Federal Medical Foods 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.