WASHINGTON -- A key advisory committee warned the U.S. Food & Drug Administration (FDA) Wednesday that little is known about the health effects of so-called modified-risk tobacco products, suggesting makers of smokeless tobacco and other alternatives to conventional cigarettes face high hurdles before they can market them as less harmful, reported the Wall Street Journal.
The report by the Institute of Medicine coincided with another government-sponsored study showing cigarette use hitting historic lows among U.S. teenagers, even as more youths have turned in recent years to smokeless products such as moist snuff and pouches called snus.
The FDA is studying whether to allow companies to advertise some tobacco products as safer than cigarettes, which still represent more than 90% of tobacco sales. The agency plans to publish regulations or guidance on scientific testing requirements by April as part of its review.
"The fundamental problem that confronts the FDA is a shortage of credible and reliable evidence about the effects of [modified-risk tobacco products] on both individual and public health,'' the Institute of Medicine, part of the National Academies, said in its report (see Related Content below for previous CSP Daily News coverage).
The FDA said it would take the report "into consideration.''
U.S. tobacco companies have cited studies to regulators showing smokeless tobacco to be less harmful than cigarettes, which release carcinogens through combustion. Altria Group Inc. and Reynolds American Inc., which are the largest U.S. sellers of cigarettes but are aggressively diversifying into smokeless products, said they were evaluating the report.
Reynolds petitioned the FDA earlier this year to change a label on smokeless products to "No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes.''
A current warning states, "This product is not a safe alternative to cigarettes.''
Under legislation passed in 2009, the FDA must determine whether the marketing of alternative tobacco products as safer would reduce harm to individual users and benefit the health of the population as a whole.
In its report, the Institute of Medicine recommended tobacco companies use FDA-approved, independent third parties to oversee health research on their products. The industry "currently lacks the trustworthiness, expertise and infrastructure'' to produce the research, Jane Henney, a University of Cincinnati professor who chaired the 15-person committee that wrote the report, said in a statement.
Anti-tobacco groups praised the report, the Journal said. Industry critics say smokeless products contribute to tobacco addiction and stop smokers quitting outright. Government-mandated labels currently warn such products can cause mouth cancer and gum disease.
But Bill Godshall, director of Smokefree Pennyslvania, a nonprofit group that campaigns against cigarettes, told the newspaper that the report ignored decades of studies by credible third parties showing smokeless products to be safer.
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