Star Scientific - will use its low-nitrosamine tobacco curing process to formulate smokeless tobacco dissolvable smokeless products..

September 24, 2009 - Star Scientific, Inc. announced today that the company will utilize a novel, patented method for cultivation, curing and preparation of tobacco to formulate dissolvable smokeless tobacco products. This new curing process was the subject of a patent application filed in December, 2008. Its use has resulted in tobacco leaf with significantly lower levels of tobacco-specific nitrosamines (TSNAs) than previously achieved using the StarCured® curing process: the International Agency for Research on Cancer previously has reported on the low levels of nitrosamines in Star's products. The company believes that this novel process, as reflected in its patent application, will enable the company to achieve the lowest toxin levels anywhere in the world. Star plans to submit the products to the FDA for approval to market as "modified risk" tobacco products, under Section 911 of the new The Family Smoking Prevention and Tobacco Control Act, once formulation and testing of the new product is completed in early 2010.

The company also formally nominated Dr. Wright (Curtis Wright, MD, MPH, Chief Medical Officer for Rock Creek Pharmaceuticals, Star Scientific's pharmaceutical division) for a position on the Scientific Advisory Committee that has been established by the FDA under the new legislation.

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, 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.

Reference: 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, Press Release, Source: Star Scientific, Inc., 9/22/2009.

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