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Star Scientific Breaks New Ground, Plans FDA Filing for Approval of First 'Modified Risk' Tobacco Product; Nominates Curtis Wright, MD, MPH for FDA Advisory Committee
Date:9/22/2009

found in several nicotine replacement therapy products (NRT) as reported by a University of Minnesota research team in December, 2007.

Late last week Star Scientific submitted comments to the FDA in response to the agency's request for input on the regulatory framework established by the Family Smoking Prevention and Tobacco Control Act, which was signed into law by President Obama in June, 2009. The company's comments, which can be viewed at http://www.regulations.gov/search/Regs/home.html#documentDetail?R=0900006480a2524f, focus on the need for tobacco product labeling that lists the levels of the most lethal carcinogens in the products in a way that is clear to adult tobacco users. Paul L. Perito, Star's chairman and president commented that "Adult tobacco users need to have access to information about the spectrum of harm associated with tobacco use in order to be able make informed choices about the products they purchase." Mr. Perito added that he hopes clear and accurate labeling will be one of the cornerstones of tobacco regulation policy.

The company also formally nominated Dr. Wright for a position on the Scientific Advisory Committee that has been established by the FDA under the new legislation. In a letter submitted to the agency on September 21, the company pointed out that "Dr. Wright has an enormous breadth of experience in the area of addictive substances, and eight years of his career were spent at the Food & Drug Administration. . .Dr. Wright can contribute not only as a scientist, but also as an executive with significant industry experience. "

This press release contains certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Star Scientific, Inc. and its consolidated subsidiaries (collectively, the "Company") has tri
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SOURCE Star Scientific, Inc.
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