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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 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
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
*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
- 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.
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 supervising 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 .
To report suspected adverse reactions, contact Entera Health, LLC 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.
EnteraGam® is manufactured and
distributed by Proliant Health & Biologicals, LLC.
©2023 Proliant Health & Biologicals, LLC.
Ankeny, IA 50021
ENT100P0121 01/22
The product information provided in this site is intended for residents of the United States.