According to the FDA, a medical food is defined 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 foods contain specific formulations designed to improve risk factors correlated with certain disease states that have a nutritional association.
Chronic conditions that can be treated include: osteoporosis; inborn errors of metabolism; mitochondrial disease; gastrointestinal disorders; certain neurological disorders; and psychological disorders, such as Alzheimer’s disease and depression.
Medical foods are not considered to be drugs or dietary supplements and are not regulated as either one by the FDA. They fall therapeutically between the two categories and don’t require prescriptions.
All efficacy claims for medical foods are based on recognized scientific principles and sound laboratory and clinical data.
Medical foods must be comprised of components designated as GRAS (Generally Regarded as Safe).