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Medical Food Defined

A medical food is a product intended for the clinical dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.

Some criteria for a medical food:

(according to the U.S. Congress and the FDA)
  • A specially formulated food for oral or enteral ingestion

  • For the clinical dietary management of a specific medical disorder, disease, or abnormal condition, for which there are distinctive nutritional requirements

  • Intended to be used under physician supervision

  • Ingredients must have GRAS (Generally Reconized As Safe) status

  • Must comply with FDA regulations and guidelines that pertain to labeling, product claims, and manufacturing

A medical food is not:

  • A change in diet-nutrients found in medical foods cannot be obtained by a simple dietary change

  • A vitamin-rich "health food" medical foods are specially formulated for a diseased patient population requiring physician supervision, and are not intended for a healthy consumer population

  • A dietary supplement (sometimes called a nutraceutical) the manufacturers of medical foods are able to make medical claims regarding the nutritional management of disease, while over-the-counter nutritional or dietary supplement manufacturers are forbidden to make disease claims and drug claims

  • Sold over the counter or via direct sales
 
Reference: 1. Frequently asked questions about medical foods. US FDA website. May 2007. Accessed January 10, 2012.
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