Posted January 4, 2014

Smoking Cessation and Anti-Inflammatory Supplements Contain Unapproved Ingredient

On December 13, 2013, the FDA issued a warning letter to Star Scientific, Inc. after the agency noted that the company's smoking cessation supplement CigRx and anti-inflammatory supplement Anatabloc contain anatabine, a chemical not currently allowed in dietary supplements. Statements made about Anatabloc were also found to be drug claims.

Anatabine is a chemical found in naturally in cauliflower, eggplant, potatoes, and tomatoes, but also in tobacco (tobacco and chemicals found in tobacco are specifically excluded from the definition of "dietary supplement", according to federal regulations. It is authorized as an investigational new drug and is also considered to be a new dietary ingredient, which is subject to premarket approval.

CigRx contains anatabine and yerba mate. It is promoted to help with smoking cessation.

Anatabloc contains anatabine, vitamin A and vitamin D, and is promoted as an anti-inflammatory supplement. It was also promoted to treat conditions like Alzheimer's disease and traumatic brain injury with statements like "anatabine may be a useful treatment for Alzheimer's disease," and "supplementation with anatabine, the active ingredient in the Company's Anatabloc dietary supplement, has the potential to alleviate the negative consequences of traumatic brain injury (TBI)."

(See's Reviews of Vitamin A Supplements and Vitamin D Supplements for tests of related products.)

Recently, the FDA warned consumers about the dangers of supplements promoted to treat brain injuries.

See Related Warnings:

Beware of Supplements With Claims to Treat Brain Injury, FDA Warns

Maker of Concussion Recovery Supplement Warned For Making Drug Claims

Maker of Omega-3, Bone and Brain and Supplements Warned For Drug Claims

To read the FDA's warning letter, use the link below.