The Virginia dietary supplement maker central to a gift scandal involving Gov. Bob McDonnell is illegally marketing two products, the U.S. Food and Drug Administration says.
In a warning letter made public Tuesday, the FDA told Star Scientific Inc. that the products contain a new dietary ingredient that requires federal approval before it can be marketed. The suburban Richmond-based company did not seek approval before selling the dietary supplement Anatabloc and the smoking cessation product CigRx, the FDA said.
The agency also said Star Scientific's website unlawfully promotes Anatabloc as a drug by citing studies suggesting it can be used to treat various diseases, including ulcerative colitis, multiple sclerosis and Alzheimer's disease.
The FDA ordered the company to correct the violations within 15 days. Warning letters are not legally binding, but the government can take companies to court if they are ignored.
"The company 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,'' Star Scientific said in a written statement.
The warning comes as state and federal authorities continue to investigate the relationship between McDonnell and former Star Scientific CEO Jonnie R. Williams Sr., who sought state help promoting the dietary supplement Anatabloc. McDonnell, whose four-year term ends Jan. 11, and some members of his family received more than $145,000 in gifts and loans from Williams. The governor has said Williams and Star Scientific received no grants or other benefits from the state.
The substance that prompted the FDA warning is anatabine, a tobacco alkaloid that the company touts as an anti-inflammatory ingredient in Anatabloc. The FDA said that anatabine, which also occurs naturally in foods including cauliflower and eggplant, has been authorized as an investigational new drug but is also considered a "new dietary ingredient'' that is subject to premarket approval.
"Because the required premarket notification was not submitted to FDA, your products containing anatabine are deemed to be adulterated ... and are prohibited from being marketed in the United States,'' the FDA said in the letter addressed to Williams, who stepped down as CEO Friday.
The FDA also listed several claims made by Star Scientific on the Internet that suggest Anatabloc is a drug "because it is intended for use in the cure, mitigation, treatment, or prevention of disease.'' Anatabloc has not been recognized as safe and effective for those uses, the FDA said, and cannot be offered in interstate commerce without prior federal approval.
In addition, the agency directed the company to remove from the Internet any customer testimonials about Anatabloc's disease-fighting qualities.