Star Asks FDA Approval for Modified-Risk Product

Source from:  Tobacco Reporter 06/22/2010

Star Scientific Inc. has filed an application with the Food & Drug Administration for approval to market Stonewall-BDL as a "modified risk tobacco product" under the Family Smoking Prevention and Tobacco Control Act of 2009. This is Star's second such application to the Tobacco Products Center of the FDA, which has been established to oversee all aspects of tobacco regulation outlined in the 2009 Act. The first modified risk tobacco product application, for Ariva-BDL, was filed by Star on Feb. 19, 2010. Stonewall-BDL, like Ariva-BDL, is a dissolvable tobacco lozenge with wintergreen flavoring. The product is made with flue-cured tobacco that contains levels of tobacco-specific nitrosamines (TSNAs) that are below detectable limits by most current standards of measure. TSNAs have been identified in scientific literature since the early 1950s as one of the most deadly and abundant groups of carcinogens in tobacco and its smoke. Enditem