Overview

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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." 

About the Office of Nutritional Products, Labeling, and Dietary Supplements

• Office of Nutritional Products, Labeling, and Dietary Supplements November 2004; Updated January 2006

FDA-DSFL Electronic Newsletter

The Dietary Supplements/Food Labeling Electonic Newsletter (FDA-DSFL) gives interested parties access to key information and updates on dietary supplements, food labeling and nutrition, including medical foods.

• Subscription information and past issues of the Dietary Supplements and Food Labeling Electronic Newsletter

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)
• Criteria Needed With Request for Certificate of Free Sale for Dietary Supplement(s), Infant Formula(s), & Medical Food(s) December 7, 2006