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Spring 2001 Vol. 1 No. 1

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ŠArtville Modified Tobacco Products May Do More Harm Than Good

Despite all that is known about the dangers associated with using tobacco, about 47 million American adults smoke. Tobacco-related disease remains one of the nation's greatest controllable health problems and one of its most significant social burdens.

In the last 50 years, convincing and generally accepted evidence has established that exposure to tobacco products is the leading single cause of premature death worldwide. It also is clear that lifelong abstinence and avoidance of second-hand smoke is the only proven way to steer clear of health risks from tobacco use. Cessation -- even after many years of smoking -- reduces risk and harm both immediately and in the long term for many tobacco-related conditions such as chronic breathing difficulties, cancer, and stroke.

For smokers desperate to quit, programs and products that could help them kick the habit are doggedly sought. Not surprisingly, several novel products have emerged that make implied or explicit claims to reduce the health burdens of tobacco use while allowing the user to continue smoking. The array of such products includes modified tobacco and cigarette-like items that purport to deliver smaller amounts of some toxicants and are being test-marketed as "safer" alternatives to traditional cigarettes. However, they have not been thoroughly studied, nor are they regulated.

Some drugs, such as nicotine in gum, patches, inhalers, and nasal spray, have been available for several years to help people quit smoking and, when used as directed, they are safe and effective. They are strictly regulated for short-term use, though, and have not been reviewed for longer use to help cut down the number of cigarettes smoked each day.

To gain a better understanding of how the government should handle these products, the U.S. Food and Drug Administration asked the Institute of Medicine (IOM) in 1999 to delve into the issue and lay out scientific methods and standards by which these so-called harm-reduction products could be assessed. In a new report, an IOM committee concluded that lessening the risk of disease by reducing exposure to toxic chemicals with these products is scientifically feasible, but in the absence of rigorous research, it is not clear if such a strategy would decrease the incidence of tobacco-related disease or actually increase it by encouraging smoking. For example, if nonsmokers thought these products were safer than ordinary cigarettes, might they start smoking? Would former smokers begin again?

The report outlines how tried-and-true public health tools -- research, surveillance, communication, and regulation -- should be used to ensure that these products confer less risk to the individual and to the population as a whole compared with conventional tobacco products.

"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."

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.

At the same time, a surveillance system is essential in assessing how the introduction and marketing of modified tobacco products has affected the public's health. The distribution, sales, and use of tobacco products should be monitored, as well as the chemicals they contain. Prompt collection and reporting of these data would help officials know if these products were detrimental to public health.

In tandem with research and 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 proving that their products reduce risk of disease.   -- Cheryl Greenhouse and Barbara Rice

Clearing the Smoke: Assessing the Science Base for Tobacco Harm Reduction. Committee to Assess the Science Base for Tobacco Harm Reduction, Board on Health Promotion and Disease Prevention, Institute of Medicine (2001, approx. 514 pp.; ISBN 0-309-07282-4; available from National Academy Press, tel. 1-800-624-6242; $49.95 plus $4.50 shipping for single copies).

The committee was chaired by Stuart Bondurant, professor of medicine and dean emeritus, department of medicine, School of Medicine, University of North Carolina, Chapel Hill. The U.S. Food and Drug Administration sponsored the study.

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Copyright 2001 by the National Academy of Sciences