Series of warning letters for a medical food manufacturer

Fourth warning letter in the last 9 months has been issued to NVN Therapeutics, a manufacturer of a medical food, by the US Food and Drug Administration (FDA). As given by the FDA guidelines, medical foods are not intended to be a part of general diet like consuming vegetables and fruits to reduce the risk of obesity or diabetes. Medical foods are to be specially formulated to treat a specific condition and should be consumed orally under medical supervision.

In the recent letter sent to this company, FDA stated that one of the company’s products is not a medical food as per the given definition. The company’s product, Glucorein PCOS, is supposed to be a medical food for treating polycystic ovarian disease with dietary management, as marketed by the company.

FDA clearly states in the warning letter that there is no evidence that patients with PCOS need to meet any specific nutritional demands. Additionally, although there may be some benefits of some important nutrients in their diet, there is no established evidence for distinctive nutritional needs on patients with PCOS.