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• Clearing the Smoke: Assessing the Science Base for Tobacco Harm Reduction 

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. . .

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.

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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.
<I>Clearing the Smoke: Assessing the Science Base for Tobacco Harm Reduction</I>