What is a medical food?

The FDA has adopted the definition of a medical food, defined in section 5(b)(3) of the Orphan Drug Act (21 U.S.C. 360ee(b)(3)), as “a food which 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.”