Star Scientific seeks FDA approval of Stonewall-BDL as "modified risk tobacco product"

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.

Star Scientific believes these developments are of great significance in light of the reality that 43 million Americans – roughly half of them women - smoke each day. More than half of this population is looking for an acceptable alternative to cigarettes.   Star originally introduced dissolvable smokeless tobacco to the marketplace almost ten years ago when it launched Ariva® in 2001, and Stonewall Hard Snuff® in 2003.  Both products are pieces of powdered and compressed StarCured® tobacco that dissolve completely in the mouth and leave no residue.  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.  

According to Paul L Perito, President of Star Scientific, "While it is true that nothing can make using tobacco risk-free, I am very pleased that our technical and production specialists have been able to remove virtually all the measurable tobacco-specific nitrosamines and benzo[a]pyrene from these new products.  The opinion has been expressed that since current smokeless products have lower TSNA levels than were found  10-20 years ago, they are "safe enough".  If this logic had been followed,  automobiles in the United States would  have neither shoulder seat belts nor air bags. I believe that it is our corporate responsibility to reduce or remove known hazards from our products when we have the means to do so. We view this newest  technology , the subject of the December 2008 patent application, as a needed contribution  that is consistent with our goal to reduce tobacco-related harm at every level."

For this reason, Star is exploring opportunities for sublicensing agreements with both domestic and international entities, so that Stonewall-BDL™ can be made available as broadly as possible to adult users of smokeless tobacco and dependent smokers.