BioNeurix Corporation – FDA Warning Letter, Jul 31, 2012

The FDA issued a Warning Letter to BioNeurix Corporation (www.pharma-tree.com) on October 15, 2012, following a website review in July 2012. The letter states that BioNeurix's "Blood Sugar 360," "Amoryn," "Seredyn," and "Mellodyn" products are promoted for conditions that classify them as drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)].

The FDA identified numerous claims on the website that establish these products as drugs, intended for the cure, mitigation, treatment, or prevention of disease. For "Blood Sugar 360," claims included "reduce blood glucose levels," "regulate insulin sensitivity," "normalize natural insulin production," and "decrease the chance of glucose-related nerve damage." Testimonials and FAQ sections also made disease claims, such as "decrease in hyperglucose" and effectiveness for "Type 1 and Type 2 diabetes." The company's "Clinical Research" webpage cited studies to "prove the efficacy of the ingredients in Blood Sugar 360" in preventing and treating diabetes and its complications, like diabetic neuropathy.

For "Amoryn," "Seredyn," and "Mellodyn," claims included "