scrutinized in addition to nicotine. Nicotine makes the product addictive, the toxins make it deadly, and the additives make it more consumer acceptable, like sweetening a poison. While the current FDA rules may not hold sway over each of these content areas, any regulatory scheme should include the consideration of these critical cigarette components. ETS and the OSHA regulations cannot be excluded in a comprehensive plan which assures protection of workers, children, and the public.

The authority to regulate cannot be construed as tantamount to regulating. Enforcement of regulation is a key component to any FDA action. Granting the FDA the right to regulate content, nicotine levels, and other ingredients must be coupled with the funds to do so. Ancillary FDA regulatory issues: labeling, disclosure of content, manufacturing, and marketing should be included in any public health policy. Other specific recommendations include:

• Explicit authority to regulate nicotine levels, other toxic constituents, and ingredients, including the authority to phase out nicotine and remove ingredients that contribute to the onset of smoking and dependence on cigarettes.
  
  
• Ability to test nicotine levels by brand based on the best science.
  
  
• Prohibition on use of marketing terms and brand names, such as "light, low, and mild" unless science supports claim and the public is proven not to be misled.
  
  
• Regulate nicotine in a way that is consistent with all other nicotine delivery systems (e.g., gum, patch, inhaler, etc.) All nicotine delivery devices, whether produced by tobacco companies or by pharmaceutical companies, should be evaluated and regulated by the FDA using a consistent set of standards.
  
  
• No limitations or special exceptions on FDA authority to regulate nicotine, other constituents and ingredients.
  
  
• Adequate funding for FDA research on nicotine to ensure appropriate regulation.
  
  
• Any burden of proof placed on the FDA regarding its authority to regulate should not be excessive; rather the lion's share of the burden of proof should rest with the tobacco industry in all areas of jurisdiction.
  
  
• Information exchange and scientific conference of industry and NIH researchers in a public national forum.
  
  
• Inclusion of pipes, cigars, roll-your-own cigarette tobacco, and smokeless in regulatory framework.
  
  
• Consideration of generic packaging for all cigarettes.

III. Timing of Jurisdiction Over Nicotine, Other Constituents, and Ingredients

Pragmatic consideration of FDA regulation roll out and enforcement should be addressed in a meaningful way. One option: to assign an arbitrary trigger for further restriction (a set number of years before agency can ban nicotine.) Yet another option: establish a standard of proof and mechanism of discovery necessary before FDA can take additional action. A realistic plan should be developed. The consensus of the committee:

• The best science, information, and health policy, and not an arbitrary deadline, should drive FDA regulatory timing.
  
  
• The FDA should take appropriate steps to protect public health and be able to further regulate nicotine, other constituents, and ingredients as the evidence suggests necessary.
  
  
• Jurisdiction by the FDA should not circumvent state and local communities from further assertion of regulation.

IV. Disclosure of Relevant Research

The need for full disclosure of both scientific and market data is necessary not only by the industry, but its associations, law firms, and service providers to the extent that such information will ensure complete and effective product regulation. Research on the health effects of the product, on why people initiate use, on the effects of marketing must be disclosed. All industry based research should be made available to the FDA for review. Data on ETS and its impact on the non smoker should be turned over as well. Penalties, both civil and criminal, for nondisclosure should be developed. A mechanism for document production must be adopted and could also serve as a trigger for additional FDA action.

• Research on nicotine levels is not enough - all science and information regarding pricing, additives, market strategy, addictiveness, toxicity, ease of use, attractiveness and consumer behavior must be made available to the FDA, and when appropriate, the public.
  
  
• Information includes all past, current, and future research.

V. Review of Regulatory Framework for All Nicotine Devices

The framework for regulation should bring to market less dangerous products and expose known science regarding "less hazardous" alternative delivery systems in full public view. But, in the broader context, a review of the requirements of all nicotine delivery devices, including pharmaceutical devices, is necessary to ensure the standard for cigarettes will achieve maximum overall reduction in disease rather than continue to give regulatory advantages compared to less toxic forms of nicotine delivery. State and local jurisdictional issues and antitrust considerations must be addressed in the context of the regulatory framework. The regulation of the tobacco industry should be on par with all other producers of regulated drugs. The regulatory framework must create an environment which yields less hazardous products and a reduced public health impact of tobacco use. Safety should be measured on the societal as well as the individual level.

• Equity and a consistent standard for all nicotine devices is necessary.

VI. International Implications Including Manufacturing and Market Issues

While international regulatory issues are not the primary purview of the FDA, consideration of the world market and the effects of US regulation deserves examination. Restricting Federal agencies from assisting tobacco companies internationally, reviewing funding and research support for the WHO, and considering compacts protecting developing countries from unfair and deceptive trade are beginning components of international regulation. Production of tobacco abroad by domestic corporations should be addressed to both protect world health and ensure US regulation contributes to that end.

• Funding of a international information exchange whereby all documents associated with the domestic Federal regulation of smoking is shared with international community.
  
  
• No use of Section 301 of the Trade Act for tobacco.

Conclusion

The strongest health policy will treat currently addicted Americans, fund research in order to develop the less hazardous alternative nicotine delivery systems, give FDA immediate authority to regulate all areas of nicotine, other constituents, and ingredients, disclose all industry information regarding all aspects of the product including pricing and market data, build a regulatory framework that is equitable and consistent with all nicotine devices, and is mindful of the international implications of domestic regulation.

Through each of these components is the overarching need to fund each aspect of this policy. Without adequate funding: regulation, research, disclosure, prevention, and treatment will not be possible. Whether these issues are addressed by regulation, legislation, or settlement: the tobacco industry will have to pay for the damage its product has inflicted on the American public. In the context of this subcommittees charge, that means the industry must fully fund these policies. Anything less is not acceptable.

Appendix 3B

Report of the Task Force on
Youth and Tobacco

More than ninety percent of people who will ever smoke on a regular basis begin doing so prior to the age of nineteen. Each day some 3,000 children take up the habit, and the average age at which they begin is about 12-1/2. While these children begin to use tobacco for a variety of reasons, they very quickly become addicted to the nicotine present in the product and studies show clearly that children have just as difficult a time quitting as do adults. Furthermore, the exposure of children to environmental tobacco smoke creates major health hazards for this age group just as it does for adults.

There are a number of reasons why children begin to use tobacco. Some perceive it as "normal," thanks in part to the media's portrayal of tobacco use. Some identify it as an adult privilege, and use it as a way to be more adult-like. Many are influenced by the barrage of advertising that depicts tobacco users as sexy, popular, "cool," macho, independent, sexy, thin and successful and feel that by using a particular brand they can incorporate these images as well. Some see tobacco use as a legal risky behavior that allows them to appear rebellious and "tough" without directly flouting the law. Others simply take up tobacco use because they are bored or their friends are doing it and they want to be "part of the crowd." The clever and accurate research conducted by the industry over the years has led to remarkably effective advertising and promotion which, in turn, has created for many young people a perceived value to the use of tobacco. Given that tobacco harms one's health, costs money, is offensive to others and fosters chemical dependency, there really is no true value to its use, save perhaps to the tobacco industry.

The nation's long term policy must focus intently on youth uptake and attack the problem from every possible angle. Advertising and promotion must be eliminated. The industry must be regulated, access controlled, excise taxes increased and price supports removed. The public must be educated about the true addictiveness and dangers of tobacco use, and outcome studies must be conducted to monitor the success of our prevention efforts.

POLICY OPTIONS

Promotion

Promotion and marketing of nicotine-containing products (cigarettes, cigars, snuff, smokeless and pipe tobacco) by the tobacco industry has been extremely successful through such methods as advertising, accessibility, product placement in movies and television, event sponsorship and enticing graphics on packaging. By purposefully targeting adolescents and young adults, women, and special populations, the industry has been able to replace those who quit and the over 400,000 smokers who die each year from tobacco-related causes.

Policy Recommendations:

• Prohibit marketing, promotion and advertising of all tobacco products, and services, goods and other items that carry tobacco brand names, logos or imagery.
  
  
• Prohibit tobacco manufacturers, distributors, or retailers from sponsoring any athletic, social or cultural events using the name of any tobacco product.
  
  
• Prohibit sale and distribution of tobacco products to persons under age 18.
  
  
• Ban all tobacco vending machines.
  
  
• Ban sale of all tobacco products near [within 1,000 ft of] schools, playgrounds, youth centers, day care centers, pharmacies, hospitals, and other health centers.
  
  
• Ban all self serve displays by requiring all tobacco products be located behind the counter, inaccessible to the customer.
  
  
• Ban all marketing and sale of tobacco products through mail-order or on Internet and other electronic systems.
  
  
• Prohibit free samples.
  
  
• Institute a minimum package size for tobacco products (e.g., 20 cigarettes would be the minimum package size).
  
  
• Strengthen warning and product content labeling on all tobacco (e.g. by enlarging labels, placing them in the center of the pack, using bright colors and bold type, etc.). Warnings should reflect nicotine addiction, risks from second-hand smoke and the increased health dangers resulting from smoking during pregnancy.

Enforcement

• Dual enforcement authority with both the FDA and the State Attorneys General, each being able to enforce these provisions. In addition, the FDA will have the power to contract with other state and local authorities to assist in enforcing the rules.
  
  
• Enforce prohibition on tobacco sales to minors through a national enforcement program consisting of the following elements:
• -- routine unannounced compliance testing enforcement through decoy "sting operations;"
• - require licensing of tobacco retailers with licensing fees, and provide for fines, license suspension and revocation for repeated sales to minors;
• - target penalties primarily to store owners;
• - require display of warning sign at cash register stating legal age-of-sale, ID required to purchase tobacco, and a toll-free number for customers to report illegal tobacco sales;
• - use civil, administrative hearings rather than the criminal justice system for violators;
• - require tobacco companies to assist merchants by installing electronic scanners which require identification with every sale. This may require that identification is required with every sale but may be essential to achieve our goals.
  
