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The US FDA defines medical food 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.“ Medical food is interpreted as 'food for special medical purposes (FSMPs)' in several countries, including Europe, India, China, and Australia and New Zealand. In Japan, medical food is interpreted as 'food for sick'. In Canada, medical food is governed by food for special dietary use (FSDU) and infant food regulations.

Globally, the regulatory landscape for medical food is not clearly defined, even in developed economies. As medical food is not intended to prevent or treat diseases, it is not subject to the same regulatory requirements as pharmaceutical drugs.