February 3, 2011 - Star Scientific, Inc. filed an application yesterday, February 2nd 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.
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 Draft guidance issued by the FDA in November 2009 stated that the agency expected to complete MRTP application approval processes in 360 days or less.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 Paul L. Perito, Star's Chairman and President requesting a meeting to respond to any questions and learn about application status.
(Star Scientific - developed a moist snuff tobacco product that has extremely low levels of carcinogens -- even lower than snus products..)
Some related Star Scientific news briefs:
Star Scientific, Inc. - U.S. patent office grants request to re-examine patents (2)..;
Star Scientific - developed a moist snuff tobacco product that has extremely low levels of carcinogens -- even lower than snus products..;
Star Scientific - date for oral arguments in patent infringement lawsuit set..;
Star Scientific - U.S. patent Patent and Trademark Office To Consider Reopening Patent Examination..;
Star Scientific asks FDA to certify Ariva-BDL lozenges as less harmful than traditional forms of tobacco..;
Star Scientific - Star Scientific q1 2010 financial report..;
Star Scientific - continue incurring losses on its smokeless-tobacco products..;
Star Scientific asks FDA to certify lozenge less harmful..;
Star Scientific denied new trial in patent infringement - files appeal..;
Star Scientific - NASDAQ trading symbol changed to CIGX..;
Star Scientific - new product (in 2010) to help adult smokers maintain a nicotine-free metabolism..;
Star Scientific - will use its low-nitrosamine tobacco curing process to formulate smokeless tobacco dissolvable smokeless products..
Star Scientific - q2 2009 report..;
Star Scientific - Filing patent for zero-nitrosamine tobacco curing process..;
Star Scientific - 2008 annual report/Stonewall vs other OTC NRTs..;
Star Scientific Corporate Study Stonewall Lozenge in NRT..;
Star Scientific Files Third Quarter Financial Report..;
Star Scientific wants to augment sales of their tobacco lozenges..;
Star Scientific , second quarter 2008, sales down 23.6%..;
Star Scientific Applauds Recent State Legislation - Banning Smoking in Cars with Children..
The Stonewall Lozenge..
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Stonewall Hard Snuff Packaging - front..
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Stonewall Hard Snuff Packaging - back..