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Company Wants FDA Blessing to Market 'Safer' Tobacco Products
September 28, 2009

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News Summary

A Virginia company plans to ask the U.S. Food and Drug Administration (FDA) for permission to market its smokeless-tobacco products as "modified risk," the Richmond Times-Dispatch reported Sept. 23.

Star Scientific Inc. aims to be the first company to seek the blessing of the FDA -- which was recently authorized to regulate tobacco products -- to tell the public that its products are potentially less harmful to their health than other products on the market. The FDA tobacco-regulation law allows manufacturers to request a scientific review by the agency for the purposes of such marketing authorization.

"The benefit of the new law is that these decisions will now be based on science from an objective viewpoint," said Matthew Myers, president of the Campaign for Tobacco-Free Kids.

Star Scientific would not reveal which products are under development or would be submitted to FDA, but the company is expected to produce dissolvable tobacco-based lozenges. "What would distinguish it is the even significantly lower nitrosamine levels," according to a company spokesperson. Nitrosamines are carcinogens found in tobacco products.

COMMENTS ON THIS ARTICLE:

Posted by Bill Godshall on 29 Sep 09 10:11 AM EDT
The editor's title of this article is misleading, as Star never mentioned the words "safe" or "safer" in its press release announcing its intent to apply to market their curing process for its low nitrosamine tobacco lozenges as a "modified risk" product. Anti smokeless tobacco researchers at the University of Minnesota have published research finding that Star's Ariva lozenge has only slightly more tobacco specific carcinogens than GlaxoSmithKline's Commit nicotine lozenge, delivers similarly low levels of nicotine to users, and tastes better than Commit. Star's tobacco lozenges also cost far less than Commit lozenges. In 2001/2002 GSK petitioned the FDA to redefine Star's Ariva lozenges as "drug delivery devices" instead of tobacco products in an attempt to ban the competitive product, and GSK even argued that Star's tobacco lozenges are virtually identical to GSK's Commit lozenges. Fortunately, the FDA rejected GSK's peitition, arguing that Star's lozenges were indeed tobacco products, and that FDA had no authority to regulate tobacco products. In sum, Star's tobacco lozenges are probably the least hazardous tobacco product ever, and are far far less hazardous alternatives to cigarettes.

Posted by preventionist on 29 Sep 09 11:31 AM EDT
It would have to be defined more clearly to me. Commit lozenges have nicotine in them but as far as I know they do not have tobacco in them. However, if the Star lozenges are tobacco then there is a difference and there will be carcinogens in them. They both will deliver the addicting agent (nicotine), but Commit again as far as I know are a pure form of nicotine without any tobacco in them. As far as the Star lozengers being a safer form of tobacco, maybe for the non-smoker because they will not be inhaling sencondhand smoke, but you still have to look at what is in tobacco products that causes cancer and heart disease. Just a caution and I hope that we will not have a market for safer forms of tobacco. Tobacco is tobacco and it is not healthy in any form.

Posted by maxwood on 30 Sep 09 07:33 PM EDT
I hate to disagree with any preventionist, but in this case it must be said that the emergence of a true market for safer forms of tobacco might prevent millions more victims ever getting hooked on the unsafest form ($igarette).

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