Medical Food

Medical food refers to specially formulated and processed products intended for the dietary management of a disease or condition that has distinctive nutritional needs that cannot be met by a normal diet alone. These foods are used under medical supervision and are regulated differently from conventional foods and drugs.

1. Intended for Specific Diseases or Conditions – Designed for patients with specific metabolic needs due to a disease (e.g., Alzheimer's disease, chronic kidney disease, or metabolic disorders like phenylketonuria).
2. Used Under Medical Supervision – Requires medical oversight to ensure appropriate use.
3. Distinct Nutritional Requirements – Addresses dietary deficiencies or special nutritional needs that cannot be met by normal food intake.
4. Regulated but Not a Drug – In the U.S., medical foods are regulated under the Orphan Drug Act of 1988 and must comply with FDA requirements, but they do not require premarket approval like drugs.

• PKU formulas (Phenylketonuria): Low-protein foods for individuals with PKU who cannot metabolize phenylalanine.
• Ketogenic diet formulas: Used in the management of epilepsy.
• Lofenalac®: A formula for infants with phenylketonuria.
• Axona®: A medical food formulated for Alzheimer's disease.
• Nepro® with Carb Steady: Designed for patients with kidney disease.
• VSL#3®: A high-potency probiotic used in inflammatory bowel disease.

Medical foods are not subject to the same FDA premarket approval process as drugs but must meet:

• Good Manufacturing Practices (GMPs)
• Labeling Requirements
• Nutritional Guidelines for Disease-Specific Conditions

• FDA Medical Foods Overview
• PubMed - Research on Medical Foods