Marketing approval filed with FDA for Ariva-BDL as first modified risk tobacco product

Star Scientific announced that it has filed an application with the FDA for approval to market Ariva-BDL as a “modified risk” tobacco product under the Family Smoking Prevention and Tobacco Control Act of 2009. 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 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.

Ariva-BDL, a dissolvable tobacco lozenge with wintergreen flavoring, is made with flue-cured tobacco.  

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