What Are Medical Foods?
Medical foods are another important tool that doctors can use to manage the nutritional needs of people who have a variety of chronic medical conditions.
As defined by the Orphan Drug Act (1988 Amendment), a medical food is1:
- A food which is specially formulated to be consumed or administered enterally (orally) under the supervision of a physician
- Intended for specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation
|The Difference with Medical Foods1|
|Medical Foods||Dietary Supplements||Prescription Drugs|
|Must be taken orally|
|Require medical supervision|
|Meet disease-specific nutritional requirements|
|Intended only for healthy people|
|Clinical study proof that they work|
Medical foods must meet strict standards1
These standards include the power to produce an effect (called efficacy) as well as safety.
The ingredients in medical foods are Generally Recognized as Safe (GRAS) by the Food and Drug Administration (FDA), which is the highest standard of safety.
Unlike dietary supplements (which may include vitamins and nutraceuticals), medical foods must be supported by1:
- Extensive safety data
- Published, peer-reviewed human study data
||Medical food requirements (called criteria) by the FDA2,*|
|Intended for specific dietary management of a disease or condition|
|For those who have trouble digesting or metabolizing food or nutrients, or cannot manage their conditions with dietary changes alone|
|Specially formulated and processed (not a natural food)|
|Taken orally (or via feeding tube)|
|*Chart adapted from IBSgroup.org at http://www.ibsgroup.org/print/medical-food.|
Consider the medical food product EnteraGam®
EnteraGam® is a medical food product for the dietary management of chronic diarrhea and loose stools due to specific intestinal disorders, like irritable bowel syndrome with diarrhea (IBS-D) and inflammatory bowel disease (IBD).
Print this free Doctor Discussion Guide to start the conversation with your doctor.