WASHINGTON Dec 31 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
Dec. 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
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
Shares in Star Scientific were down 8.8 percent at $1.14
after hitting $1.12, a one-year low.