FDA Home Page |
CFSAN Home | Search/Subject Index |
Q & A | Help
Overview
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
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.
Guidance, Compliance, and Regulatory References