National Academy of Sciences
National Academy of Engineering
Institute of Medicine
National Research Council
Office of Congressional and government Affairs
At A Glance
: FDA Regulation of Tobacco
: 09/19/2002
Session: 107th Congress (Second Session)
: Stuart Bondurant

Professor of Medicine, University of North Carolina, and Chair, Committee to Assess the Science Base for Tobacco Harm Reduction, Board on Health Promotion and Disease Prevention, Institute of Medicine and The National Academies

: Senate
: Committee on Health, Education, Labor, and Pensions


Evaluation of Products Intended for Tobacco Harm Reduction

Statement of

Stuart Bondurant, M.D.
Chairman of the Committee to Assess the Science Base for Tobacco Harm Reduction
Institute of Medicine/The National Academies
Professor of Medicine, University of North Carolina

Submitted for the Record to

Committee on Health, Education, Labor, and Pensions
U.S. Senate

September 19, 2002

Thank you Mr. Chairman and Members of the Committee for inviting me to submit a statement for the record. My name is Stuart Bondurant and I was the chair of an Institute of Medicine committee that was asked in 1999 by the Food and Drug Administration to provide guidance on the evaluation of tobacco or pharmaceutical products that are intended for use as a means to reduce the health risks of tobacco for those who cannot or will not quit using tobacco. This is known in public health as harm reduction -- it is an explicit acknowledgment that unhealthful or risky behavior cannot always be prevented, so means to ameliorate the risk to health are sought. Seat belts and airbags are intended to lessen the damage from automobile accidents. We probably can never prevent everyone from speeding or prevent all other causes of automobile accidents, but we can try to lessen the damage. Such it is with tobacco. As I’m sure you know, a significant number of Americans cannot or will not quit the tobacco addiction.

The report we authored is entitled "Clearing the Smoke: Assessing the Science Base for Tobacco Harm Reduction". The report was released in February 2001. The committee reviewed a tremendous amount of literature -- from the biomedical and public health literature, the social science literature, and from the public policy literature in developing our recommendations.

The committee was not asked to review specific products and it did not do so. The committee was not asked whether or not the nation should allow harm reduction products on the market or whether the nation should pursue a harm reduction policy for tobacco. The committee understood that these products, sometimes referred to as "safer cigarettes" or "reduced risk products", are on the market and will continue to be developed. The committee task was to outline a way of analyzing such products, in order that they are fully understood by those who might choose to use them. The committee was asked to consider the potential public health impact of the availability of these products.

The committee felt it was important to state four key operating precepts.

Precept 1. Tobacco use causes serious harm to human health,

Precept 2. Nicotine is addictive,

Precept 3. The best means to protect individual and public health from tobacco harms are to achieve abstinence, prevent initiation and relapse, and eliminate environmental tobacco smoke exposure, and

Precept 4. A comprehensive and authoritative national tobacco control program, with harm reduction as one but only one component, is necessary to minimize adverse effects of tobacco.

The committee believes that tobacco harm reduction is a feasible and justifiable public health policy – but only if it is implemented carefully to achieve the following objectives:

Manufactures have the necessary incentive to develop and market products, which we termed PREPS - potential reduced-exposure products, that reduce exposure to tobacco toxicants and that have a reasonable prospect of reducing the risk of tobacco-related disease. I’d like to stress that the incentive the committee discussed was the ability to make exposure- and risk-reduction claims, if they are true and not misleading and if other safeguards of regulation and surveillance are in place. I’ll elaborate on this in a subsequent portion of my discussion.

• Consumers are fully and accurately informed of all the known, likely, and potential consequences of using these products.

• Promotion, advertising, and labeling of these products are firmly regulated to prevent false or misleading claims, explicit or implicit.

• Health and behavioral effects of using PREPs are monitored on a continuing basis,

• Basic, clinical, and epidemiological research is conducted to establish their potential for harm reduction for individuals and populations, and

• Harm reduction is implemented as a component of a comprehensive national tobacco control program that emphasizes abstinence-oriented prevention and treatment.

The committee developed six main conclusions.

The committee made a number of research recommendations that were intended to bolster the scientific foundation for the first four conclusions listed above, and to provide evidence that is specifically relevant for evaluation of these products for regulatory purposes. The committee, along with many in the public health field, was concerned that the availability of these products will give tobacco users a false sense of security, allowing some to continue tobacco use who might otherwise have quit, some to begin tobacco use who never would have, or some who had already quit to begin again, or relapse. This concern led to specific recommendations on regulation and surveillance. The committee developed a framework for the regulation of these products, the fifth conclusion listed above, and it outlined important components of a surveillance system that would help link certain types of data, particularly population-based data, with the regulatory agency in order to assure that net population impact is positive and not negative.

I’d like to make a few important points regarding the regulatory framework as it applies to the PREPs, specifically the issues of exposure-reduction claims. The committee, as mentioned before, understands there is an argument that manufacturers have a right to make claims that their products reduce the exposure to tobacco toxicants. The committee, however, believes it is in the best interest of individual and public health that these exposure claims be made only in the context of the entire regulatory and public health framework outlined in the report. Without the protection of regulation, without publicly reviewed and verified scientific evidence, and without a strong surveillance system that includes study of the public understanding of the claims being made, we run the risk of repeating the public health experiment gone wrong of the last century with low yield cigarettes.

The committee laid out 11 regulatory principles. Four of these principles are particularly relevant to today’s discussion. I’d like to review these briefly.

Regulatory principle 3 states that manufacturers of PREPs should be required to conduct appropriate toxicological tests in laboratory and animals models, as well as appropriate clinical testing in humans to support the health-related claims and to disclose the results of such testing to the regulatory agency.

Regulatory principle 4 states that manufactures should be permitted to market tobacco-related products with exposure reduction claims ONLY after prior agency approval based on scientific evidence that the product reduces exposure to an extent that independent scientific experts would anticipate measurable reduction in morbidity or mortality in subsequent clinical or epidemiological studies.

Regulatory principle 4 also states that risk-reduction claims should be permitted if the product can reasonably be expected to reduce the risk of one or more specific diseases or other adverse health effects, as compared with whatever benchmark product the agency requires to be stated in the labeling. Key to this principle is that independent scientific experts review the evidence on which the claim is based for evidence that there would likely be a real reduction in morbidity and mortality.

Regulatory principle 5 states that labeling, advertising, and promotion of tobacco-related products with exposure or risk claims must be carefully regulated under a "not false or misleading" standard with the burden of proof on the manufacturer, not the government. In addition, the regulatory agency should have the authority and resources to conduct its own surveys of consumer perceptions relating to these claims. The report reviews data showing that consumers often misunderstood the claims relating to low-tar and -nicotine products of the past and that their smoking behaviors reflect that misunderstanding.

Regulatory principle 6 states that the regulatory agency should be empowered to require manufacturers of produces marketed with reduced-risk claims to conduct post-marketing surveillance and epidemiological studies as necessary to determine the short-term behavioral and long-term health consequences of using their products and to permit continuing review of the accuracy of the claims.

In summary, the committee believes that regulation and a strong public health surveillance system are necessary to reduce the possibility that these products could increase harm to both individual and public health above and beyond that already wreaked by conventional tobacco products. Let me emphasize that a system that allows exposure and risk reduction claims MUST be built on independent, verifiable, and scientific analysis. In addition, the public health surveillance system must be designed to provide timely information as to the impact of the marketing and availability of PREPs on many aspects of public understanding about, and behavior with regards to, these products.

Thank you for the opportunity to comment on this very important topic. I would be happy to answer questions you might have in the future.