Star Scientific (STSI -6%) acknowledges it received a warning letter on Dec. 20 from the FDA stating "[Y]our Anatabloc and CigRx products contain anatabine [...] Anatabine [...] is also considered a new dietary ingredient, which is subject to premarket approval. To date, a premarket notification has not submitted to FDA; [...] therefore, [Anatabloc and CigRx] are deemed to be adulterated."
The agency continues that Anatabloc has been advertised by Star Scientific on its websites as a drug, which the FDA has "not generally recognized as safe and effective for the [...] referenced uses." The FDA urges Star Scientific to "take prompt action to correct the violations." Failure "may result in regulatory action without further notice, such as seizure and/or injunction."
Star Scientific 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 the Company's websites."