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GLEN ALLEN, Va. -- Star Scientific received some good news from the Food and Drug Administration regarding its pending Ariva-BDL and Stonewall-BDL modified risk tobacco product applications: the products are not subject to regulation under Chapter IX of the Federal Food Drug & Cosmetic Act.
"Not all tobacco products are currently subject to Chapter IX of the FDCA. At this time, only cigarettes, cigarette tobacco, smokeless tobacco and roll-your-own tobacco are subject to Chapter IX FDCA Section 901(b). Based upon the information in your submission, [Ariva-BDL and Stonewall-BDL are] not currently subject to Chapter IX requirements," Dr. Lawrence Deyton director of the FDA Center for Tobacco Products, stated in the notices.
With the FDA ruling in hand, Star Scientific now has a clear path to move forward with marketing these products. "We are pleased to have received a determination from the FDA on Ariva-BDL and Stonewall-BDL. It is clear from the notices we received that the Center for Tobacco Products does not believe these products are subject to regulation under FDC Act Chapter IX at this time. We intend to move forward with marketing and distribution of Ariva-BDL and Stonewall BDL, and these initiatives will be undertaken consistent with our belief that adult tobacco users should be able to have information about the toxin levels in all tobacco products," said Paul L. Perito, Star's chairman, president and COO.
As CSNews Online previously reported, the company submitted two modified-risk applications to the FDA in February and June 2010 for approval for the company’s Ariva-BDL and Stonewall-BDL dissolvable smokeless products. In addition, the company filed a similar request with the agency in February of this year for its Stonewall Moist-BDL. Star Scientific says the tobacco in Stonewall Moist-BDL contains 90 percent to 99 percent less tobacco-specific carcinogens than products currently on the market.