Product Monographs


Per the FDA: The term medical food, as defined in section 5(b) of the Orphan Drug Act (21 U.S.C. 360ee (b) (3)) is "a food which is formulated to be consumed or administered internally 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." The agency advises that it considers the statutory definition of medical foods to narrowly constrain the types of products that fit within this category of food - see Food Labeling; Reference Daily Intakes and Daily Reference Values; Mandatory Status of Nutrition Labeling and Nutrition Content Revision proposed rule (56 FR 60366 at 60377, November 27, 1991).

Medical foods are distinguished from the broader category of foods for special dietary use and from foods that make health claims by the requirement that Medical Foods be intended to meet distinctive nutritional requirements of a disease or condition, used under medical supervision and intended for the specific dietary management of a disease or condition.

There are numerous Medical Foods from a multitude of manufacturers that target a wide array of disease states, including, pancreatic insufficiency caused by cystic fibrosis, end-stage renal disease, moderate cognitive impairment and osteoarthritis.