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Star Scientific Applauds The FDA Draft Guidance On Disclosure Of Harmful And Potentially Harmful Tobacco Toxins; Comment On Dissolvable Tobacco Products Summary Report

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2, 2012 /PRNewswire/ -- Star Scientific, Inc. (NASDAQ: CIGX) issued the following comments on the March 30, 2012 FDA Draft Guidance on Harmful and Potentially Harmful Constituents in Tobacco Products under Section 904 of the 2009 Family Smoking Prevention and Tobacco Control Act ("Tobacco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  Under the draft guidance issued by FDA last week, companies, as part of that process, will be required to report on, among other constituents, amounts of tobacco specific nitrosamines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.

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