The first modified risk tobacco product application, for ARIVA-BDL, was filed by Star on Feb. 19, 2010. The company said [image-nocss] it 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, the company said.
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, said the company. This innovation is the subject of a patent application filed in December 2008.
Star originally introduced dissolvable smokeless tobacco to the marketplace almost 10 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."
Paul L Perito, president of Star Scientific, said, "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."
Star Scientific is exploring opportunities for sublicensing agreements with both domestic and international entities, it said, so that Stonewall-BDL can be made available as broadly as possible to adult users of smokeless tobacco and dependent smokers.
Glen Allen, Va.-based Star Scientific is a technology-oriented company with a mission to reduce the harm associated with tobacco at every level. It is engaged in the development of dissolvable smokeless tobacco products that deliver fewer carcinogenic toxins, principally through the use of the StarCured tobacco curing technology. Through its Rock Creek Pharmaceuticals subsidiary, it is also involved in the development of nutraceuticals as well as products to address neurological and mood disorders.
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