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Final Report

of

The Advisory Committee on
Tobacco Policy and Public Health



***


Co-chairs:

C. Everett Koop, M.D., Sc.D. and David A. Kessler, M.D.



***


JULY 1997








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



TABLE OF CONTENTS



Introduction by the Co-Chairs 1
Summary of Major Recommendations of the Task Force
on the Regulation of Nicotine and Tobacco Products
3
Summary of Major Recommendations of the Task Force on
Youth and Tobacco
5
Summary of Major Recommendations of the Task Force on
Current Users of Tobacco Products
10
Summary of Major Recommendations of the Task Force on
Environmental Tobacco Smoke
13
Summary of Major Recommendations of the Task Force on
the Future of the Tobacco Industry and Tobacco Control Efforts
15
Footnotes
Appendices:
Congressional Letter of Invitation to Task Force Members Appendix 1
List of Task Force Members and Staff Appendix 2
Reports of the Task Forces Appendix 3
Report of the Task Force on the
Regulation of Nicotine and Tobacco Products
Appendix 3A
Report of the Task Force on
Youth and Tobacco
Appendix 3B
Report of the Task Force on
Current Users of Tobacco Products
Appendix 3C
Report of the Task Force on
Environmental Tobacco Smoke
Appendix 3D
Report of the Task Force on the
Future of the Tobacco Industry and Tobacco Control Efforts
Appendix 3E






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:

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.

C. Everett Koop, M.D., Sc.D. David A. Kessler, M.D.






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



Research Policy



Fiscal Policy






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



Public Education and Other Public Health Policy



Research Policy



Fiscal Policy






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



Public Education and Other Public Health Policy



Research Policy



Fiscal Policy






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



Public Education and Other Public Health Policy



Research Policy



Fiscal Policy






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



Research Policy



Fiscal Policy



Tobacco Farms and Farm Communities

Public Education and Other Public Health Policy



Fiscal Policy



International Tobacco Policy

Regulatory Policy



Research Policy



Fiscal Policy






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



May 22, 1997

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.

Sincerely,


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:



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:



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:



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.



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.



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.



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:



Enforcement



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:



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

Schools

Community Programs

Health Professionals



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:



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:



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:








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:



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.



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.



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:



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.






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.



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):



  2. Economic incentives for smoke free workforces should be developed.



  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.

  1. 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.

  1. 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.
  1. 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.
  1. 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.
  1. 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 eithe