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 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 Draft guidance issued by the FDA in November 2009 stated that the agency expected to complete MRTP application approval processes in 360 days or less.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.