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Electronic Cigarette Makers Must Prove Safety of Products: Report
Date:12/14/2011

By Steven Reinberg
HealthDay Reporter

WEDNESDAY, Dec. 14 (HealthDay News) -- A new report details exactly what kind of scientific proof the U.S. Food and Drug Administration should require from the makers of electronic cigarettes and tobacco lozenges to show that what they are selling is not harmful to the overall public health.

These "modified risk" products claim to offer individuals nicotine without the health risks, namely lung cancer and heart disease, that are associated with the use of traditional tobacco products such as cigarettes.

"These products are ones that might carry a claim that they have less risk to the user than a traditional tobacco product," said Dr. Jane Henney, a professor of medicine and public health sciences at the University of Cincinnati and chairwoman of the Institute of Medicine (IOM) committee that wrote the report. "We believe that if those claims are to be approved by the FDA, the sponsor will have to bring to the agency a series of data to support that claim."

These products are sold as part of a strategy to lower tobacco-related death and disease, especially among smokers who have had trouble quitting, but not much is known about the overall health risks of these products, according to the committee.

To determine that, the IOM report suggests that the FDA require testing in the laboratory and in animals, clinical trials with people, and post-marketing studies to see if any health problems show up once the products are in widespread use.

Given the "tobacco industry's well-documented history of improper conduct," the committee believes these studies should be done by independent third parties.

The authority for this kind of oversight was included in the 2009 Family Smoking Prevention and Tobacco Control Act, which requires that modified risk tobacco products undergo an approval process similar to drugs and medical devices.

Several groups applauded the IO
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