A medical food, could also be defined as “a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is meant for the specific dietarymanagement of a disease or condition that distinctive nutritional requirements, supported recognized scientific principles, are established by medical evaluation.” 
Medical foods must suits all applicable FDA requirements for foods. This includes the regulations pertaining to current good manufacturing practices (cGMPs),Registration of Food Facilities, and, if applicable, those specific to the product formulation and processing. Examples of formula- and processing-specific regulations include those for thermally processed low-acid foods packaged in hermetically sealed containers, acidified foods, and emergency permit control.Even though the level of industry experience in the cGMP and internal control procedures necessary to supply medical foods (i.e., products that contain nutrients within a narrow range of declared label values) increased within the decade directly following the establishment of the statutory definition of medical food, the agency felt it necessary to make compliance programs specifically designed for medical foods.

As noted in the 1996 ANPR, medical foods are complex formulated products requiring sophisticated and exacting technology comparable to that used in the manufacture of infant formulas and drugs. Moreover, the populations that consume such foods are often extremely vulnerable, like pediatric patients at periods of growth and development or the elderly. For these reasons, the FDA published its Medical Foods Compliance Program for domestic and imported products as a neighborhood of the agency’s Compliance Program Guidance Manual in 1996. This program, which the FDA has explicitly stated may be a “high priority” thanks to the “susceptible population that the products are intended,”remains in effect today.