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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  Check  Check
Require medical supervision  Check  Check
Meet disease-specific nutritional requirements  Check
Intended only for healthy people  Check
Clinical study proof that they work  Check  Check

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

 

icon1
Medical food requirements (called criteria) by the FDA2,*
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 icon2 Intended for specific dietary management of a disease or condition
 icon3 Medical supervision
 icon4 For those who have trouble digesting or metabolizing food or nutrients, or cannot manage their conditions with dietary changes alone
 icon5 Specially formulated and processed (not a natural food)
 icon6 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:
References
  1. Morgan SL, Baggott Medical foods: products for the management of chronic diseases. Nutr Rev. 2006;64(11):495-501.
  2. What you should know about medical foods. IBS Group Website. http://www.ibsgroup.org/print/medical-food. Accessed February 5, 2017.

Intended Use

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.