GLEN ALLEN, Va. -- Star Scientific Inc. said that it has developed a moist snuff tobacco product that has extremely low levels of carcinogens--much lower than any snuff products currently in the marketplace. Star said it intends to submit an application for approval to market Stonewall Moist-BDL as a modified-risk tobacco product under the Family Smoking Prevention & Tobacco Control Act of 2009 during early first-quarter 2011.
This new product has levels of tobacco-specific nitrosamines (TSNAs)--recognized by scientists as one of the most powerful cancer-causing agents [image-nocss] in tobacco leaf and smoke--below 20 parts per billion (nanograms-per-gram moist weight, as used) in initial testing.
This is 99% lower than the levels found in conventional American moist snuffs and 90% less than the level found in current "snus" products, according to the company.
Moist snuff products account for the largest portion of the smokeless tobacco market (73%), and this has been the fastest-growing segment of the tobacco marketplace in the United States in recent years, it said. First-quarter 2010 sales alone increased at a rate of 7%.
Star Scientific said that it is developing technologies that result in reduced toxins in tobacco.
"We knew we could make a snuff product that had hundreds of times lower toxin levels, since we already had pioneered this achievement with our BDL dissolvable smokeless products," said Paul L. Perito, chairman and president of Star Scientific, parent company of Star Tobacco, developer of the new product. "It is clear that the means are available for all tobacco companies to reduce well-established toxins in the tobacco they use in manufacturing."
The company said it believes this would be the first modified-risk application for a moist-snuff tobacco product. Star submitted two modified-risk applications to the Food & Drug Administration (FDA) in February and June 2010 for approval for the company's Ariva-BDL and Stonewall-BDL dissolvable smokeless products; the FDA's Center for Tobacco Products stated in a guidance document in November, 2009 that it anticipated the approval process would take 360 days or less after filing.
Star developed and scaled up the StarCured, nonchemical tobacco-curing technology over a decade ago, it said. This process reduces the formation of TSNAs that occurs during traditional tobacco curing.
While the company believes that the best option is to quit or not to start using tobacco, Star's corporate mission is centered on reducing the harm associated with tobacco use at every level; the company was founded on the belief that it is technologically possible to lessen the health risks associated with long-term tobacco use, and particularly smoking.
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 utilization of the innovative StarCured tobacco curing technology. Its subsidiary, Rock Creek Pharmaceuticals, Inc., is involved in the development of nutraceuticals as well as products to address neurological and mood disorders.
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