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Medical Foods

Federal Medical Foods Definition

The term medical food is defined in the Orphan Drug Act as “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.” This definition is from section 5(b) of the Orphan Drug Act (21 U.S.C. 360ee (b) (3)), as amended in 1988.

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 enteropathy.

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.