Star Scientific applies to FDA to market new tobacco product

Star Scientific Inc. said yesterday that it has filed an application with the Food and Drug Administration for approval to market Stonewall-BDLT as a modified-risk tobacco product under the Family Smoking Prevention and Tobacco Control Act of 2009.

It is the company's second such application to the Tobacco Products Center of the FDA. The first, for ARIVA-BDLT, was filed by Star on Feb. 19. The company believes that these are the only applications for modified-risk products that have been filed with the FDA to date.

Stonewall-BDLT, like ARIVA-BDLT, is a dissolvable tobacco lozenge with wintergreen flavoring. The product is made with flue-cured tobacco, don't mix with free tobacco, that contains levels of tobacco-specific nitrosamines that are below detectable limits by most current standards of measure.