  
• Enforcement funded by a combination of moneys paid by tobacco industry, tobacco licensing fees, taxes or surcharges;
  
  
• Ongoing education of retailers and distributors about tobacco regulations and restrictions is an essential component of compliance.

Advertising

Adolescents are particularly susceptible to tobacco advertising as they strive for autonomy and social acceptance, and work toward an identity of their own. Young people evaluate advertising messages indirectly with their emotions as opposed to making logical analyses of its content. The billions of advertising dollars spent by the tobacco industry have been disproportionately successful with teenagers. (Reference: American Psychological Association comment. Fed Reg. 1996;61:44396-44468)

Policy Recommendations:

• Counter-advertising should take place in all media markets, requiring at least $500 million per year (in 1997 dollars) to be provided by the industry but managed by an independent panel of public health experts.
  
  
• Broadcast counter-advertisement should appear on all cable and commercial broadcast channels during prime time when children are watching television or listening to the radio.
  
  
• Counter-advertising must highlight the negative health effects and addictiveness of nicotine and tobacco, and be written at age appropriate levels.
  
  
• The possibility of using a coalition of movie stars, sports celebrities, television stars, and popular musicians, particularly ones who are popular with the target audience, as spokespeople for the tobacco-free message should be explored.
  
  
• Prohibit all tobacco advertising and promotion in public entertainment. This includes product placement in movies and on television.
  
  
• Prohibit the payment of fees or "in kind" services in exchange for placement or use of tobacco products in movies or television.

Public Education

It is essential that there be well-funded, effective and sustained educational programs for youth, parents, and the public in schools, in homes, in health care offices and hospitals, in the community and in the media.

There are a number of tenets that must be included in effective public education programs. These include: child-centered family-focused efforts; long-term and repeated prevention and intervention strategies; age appropriate, developmentally appropriate, and culturally sensitive content; increasing social competency such as communication skills, peer relationships, self-efficacy, assertiveness, critical thinking skills, media literacy, and other protective factors. Religious and "community-specific" organizations, businesses, government, schools, and other community organizations must play an active and visible role in strengthening the norms against tobacco use.

Policy Recommendations:

Industry

• Tobacco manufacturers would be required to provide and maintain adequate financial support for a national educational campaign -- with a major reliance on television, radio, print and Internet messages -- in order to counter pervasive imagery and reduce the appeal created by decades of pro-tobacco messages. (Fed Reg. 8/11/95, p. 41326)
  
  
• The program must be national in scope and require companies purchase certain times and places on television programming (e.g., 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). The buy could ensure that the message reach an average of 70 to 90 percent of all persons between the ages of 12 and 17 years five to seven times per each 4-week period. There shall be an evaluation tool developed to be certain this is accomplished.
  
  
• Messages shall change over time to remain novel and of interest to young people.

Schools

• All schools should adopt and implement the Centers for Disease Control and Prevention (CDC) guidelines to prevent tobacco use and addiction. (IOM Rpt.)
  
  
• Schools should serve as a focal point for a community-wide effort promoting non-use of tobacco.
  
  
• Ban the wearing and carrying of apparel with tobacco names, logos, and insignia while on school property or while attending school-sponsored events.
  
  
• Schools should institute a "zero tolerance" policy against tobacco use within 200 feet of school property that applies equally to both students and staff not only at school, but at all school-sponsored and sanctioned activities. Penalties for noncompliance should be clear and enforced, and alternative programs for students excluded from school must be available.
  
  
• Schools should institute tobacco prevention programs in pre-kindergarten through 12th grade. Ideally, the program should be incorporated into the existing school curricula with financial support from the tobacco industry, for curriculum development and its implementation. Tobacco use prevention can also be included in the curriculum as a stand-alone program, as part of a substance abuse program or as part of a comprehensive school health education curriculum. As students transition from elementary school to junior high or middle school (sixth and seventh grade), the educational program should emphasize the social factors that influence smoking onset, short-term consequences and refusal skills. Students should be involved with the development and delivery of the program. Parental involvement should be encouraged. Teachers should be adequately trained. The programs should be socially and culturally acceptable to each community. (SGR Report 1994, p. 219)
  
  
• Schools should seek public/private partnerships to sponsor non-smoking events that are considered "cool", i.e. concerts.
  
  
• Schools should facilitate cessation programs for students, faculty and staff.

Community Programs

• There must be the continuation nationwide of IMPACT and ASSIST-like coalition grants that allow for local autonomy and creativity for involving young people in these positive programs.
  
  
• Families need full information regarding the risks of exposure to environmental tobacco smoke and the risks to fetuses for maternal smoking.
  
  
• Communities should institute a "zero tolerance" policy against tobacco use that applies equally to parents and care givers as well as staff at child care centers, community health clinics, family planning centers, pre-school, camps and other programs for children. This would apply not only at the site, but at all activities sponsored and sanctioned by the group. Penalties for noncompliance should be clear and enforced.
  
  
• Communities should form partnerships between business and schools to develop community service media campaigns against smoking.
  
  
• Youth-serving organizations can provide youth with the skills and experience to take meaningful local action against the tobacco problem. A number of states have successfully involved youth in solving the problems of youth use and access. These programs need to be recognized and the lessons from them disseminated to other communities.
  
  
• Special attention and funding must be given to pre- and post-natal smoking cessation programs to assure a healthy start for all babies and to protect them from environmental tobacco smoke.
  
  
• Develop and test educational materials for every hospital waiting room, doctor and dentist office for smoking and non-smoking parents and their children.

Health Professionals

• Inquiry into tobacco use should be a routine part of prenatal visits and regularly as part of pediatric visits.
  
  
• The health care providers should routinely counsel children and youth to prevent their initiation of tobacco use and to help those that have started to quit.
  
  
• Providers should receive education about how to effectively counsel children to prevent tobacco use and to help those who have started using to stop.
  
  
• Tobacco use behavior by children/youth should be included as outcome measures in assessing the quality of health care services.

Fiscal

Data indicate that children and youths are more price-sensitive than adults, and that pricing has a strong and immediate impact on reducing sales of tobacco products overall. Increasing the price puts a higher barrier between youths and easy access (affordability) to the products, and therefore between youths and sustained tobacco use. A number of studies suggest that a two dollar increase in the price of a package of cigarettes will lead to a fifty percent reduction in teen use. Thus, this barrier will delay the initiation and reduce the number of new tobacco users. (IOM Rpt. 1994) "In economic terms, improved health and life-years saved is valued at from $28 to $43 billion per year." (Kessler, et al, PEDIATRICS June 1997, pp 884- 887)

Policy Recommendations:

• Increased excise taxes on the sale of tobacco products should be established by placing the tax at a rate higher than taxes among other industrial nations. The price of a package of cigarettes or container of smokeless tobacco should be raised by two dollars per package in 1997 dollars and this amount should be adjusted for inflation as appropriate. Cigar prices should be raised a proportional amount.
  
  
• Federal subsidies to tobacco farmers should be redirected to alternative crops and to maintenance of the "family farm." (Dr. David Altman, Bowman Grey School of Medicine)
  
  
• Some of the state funds collected from tobacco liability shall be designated to support state and local anti-smoking programs.
  
  
• Tobacco taxes should be increased periodically to assure funding of enforcement, counter- messages and education.
  
  
• The net price of tobacco products must rise consistent with inflation and excise tax increases.
  
  
• A portion of the Federal excise tax revenue should be set aside to establish an endowed foundation with the explicit function of developing and funding tobacco prevention and control programs and activities, with a percentage of this revenue going directly to support prevention programs.

Regulation

Tobacco products have been consistently exempted from coverage under consumer safety, food and drug legislation, and as a result have been largely unregulated. This lack of regulation stands in stark contrast to other products that have far less disastrous long-term health implications than the use of tobacco products such as over-the-counter drugs. (IOM Rept. 1994)

Policy Recommendations:

• The issuance of the FDA tobacco regulations in August 1996 are the cornerstone of national tobacco policy and must be retained and strengthened.
  
  
• Congress should repeal the Federal law that precludes State and Local governments from regulating tobacco promotion and advertising occurring entirely within a state's borders.
  
  
• States should license retailers, manufacturers, distributors, wholesalers and importers with graduated penalties and license suspension for violating access laws, using fees to pay for enforcement in limiting youth access.
  
  
• Communities should work toward smoke free environments and receive assistance from state and local public health agencies to develop ordinances and implementation strategies.
  
  
• States and local jurisdictions should ban smoking in environments where children are present, especially in restaurants and where youth live, work and play.
  
  
• The National Cancer Institute should be particularly active in designing, promoting and evaluating tobacco control strategies.
  
  
• State and Local governments should not be preempted from enacting stronger laws.
  
  
• The Centers for Disease Control and Prevention shall provide sufficient funds to ensure statewide, community-based tobacco use prevention and control programs.
  
  
• The warning on packages should be moved to the front of the cigarette package and the most prominent side of the smokeless tobacco product package.
  
  
• The industry should be subject to penalties if youth tobacco use fails to drop by 15 percent in 2 years, 30 percent in 5 years, 50 percent in 7 years and 60 percent in ten years. The penalty would be based on the value of a teen tobacco user to the industry over the lifetime of the individual. It would be worth approximately $80 million per percentage point by which the target was not met. At a minimum, the FDA should incorporate the following criteria into its rulemaking process for establishing performance based penalties:
• -- give the industry powerful incentives to meet the targets,
• -- not limit the potential liability for failing to reach the targets,
• -- take into consideration the economic costs of all sectors of society of not meeting the targets,
• -- be based on the estimates of independent financial experts with full disclosure of economic assumptions used,
• -- become effective in the first two years after completion of the FDA rulemaking process.
• -- consider a variety of penalties including the enforcement of plain packaging without the use of color and logos.

Research

Youth tobacco use is a complex, multi-faceted problem which requires an intense research agenda which goes beyond reducing access and restricting advertising. Youth live in families and communities where they are exposed to the dangers of environmental tobacco smoke at home, in restaurants, in public buildings and other places in the community. The acceptability of tobacco use among children and teens may be fostered by parents, siblings, other family members, adult role models, friends and peers. Strategies to change these social norms must be developed and evaluated.

