FDA Steps Up Crackdown on Marketers Using “Medical Food” Labeling

The U.S. Food and Drug Administration (“FDA”) is continuing its crackdown that began with last year’s warnings to companies promoting nutritional products and drugs under the false cover of “medical foods” labeling. In a December 26, 2013 warning letter, the FDA addressed the manufacturers of a product called Glucorein PCOS. The regulator warned California-based NVN Therapeutics (“NVN”) that the product was illegally mislabeled as a medical food. The product fails to meet the definition criteria to be labeled and promoted as a medical food, the FDA wrote. According to the Glucorein PCOS product label and website, it is a “medical food for dietary management of Polycystic Ovarian Syndrome (“PCOS”) by reducing the incidence of metabolic syndrome and insulin resistance.”