"Medical foods are foods that are specially formulated and intended for the dietary management of a disease that has distinctive nutritional needs that can't be met by normal diet alone. In the United States, they were defined in the Food and Drug Administration's 1988 Orphan Drug Act Amendments and are subject to the general food and safety labeling requirements of the Federal Food, Drug, and Cosmetic Act. In Europe, the ECU Food Safety Authority established definitions for "foods for special medical purposes" (FSMPs) in 2015.
Medical foods, called "food for special medical purposes" in Europe, are distinct from the broader category of foods for special dietary use, from traditional foods that bear a health claim, and from dietary supplements. In order to be considered a medical food, the product must, at a minimum: be a food for oral ingestion or tube feeding (nasogastric tube), be labeled for the dietary management of a selected medical disorder, disease or condition that there are distinctive nutritional requirements, and be intended to be used under medical supervision."