Medical food

Medical food is food that is specially formulated and intended for the dietary management of a disease that has distinctive nutritional needs that cannot be met by normal diet alone.

[1] 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 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.

"[6] Medical foods are not required to undergo premarket review or approval by FDA.

In 2016 the FDA published an update: Guidance for Industry: Frequently Asked Questions About Medical Foods; Second Edition.