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.