WASHINGTON The company at the heart of a scandal involving the Virginia governor's promotion of one of its dietary supplement products, has received a warning from the Food and Drug Administration, the agency said on Tuesday.
The FDA sent a letter to Star Scientific Inc on December 20, saying it was making claims on its website about the supplement, Anatabloc, that would require its approval as a drug, the FDA said on its website.
Star Scientific has been at the center of a scandal involving Virginia Governor Robert McDonnell, a Republican whose term ends next month.
Federal authorities are investigating the relationship between McDonnell and Star Scientific founder and former Chief Executive Jonnie Williams Sr, who sought state help promoting Anatabloc.
McDonnell has acknowledged that he and his family accepted more than $160,000 in gifts and loans from Williams, a major campaign donor. But the governor has said Williams and Star Scientific received no grants or other help from the state.
In July, the governor apologized for embarrassing the state and repaid the loans. He said he returned the gifts to Williams.
A spokesman for McDonnell did not immediately respond to a request for comment on Tuesday.
Williams resigned last week. He was replaced by Dr Michael Mullan, head of the Roskamp Institute, a research center.
The FDA gave Star Scientific, of Glen Allen, Virginia, 15 days to say what steps it has taken to correct violations.
In a statement on its website, Star said it was responding to the FDA and "has already advised the agency that it intends to work cooperatively to resolve these issues."
The FDA also said the company failed to seek approval for selling the smoking cessation product CigRx.
Both items contain a new ingredient, the tobacco alkaloid anatabine, that requires federal approval before it can be marketed, the FDA said.
Virginia Attorney General Ken Cuccinelli, a Republican, also apologized in September for accepting about $18,000 in gifts from Williams and gave that amount to a charity.
Cuccinelli lost the governor's race in November to Democrat Terry McAuliffe.
Shares in Star Scientific were down 8.8 percent at $1.14 after hitting $1.12, a one-year low.
(Reporting by Ian Simpson; Editing by Ellen Wulfhorst and Gunna Dickson)