Company in VA Governor’s Supplement Scandal Receives FDA Warning
January 6th, 2014 // 2:32 pm @ jmpickett
The firm that is the middle of a scandal that involves the governor of Virginia’s promotion of a dietary supplement, has gotten a warning from FDA.
FDA sent a warning letter to Star Scientific on December 20. FDA stated that the company is making drug claims on its website about the supplement Anatabloc. Those claims mean that the supplement must receive approval as a drug.
Star Scientific has been in the middle of a scandal that involves VA Governor Bob McDonnell, whose term comes to an end next month.
US officials have been looking into the relationship between the governor and the founder of Star Scientific, Jonnie Williams, who got state help in the promotion of Anatabloc.
McDonnell last year acknowledged that he had accepted $150,000 in gifts and loans from the head of Star Scientific, who also was a major donor to his campaign. The governor said that Williams and his company did not receive grants or help from the state of Virginia.
Last summer, McDonnell apologized for the embarrassment he had caused the state, and he paid back the loans. He also returned all of the gifts to Williams. Willaims left the company last week and he was replaced by Michael Mullan, who was the head of the Roskamp Institute.
FDA gave Star Scientific 15 business days to tell the agency what it is doing to correct the warning letter violations.
Star Scientific stated on its website that it is responding to the agency, and it has advised FDA that it will work with the agency to resolve all warning letter issues.
FDA also stated that the firm did not get proper approval for selling the smoking cessation product called CigRx.
Both products have an ingredient, the tobacco alkaloid antabine, which requires FDA approval before it is allowed to be marketed.
