FDA WARNING_LETTER - Advantage Biosciences

On December 17, 2015, the FDA issued a Warning Letter to Advantage Biosciences, Inc., regarding their "nutritional supplements" for animals: Resvantage Canine, Resvantage Feline, and Resvantage Equine. The FDA reviewed product labeling and the company website, www.resvantage.com.

The FDA determined these products are intended for use in the mitigation, treatment, or prevention of diseases in animals, classifying them as drugs under section 201(g)(1)(B) of the FD&C Act [21 U.S.C. § 321(g)(1)(B)]. Specific claims cited include "cancer therapy," "anti-cancer activity," "chemo preventive/curative agent," "sensitized by resveratrol" for various tumors, "anti-inflammatory, cardiovascular protective and cancer chemopreventive properties," "curb insulin resistance," "new therapy for treating type II diabetes," "manage diabetes and reduce the incidence and severity of glycemic seizures," "treatment of cardiovascular diseases," "prolong the life," "anti-inflammatory, cardioprotective, antioxidant, anti-cancer, and neuroprotective properties," "anti-viral properties," and "attenuate chronic intestinal inflammation."

These products are considered unapproved new animal drugs under section 201(v) of the FD&C Act [21 U.S.C. § 321(v