Date: Feb. 22, 2001
Contacts: Saira Moini, Media Relations Officer
Mark Chesnek, Media Relations Assistant
(202) 334-2138; e-mail <>

Health Effects of Modified Tobacco Products Uncertain;
Greater Scrutiny Needed

WASHINGTON -- Pharmaceutical and modified tobacco products designed to reduce the health risks of smoking cannot yet be proved to reduce tobacco-related disease, says a new report from the Institute of Medicine (IOM) of the National Academies. Products developed to lessen the risk of disease by reducing exposure to toxic chemicals are scientifically feasible, but in the absence of rigorous research, no one knows if these products decrease the incidence of tobacco-related disease or actually increase it by encouraging smoking.

The report outlines how tried-and-true public health tools -- research, surveillance, communication, and regulation -- should be used to ensure that the availability of these products confers less risk to the individual and to the population as a whole compared with conventional tobacco products. It recommends a regulatory strategy to assure that these products reduce risk of disease. Other potential regulatory approaches to tobacco control are not addressed.

"Our committee applauds the notion of helping individuals who cannot or will not quit smoking," said Stuart Bondurant, professor of medicine, University of North Carolina, Chapel Hill, and chair of the committee that wrote the report. "We believe that it may be possible to reduce harm from tobacco use with new products, but we frankly do not know the health effects of the various products on the market today that claim to do this. Many still incorporate tobacco, and because no tobacco product is safe, the effects of these new products must be studied carefully to make a reliable judgment as to whether they actually reduce risk and harm."

The continuing toll of tobacco use has prompted the search for a way to reduce the harm caused by smoking. Smokers are at increased risk of heart attack, stroke, lung disease, and many types of cancers, and pregnant women who smoke are more likely to give birth to low-weight babies. About one-quarter of American adults -- around 47 million people -- smoke cigarettes and 70 percent of them wish to quit, but each year less than 3 percent of them succeed.

In 1999, the U.S. Food and Drug Administration (FDA) called on the IOM to provide a framework for assessing "harm-reduction" products that allow the user to continue to smoke. The array of such products includes modified tobacco and cigarette-like items that deliver smaller amounts of toxicants. Drugs -- such as an antidepressant and nicotine in gum, patches, inhalers, and nasal spray -- are strictly regulated by the FDA for short-term use to help people quit smoking, but they are not approved for long-term use in harm reduction. Modified tobacco and cigarette-like products are not regulated by the FDA or any federal agency for their potential to reduce tobacco-related disease. The recent introduction of these products to the marketplace and growing competition between the industries to develop more of them make it urgent that such products are studied, and that information about them is easily and accurately communicated to consumers, the committee said.

To demonstrate that these products decrease exposure to tobacco toxicants, they must be tested in the exact way that people would use them, the committee said. Previous experience suggests that smokers who switched to low-tar and low-nicotine cigarettes changed the way they smoked to obtain the same level of nicotine intake -- by inhaling more deeply and smoking more cigarettes than when they smoked higher-yield products. These behavioral changes meant that there was little or no benefit from the introduction of low-tar, low-nicotine products.

Even if a product is shown to reduce the risk of disease for an individual who gives up conventional tobacco, the committee cautioned that the overall effect on the population could be negative because smokers who might have quit, or young people who have not yet started, will use these products instead. The report calls for immediate development of a comprehensive surveillance system to track and assess how the introduction and marketing of products affect public health and to what extent the prevalence of tobacco use changes. Key aspects would involve tracking the distribution, sales, and use of tobacco products, identifying the chemicals they contain, and determining impact on disease. The prompt collection and reporting of data would help public health officials determine if these products negatively affect health.

At the same time, new biomedical and behavioral research will be essential to show conclusively the health effects of these products. For example, biomarkers could be designed with the sensitivity needed to measure the effect of a tobacco toxicant on the human body. Over the longer term, animal, clinical, and population studies could specifically address the health outcomes of modified vs. conventional tobacco products. The committee found that none of the new nonconventional tobacco products could be proved at this time to reduce illness or death because research is inadequate.

