GLEN ALLEN, Va., - Star Scientific, Inc. reports that it has successfully developed a moist snuff tobacco product that has extremely low levels of carcinogens — much lower than any snuff products currently in the marketplace. This new product has levels of tobacco-specific nitrosamines (TSNAs) — recognized by scientists worldwide as one of the most powerful cancer-causing agents 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 such as Copenhagen or Skoal, and 90% less than the level found in current “snus” products. 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. First-quarter 2010 sales alone increased at a rate of 7%.
Star Scientific is leading the tobacco industry in developing technologies that result in reduced toxins in tobacco. A letter by Drs. Hecht, Stepanov and Hatsukami that was published in the October online issue of the journal Tobacco Control challenged the major tobacco companies to apply modern nitrosamine-reducing technology to their products. That challenge underscores the significance of Star’s latest development. “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. “We are proud of our continued leadership in innovation — 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 believes this has particular importance in light of the fact that the smokeless tobacco market segment has been growing at an annual rate of 4-7% for the past five years.
Star intends to submit an application for approval to market Stonewall Moist-BDL as a modified-risk tobacco product under the Family Smoking Prevention and Tobacco Control Act of 2009 during early first quarter 2011. The company believes this would be the first modified-risk application for a moist-snuff tobacco product. Star submitted two modified-risk applications to the FDA in February and June, 2010, for approval for the company’s Ariva-BDL™ and Stonewall-BDL™ dissolvable smokeless products; the 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 has been the industry leader in low-nitrosamine tobacco technologies for more than a decade.
Star developed and scaled up the StarCured®, non-chemical tobacco-curing technology over a decade ago. This process sharply reduces the formation of TSNAs that occurs during traditional tobacco curing. Scientists worldwide have identified TSNAs as one of the most powerful cancer-causing agents in tobacco leaf and smoke. 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.
Certain statements in this press release other than purely historical information, including estimates, projections, statements relating to our business plans, objectives, and expected operating results, and the assumptions upon which those statements are based, are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We have tried, whenever possible, to identify these forward-looking statements using words such as “anticipates,” “believes,” “estimates,” “continues,” “likely,” “may,” “opportunity,” “potential,” “projects,” “will,” “expects,” “plans,” “intends” and similar expressions to identify forward-looking statements, whether in the negative or the affirmative. These statements reflect our current beliefs and are based on information currently available to us. Accordingly, such forward-looking statements involve known and unknown risks, uncertainties and other factors which could cause our actual results, performance or achievements to differ materially from those expressed in, or implied by, such statements. These risks, uncertainties, factors and contingencies include, without limitation, the challenges inherent in new product development initiatives through Star Tobacco and Rock Creek, the uncertainties inherent in the progress of scientific research, our ability to raise additional capital in the future that is necessary to maintain our business, potential disputes concerning our intellectual property, risks associated with litigation regarding such intellectual property, uncertainties associated with the development, testing and regulatory approvals of our low-TSNA tobacco, related tobacco products and pharmaceutical and nutraceutical products , market acceptance of our new smokeless tobacco products and nutraceutical and pharmaceutical products, competition from companies with greater resources than us, our dependence on key employees and on our prior strategic relationships with Brown & Williamson Tobacco Corporation in light of its combination with R.J. Reynolds Tobacco Company, Inc.
Although the Company believes the expectations reflected in such forward-looking statements are based on reasonable assumptions, it can give no assurance that the expectations will be attained or that any deviation will not be material. See additional discussion under “Risk Factors” in the Company’s Annual Report on Form 10-K as filed with the SEC on March 16, 2010, and other factors detailed from time to time in the Company’s other filings with the SEC, available at www.sec.gov. All information in this release is current as of this date, and the Company undertakes no obligation to update or advise upon any such forward-looking statements to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events.
Sara Troy Machir
Vice President, Communications & Investor Relations