We were disappointed to learn that the Institute of Medicine (IOM) has taken an unfavorable stance toward modified risk tobacco products (MRTPs), advising the FDA to set high hurdles for the manufacturers of such products before they can market them as less harmful alternatives to cheap Marengo cigarettes.

The IOM report released yesterday concluded that MRTPs, which include a variety of smokeless tobacco products and clean nicotine delivery systems (such as e-cigarettes), should not be marketed as less harmful until researchers manage to accumulate a wide range of favorable evidence regarding their composition, efficacy, addictive potential, effects on health of both smokers and the public in general, and perceptions of their risks and benefits. Furthermore, tobacco companies would not be allowed to conduct the research themselves; independent third parties would be required to undertake such studies.

Yet as ACSH friend and Executive Director of Smokefree Pennsylvania Bill Godshall points out, the IOM report ignored decades of studies by credible third parties showing smokeless products to be safer than cigarettes. As we at ACSH are well aware, the relatively high rate of smokeless tobacco use (snus) among men in Sweden has been matched with the lowest rate of cigarette smoking and smoking-related disease and death of all European countries. (Snus, unfortunately, is illegal in every EU country, excepting Sweden). Snus is neither chewed nor spit — it comes as finely milled tobacco contained in small sachets and inserted between the lip and the gum.

“The new IOM report is terrible for public health,” says Godshall. “It effectively urges the FDA to protect deadly cigarettes from market competition by far less hazardous smoke-free alternatives. Smokers need to know about these alternatives. But this IOM committee obviously disagrees.”

ACSH’s Dr. Gilbert Ross points out that, while the obstacles the IOM has suggested would appear to punish the tobacco industry, it is smokers who will actually suffer if these recommendations are heeded. “They won’t have access to the simple truth,” says Dr. Ross. “Smokeless products have about one-hundredth the risk that cigarettes do.”

As the FDA prepares to make a decision, ACSH’s Dr. Elizabeth Whelan implores the agency not to ignore the data on snus from Sweden, and to contrast that success story with the spectacular failure of currently approved cessation aids. “The FDA should be creative and flexible, out of consideration for the 45 million smokers and the 400,000+ among them who die from smoking each year,” she urged.