GLEN ALLEN, Va., Feb. 2, 2011 /PRNewswire/ -- Star Scientific, Inc. (Nasdaq: CIGX) filed an application yesterday with the U.S. Food & Administration (FDA) for approval to market a moist-snuff product, Stonewall Moist-BDL™, as a modified-risk tobacco product (MRTP). The company believes that this is the first application filed with the FDA for approval of a tobacco product in a longstanding market segment. The data submitted in the application to the Center for Tobacco Products at FDA document TSNA levels in Stonewall Moist-BDL™ that are below limits of detection, or "BDL", by current standards of measure. Recent findings in the form of test results from an independent international laboratory validate the extraordinarily low levels in recently submitted samples of Stonewall Moist-BDL™, which the company believes are the lowest found anywhere in the world.
The company pointed out that this application is particularly significant in two ways. First, moist snuff product sales accounted for roughly 75% of the total smokeless tobacco market in 2009. Moist snuff sales increased from 31,500 metric tons and $3.3 billion in 2004 to 37,990 metric tons and $4.64 billion in 2009 – an average annual growth rate of roughly 4%, and a 41% overall increase in sales over the six-year period. The moist snuff market segment has been well established for many decades, and is one of the oldest tobacco product categories in the United States. Second, tobacco-specific nitrosamine (TSNA) levels among the moist snuff products with the largest sales volume in 2009 averaged over 10,000 parts per billion in comparison to TSNA levels in Stonewall Moist-BDL, which in initial testing were less than 20 parts per billion, a 99% reduction. Paul L. Perito, Star's Chairman and President, commented, "We are very pleased to be at the forefront of a vital effort to provide adult tobacco users with ways to reduce their exposure to tobacco toxins to the maximum level that technology permits. This represents the essence of our corporate mission, and we believe it is imperative that adult users of traditional tobacco products be informed that there are critical choices to be made if they use tobacco."
In its application the company requested that, upon approval of the application, it be allowed to show the levels of tobacco carcinogens on Stonewall Moist-BDL™ labeling and packaging. Draft guidance issued by the FDA in November 2009 stated that the agency expected to complete MRTP application approval processes in 360 days or less.
The company also submitted two applications for approval of dissolvable smokeless tobacco products in 2010: Ariva-BDL™ in February, and Stonewall-BDL™ in June. Less than two weeks remain until the one-year anniversary of Star's first modified risk application to the FDA. The company to date has not received a response from the Center for Tobacco Products on the status of either of the first two applications, or to an October 2010 letter from Mr. Perito requesting a meeting to respond to any questions and learn about application status. Mr. Perito, while expressing concern about the delay, commented that the company has faith in the FDA meeting its self-imposed review deadlines. "We trust that the agency will respond to our request this month. We believe that the FDA's primary mission always has been to ensure that consumers know the truth about the products they use. It is important that adult consumers be informed that they can choose products which reduce their exposure to a group of deadly and abundant tobacco carcinogens and we simply are following the mandate stated by the US Surgeon General in 'Reducing Tobacco Use' (USDHHS 2000):
As with all other consumer products adult users of tobacco should be fully informed of the products' ingredients and additives and of any known toxicity when used as intended. Additionally, as with other consumer products the manufactured tobacco product should be no more harmful than necessary given available technology. "
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.
About Star Scientific
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. Rock Creek Pharmaceuticals has scientific and research offices in Gloucester, MA, and a regulatory office in Washington, D.C. Star Scientific has a Corporate and Sales Office in Glen Allen, VA, an Executive, Scientific & Regulatory Affairs office in Bethesda, MD, and a manufacturing facility in Chase City, VA.