March 24, 2011 - The FDA's determination that Ariva-BDL(TM) and Stonewall-BDL(TM) are not tobacco products that are currently regulated under Chapter IX of the FDCA clears the way for Star to proceed with marketing these products. Star Scientific Inc said U.S. health regulators informed the company that two of its products do not come under a federal law that restricts the sale of tobacco products, clearing the way for Star to market them.
The notices from Lawrence Deyton, MD, MSPH, Director of the FDA Center for Tobacco Products (CTP), state, in part, "Not all tobacco products are currently subject to Chapter IX of the FDCA [Federal Food Drug & Cosmetic Act]. 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(TM) and Stonewall-BDL(TM) are] not currently subject to Chapter IX requirements."
"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," Star said.
References: Star Scientific Receives Notices from FDA: Ariva-BDL(TM) and Stonewall-BDL(TM) Not Subject to Regulation Under FDC Act Chapter IX, PRNewswire via COMTEX/, SOURCE Star Scientific, Inc., 3/213/2003..-
UPDATE 1-Star Scientific says 2 products outside tobacco law, shares rise, Reporting by Esha Dey in Bangalore; Editing by Gopakumar Warrier, Reuters, 3/23.2011..
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The Stonewall Lozenge..
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Stonewall Hard Snuff Packaging - front..
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Stonewall Hard Snuff Packaging - back..