Policy Recommendations:

• Research the effects of environmental tobacco smoke on human growth and development and develop health policies that stress the benefits of the smoke-free home for children, including studies of the effectiveness of incentives for families with asthmatic children (e.g. testing child for nicotine metabolites and rewarding families with coupons, discounts at local stores).
  
  
• Secure access to industry research on nicotine and other chemicals found in tobacco products relating to use by children and teens.
  
  
• Research the effects of nicotine and how it medicates youth anxiety, social malaise, weight control, and provides pre-packaged social rebellion.
  
  
• Research attitudes, turning points and developmental markers which may identify youth at risk for initiating tobacco use or progressing to more regular use.
  
  
• Research the progression of youth from non-smoker to experimental smoker to regular tobacco user to addicted user with a goal of identifying effective and targeted interventions for youth of different ages and different stages of use.
  
  
• Research the role of health providers in children's lives -- look at the effectiveness of person- to-person educational interventions with children and their care givers in preventing the uptake of tobacco use. (Perhaps prescriptions for smoke-free space)
  
  
• Research myths and misconceptions held by children and their parents/caregivers about the perception of risk, understanding of addiction, and the long-term consequences of early tobacco use.
  
  
• Research adolescent and maternal tobacco use cessation interventions.
  
  
• Research on effective school tobacco curriculum and what the goal of the education is: knowledge of health effects, implementation of healthy behaviors, media literacy and advocacy. Knowledge-based programs are insufficient without policy in place to address epidemic levels of tobacco use.
  
  
• Research what constitutes effective public education. All aspects of society need re- education on tobacco including knowledge and attitudes/beliefs which have been shaped by the tobacco industry and tobacco industry dollars for 60 years. Professional health organizations must educate their membership on the need to transfer their knowledge to the general public. All health education materials must be reviewed for accuracy. The media must be included as a group which needs education.
  
  
• Research the effect of subliminal messages in early childhood and among elementary school- aged children and how the social context influences future smoking and other tobacco use.
  
  
• Secure funding for the research agenda from the tobacco "settlement."

Appendix 3C

Report of the Task Force on
Current Users of Tobacco Products

Reducing the prevalence of tobacco use is vital to subsequent reductions in morbidity and mortality from tobacco use, currently the leading cause of death in America. The World Health Organization projects that, by the year 2025, 10 million people annually will die of tobacco-related diseases; it should be noted that this projection counts only current tobacco users. Helping current tobacco users stop not only promises to reduce the severity of the tobacco pandemic, but also will reduce the onset of smoking by youth, as they change their beliefs about tobacco use as the norm in society.

At the outset, the subcommittee recognizes that a wide definition of the population of tobacco users should be dealt with in this report, and that this discussion and the recommendations refer to persons who smoke cigarettes, cigars, pipes, and "roll-your-own" products, as well as those who use smokeless tobacco products. The report is divided into the following sections:

• Smoking cessation programs
• Education and public awareness
• Environment issues
• Research

I. Smoking Cessation Programs

The subcommittee recognizes that excellent clinical guidelines on smoking cessation have been produced by the Agency for Health Care Policy and Research; other groups such as the American Academy of Family Physicians, the American Medical Association, and the National Cancer Institute have also produced materials that have been very useful for clinicians in helping patients stop smoking. These guidelines should become a cornerstone of clinical practice, and tobacco use cessation should become a routine part of care.

We recognize that a variety of barriers to this goal exist, including education of clinicians, medical office systems that are not geared to providing clinical preventive services, and coverage of tobacco use cessation services by insurance, among others. A discussion of some of these follows; however, a detailed analysis is beyond the scope of this report.

• There should be widespread, readily available clinical services for treatment of nicotine dependence for both adults and youth. Better access to cessation programs is essential, and information on program availability is critical.
  
  
• Services should be wide in scope, including self-instruction courses such as those from 1-800-4-CANCER; over-the-counter products and support services offered by pharmaceutical companies, brief clinical interventions as detailed in the AHCPR guidelines; group and individual counseling services; and a mix of intensive services that can be provided to hospitalized patients in general hospital settings, psychiatric and drug treatment facilities, and inpatient nicotine dependence centers.
  
  
• Reimbursement for tobacco use cessation and appropriate use of pharmacotherapy should be covered by all insurance, managed care, and employee benefit plans, including Medicaid and Medicare. A lifetime benefit, rather than a single or one-time opportunity for cessation is essential. Nicotine dependence is a chronic disease, and should be addressed as such by both clinicians and payors. Most individuals will require more than one attempt at cessation for ultimate success, so there should be no arbitrary cap on the number of sessions or cost of treatment.
  
  
• Tobacco companies should be required to contribute to and provide financial support for cessation programs for both adults and youth who are nicotine dependent.
  
  
• Funds that are set aside from tobacco companies for cessation should be managed in the most efficient way possible, with maximum flexibility regarding clinical needs and options for treatment, administered by a responsible group, and shielded from political influence. Specific attention to the uninsured might be a priority for the use of this fund.

II. Education and Public Awareness

Although primary prevention in tobacco use is crucial, current tobacco users must be informed as to the need to stop tobacco use and to seek help in cessation, using the most powerful means available. Behavior change is the goal, and creating public demand for and acceptance of tobacco use cessation is key in the effort to forge such changes.

• Public awareness programs should be broadly used, and directed toward specific populations and subgroups such as persons of color, Native Americans, women, youth, and those with special occupational hazards that produce morbidities with tobacco use. Pharmaceutical companies should partner with others in the health community to provide such messages, communicating much more than "brand share" information.
  
  
• As part of the public education program, tobacco manufacturers should be required to discuss and encourage the participation of tobacco users in cessation programs.
  
  
• Tobacco use prevention and control subjects, including cessation, must become a standard series of courses taught in undergraduate medical and nursing schools, in postgraduate residency training programs, and as a part of life-long learning in continuing medical education courses.
  
  
• Innovative programs in providing information and assistance to tobacco users should be encouraged and funded, such as using pharmacies and pharmacists as a source for tobacco use prevention and cessation, effective school-based education/treatment programs, use of the Internet, recreational and church- based organizations, and other non-traditional venues for tobacco control.

III. Environmental Issues

As important as the measures outlined above are to the individual tobacco user, societal norms must also change in order to support and encourage cessation. Public attitudes about tobacco use are key in this regard. Tobacco sales in pharmacies, for example, sends mixed messages to the public, particularly youth, about tobacco and health. Pharmacies should stop selling tobacco products, as one of several strategies to change the consumer culture related to tobacco use. As this applies to cessation, the public must understand that tobacco use is not a matter of "sin," that failure to stop use is not lack of "will power," and that tobacco use cessation is not an impossible task.

Among environmental issues, specific areas include the following:

• The price of tobacco products must increase dramatically, as this provides both an incentive for tobacco users to stop, and a deterrent for youth who might start.
  
  
• Widespread restrictions on environmental tobacco smoke (ETS) exposure should be enacted, since this has been shown not only to protect the nonsmoking majority from the hazards of ETS, but also to increase the rate of cessation among employees whose workplaces have become smokefree. ETS restrictions also provide societal modeling for youth showing that smoking is not the norm.
  
  
• Differential rates for health, life, and other related insurance premiums should be widely enacted as an incentive for cessation as well as to adequately cover the costs of tobacco use.

IV. Research

Well-funded research is essential to solving the personal health, medical care delivery, and public health problems related to tobacco use. Several areas of research pertain to cessation, and should target therapies and standards for nicotine dependence interventions that establish their validity and effectiveness.

• Epidemiological information regarding tobacco use, its patterns in specific populations (youth, women, communities of color), brand uptake, use of different types of tobacco products, and the effect of cessation programs is critical.
  
  
• Sustained, high level research funding on a broad range of tobacco cessation programs and therapeutics is needed, including funding for innovative behavioral approaches and non-pharmacological therapies, as well as research into new pharmacotherapy.
  
  
• Specific population groups must be a focus of well-funded cessation research and demonstration projects: adolescents, women, communities of color, and recent immigrants are a few of these.
  
  
• Research should target smokeless tobacco and cigar use, particularly among adolescents and young adults.
  
  
• Rapid dissemination of the best available tobacco use cessation tools is paramount.
  
  
• Tobacco manufacturers should be required to support and fund effective research related to cessation programs that address both adolescent and adult tobacco users.
  
  
• Adolescent tobacco cessation should be a special priority for research, including investigations of the origins and onset of tobacco use, the transition from experimentation to regular use, and a wide range of cessation modalities.

Appendix 3D

Report of the Task Force on
Environmental Tobacco Smoke

Environmental Tobacco Smoke (ETS) has been classified as a Group A (known human) carcinogen by the U.S. Environmental Protection Agency. This classification is traditionally reserved for the most dangerous of cancer-causing agents, including asbestos, benzene and radon. In its landmark 1992 risk assessment, Respiratory Health Effects of Passive Smoking: Lung Cancer and Other Disorders, EPA estimated that 3,000 lung cancers deaths per year in nonsmokers are attributable to ETS. Similarly, the National Institute for Occupational Safety and Health in their Current Intelligence Bulletin 51 found ETS to be a potential occupational carcinogen, the agency's most significant warning. In addition, the American Heart Association estimates that ETS is responsible for up to 60,000 deaths yearly from cardiovascular disease. Moreover, tens of millions of American have medical conditions, including asthma, bronchitis, emphysema, allergies, sinusitis, rhinitis, and laryngitis which cause them to suffer very severe and often-life threatening reactions upon exposure to ETS.

