ABOUT MEDICAL FOODS1
A medical food is intended for the specific clinical dietary management of a particular condition or disease—in the case of Axona, Alzheimer's disease. Axona was developed after scientific studies established the need for distinctive metabolic and nutritional requirements in Alzheimer's patients. Axona offers a novel approach to managing Alzheimer's disease by providing an alternative energy source for brain cells that safely improves cognitive function and memory.
What is a medical food?
A medical food is 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 that pertain to labeling, product claims, and manufacturing
- 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
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Reference: 1. Frequently asked questions about medical foods. US FDA website. http://www.cfsan.fda.gov/~dms/medfguid.html. Updated May 2007. Accessed October 28, 2008.
