Star Scientific Applies for Modified-Risk Product Approval

GLEN ALLEN, Va. – Smokeless tobacco company Star Scientific Inc. filed an application with the Food and Drug Administration (FDA) for approval to market a new smokeless tobacco item as a modified-risk tobacco product, under regulations by the Family Smoking Prevention and Tobacco Control Act of 2009, the Winston-Salem Journal reported.

The new product, under the name Stonewall-BDLT, is the company's second application of its type to the Tobacco Products Center of the FDA, according to the report. The first, for ARIVA-BDLT, was filed by Star Feb. 19. The company stated that it believes these are the only applications for modified-risk products that have been filed with the FDA to date.

Stonewall-BDLT, like ARIVA-BDLT, is a dissolvable tobacco lozenge with wintergreen flavoring, the Journal reported. The product is made with flue-cured tobacco containing levels of tobacco-specific nitrosamines that are below detectable limits by most current standards of measure, the report stated.

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