Agency recommends tobacco companies use third-party researchers

A federal agency recommended Wednesday that tobacco companies have "modified-risk" tobacco products tested by third-party researchers approved by the Food and Drug Administration before submitting them for approval.

The 310-page report by the Institute of Medicine also specifies the type of research the FDA should require of manufacturers that want to advertise or sell smokeless products by saying they are less harmful than cigarettes.

Smokeless products facing the scrutiny include not only moist snuff and snus products, but also dissolvable products being sold in trial markets by R.J. Reynolds Tobacco Co. and e-cigarettes and nicotine-replacement products.

Tobacco and health-care officials and advocates had been waiting for more than two years for the institute's recommendations.

A company that wants to market a lower-risk tobacco product in the United States must offer scientific proof to FDA that the marketing of the product will not only reduce harm to individual users, but also benefit the health of the population as a whole.

The institute said modified-risk tobacco products "could be one part of a comprehensive strategy to lower tobacco-related death and disease in the United States, especially among tobacco users who are unable or unwilling to quit entirely."

The report says studies should examine all of the areas needed to forecast and monitor a proposed product's impact on public health, including its composition and addiction potential; the amount of human exposure to harmful components; perceptions about the product's effects and likelihood of addiction; and effects on human health.

Tobacco manufacturers' past denial of the addictiveness of nicotine is at the heart of the institute's insistence that third-party researchers review any modified-risk research.

"Right now, there's a shortage of scientific evidence on the health effects of modified-risk tobacco products, and the tobacco industry currently lacks the trustworthiness, expertise and infrastructure to produce it," said Jane Henney, chairwoman of the committee that wrote the report.

"Having trusted third parties oversee the conduct of research could help re-engage scientists and enable generation of credible research data on the health effects of these products."

The center's request strikes at the core of Reynolds' attempt to create a reputation as an innovator of products that could be less harmful to consumers than cigarettes. Reynolds has bought a company, Niconovum, that specializes in smoking-cessation products.

Reynolds spokesman David Howard said the company will evaluate the institute's recommendations and their applicability to FDA oversight over modified-risk products.

Philip Morris spokesman David Sutton said standards to evaluate modified-risk products "need to be rigorous, yet feasible. A national policy that recognizes the role of less harmful tobacco products on improving public health is the right direction for the country."

Dr. John Spangler, a professor of family and community medicine at Wake Forest University School of Medicine, said he supports "a higher scientific bar" for potential modified-risk products. Spangler is conducting a National Cancer Institute study that's aimed at developing strategies to encourage reduced use or even quitting smokeless-tobacco products.

"This requires the FDA to consider whether any reduction in harm to an individual tobacco user may be offset by marketing that encourages non-users, including kids, to start using tobacco or discourages current tobacco users from quitting," Spangler said.

Bill Godshall, executive director of SmokeFree Pennsylvania, decried the institute's report because he believes the recommendations put unnecessary hurdles in front of potential modified-risk tobacco products.

"The committee's recommendation would require a tobacco company to conduct far more research than the FDA requires that drug companies conduct on nicotine-replacement therapy products before they can be marketed as smoking cessation aids," Godshall said.