The US Food and Drug Administration (FDA) defines it as "a food that is formulated to be consumed or administered enterally under the supervision of a physician and that is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognised scientific data, are required."
The FDA's U.S. Medical Foods compliance programme gives FDA inspectors instructions on how to gather information about the manufacturing/control processes and quality assurance programmes used by domestic medical food manufacturers through establishment inspections, collect domestic and import surveillance samples of medical foods for nutrient and microbiological analyses, and recommend action when significant FDCA and/or related regulations violations are detected.
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