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Star Scientific’s Tobacco Lozenges Get Favorable FDA Ruling

Star Scientific Inc. said U.S. regulators ruled that two of the company’s lozenge brands aren’t subject to regulation under the 2009 tobacco law.

The Food and Drug Administration’s decision clears the way for Star Scientific, based in Glen Allen, Virginia, to start selling its Ariva-BDL and Stonewall-BDL tobacco lozenges, the company said today in a statement. The company’s shares jumped to their highest value in about 21 months.

The dissolvable products contain reduced levels of carcinogens known as tobacco-specific nitrosamines. Star Scientific said it was notified by Lawrence Deyton, director of the FDA’s Center for Tobacco Products, that “cigarettes, cigarette tobacco, smokeless tobacco and roll-your-own tobacco” are the only products subject to regulation under the 2009 law.

“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,” Paul Perito, the company’s president and chief operating officer, said in the statement.

The 2009 law restricts tobacco marketing and requires an FDA advisory panel to evaluate dissolvable tobacco’s impact on public health. The panel, which said last week after a yearlong analysis that menthol cigarettes harm public health, will begin its examination of dissolvable tobacco later this year.

“FDA recognizes there are uncertainties regarding the regulatory status of a variety of nicotine-containing products derived from tobacco; more specifically, whether these products are regulated as drugs or tobacco products,” Jeffrey Ventura, an agency spokesman, said today in an e-mail. “FDA is currently considering its legal and regulatory options regarding these products.”

Star Scientific gained 34 cents, or 9.4 percent, to $3.96 at 4 p.m. New York time in Nasdaq Stock Market trading, its highest value since June 16, 2009.

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