U.S. flag An official website of the United States government
  1. Home
  2. Food
  3. Guidance & Regulation (Food and Dietary Supplements)
  4. Guidance Documents & Regulatory Information by Topic (Food and Dietary Supplements)
  5. Medical Foods Guidance Documents & Regulatory Information
  1. Guidance & Regulation (Food and Dietary Supplements)

Medical Foods Guidance Documents & Regulatory Information

Medical Foods Guidance Documents & Regulatory Information

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."