Star Scientific – filed application with U.S. FDA for approval to market a moist-snuff product
Source: snus-news.blogspot.com Author: staff 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 [...]