A Warning Letter to supplement maker Star Scientific On December 20, 2013, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to supplement maker, Star Scientific, Inc., over its Anatabloc product, which is being promoted for claims that have not been approved.
Anatabloc is an over-the-counter (OTC) dietary supplement that Star Scientific touts for its so-called anti-inflammatory properties, according to a report issued by The Richmond Times Dispatch.
Anatabloc Deemed a Drug, Has Not Received FDA Approval
According to the FDA, Anatabloc is touted for use in the cure, mitigation, treatment, or prevention of disease. Based on these therapeutic claims, which have been made on the Star Scientific websites concerning the product, the agency has deemed Anatabloc to be a drug under the Act.
Anatabloc, and another Star Scientific product sold as CigRx, both contain anatabine as their active ingredient. Anatabine is described as a dietary ingredient by the federal regulator, is considered an investigational new drug, and is considered a new dietary ingredient. Because of this, anatabine is subject to pre-market approval.
As of the date of the agency’s Warning Letter, Star Scientific had not yet submitted the required premarket notification for the anatabine-containing products, which has caused Anatabloc and CigRx to also be deemed adulterated. When an adulterated product makes its way on to the market, its Introduction and delivery 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. The FDA has 15 days to take corrective action to the letter.
Meanwhile, the former CEO of Star Scientific, which is based in Virginia, is involved in a separate scandal that involves gifting and Governor Bob McDonnell, according to The Richmond Times Dispatch.
Anatabine is a tobacco alkaloid and Anatabloc, which is Star Scientific’s key income revenue product, is available for sale online and through GNC, The Richmond Times Dispatch reported.
Anatabloc Claims Not Proven, Despite Pro Athlete Endorsements
Star Scientific’s Anatabloc marketing campaign has included athlete endorsements, including endorsements from pro golfer, Fred Couples, and tennis pro, John Isner, who have both said in Anatabloc advertising that Anatabloc has minimized their muscle soreness and their inflamed joints, The Richmond Times Dispatch wrote.
According to Star Scientific, anatabine, which is found in a variety of plants including tobacco, eggplant, cauliflower, peppers, and tomato, has anti-inflammatory properties and these may help mitigate some health issues, according to The Richmond Times Dispatch report. The agency also cited statements made by Star Scientific that anatabine might assist in traumatic brain injury recovery, may minimize the severity of multiple sclerosis, and reduce inflammation tied to Alzheimer’s disease.
The FDA indicated that anatabine “is not generally recognized as safe and effective” for these uses.
The agency has advised Star Scientific to remove customer testimonials concerning Anatabloc’s disease-fighting qualities from the Internet, according to a CBS DC report. The FDA also indicated that it may take action, including “seizure and/or injunction” if Star Scientific does not take corrective action within 15 days. Corrective action includes that Star Scientific “must cease making therapeutic claims that its product, Anatabloc, can be used in the cure, mitigation, treatment or prevention of disease,” according to the letter.
An FDA spokeswoman stated that “The warning letter cites multiple violations” and that “all violations must be addressed.” Star Scientific has not yet been directed to remove Anatabloc from the market, according to The Richmond Times Dispatch report.
Warning Letters are only issued for what the agency describes as “violations of regulatory significance. These letters are the FDA’s key method of eliciting rapid and voluntary compliance with the Federal Food, Drug, and Cosmetic Act.
Need Legal Help Regarding Unapproved Claims of Star Scientific Anatabloc?
If you or a loved one purchased Anatabloc based on its advertising and unsubstantiated claims, or if you or a loved one sustained a an injury after taking Anatabloc, you may have valuable legal rights. We urge you to contact our supplement lawyers today by filling out our online form, or calling 1-800-968-7529 (1-800-YOURLAWYER) today.