A medical food is an FDA-regulated category of specialized products defined by the Orphan Drug Act of 1988. It is a medical product with food-based ingredients that is specially formulated to be consumed or administered enterally, and is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, have been established by medical evaluation.

 

This category of clinical dietary management is unique because of the distinctive characteristics of the disease it targets, and the way in which the disease is nutritionally managed. Unlike a conventional food, or a dietary supplement (which is a sub-category under foods) both of which are intended for healthy individuals, a medical food is intended for a particular patient population undergoing medical care for a disease or condition under the supervision of a physician or other qualified medical practitioner.