Neuliven Health, Inc. – FDA Warning Letter, Apr 30, 2013

The FDA issued a Warning Letter to Neuliven Health, Inc. on July 15, 2013, following a review of their website, www.glucocil.com, in April 2013. The FDA determined that the product Glucocil is promoted for conditions that classify it as a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)], due to claims of intended use in the cure, mitigation, treatment, or prevention of disease.

Numerous examples of such claims were cited from the company's website, Facebook page, Twitter account, internet advertisements, product label, and promotional materials. These claims include, but are not limited to, "Lower fasting blood sugar levels up to 29%," "Lower A1c levels significantly," and "Glucocil helps stabilize your blood sugar all day." Testimonials on the website also describe Glucocil's use for managing type 2 diabetes, lowering A1c, and reducing reliance on prescription medications.

The FDA states that Glucocil is an unapproved new drug under section 201(p) of the Act [21 U.S.C. § 321(p)] because it is not generally recognized as safe and effective for its claimed