Medical Foods
Federal medical food definition
The term medical food, as defined in section 5(b) of the Orphan Drug Act (21 U.S.C. 360ee (b) (3)), as amended in 1988, is “a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.”1
The ingredients in EnteraGam® are generally recognized as safe (GRAS).
EnteraGam® is not:
- A dietary supplement
- A probiotic
- A change in diet
The specially formulated immunoglobulins in EnteraGam® are not found in the diet at sufficient quantities to manage patients with chronic diarrhea and loose stools due to specific intestinal disorders
EnteraGam® is a medical food product intended for the dietary management of chronic diarrhea and loose stools.
EnteraGam® must be administered under medical supervision.
References
1. FDA Website. Orphan Drug Act. http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/medicalfoods/default.htm. Updated May 12, 2016. Accessed February 4, 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.
The product information provided in this site is intended for residents of the United States.
EnteraGam® is manufactured and
distributed by Proliant Health & Biologicals, LLC
©2021 Proliant Health & Biologicals, LLC
Ankeny, IA 50021
ENT100H0121 01/21
