As defined by the Orphan Drug Act (1988 Amendment), a medical food is:1
A food that 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 Foods 1|
|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 by:1
Extensive safety data
Published, peer-reviewed human study data
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.
EnteraGam® is Unlike Anything Else for:
- Morgan SL, Baggott Medical foods: products for the management of chronic diseases. Nutr Rev. 2006;64(11):495-501.
- What you should know about medical foods. IBS Group Website. http://www.ibsgroup.org/print/medical-food. Accessed February 5, 2017.
A positive change
By providing dietary management of chronic diarrhea and loose stools, EnteraGam® restores gut homeostasis in ways that common approaches may not.1 EnteraGam® uniquely binds microbial components to help1-8:
EnteraGam® uniquely binds microbial components to help1-8:
- Rebalance bacterial flora
- Manage gut barrier function
- Increase uptake and utilization of nutrients
EnteraGam® patient support &
EnteraGam® is a medical food product intended for the dietary management of chronic diarrhea and loose stools. EnteraGam® must be administered under medical supervision.
Important Safety Information:
EnteraGam® contains beef protein: therefore, patients who have an allergy to beef or any other component of EnteraGam® should not take this product. EnteraGam® has not been studied in pregnant women, in women during labor and delivery, or in nursing mothers. The choice to administer EnteraGam® during pregnancy, labor and delivery, or to nursing mothers is at the clinical discretion of the prescribing physician.
EnteraGam® does not contain any milk-derived ingredients such as lactose, casein, or whey. EnteraGam® is gluten-free, dye-free, and soy-free.
Please see Full Product Information.
To report suspected adverse reactions, contact Entera Health, Inc. at 1-855-4ENTERA (1-855-436-8372), or the FDA at 1-800-FDA-1088 (1-800-332-1088) or www.fda.gov/medwatch.