On 2/19/10, Star Scientific (NASDAQ: CIGX) filed an application with FDA, seeking marketing approval for Ariva-BDL as a "modified risk" tobacco product under the Family Smoking Prevention and Tobacco Control Act of 2009. This submission is the first such application to be filed with the Tobacco Products Center of the FDA, which has been established to oversee all aspects of tobacco regulation outlined in the 2009 Act.

Ariva-BDL is a dissolvable tobacco lozenge with wintergreen flavoring that is made with flue-cured tobacco that contains levels of tobacco-specific nitrosamines (TSNAs) that are below detectable limits ("BDL") by most current standards of measure. Draft guidance posted at the Agency's website indicates that the preliminary review period for applications of Modified Risk Tobacco Products (MRTP) (pending further guidance or rulemaking) is 360 days, which is twice as long as the expedited new drug review and also longer than the standard, 10-month new drug review period by the Agency.

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