Medical Foods

Overview

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."

 

Guidance, Compliance, and Regulatory References

• Guidance for Industry: Frequently Asked Questions about Medical Foods May 2007
• Medical Foods Compliance Program - Import and Domestic (FY 06/07/08)