Star Scientific, Inc. (Nasdaq: CIGX) announced that on Friday, June 18 the company 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 February 19, 2010. The company believes that these are the only applications for modified risk products that have been filed with the FDA to date.
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 ("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. Achieving this reduction, known within Star as "ZNT" (zero-nitrosamine tobacco) was accomplished by new work on the StarCured® tobacco curing technology that originally was developed in the 1990s. This innovation is the subject of a patent application filed in December 2008. A recent article by Rickert et al. (Regulatory Toxicology and Pharmacology 2009;53(2):121-33) reported total TSNA levels in currently marketed popular moist snuff and "pouch" tobacco products that ranged from 8,814 – 14,557 parts per billion. This range is 1000 times greater than the levels measured in Stonewall-BDL™, as outlined in the company's submission.