The Committee is particularly concerned about the effect of ETS on children. Children are powerless to control their exposure to ETS and yet they are the group most adversely affected by exposure. Children are at risk simply because they are young--they take in more air (and more pollution) relative to their body weight and lung surface area, their lungs are still developing and their biologic defenses against pollution are not fully mature. ETS exposure is associated with additional episodes and increased severity of symptoms in children with asthma. ETS exposure exacerbates symptoms in approximately 20 percent of this country's 4.8 million asthmatic children. The EPA estimates that exposure to ETS from parental smoking causes 150,000 to 300,000 lower respiratory tract infections per year in children under 18 months of age, resulting in 7,500 to 15,000 hospitalizations. Sudden Infant Death Syndrome, the leading cause of death in infants between one month and one year of age, has been linked to exposure to ETS.

Federal, State, and Local governments as well as the courts have all provided important protections for nonsmokers.

• At the Federal level, the 1994 Pro-Children Act banned smoking in all facilities providing services to children that receive Federal aid including schools, day care centers, certain health care facilities and libraries. The Airline Smoking Ban has virtually eliminated smoking on all domestic flights and the U.S. has been supportive of the International Civil Aviation Organization resolution encouraging member nations to prohibit smoking on their international flights. However, President Bush failed to respond to a proposal from HHS Secretary Louis Sullivan for an executive order requiring Federal agencies to be smoke free and the Clinton Administration has not pursued such an order. OSHA remains mired in a regulatory process to address smoking in workplaces under its jurisdiction.
  
  
• State and Local governments have also taken action. Forty eight states and the District of Columbia have laws that in some way restrict smoking in public places. These laws range from limited prohibitions, such as no smoking on school buses, to comprehensive clean indoor air laws that limit or ban smoking in virtually all public places. Twenty two states and the District of Columbia restrict smoking in some way in private workplaces. (Attached are several appendices detailing State and local clean indoor air laws)
  
  
• The courts have acted on a case-by-case basis in 15 states to provide legal protections for children especially sensitive to environmental tobacco smoke. These cases, generally, have involved action to protect children from parental smoke.

Policy Concerns

Each level of government can make unique contributions to protection for nonsmokers. The goal of any such regulation is to change the behavior of smokers in order to eliminate the exposure of nonsmokers to ETS by prohibiting smoking, and it is the effectiveness of a given regulatory approach in actually changing smokers' behavior, rather than simply the comprehensiveness of regulations enacted, that determines the extent of protection provided nonsmokers. The effectiveness of any law in changing the behavior of smokers is heavily influenced by the norms for expected behavior among smokers and nonsmokers, by the support and peer enforcement within a given community, and by the awareness of smokers and nonsmokers that the "rules" have changed.

In determining where to direct efforts to regulate smoking, the following issues must be considered:

1. Each jurisdiction should take action to eliminate exposure to ETS by prohibiting smoking.
2. Each jurisdiction should take action to provide the most effective enforcement of the prohibitions on smoking.

Goals

The Committee believes that all Americans are entitled to a smoke free environment. The Committee recommends that Federal/State/Local legislation and regulations be enacted to protect all Americans from the physical irritation, disease, disability and death attributable to ETS. Accomplishing this goal will also require renewed education efforts to increase the public awareness of the health effects of exposure to ETS.

To accomplish these goals, the committee recommends the following:

1. All jurisdictions enact and enforce legislation and regulations to eliminate exposure to ETS by prohibiting smoking. Policy actions include but are not limited to actions listing below (not in order of priority):
   
   
• Congress should enact legislation, to the full extent of its jurisdiction, to prohibit smoking in all work sites and in all places of public assembly. Such action must not preempt or otherwise limit or preclude state and local jurisdictions from acting similarly. Further, Congress should enact regulations to protect all of its employees from exposure to ETS by prohibiting smoking in all work sites and places of public assembly directly within its jurisdiction.
  
  
• State and Local governments should enact legislation, regulations and ordinances requiring the prohibition of smoking in all work sites. Such regulations should also include requirements for public awareness campaigns related to the health effects of exposure to ETS.
  
  
• State governments should establish comprehensive clean indoor air legislation that prohibits smoking in all public places, including outdoor areas where people assemble and congregate, without preemption of local mandates. In those statutes where preemption exists, states should act to remove the preemptive clauses. Such regulations should also include requirements for public awareness campaigns related to the health effects of exposure to ETS.
  
  
• State and local school boards should enact regulations requiring all elementary and secondary schools to be 100% smoke free in all areas of the campus. Such regulations should also include requirements for education of students and faculty regarding the health effects of exposure to ETS.
  
  
• State and local school boards should revise comprehensive school health education programs and general health education programs to include subject matter on the health effects of exposure to ETS.
  
  
• The Congress should enact legislation, to the full extent of its jurisdiction, to implement the International Civil Aviation Organization resolution by requiring all international airline flights originating from or landing in the United States or its territories be 100% smoke free. Similarly, federal law should prohibit smoking on any bus, train or cruise ship which originates or arrives at any point in the United States.
  
  
• The government (EPA, CDC, NIOSH) should complete a risk assessment of the cardiovascular health effects of exposure to ETS.





2. Economic incentives for smoke free workforces should be developed.
   
   
• Insurers should be encouraged to differentially rate work sites by their no smoking policies, including smoke free work sites and opportunities for employee smoking cessation, for purposes of providing health insurance, business insurance, and workers compensation.





3. To complement the laws and regulations prohibiting smoking as well as adoption of additional restrictions imposed by the private sector, adequate funds should be provided for a program of education and public awareness about the dangers of ETS. A secondary benefit of such education and public awareness programs is the growing recognition that this type of program can also serve as another mechanism for the prevention of youth smoking.
   
   In addition to the above recommendations, the Subcommittee urges the full Committee to request, immediately, the President sign an executive order making federal workplaces, including all branches of the military and the Department of Veterans Affairs hospitals, 100% smoke free. Such an action would demonstrate the continued support of the Administration for a tobacco free society.

Appendix 3E

Report of The Task Force on
the Future of the Tobacco Industry and
Tobacco Control Efforts

RECOMMENDATIONS

I. Sustaining Essential Tobacco Control Efforts

Tobacco control advocates, the State Attorneys General, the Food and Drug Administration, the Federal Trade Commission, private tort claimants in class actions and in individual cases, and state and local legislative initiatives have brought a wide and effective range of forces to bear on the tobacco industry. After thirty years of virtually unconstrained marketing abuses, subversion of public health regulation, and anti-democratic political activities, these forces have at last placed the industry on the defensive.

These forces include not only the first judicially sustained assertion of comprehensive tobacco regulatory authority by a Federal agency, but the high promise of pending civil litigation. They include the emerging strength and moral authority of the tobacco control movement and the eruption of public antipathy towards the tobacco industry -- the product of unprecedented mass media coverage and exposure of tobacco industry wrongdoing.

The President and Congress need to be fully mindful of the actual and potential benefits from, as well as the limitations of, the forces at work under existing law.

It is the Committee's firm conviction that the White House and Congress must assure the continuity of those forces which remain essential counterweights to the economic and political power of the tobacco industry.

This requires:

1. Unambiguous non-preemption provisions in any Federal regulation of tobacco, expressly disclaiming any intent of, or authority from, Congress to preempt the imposition of higher standards by states and local jurisdictions, except to the extent that such standards violate constitutional constraints.
   
   
2. Funding for Federal, State, and Local government and non-government tobacco control activities at levels equivalent to those in states, such as California, Massachusetts, Arizona, and Oregon, which have dedicated portions of cigarette excise tax increases to such efforts. Such funds must be made available for:
   
   
1. Support of diverse tobacco control coalitions and watchdog advocacy organizations in all states to promote tobacco control broadly, including the freedom and resources to monitor and oversee government enforcement of legislation and regulation and to continue monitoring and exposing any future industry efforts to undermine reforms and regulation. It is particularly important that funds be available to strengthen those culturally diverse, community-based organizations working in and for those populations at greatest risk.
   
   
2. Support for local and state health departments and other agencies, as well as Federal agencies in maintaining active tobacco control programs, including the aggressive enforcement of tobacco control regulations.
   
   
3. Support for Federal and State programs to provide communications infrastructure, technical assistance, training, and other resources to build the capacity of both public and private non-profit organizations, including the ability to provide assistance for advocacy and assistance for conducting litigation.
   
   
4. Support for the collection and analysis of comprehensive data on tobacco use, behavior, and attitudes, down to the local level.
   
   
5. National Cancer Institute leadership among National Institutes of Health to establish a coordinated program of tobacco control research and development.
   
   
6. Support through appropriate Federal agencies and their partners in chronic disease prevention for comprehensive, policy-focused, state-wide innovative intervention research, development, and dissemination, including demonstration programs for implementing effective interventions.

Such funding must be structured to assure such programs will be as free as possible from tobacco industry and political censorship or constraints, including the freedom to advocate the enactment of tobacco control policies, to expose tobacco industry wrongdoing and to challenge the failure of government entities to carry out the law, whether the funds are allocated to government agencies, such as state health departments, or to non-government organizations.

One potential approach: a portion of available funds flowing into a trust administered, as in the Australian model, by a state-chartered, but independent, state Health Foundation, governed by a board composed of the leaders of health and other non-government organizations who are not recipients of funding.

3. Mandated disclosure of all internal tobacco company documents which bear upon the public health, including past and present acts to undermine public health, such as (but not limited to) the following:
   
   
1. Full disclosure of the funding and activities of industry front groups.
   
   
2. All technical and health/safety data, with a possible exception for those true trade secrets which the companies can clearly establish have no health implications.
   
   
3. All information relating to marketing, including opinion and behavioral research; the targeting of persons under age 18, women, and minorities; and all marketing information after a brief, specified period, since without such information, it is much more difficult to design an effective anti-tobacco program.
   
   
4. Full disclosure of all documents relating to the effects of secondhand smoke.

There must be a waiver of any claims of attorney-client and work-product privilege for any documents except those recently created, since those privileges have been seriously abused and any information that may have been properly privileged is unlikely to continue to be sensitive (or even relevant in litigation) now.

