ADVISORY COMMITTEE ON TOBACCO POLICY AND PUBLIC HEALTH [footnotes and appendices omitted, some minor formatting errors]

Presented here by Action on Smoking and Health (ASH), a 30-year old national legal-action antismoking organization which is one of the members of the Advisory Committee.

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



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




"[N]icotine in cigarettes and smokeless tobacco has the same pharmacological effects as other drugs that FDA has traditionally regulated." 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." 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.





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




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.





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. 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


· 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


· 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 grants 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.


· 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




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 use Nicotine, a major constituent of tobacco, is highly addictive and "cigarettes and other forms of tobacco are just as addicting as heroin and cocaine. . . ." 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 guidelines 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.





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 Research 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




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. 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.


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.





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



Summary of Major Recommendations of the Task Force on

the Future of the Tobacco Industry and

Tobacco Control Efforts




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.












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



· 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


· 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



· 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 consumption 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



· 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


· 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


· 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.


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