For example, insomnia is associated with serotonin deficiency. Medical foods have now been developed that are designed to promote increased synthesis of serotonin. Autonomic Imbalance Medical foods are intended for use only under medical supervision.
Medical foods add value to a patient's treatment program.
Medical foods are intended for patients receiving active and ongoing medical supervision. Medical Foods must be intended to meet distinctive nutritional requirements of a disease or condition. Medical foods must be formulated to be consumed or administered eternally under the supervision of a physician. Thus medical foods in the agency's view require ongoing physician oversight because they are intended to meet the medical need for a particular nutrient or combination of nutrients to meet distinctive nutritional requirements. Despite the concerns stated by the FDA in 1996, the agency has not followed the ANPR with any other rulemaking initiatives and does not appear to have plans to further address its concerns by regulation in the near future.