FDA considers the requirement that a medical food be formulated to be consumed or administered entirely under the supervision of a physician to mean that the intended use of a medical food is for the dietary management of a patient receiving active and ongoing medical supervision (e.g., in a healthcare facility or as an outpatient) by a physician who has determined that the medical food is necessary to the patient’s overall medical care. The patient should generally see the physician on a recurring basis for, among other things, instructions on the use of the medical food as part of the dietary management of a given disease or condition.
