Star Scientific Inc.
The FDA has specifically targeted claims made in the promotion of Anatabloc.
The Food and Drug Administration is questioning the legality of a dietary supplement linked with the investigation of Virginia Governor Bob McDonnell.
In a warning letter to Virginia-based Star Scientific Inc., the FDA says the company’s marketing of a product called Anatabloc was illegal for several reasons.
First, the FDA says a chemical in Anatabloc, called anatabine, is considered a new dietary ingredient. As a result, the FDA says, the company needed to alert the federal government before marketing it.
In addition, the FDA says the Star Scientific suggested in marketing materials that Anatabloc could be used to treat a number of diseases, including Alzheimer’s disease and multiple sclerosis. Those kinds of claims are prohibited in marketing of dietary supplements.
But Dr. Daniel Fabricant, director of the FDA’s Division for Dietary Supplement Programs, says the agency’s concerns go beyond marketing.
“The question put for them is how exactly is the ingredient in Anatabloc a lawful dietary supplement?” Fabricant says. “How can it be sold at all?”
Fabricant says anatabine was previously submitted for drug approval through the FDA, and once a product is submitted for consideration as a drug, it cannot be sold as a supplement.
“Once you go the drug route the law restricts you in many ways,” he says.
Fabricant also points out that while some Star Scientific materials claim anatabine is synthetic, other materials have suggested it comes from tobacco. Federal law prohibits tobacco products from being sold as supplements.
According to the warning letter, Star Scientific has 15 working days to respond to the FDA. A company spokeswoman declined a request for an interview but issued a statement saying it is cooperating with the FDA.
Meanwhile, state and federal authorities are investigating more than $100,000 in gifts and loans Star Scientific's former CEO Jonnie Williams gave Gov. McDonnell and his family while the company sought help promoting Anatabloc. Williams resigned his position as chief executive on Friday, though he will stay on for an additional year in an advisory capacity.