4. The establishment and funding support for a Federally-funded data collection and analysis, and an electronic data bank to enable and facilitate regulators, health groups and litigants to obtain the information described above and other relevant materials.

5. The full preservation of all currently available avenues of litigation, both civil and criminal, involving the tobacco industry, with no special rules of any kind, substantive or procedural.

6. Fundamental campaign finance reform as essential tobacco control policy, since the tobacco companies, more than any other industry, have flooded the political process at all levels of government with millions of campaign dollars in the sustained effort to resist all necessary and reasonable public health measures, such as restraining tobacco marketing practices.

7. Before accepting any comprehensive legislation, the President and the Congress must obtain firm commitments from all U.S. tobacco companies that they and organizations affiliated with them will cease all lobbying resistance and will actively support all Federal, State and local efforts to achieve the uniform adoption and enforcement of laws and regulations consistent with the blueprint embodied in the legislation.

II. Support for Those Economically Disadvantaged, Without Fault, by Tobacco Control Policies

Tobacco farmers and farm communities will be at severe economic risk should comprehensive tobacco control policies be enacted and take full effect. Most Americans consider the tobacco farmer as much an economic victim as perpetrator of tobacco-related disease, and support Federal government efforts to help farmers find other ways of making a living. The Committee therefore supports:

1. The establishment of a high-level blue-ribbon panel either appointed through an Executive Order or mandated through legislation. Such a panel should have as its mandate a thorough review of the domestic and international tobacco growing, manufacturing and marketing operations and trends of the U.S. tobacco companies and U.S. leaf dealers; a review of the current tobacco program as administered by the Department of Agriculture; and a thorough review and understanding of the economies of the tobacco-growing states and their communities. The panel should conduct extensive field hearings to ensure the involvement of the tobacco-growing communities in the process. It would then report back to the Congress and the President with specific recommendations for short-term and long-term strategies for reducing the dependence of tobacco-growing states and communities on tobacco, including funding recommendations for providing short-term and long-term economic development assistance.
   
   
2. The establishment of an "economic assistance and development fund" funded by the tobacco companies and administered by the tobacco-growing groups that in the short term assists tobacco farmers and their communities to implement model and pilot programs for supplementing the production of tobacco with other on-farm activities as well as other alternatives and incentives to reduce the growing of tobacco. These pilot programs could provide critical information and recommendations to the task force established under (1) above. The fund could then be used to implement some of the longer-term objectives and recommendations made by the blue ribbon panel established under (1).
   
   
3. Elimination of the Federal government's economic involvement and support for programs and projects that relate to maintenance and expansion of tobacco production. Funds presently being expended to maintain and support the programs and activities could at least for the short term be allocated for funding the aforementioned blue ribbon panel as well as funding pilot projects and programs for economic development, creation of alternative economic infrastructures and agricultural supplementation and diversification.
   
   
4. The Committee also believes that a portion of available fund should be allocated for economic development assistance to other groups who, without fault, will suffer economic risk and dislocation if the policies urged by the Committee are put in place, to include:
   
   
1. Compensation to Native Americans who will lose reservation revenues to which they are constitutionally entitled if they adhere to non-reservation sales and marketing standards.
   
   
2. Compensation to cultural, civic, and sports organizations now dependent on tobacco industry philanthropy and sponsorship.
   
   
3. Economic conversion funds to assist tobacco manufacturing and related tobacco non-farm workers.

III. Maximizing the Influence of U.S. Policies and Resources on Raising International Tobacco Manufacturing and Marketing Standards to U.S. Levels

According to the World Health Organization, tobacco use is estimated to have caused around 3 million deaths a year worldwide in the early 1990s, and is projected to cause ten million deaths a year worldwide by the 2020s or early 2030s, with 70 percent of those deaths occurring in developing countries. Many of these deaths will result from the increasingly aggressive marketing efforts of U.S.-based transnational tobacco companies.

The adoption of comprehensive national legislation governing tobacco will constitute a national finding that no civilized society can do less to stem the toll of disease and death from tobacco use. Since the marketing abuses which the U.S. seeks to control at home are practiced without restraint abroad -- by U.S.-based companies -- the U.S. government has both a public health and a moral obligation to do all within its power to see that the protections it extends to its own citizens are extended to all.

This must include adherence to the following principles:

1. The U.S. should use the broad range of its international activities and influence to actively promote tobacco control, including the adoption of U.S. domestic tobacco control standards as at least minimum global standards.
   
   
2. The U.S. must insist that public health concerns overrule trade concerns in all trade negotiations and related proceedings.
   
   
3. The U.S. should allocate substantial resources to fund effective international government and non-government institutions engaging in tobacco control activities.
   
   
4. The U.S. must obtain and enforce commitments from U.S.-based transnational companies to support, not undermine, these efforts.

Both the executive and legislative branches of the Federal government can do much, within reason, to promote these principles and bring about worldwide adoption of tobacco manufacturing and marketing standards at least as comprehensive and stringent as those enforced within the United States.

Key measures include:

1. An executive order from the President to all Departments, including State, Commerce, and the United States Trade Representative to promote actively the global adoption of U.S. domestic tobacco control policies and standards through all international interventions including diplomatic communications, export initiatives, Aid for International Development programs, U.S. information programs, and fiscal support for international bodies. The White House should also establish an Interagency Task Force, chaired by the Secretary of Health and Human Services, to oversee and implement the executive order.
   
   
2. Specific executive orders and White House support for legislation to accomplish the following:
   
   
1. The development and implementation of the Framework Tobacco Control Convention by the World Health Organization, and efforts by UNICEF to eradicate tobacco use among children.
   
   
2. In all dealings with or pertaining to the World Trade Organization, recognition of the preeminence of public health concerns over normal trade concerns, as is done for child labor. This includes support for the framing of World Trade Organization Agreements (such as the Sanitary and Phytosanitary Agreements) to support the Framework Tobacco Control Convention, not to promote tobacco trade.
   
   
3. Initiation and support for bilateral and multilateral treaties making the Framework Convention legally binding on all countries.
   
   
4. Removal of tobacco products from Section 301 of the 1974 Trade Act, combined with prohibitions against Federal agencies interfering in any efforts by international or national public health authorities to control tobacco use.
   
   
3. White House directives to the Office on Management and Budget to allocate at least $150,000,000 in appropriated or other funds, and support from Congress for such funding for international tobacco control efforts, including:
   
   
1. Funding support to WHO allocated to the development, adoption, and enforcement of the Framework Tobacco Control Convention and other tobacco control initiatives.
   
   
2. Funding support for UNICEF to promote youth-oriented tobacco control initiatives.
   
   
3. Funding support for the development of a non-government International Tobacco Control Commission, governed by senior public health leaders to: 1) Monitor international tobacco control efforts, issuing annual report on progress around the world; 2) Develop uniform standards, review procedures and provide grants to international and national non-governmental organizations advocating tobacco control; 3) Administer an international information exchange for sharing all disclosed tobacco industry documents.
   
   
4. Funding for active, aggressive efforts, by all appropriate Federal agencies, including Health and Human Services, to promote tobacco control internationally.
   
   
5. Funding for domestic and international public health investments that support tobacco control. This includes supporting research of benefit to all countries on the most effective means of quitting smoking and preventing people from starting to smoke; developing global surveillance systems to support global tobacco control strategies and to monitor implementation of the planned Convention; and funding for the development of human and institutional capacity, non-government as well as government, to promote tobacco control in developing countries.





4. The President and the Congress must obtain firm commitments from all U.S. tobacco companies that they and organizations affiliated with them will fully support the uniform international application and enforcement of laws and regulations embodied in U.S. domestic tobacco control legislation and regulation. This must include a promise to cease and desist from all attempts to influence governments and other stakeholders, domestic or international, that are inconsistent with any such legislation or regulation. U.S. tobacco companies found engaging in such practices should be subject to civil penalties based on the amount that they spend on these efforts, just as U.S. companies are now subject to fines for giving bribes abroad --even if bribery is not forbidden in that country.
   
   
5. The White House should support and Congress should enact legislation providing for the surveillance and prevention of international tobacco smuggling, including strict penalties for companies shown to be supporting smuggling.

Appendix: Background and Discussion of the Recommendations Made by the Task Force on the Future of the Tobacco Industry and Tobacco Control Efforts

Overview

Tobacco control advocates, the State Attorneys General, the Food and Drug Administration, the Federal Trade Commission, private tort claimants in class actions and in individual cases, and state and local legislative initiatives have brought a wide and effective range of forces to bear on the tobacco industry. After thirty years of virtually unconstrained marketing abuses, subversion of public health regulation, and anti-democratic political activities, these forces have at last placed the industry on the defensive.

These forces include not only the first judicially sustained assertion of comprehensive tobacco regulatory authority by a Federal agency, but the high promise of pending civil litigation. They include the emerging strength and moral authority of the tobacco control movement and the eruption of public antipathy towards the tobacco industry -- the product of unprecedented mass media coverage and exposure of tobacco industry wrongdoing.

These forces have been and remain an essential counterweight to the vast array of economic and political abuses which the tobacco industry and its allies continue to commit: lobbying excesses; gross campaign financing largess; public relations distortions and propaganda; seductive political advertising; the co-opting of communities through promotional supports; the propping up with cash infusions to phony fronts; the buying of corrupt science; the perversion of philanthropy to buy the silence of those desperate for resources; and the abuse of processes designed to serve basic citizen interests, such as "SLAP" law suits and the use of Freedom of Information Act demands as instruments of intimidation.

So, before embracing any proposed legislation which purports to offer a comprehensive framework for tobacco control, the President and Congress need to be fully mindful of the actual and potential benefits from, as well as the limitations of, the forces at work under existing law.

It is the Task Force's firm conviction that no legislation should be supported which does not assure the continuity of those forces which must remain essential counterweights to the economic and political power of the tobacco industry.

