"The term medical food, as defined in section 5(b) of the Orphan Drug Act (21 U.S.C. 360ee (b) (3)) 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."
Manufacturers of medical foods must comply with all applicable FDA requirements for foods, including the following regulations:• Current good manufacturing practice (21 CFR part 110);
• Registration of food facilities (21 CFR part 1 subpart H);
• Thermally processed low-acid foods packaged in hermetically sealed containers (21 CFR part 113);
• Acidified foods (21 CFR part 114); and
• Emergency permit control (21 CFR part 108).
Medical foods are not drugs and, therefore, are not subject to any regulatory requirements that specifically apply to drugs. Medical foods are also not health supplements which can not make medical claims.