Star Scientific seeks FDA approval for tobacco lozenge

GLEN ALLEN, Va. Star Scientific on Friday filed an application with the Food & Drug Administration for approval to market Ariva-BDL, a wintergreen-flavored tobacco lozenge, 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.

The tobacco product is manufactured with flue-cured tobacco that contains levels of tobacco-specific nitrosamines below detectable limits by most current standards of measure. TSNAs have been identified in scientific literature as one of the most deadly and abundant groups of carcinogens in tobacco and its smoke.

Star Scientific originally introduced dissolvable smokeless tobacco almost 10 years ago when it launched Ariva in 2001 and Stonewall Hard Snuff in 2003. Both products are pieces of powdered and compressed tobacco that dissolve completely in the mouth.