Therefore, this report first assesses the current and potential impact of pending civil litigation on tobacco control, the present and future role of the tobacco control movement, and the effect of sustained mass media focus on tobacco industry wrongdoing. It looks at the likely consequences for each of these forces if legislation which otherwise meets the standards elsewhere set forth in this blueprint are met. The report also examines the implications of comprehensive legislation for international tobacco control, and the reasonable economic conversion needs of tobacco farmers and others.

I. Sustaining Essential Tobacco Control Efforts

By the mid 1990's the nation's tobacco control movement was beginning to come of age as a powerful advocacy force for tobacco control policy and an effective counterweight to the tobacco lobby. This is a movement which has now welded together layer upon layer of diverse citizen organizations and public health authorities. At its foundation are the laser-beam-focused local non-smokers rights groups and the great national voluntary health associations -- Cancer, Heart, Lung -- who reach out to their millions of volunteers with increasingly energetic and effective calls to action on public policy issues relating to tobacco.

In turn, these groups have joined forces against the tobacco lobby with medical and scientific organizations, consumer advocates, education and children's advocates. And they have been newly committed and successful in reaching out and drawing into partnership ethnic minority and women's advocacy organizations.

To the energy of citizen volition has been added the fuel of new outside resources to build a movement infrastructure -- though still far less than the profits tobacco companies gain from illicit sales to children. But, for now, there is substantial funding and professional staff support for broad state citizen coalitions from the National Cancer Institute, the Centers for Disease Control, the Robert Wood Johnson Foundation and others, and, by ballot initiative, directly from the voters of California, Massachusetts, Oregon, and Arizona.

And what essential functions do these groups and coalitions perform? They are visible across the spectrum, from apolitical public health education campaigns, which keep a public focus on America's "brown plague," to the wildfire spread of grass roots community campaigns for local clean indoor air ordinances and billboard and vending machine bans -- laws which can count on community support in enforcement because they are born of community engagement.

At the state legislatures, where tobacco lobbyists burrow in, these coalitions have exposed and overcome the tobacco lobby's stealthy efforts to gain enactment of weak laws that preempt strong local action -- and they have launched successful statewide campaigns to raise cigarette excise taxes, most recently in Alaska, boosting the state tax to $1.00 a pack, highest in the nation.

At all levels of government, these watchdog coalitions track and expose tobacco campaign contributions, tobacco lobbyists, and ethically compromised government officials and law- makers. And after they succeed in promoting sound laws and regulations, and the focus of public attention shifts, the advocates and the coalitions remain to make sure enforcement matches promise.

But perhaps the greatest achievement of the tobacco control movement in the last decade has been its triumph in mass media advocacy -- in skillfully assuring in a hundred different ways, with a hundred different stories -- that tobacco industry fraud, deceit, conspiracy, and corruption has occupied prime space and prime time in the national news media. To be sure, this task has been amply abetted by tobacco industry whistle blowers, leaked documents, active Congressional oversight (until 1995), campaign financing reporting, and the systematic unearthing of revealing secret industry documents through the litigation discovery process.

But the frequency of such stories and their spotlight on industry wrongdoing owe much to the media advocacy skills of tobacco control advocates - both through strategic approaches to the news media and reinforcement through selective paid advertising. This media effect can be seen clearly in polling data which show dramatic increases in public recognition of tobacco as an addictive drug, public belief that tobacco companies deliberately target kids in their ads, and public support for criminal prosecution of tobacco executives for lying to Congress.

This focus of public opprobrium helps explain why this Congress, despite huge tobacco industry campaign contributions, has thus far been inhibited from attempting to enact what the tobacco industry has eagerly sought: legislation eviscerating FDA's asserted jurisdiction over tobacco products -- and legislation shielding the tobacco industry from liability under cover of "tort reform." The tobacco industry no doubt fears, too, that prospective jurors, who have been reluctant to hold tobacco companies accountable, may now be among the majorities who view them more negatively than before. So the storm of media criticism, in reinforcing greatly the threat of ruinous litigation and punitive damages, has driven the tobacco industry to the bargaining table and towards accepting demands that exceed the most optimistic policy goals of public health advocates just a few years ago.

There is also reason to believe that the continuous media coverage of the litigation and other investigative disclosures of tobacco industry practices, including the effect of future jury findings of industry culpability in civil, as well as possible criminal trials, will have a direct public health benefit in changing peoples' attitudes towards tobacco use, and, eventually, their behavior.

It is, of course, uncertain that current levels of media attention on tobacco and tobacco company behavior will continue indefinitely under existing conditions -- at some point the media may run out of newsworthy revelations, at least as to past misbehavior. And, at some point, other issues and stories will gain attention and dominate the news.

But a comprehensive legislated "settlement" -- even legislation that meets the regulatory standards set forth in other parts of the Committee report -- will threaten the virtual disappearance of such media coverage. It will do so for two reasons:

1. Passage of such legislation will convey to most Americans, including journalists, opinion leaders, and policymakers, the impression that the tobacco problem in this country has been "solved." Not only that, but the tobacco industry will be seen as a willing partner to the solution. This will mean that tobacco, and the past culpability of the tobacco industry, is no longer "news." (Of course, criminal prosecutions, not within the scope of any limitation of liability, will produce powerful media images and messages.)
   
   
2. Passage of such legislation will deflate the tobacco control movement, enervate tobacco control advocates, and shrink funding for tobacco control advocacy. This is true, even though, given the 46 million smokers remaining, tobacco use will remain our number one public health threat for many years, providing a strong rationale for funding tobacco control efforts.

So the enactment of a comprehensive blueprint of substantive provisions for tobacco control, as delineated by the other Task Forces, will not be sufficient unless there are also provisions to assure the continuation of a vigorous, adequately funded tobacco control movement and infrastructure.

Unless that happens, the tobacco industry will be relatively free to revert to undermining tobacco control policies through its lobbying practices quietly and out of the spotlight -- a major setback for the public health. This will be doubly true if there is no fundamental reform of campaign financing laws which have allowed the tobacco companies grossly to tilt the electoral and legislative process against the unfunded public interest in preventive health.

Unless the settlement legislation provides for adequate funding to sustain the nation's tobacco control infrastructure, the vital local grass roots organizations will be parched for basic resources, and we will have rendered the national tobacco control movement an emaciated watchdog, inadequate to keep pressure on regulators to regulate vigorously, politicians to focus on public health rather than campaign money, and the tobacco lobby from renewing its dirty work.

Impact of Litigation

We wouldn't be where we are today without the power of litigation. The individual actions by smokers and their families began the process, starting the trickle of evidence that is now becoming a tidal wave. Cippolone, although eventually dropped, deeply probed the use of third parties to hide the mounting evidence of harm from smoking, and the Supreme Court knocked out enough of the preemption defenses to enable others to come back and fight another day. Sean Marsee lost his suit over smokeless tobacco, but the court case brought a whole new awareness that smokeless was not harmless. Castano, in which the class was decertified, hung around long enough to rally the trial lawyers and to start to shift the momentum. The flight attendants' class action is paving new roads for victims of secondhand smoke, and the state class actions and the Medicaid suits by the State attorneys general are what has brought the industry to the bargaining table. And all of this has occurred without the industry paying a single penny to any plaintiff.

Of course, the ultimate goal of these and other lawsuits is to recover billions of dollars from the tobacco industry, either in the form of direct payments to individuals, the states, or others, or establishing and funding programs to deal with those who are already addicted and to educate our youth about the dangers of tobacco. Some day, in the not-too-distant future, there may be payments, perhaps modest at the start, but ever increasing in amounts, whether by judgments or settlements, and eventually, unless Congress steps in, everyone who has been injured by tobacco will have the opportunity to take their case to court and try to prove their damages.

However, on a more cautionary note, it is well to remember that only one successful liability lawsuit filed on behalf of a smoker has yet been prosecuted, and that over time, as juries deem smokers fully informed of the hazards of tobacco use and the unreliability of any representations by the industry, juries may be even less likely to sympathize with tobacco users. In any event it may well be years before even initially successful litigation can begin to change tobacco companies' behavior on such matters as marketing.

In the meantime, the litigation process will go forward, and with every day, the public will learn more and more of the industry's misdeeds and of the means that it devised to hook our young. Unlike legislative hearings and agency proceedings, where subpoena power is either lacking or rarely used, the industry must both respond to specific allegations by taking a position -- if you thought tobacco was not dangerous, how could you have adequately warned the public if it turned out to be harmful ? -- and disclose its documents and produce its witnesses, at least eventually. Not only does the public become aware of the truth, but attitudes change -- about tobacco addiction and the inability of many people to quit, no matter how hard they try, about marketing directed at kids, about the use of industry fronts and law firms to cover up damaging research, and about the industry's deliberate manipulation of the levels of nicotine to assure continued use of tobacco -- without which juries will not side with victims, and legislators will learn that the public will no longer countenance their taking money from Big Tobacco and doing its bidding.

The process of litigation is far from running its course. Even if the industry were to fully fund all the programs anyone can imagine, including compensating all of its victim (which it will never agree to do), the process should continue until all the facts are out and the American people truly understand the magnitude of the wrongdoing that has taken place. The Federal government also must be allowed to continue its criminal investigations so that individuals and corporations that violated the law are held accountable as well. And if the evidence shows the kind of outrageous conduct for which the law awards punitive damages, as surely seems to be the case, those claims must not be cut off by legislative fiat, not only because doing that would allow the industry to escape liability, but because it would make it far more difficult to respond to similar pleas for leniency from other businesses, most of whose wrongdoing pales by comparison with that of the tobacco companies.

There is another category of lawsuits that is vital to the long-term health of the tobacco control movement. Today, the FDA is run by individuals who are dedicated to preventing tobacco from addicting our youth and killing those that are already addicted. But that will not always be the case. Like all regulators, the FDA has been guilty of industry capture in the past, and it would be a miracle if that phenomenon did not repeat itself for tobacco at some time in the future. Therefore, to protect the public, the law must provide for citizens suits against the FDA, with attorneys' fees for prevailing plaintiffs to assure that these cases are brought since there is no money in them for trial lawyers. Similarly, when the inevitable industry resistance to new FDA regulations arises, funding must be available to non-profit public health advocates to assure that they are heard at the agency and in the courts. Simply knowing that citizens are there, watching over FDA, ready and able to go to court to enforce the agency's duties upon it, may not be enough to prevent all FDA backsliding, but it may make resort to litigation less necessary.

