Star Asks FDA Permission to Sell Reduced Risk Product

Source from:  Tobacco Reporter 02/24/2010

Star Scientific, Inc. has filed an application with the Food & Drug Administration for approval to market its Ariva-BDL brand as a "modified risk" tobacco product under the Family Smoking Prevention and Tobacco Control Act of 2009. According to the company, this submission is the first such application to be filed with the Tobacco Products Center of the FDA, which has been established to oversee all aspects of tobacco regulation outlined in the 2009 Act. Ariva-BDL, a dissolvable tobacco lozenge with wintergreen flavoring, is made with flue-cured tobacco that contains levels of tobacco-specific nitrosamines (TSNAs) that are below detectable limits ("BDL") 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. Star says that TSNA levels in Ariva-BDL are significantly lower than those measured in currently marketed popular moist snuff and "pouch" tobacco products. The company believes that Ariva-BDL, if approved, will be attractive to other companies. For this reason, Star has committed to exploring opportunities for sub-licensing agreements with both domestic and international entities. Enditem