Federal regulators just issued a Warning Letter to supplement maker, Star Scientific, over its Anatabloc product. The U.S. Food and Drug Administration (FDA) letter was dated December 20, 2013.
Star Scientific is being warned over Anatabloc claims that have not received agency approval, including that the over-the-counter dietary supplement has so-called anti-inflammatory properties, according to The Richmond Times Dispatch. According to the FDA, the product is being promoted for use in curing, mitigating, treating, and preventing disease. These therapeutic claims, which have been made on Star Scientific websites, change the purpose of Anatabloc, which is now considered a drug under the Federal Food, Drug, and Cosmetics Act (ACT).
The FDA indicated that Anatabloc, and another Star Scientific product that is sold as CigRx, both contain anatabine as their active ingredient. The FDA describes anatabine as a dietary ingredient that is also considered an investigational new drug, making it subject to pre-market approval. As of the date of the agency’s letter, Star Scientific had not provided the required premarket notification for the anatabine-containing products. This has also caused the anatabine-containing products to be deemed adulterated. When an adulterated product is released to the market, that product’s release is then considered a violation of the Act.
“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’s letter indicated. Star Scientific has 15 days to take corrective action.
Anatabine is described as being a tobacco alkaloid and, according to Star Scientific, is found in an array of plants such as tobacco, eggplant, cauliflower, pepper, and tomato. Star Scientific also claims that anatabine, along with having anti-inflammatory properties, may also assist in the mitigation of various health issues, according to The Richmond Times Dispatch report. The FDA, in its correspondence, cited some of Star Scientific’s statements, including that anatabine might assist in the recovery of traumatic brain injury, may reduce the severity of multiple sclerosis, and may lessen inflammation associated with Alzheimer’s disease.
Star Scientific also employed a marketing campaign for Anatabloc that included athlete endorsements. For example, pro golfer, Fred Couples and John Isner, the tennis pro, have said in Anatabloc advertising that the product has reduced muscle soreness and inflamed joints, The Richmond Times Dispatch reported. For its part, the FDA indicates that anatabine “is not generally recognized as safe and effective” for these uses.
Anatabloc is Star Scientific’s key income revenue product and may be purchased online and through GNC, according to The Richmond Times Dispatch.
Star Scientific has been advised to remove all customer testimonials concerning Anatabloc’s disease-fighting qualities from the Internet, CBS DC reported. The FDA’s letter also indicated that the agency may take action, including “seizure and/or injunction” if Star Scientific does not, within 15 days, take corrective action, including that it “cease making therapeutic claims that Anatabloc can be used in the cure, mitigation, treatment or prevention of disease,” according to the letter.
Star Scientific, which is based in Virginia, has been the focus of myriad controversy, including that its former CEO is involved in another separate scandal that involves gifting and Governor Bob McDonnell, according to The Richmond Times Dispatch.