Lawsuits are means to achieve ends, in tobacco control as elsewhere. The measure of a lawsuit's importance is not limited to the bottom line of who won, who lost, and how much. The Supreme Court has recognized that litigation is an activity protected by the First Amendment, because it is a form of political expression and one of the essential means by which our citizens petition their government for a redress of grievances. It is often messy and unpleasant, but it has been and must continue to be a vital tool in the tobacco control movement.

The most significant current litigation is one that most tobacco control advocates never dreamed would be brought: the industry is challenging the authority of the FDA for its rules issued in August 1996 that would, for the first time, provide meaningful regulation over tobacco products. The first round was largely won by FDA, even though the industry hand-picked the judge, but the case being appealed over two issues: whether the FDA has the authority to treat tobacco products as drugs and medical devices and whether it has the authority to issue rules governing advertising directed at children. There is reason for guarded optimism (even including the First Amendment issues that have yet to be addressed), but the courts could strike down the entire effort.

Current litigation against the tobacco industry might have a range of impacts, but the two most important to consider are at the extremes: the companies might win almost all of the major cases, or the industry might lose those cases in a way to cause either or both Philip Morris or RJR to file for bankruptcy protection under Chapter 11. A result in the middle is unlikely to alter the current dynamics of tobacco control significantly.

It is difficult to assess the likelihood of success, including what size judgments might be awarded, in any of the major cases without a detailed review of the evidence (which is largely under seal or not disclosed) and of the law, which varies from state to state and among the three basic types of actions (Medicaid, statewide class-action, and individual suits). There is also the inevitable unpredictability of juries and the fact that the Mississippi case will be tried to a judge, not a jury. Even if the information were available, along with the time to do the analysis, case- by-case predictions are fraught with difficulty. Nonetheless, it seems reasonable to assume that, among the individual cases, some plaintiffs will prevail, but that overall their success is unlikely to bring the industry to its knees, largely because juries have very skeptical of these claims, as mentioned above.

While an assessment of the class actions and Medicaid suits is little more than an educated guess, it is difficult to imagine a scenario in which either extreme results. The presence of the industry at the bargaining table suggests that it is concerned about both types of cases, in large part because it rather than the individual smoker will be the focus of the litigation and because there is now so much evidence of the industry's knowledge and cover-up of tobacco's dangers. Still, the industry has very able lawyers, and the cases are not easy, on the facts or the law. Moreover, counsel for the states and the class plaintiffs must know that even if they were awarded astronomical actual or punitive damages, that were upheld on appeal, the companies could go into Chapter 11, which would tie the matter up for years, and make it impossible for the plaintiffs (and their lawyers) ever to get paid anywhere near what they were awarded.

On the other hand, despite its threats, there are several reasons why the industry is very unlikely to go into Chapter 11 unless the situation becomes dramatically worse. First, a company loses much of its freedom and of its control over access to its files. There will be an examination, and it is possible that a trustee would be appointed who would be able to waive various privileges the company might have.

Second, although it is possible to sell non-tobacco parts of a company while in Chapter 11, the court must approve the sale, which includes asking whether the creditors will be as well off with the proceeds rather than keeping the operating entity. (If such a sale took place now, the proceeds could be passed onto the stockholders, but any buyer at this time would have to be very concerned about the possibility of successor liability, a risk that is reduced under Chapter 11.)

Third, going into bankruptcy puts the company in play, which means that someone could come in and buy it all, leaving management without jobs, perks etc. Fourth, it is not at all clear that Chapter 11 could rid the company of claims from smokers who are not yet sick, let alone from those who will start/continue to smoke in the future, assuming the company continues in the tobacco business. There is also some possibility that the Court might curtail some of the company's lobbying or issue/product advertising, but only if someone could convince the Court that it was better for the creditors (including smoking victims) to do so.

Furthermore, once Chapter 11 is sought, existing creditors cannot collect a penny until a plan to settle all claims has been confirmed, which would take many years. In short there are many reasons why Chapter 11 will not be attractive for anyone, which makes it likely that, before that point is reached, everyone will see the need for a settlement of the major litigations, perhaps on an individual or group basis, because there is too much to risk on both sides. This does not mean that a settlement will necessarily come soon or that it will go beyond money issues, which for the class actions could include establishing smoking cessation programs and other ancillary relief.

From a tobacco control perspective, one advantage of a settlement (with a consent order injunction) plus legislation, rather than just legislation, is that having the industry agree to limitations on aggressive marketing practices avoids the chance of a First Amendment challenge. Thus, billboard operators or the media could not sue since the consent order would prevent all U.S. companies from advertising even if the legislative restrictions were struck down. There remains the possibility of a non-U.S. company, not subject to any consent orders, coming into the U.S. market and replicating what the U.S. industry did in the past by buying and rejuvenating old domestic brands. One fairly easy way to discourage this is to make sure that the court orders apply to anyone who acquires any tobacco company or any right to make a product or use a trademark of that company.

The more difficult situation to confront would involve a wholly foreign company and its products. Such a company would have to plan to make a massive investment in advertising and promotion (assuming that the media would be willing to carry tobacco ads for non-U.S. tobacco companies) and would have to conclude that its costly advertising would benefit its sales, and not primarily those of its existing U.S. competitors. In addition, it would have to bring and win a lawsuit to overturn the statutes that would replicate the court orders, a result that seems unlikely for most of the rules that are likely to be imposed. Congress could also impose tariffs on non- complying companies that can create major barriers to entry, assuming that GATT and various treaties do not forbid them. Therefore, although there are steps that must be taken to guard against a major non-U.S. tobacco invasion, the likelihood that foreign products will undermine tobacco control is small.

One of the principal concerns about any possible "global" settlement at this time is that many of the key facts are not yet public. Counsel for the states and the class action plaintiffs may have enough information to make informed judgments about the extent of the industry's wrongdoing and the type of relief needed to remedy it, but the public does not because much of that information is still under seal. Continuation of litigation would help assure that this information came out at trial, although some of it may not because of relevance or privilege claims. Any legislation and settlement must make certain that all such information is fully disclosed to the public.

II. Support for Those Economically Disadvantaged, Without Fault, by Tobacco Control Policies

Tobacco Farmers

Except for efforts made in recent years, and following some ground breaking efforts by President Jimmy Carter and the Carter Center in 1985, the public health community has all but ignored the tobacco farmer and the difficult situation that many of the tobacco farmers have found themselves in. The public health community has to a large extent viewed the farmers as part of the tobacco "family" carrying out the political agenda of the tobacco companies. Although the farmers have often defended the industry and the production and marketing of tobacco, their motivations, their beliefs, and reasons are in many cases significantly different than those of the tobacco companies.

Over the years the economic stability of the tobacco farmer has continued to decline while the tobacco companies have continued to flourish both domestically and internationally. There is no reason to believe that this scenario will change in the future, although the tobacco companies can be expected to continue to provide economic incentives to the growers to keep them allied with the companies' interests. Several examples support this conclusion of a continuing long-term decline in spite of tobacco company efforts to assure the farmers of economic stability. In 1969, U.S.-manufactured cigarettes contained 90% American grown tobacco. By the 1990's, that figure has dropped to barely 60%. The number of U.S. tobacco farms has also dropped dramatically, from 512,000 in 1954 to 124,000 in 1992. And the contribution that tobacco makes to the various tobacco producing states, though significant, has also been dropping. In North Carolina for example, tobacco's contribution to the economy has dropped from 11.3 % in 1960 to 7.8 % in 1993.

Farmers and tobacco allotment holders are increasingly aware of these realities. A 1997 survey of tobacco growers and tobacco allotment owners conducted by the Bowman Gray School of Medicine in North Carolina and the Center for Sustainable Systems in Berea, Kentucky found that over 70 % of the respondents have taken steps to learn about on-farm alternatives to tobacco. Fully 66 % have discovered that on-farm alternatives can be profitable. But the survey also noted important barriers. Between 64 % and 79 % of those surveyed said that few processing plants connecting farmers to consumers, lack of capital for new business ventures, no places to sell new products, and few low-interest loans or grants for new business ventures were just some of the barriers to change.

And finally, the poll indicated that 66% of those surveyed believed that the Federal government should actively help farmers find other ways of making a living.

Serious efforts to reduce the use and consumption of tobacco products in the United States must address the issue of the tobacco farmers, their families and the economic viability of their communities. Not unlike many smokers who know the dangers of tobacco but got seduced and "hooked" on the product and cannot quit, the American tobacco farmer and the economic infrastructures of tobacco states are and have been for a long time "tobacco dependent." They are a part of the deeply imbedded economic and political system that the tobacco companies have established and maintained to protect the companies' interests. In many of these communities tobacco is a way of life, often the only way of life, going back generations. As organizations concerned about public health and the general well being of our society we must be willing to recognize and accept our responsibilities in helping to reduce this dependence as part of our overall efforts to reduce tobacco use as a public health matter. The public health community, religious organizations and other civic organizations need to work cooperatively and collaboratively to effect positive change.

It is not enough to suggest that tobacco farmers merely transition to an alternative crop. There are complex issues that must be assessed before any short term or long term strategies are implemented, taking into account both domestic as well as international considerations. Tobacco production, size of plots, type of land, and product varies significantly from state to state. The public health community's role should be to provide the necessary vision and leadership and to serve as a catalyst for effecting the necessary short term and long term change that must occur in order for us to be successful in helping wean the tobacco farmer and their communities off their tobacco dependence. We must make the tobacco farmer, his family and his community a part of the "solution" not the problem. A significant side benefit in establishing a short term and long term plan to deal with these issues is that politically, the power of the tobacco companies can be significantly reduced, and that policy decisions could therefore be made that benefit public health and the tobacco growers rather than the tobacco industry. Tobacco state politicians and policy makers who have often carried out the agenda of the tobacco companies under the pretense of protecting their tobacco farming constituencies have in some ways done more harm than good in maintaining the "status quo." They also should begin to provide new visionary thinking and leadership for effecting change.

