Virginia tobacco maker seeks new FDA designation

Editors Note:   CRE looks forward to FDA’s  program to allow the public to express its views on this matter as well as the weight to be accorded to the Data Quality Act in making the resultant determination.


Tobacco maker Star Scientific Inc. is asking the Food and Drug Administration to certify a moist smokeless tobacco it has developed as less harmful than other forms of tobacco on the market.

The small Virginia company said Wednesday it has filed an application with the FDA to approve its Stonewall Moist-BDL as a “modified risk” product under the 2009 law that gave the FDA authority over tobacco.

Star Scientific says the tobacco contains 90 percent to 99 percent less tobacco-specific carcinogens than others currently available on the market.

The FDA is still considering similar applications from Star Scientific for two dissolvable tobacco products. Star has sold dissolvable tobacco under the Ariva and Stonewall brands since 2001.

Star states:  “The company believes that this is the first application filed with the FDA for approval of a tobacco product in a longstanding market segment.”

Associated Press

Star Press Release

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