The U.S. Food and Drug Administration (FDA) has released a warning letter accusing California-based NVN Therapeutics of illegally selling a prescription drug under the guise of a “medical food,” continuing what appears to be a crackdown on the product category. Although FDA warning letters FDA about medical food issues are apparently uncommon, with the agency issuing only 13 since 2001, a recent spate of letters sent to medical food manufacturers suggests that the agency is taking a more active role in enforcing this product category. Since April 2013, FDA has issued four letters citing medical food issues and nearly one-third of all medical food-related warning letters ever issued by FDA have been released during the past nine months.

Under the Orphan Drug Act of 1984, a medical food is defined as a food that is “formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.” In August 2013, FDA released new draft guidance for medical foods adding  that such foods are “intended only for a patient receiving active and ongoing medical supervision wherein the patient requires medical care on a recurring basis for, among other things, instructions on the use of the medical food.”

At issue in the recent warning letter is a product called Glucorein PCOS, whose active ingredients are chlorogenic acid and l-cysteine, and which is marketed as a medical food intended for “dietary management of Polycystic Ovarian Syndrome (PCOS) by reducing the incidence of metabolic syndrome and insulin resistance.” Noting that it was unable to find any evidence that patients with PCOS have any medically determined nutrient requirements, FDA wrote, “although there are benefits to these patients obtaining Chlorogenic Acid and L-Cysteine in their diet, there are no established distinctive nutritional require- ments or inherent needs for patients with PCOS to have these substances in their diets.” As a result of failing to meet the medical food standards, FDA said it considered NVN’s product a drug, misbranded under the Federal Food, Drug, and Cosmetic Act. See RegulatoryAffairsProfessionalsSociety.org, January 21, 2014; Nutraingredients-usa.com, January 22, 2014.