Medical foods must meet the distinctive nutritional requirements or metabolic deficiencies of a particular disease state, are formulated to be consumed or administered under the supervision of a physician, and contain ingredients that are generally recognized as safe (GRAS). Medical foods are meant to be an integral part of an overall disease management plan. Medical foods are not approved by the FDA in the same manner as drugs, but are required to support all claims with good laboratory and clinical science. Medical foods are required to be manufactured under Current Good Manufacturing Practices conditions. Drugs and medical foods, unlike dietary supplements, can be labeled for medical conditions, such as inflammatory bowel disease
Last date updated on September, 2024