Star Scientific Inc. (NASDAQ: STSI) announced the receipt on Dec. 24, 2013, of a warning letter from the U.S. Food and Drug Administration (FDA) regarding two consumer products, Anatabloc® and CigRx®, which are marketed by the company. The letter requires the company to respond to the FDA with information and remedial steps.
Both of the company's 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 the company's websites. As is typical for warning letters issued by FDA, the agency stated that the company's failure to address these alleged violations may result in regulatory action by the FDA without further notice. The company 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.