In Virginia, Star Scientific announced the receipt on December 24, of a warning letter from the U.S. Food and Drug Administration regarding two consumer products, Anatabloc and CigRx, which are marketed by Star. Both the consumer products contain anatabine, a substance naturally occurring in various plants.
In the letter, the agency asserts that anatabine is a new dietary ingredient that required premarket notification to the agency. The agency also asserts that the Company’s products are unapproved new drugs based on statements made on its website. Star is responding to the letter and has already advised the agency that it intends to work cooperatively to resolve these issues, including undertaking a review of its websites.
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