In tandem with research and public health surveillance, careful regulation of these products is required, the committee said. It recommends 11 regulatory principles intended to assure that the public is accurately informed about the health effects of new products, to prevent cigarettes with greater toxicity than those sold today from entering the market, and to gather complete information about new products. Regulations would do this by requiring manufacturers to base claims on scientific evidence. For example, manufacturers should be required to conduct toxicological and clinical testing. If a manufacturer makes a claim, its product should be subject to regulatory review to assure that it substantially reduces an individual's exposure to at least one toxicant and that, even with the remaining toxicants, it can reasonably be expected to reduce risk of a disease or other adverse health effect among users.

A strategy of harm reduction is likely to succeed, the committee said, only if manufacturers have the incentive to develop and market products that reduce harm; consumers are accurately informed of all known and potential consequences of using these products; if advertising and labeling are firmly regulated to prevent false or misleading claims; if basic, clinical, and population studies are conducted to indicate reduced harm; and if health effects of using these products are continually monitored. Most important, the committee stressed the need to make harm reduction a component of a comprehensive national approach that includes the prevention of smoking initiation and relapse, as well as the promotion of smoking cessation.

The study was sponsored by the U.S. Food and Drug Administration. The Institute of Medicine is a private, nonprofit institution that provides health policy advice under a congressional charter granted to the National Academy of Sciences. A committee roster follows.

Pre-publication copies of Clearing the Smoke: Assessing the Science Base for Tobacco Harm Reduction are available from the National Academy; tel. (202) 334-3313 or 1-800-624-6242. Reporters may obtain a copy from the Office of News and Public Information (contacts listed above).

Board on Health Promotion and Disease Prevention
Board on Neuroscience and Behavioral Health

Committee to Assess the Science Base for Tobacco Harm Reduction

Stuart Bondurant, M.D.* (chair)
Professor of Medicine and Dean Emeritus
Department of Medicine
School of Medicine
University of North Carolina
Chapel Hill

Robert B. Wallace, M.D., M.Sc. (vice chair)
Professor of Epidemiology and of Internal Medicine
Departments of Epidemiology and Internal Medicine
Colleges of Public Health and Medicine
University of Iowa
Iowa City

J. Richard Crout, M.D.
Crout Consulting
Bethesda, Md.

Garret A. FitzGerald, M.D.
Professor of Medicine and Pharmacology;
Chair, Department of Pharmacology; and
Director, Center for Experimental Therapeutics
School of Medicine
University of Pennsylvania

Adi F. Gazdar, M.D.
Department of Pathology, and
Deputy Director
Hamon Center for Therapeutic Oncology
University of Texas Southwestern Medical Center

Gary A. Giovino, M.S., Ph.D.
Senior Research Scientist
Department of Cancer Prevention, Epidemiology and Biostatistics
Roswell Park Cancer Institute
Buffalo, N.Y.

Dorothy Hatsukami, Ph.D.
Departments of Psychiatry and Psychology and Division of Epidemiology, and
Director, Tobacco Research Laboratory and Treatment Programs
University of Minnesota

Rogene F. Henderson, Ph.D.
Deputy Director
National Environmental Respiratory Center, and
Senior Scientist
Toxicology Division
Lovelace Respiratory Research Institute
Albuquerque, N.M.

Peter Reuter, Ph.D.
Professor of Public Policy and of Criminology
Departments of Public Policy and Criminology
School of Public Affairs
University of Maryland
College Park

David J. Riley, M.D.
Professor of Medicine
Division of Pulmonary Disease and Critial Care Medicine
University of Medicine and Dentistry of New Jersey - Robert Wood Johnson Medical School

Peter G. Shields, M.D.
Professor and Chief
Division of Cancer Genetics and Epidemiology
Lombardi Cancer Center
Georgetown University Medical Center
Washington, D.C.

James T. Willerson, M.D.*
Edward Randall III Professor and Chair of Internal Medicine
Department of Internal Medicine
University of Texas Medical School, and
Medical Director and Director of Cardiology Research
Texas Heart Institute


Kathleen R. Stratton, Ph.D.
Study Director

* Member, Institute of Medicine