GLEN ALLEN, Va., April 2, 2012 /PRNewswire/ -- Star Scientific, Inc. (NASDAQ: CIGX) issued the following comments on the March 30, 2012 FDA Draft Guidance on Harmful and Potentially Harmful Constituents in Tobacco Products under Section 904 of the 2009 Family Smoking Prevention and Tobacco Control Act ("Tobacco Act") and the Summary Report of the Tobacco Products Scientific Advisory Committee ("TPSAC") posted by the FDA on March 21st.
The FDA Tobacco Act requires a list of harmful and potentially harmful toxins in tobacco that is understandable and not misleading to lay persons be developed and FDA has stated that it will make such information available by April 2013. Under the draft guidance issued by FDA last week, companies, as part of that process, will be required to report on, among other constituents, amounts of tobacco specific nitrosamines (TSNAs – NNNs and NNKs) in their tobacco products.
Star Scientific believes it has been the industry leader for well over a decade in developing cutting edge, patented, curing technology that results in tobacco products with greatly reduced levels of TSNAs (NNNs and NNKs), known to be important carcinogens , in tobacco smoke and leaf. That technology has been affirmed by the US Court of Appeals for the Federal Circuit and through the PTO re-examination process. Further, Star has continued to refine its technology, and recently the PTO allowed additional claims for its curing technology, which enables Star to produce tobacco that contains virtually undetectable levels of TSNAs, as measured by prevailing standards.
Paul L. Perito, Star's Chairman, President and COO, stated: "We are grateful that the FDA is moving forward to require disclosure of the most critical toxins in tobacco products. I believe that the record is clear that Star Scientific has been urging such action since the late 1990s, when we were the only tobacco company to support the February 29, 2000 Smoker's Right to Know and Truth in Labeling Act. Although that Act had bi-partisan support, including that of Senators Frank Lautenberg (D-NJ) and Senator Richard Lugar (R-IN), it died in committee without a public hearing. Star's intent has always been to license our patented technology to major tobacco companies with established distribution facilities, similar to the relationship we had with Brown and Williamson in the years 1998-2004."
Mr. Perito further noted that former Surgeon General Sacher, in the Surgeon General's Office 2000 Report stated "that all consumer products ought to be manufactured in the least hazardous fashion possible, given the availability of relevant technologies…". The fact that the FDA is moving forward to require disclosure of significant toxins, including TSNAs, underscores that not all tobacco products are created equal and that some are less hazardous than others.
The TPSAC was mandated by the 2009 Family Smoking Prevention and Tobacco Control Act to review and report on the "nature and use of dissolvable smokeless tobacco products." This provided our Company with the opportunity to share with the Committee a substantial quantity of information about our experience with the development, manufacture, marketing and product use in a category we created in 2001 when our Ariva® product entered the marketplace.
Since that time more than 5,000,000 packages of our Ariva® and Stonewall Hard Snuff® dissolvable tobacco products have been distributed to adult tobacco users seeking an alternative to exposing themselves and those around them to cigarette smoke. Over this period we have received many emails from our customers relating their use of these products as a viable substitute for cigarettes. This was precisely our hope when we embarked on the efforts that resulted in the creation of our dissolvable tobacco as a new product category and an alternative to traditional tobacco products.
Now that the FDA has acted to affirm the requirement that the content of important toxins of every tobacco product be made publically available, we believe that every smoker and smokeless tobacco user will be provided with information they can use in making purchase decisions.
We were gratified that the TPSAC in its summary concluded that "the exclusive use of DTPs [dissolvable tobacco products] by an individual would greatly reduce risk for smoking caused disease compared with regular use of cigarettes." While the Committee pointed out that "DTP use does not completely substitute for smoking in most regular cigarette smokers," the report also noted that "users of DTPs smoke fewer cigarettes than non-users." This is the first time that we know of that an FDA Committee has taken the position that one form of tobacco product, if used exclusively, could result in a significant reduction of the health risk associated with tobacco use.
Star believes the anticipated disclosure of toxin levels that will be required under the Tobacco Act will enhance the value of its patented tobacco curing technology.
Certain statements contained in this release constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to statements identified by words such as "believes," "expects," "anticipates," "estimates," "intends," "plans," "targets," "projects" and similar expressions. The statements in this release are based upon the current beliefs and expectations of our company's management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements. Numerous factors could cause or contribute to such differences, including, but not limited to, the challenges inherent in new product development initiatives, including the continued development and market acceptance of our nutraceutical and low-TSNA tobacco products, our ability to license and protect our intellectual property, our ability to raise additional capital in the future that is necessary to maintain our business, changes in government policy and/or regulation, including with respect to our nutraceutical and low-TSNA tobacco products, as well as other risks discussed from time to time in our filings with the Securities and Exchange Commission, including, without limitation, our annual report on Form 10-K for the fiscal year ended December 31, 2011. We undertake no duty to update any forward-looking statement or any information contained in this press release or in other public disclosures at any time.
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, DC. 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.
Curtis Wright, IV, MD/MPH
Medical/Clinical Director and Sr. Vice President of Rock Creek Pharmaceuticals, Inc.
SOURCE Star Scientific, Inc.