In discussions and dialogues with farmers, organizations representing the interests of the tobacco farmer as well as public health groups in the primary tobacco growing states, there is a cautious optimism that there can be productive solutions that seek to reduce tobacco use in this country as a major public health problem while at the same time working to ensure the economic viability and vitality of those states and those communities. But it must be stressed that finding the various options and implementing them will take time.

Intrinsically tied to the future fate of the tobacco farmer is what happens not only in the domestic growing arena but in the international growing, manufacturing and marketing arena as well. It is clear that agricultural production and marketing of tobacco is increasing world wide and that the quality of the crop in foreign countries is increasingly comparable to the quality of U.S. product -- often the result of assistance from U.S. companies and leaf dealers. American tobacco companies and leaf dealers are increasingly doing business in those countries including buying and importing foreign leaf into the United States, and pumping up the economies and dependency of those countries through intensifying investments. It makes good business sense for the companies but represents a serious threat to the health of the rest of the world as well as to the U.S. tobacco farmer. The high priority and attention that such companies as Philip Morris and RJ Reynolds are giving to the expansion of their international headquarters and operations out of Switzerland attest to their long term motives and plans. While the industry continues to provide the U.S. farmers "incentives" and "assurances" for staying in the business and remaining loyal to the tobacco companies it is clear that such commitments from the companies are transitory and can easily be abandoned or curtailed. We have a chance to change the "status quo" in a positive visionary way.

Whether or not there is an agreement or settlement with the tobacco companies, the public health community must now be willing to provide the leadership at the national, state and local level to assist in reshaping the agricultural systems and structures in the tobacco growing states. The tobacco farmers are not looking for handouts but looking for assistance and opportunities to make changes. This effort should be viewed as a five-to-ten year initiative and commitment.

Non-Farm Tobacco-Related Workers

Tobacco companies routinely predict that tobacco control measures, such as excise taxes or regulation by the Food and Drug Administration, will sacrifice vast numbers of jobs and cause other dire economic consequences. While a number of studies have found that these numbers are grossly inflated, communities economically dependent on tobacco manufacturing plants will no doubt suffer if the Committee's vision of reduced tobacco consumption becomes a reality. The Committee therefore calls for funds to cushion the transition to other work.

Native Americans

PENDING

Organizations Dependent on Tobacco Philanthropy and Sponsorship

The tobacco industry has shrewdly used philanthropy and sponsorship to its benefit. From donations to organizations that help homebound senior citizens to professional women's tennis to arts organizations, the industry donates money, services and other resources to a wide variety of organizations and causes. There is no exact ranking for arts benefactors, but Philip Morris is believed to be the largest corporate sponsor in the United States. According to a 1993 estimate, the company gives $15 million annually to support museums and the performing arts. The industry is also a major sports sponsor, spending an estimated $195 million on sports sponsorships in 1996.

Obviously, the industry benefits from its philanthropy and sponsorship, or else it wouldn't engage in such activities. Philanthropy and sports sponsorship builds relationships with decision-makers and citizens; allows the industry to portray itself as a good corporate citizen; provides another advertising outlet; and, most covertly, can buy either inaction towards tobacco- related issues or loyalty towards the industry on the part of the beneficiary. Given that, the industry's notable generosity towards women's, minority, arts and community service organizations is particularly shrewd. The industry positions itself as a valuable friend and sponsor of these worthy groups often in sore need of funds, and polishes its image by its link with groups promoting civil rights, social justice, and artistic freedom and innovation.

The blueprint calls for a ban on tobacco sponsorship and philanthropy to prevent tobacco companies from using them as tools to buy innocence by association and create new advertising outlets. However, the organizations abruptly cut off from such funding will no doubt suffer economically, which is why the Committee calls for compensation to such groups.

Australia has already instituted such a policy. The government taxes tobacco companies and directs the proceeds to state-level Health Promotion Foundations, which sponsor arts and sporting events.

V. The International Impact of Comprehensive U.S. Legislation

According to the World Health Organization, tobacco use is estimated to have caused around 3 million deaths a year worldwide in the early 1990s, and is projected to cause ten million deaths a year worldwide by the 2020s or early 2030s, with 70 percent of those deaths occurring in developing countries. Many of these deaths will result from the increasingly aggressive marketing efforts of U.S.-based transnational tobacco companies.

The adoption of comprehensive national legislation governing tobacco will constitute a national finding that no civilized society can do less to stem the toll of disease and death from tobacco use. Since the marketing abuses which the U.S. seeks to control at home are practiced without restraint abroad -- by U.S.-based companies -- the U.S. government has both a public health and a moral obligation to do all within its power to see that the protections it extends to its own citizens are extended to all.

This must include adherence to the following principles:

1. The U.S. should use the broad range of its international activities and influence to actively promote tobacco control, including the adoption of U.S. domestic tobacco control standards as at least minimum global standards.
   
   
2. The U.S. must insist that public health concerns overrule trade concerns in all trade negotiations and related proceedings.
   
   
3. The U.S. should allocate substantial resources to fund effective international government and non-government institutions engaging in tobacco control activities.
   
   
4. The U.S. must obtain and enforce commitments from U.S.-based transnational companies to support, not undermine, these efforts.

The U.S.'s domestic actions on tobacco control will reverberate around the world. We should take care to enact no policies which undermine tobacco control efforts abroad or redirect the marketing aggression of U.S.-based tobacco companies abroad. Additionally, we are in a position to seize the opportunities created by the current strength of the tobacco control movement to help set a strong international standard.

A weak scheme of U.S. tobacco control regulation will be cited aggressively by tobacco lobbyists in other countries and international bodies as grounds for resisting stronger regulation, as unwarranted non-tariff trade barriers. Most important, any legislation which undercuts current FDA authority over tobacco products as addictive drugs will undermine efforts now underway in many countries to bring tobacco under drug regulatory laws and authorities. Since, in many areas of drug and food regulation, the U.S. FDA has become the world's standard setter, the U.S. is in a particularly strong position to help set world standards for tobacco product regulation, including the control of nicotine, tar, and additives.

Recognizing that U.S. constitutional limits may not allow the total bans on tobacco advertising and marketing now the law in some countries, and moving forward in others, U.S. domestic regulations on tobacco marketing and advertising should extend to the full reach of U.S. constitutional authority to limit unfair and deceptive practices.

Care must also be taken that the legal rights now held by tobacco's victims overseas to obtain redress against U.S.-based transnationals not be undercut by U.S. legislation.

Both the executive and legislative branches of the Federal government can do much, within reason, to bring about worldwide adoption of tobacco manufacturing and marketing standards at least as comprehensive and stringent as those enforced within the United States. In the settlement negotiations, the transnational tobacco companies have accepted the legitimacy of stringent controls on tobacco manufacture, marketing and advertising. Seducing children to start an addictive product is just as wrong in China or Africa as it is in California or Alabama. So too, if cigarettes contain additives that make them even more harmful, they should not be sold anywhere with that additive or with an excessive level of nicotine. This is not just the United States attempting to impose its morality on other nations, but an effort to ensure that the conduct of U.S. corporations abroad is consistent with our domestic policies and national values. Of course, any attempt to enforce U.S. standards which leaves foreign tobacco companies -- and foreign subsidiaries or counterparts of U.S. companies free to continue business as usual -- raises questions of efficacy, as well as equal treatment. The problem is whether it is possible to achieve these goals as a matter of U.S. law.

For the physical attributes of the product itself, including its packaging, direct control can be achieved by applying U.S. laws to all products manufactured in this country, regardless of their destination. But the industry could, within a short period of time, circumvent that requirement by shifting the remainder of its manufacturing for foreign consumption abroad. Therefore, unless complemented by other means of enforcement, that approach would only result in a loss of jobs for U.S. tobacco farmers and workers in domestic cigarette manufacturing.

One answer is an excess profits-type tax imposed on export sales of cigarettes that do not comply with U.S. standards, even if they are in compliance with the laws of the country where the sale takes place, unless compliance with both laws is a physical impossibility (i.e., conflicting warning labels for packages). The tax would apply to all sales by U.S. companies or their subsidiaries and be made payable by the U.S. parent; for less than wholly-owned subsidiaries, the tax would be based on the U.S. parent's percentage of ownership. The level of the tax would be set based on an estimate of how much the company would have made if it had complied with U.S. laws (thereby driving down sales to minors and paying for damages inflicted by faulty products). The simplest form of tax would be an excise tax based on an amount per package or percentage of gross sales. It would also be necessary to make the tax payable on an annual basis, even if the profits were retained abroad, to prevent long term avoidance problems.

There are several possible objections to the tax approach. Since any "handicap" from the tax is to domestic not foreign companies, neither GATT nor tax treaties are likely to be a problem. Similarly, foreign makers will have an advantage in the marketplace (although the amount is unclear given the positive image of U.S. cigarettes and their higher quality and consistency), but that would be because the United States has made a policy choice for U.S. companies that selling cigarettes by any means possible is not acceptable conduct, just as if Congress decided it was improper to sell automatic rifles or machine guns abroad that are banned in this country. And if, as a result, U.S. companies sold off their foreign subsidiaries, at least Americans would not be responsible in any way for the harm that tobacco products inflict on others abroad. Of course, the tax could have the additional positive effect of increasing the incentive for the tobacco companies to lobby for adoption of U.S. standards abroad, thereby eliminating any advantage that foreign manufacturers might have.

In addition to the tax, any export of cigarettes bearing the "made in the USA" label that does not comply with U.S. health and safety laws could be clearly labeled with words to the effect that "this product does not comply with U.S. health and safety laws."

Action on Smoking and Health (ASH)
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