June 21, 2010 - Star Scientific, Inc. 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. (Star Scientific asks FDA to certify Ariva-BDL lozenges as less harmful than traditional forms of tobacco..)
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.
Ariva®, launched in 2001, was developed for adult smokers who cannot or choose not to smoke. Stonewall Hard Snuff®, launched in mid-2003, is an alternative for adults who use traditional smokeless tobacco products or who identify themselves as "heavy smokers". Over the past nine years the company has learned that Ariva® customers range in age from 30-70, and more than half of them are women. Stonewall Hard Snuff® purchasers range in age from 25-65 and show two major patterns of tobacco use. Customers who are looking for an alternative to moist snuff are largely male, while roughly 30-40% of those who purchase the products as an alternative to "heavy" daily cigarette smoking are female. According to callers to the company's consumer call center, the majority of purchasers are concerned about continued smoking.
Reference: Star Scientific Files Second Application With FDA for Approval of a Modified Risk Tobacco Product, SOURCE Star Scientific, Inc., PR Newswire, 6/21/2010.
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