The U.S. Food and Drug Administration (FDA) has warned former Star Scientific, Inc. CEO Jonnie Williams that the company makes therapeutic claims for its Antabloc dietary supplement, thereby rendering the product a drug subject to FDA approval under the Food, Drug, and Cosmetic Act. The company has reportedly been linked to an investigation into the conduct of outgoing Virginia Governor Robert McDonnell (R) and his wife, Virginia. Details about the executive couple’s alleged involvement with the company appear in Issue 8 of this Report.
In its December 30, 2013, warning letter, FDA also focuses on the ingredient antabine in two of the company’s products, Antabloc and CigRx, stating that they were promoted as dietary supplements before the ingredient was “authorized for investigation as a new drug under an investigational new drug application (IND).” Under the law, “a dietary supplement that contains a new dietary ingredient shall be deemed adulterated” unless the ingredient has been present in the food supply “as an article used for food in a form in which the food has not been chemically altered” or it has a history of safety “and, at least 75 days before being introduced or delivered for introduction into inter- state commerce” the manufacturer provides FDA “with information, including any citation to published articles, which is the basis on which the manufac- turer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe.”
The company has acknowledged receiving the warning letter and claims that anatabine is “a substance naturally occurring in various plants.” According to Star Scientific, it 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.” FDA highlights company Website statements about the supplements and their ability to alleviate symptoms or treat a variety of diseases, including ulcerative colitis, multiple sclerosis, Alzheimer’s disease, and traumatic brain injury.
Press reports indicate that Williams has resigned his position with the company, and it is now led by Michael Mullan, who formerly headed the Roskamp Institute, a senior living facilities developer. Meanwhile, federal pros- ecutors reportedly indicated, after meeting with the McDonnell’s legal team, that they would delay charging the couple in connection with the alleged gift scandal. See The Washington Post, December 18, 2013; NaturalProductsInsider. com, December 31, 2013.