====== 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.

===== Key Features of Medical Foods =====
  - **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).
  - **Used Under Medical Supervision** – Requires medical oversight to ensure appropriate use.
  - **Distinct Nutritional Requirements** – Addresses dietary deficiencies or special nutritional needs that cannot be met by normal food intake.
  - **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.

===== Examples of Medical Foods =====
  * **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.

===== How Medical Foods Differ from Dietary Supplements and Functional Foods =====

^ Category            ^ Definition |
| **Medical Food**    | Specifically formulated for disease management and requires medical supervision. |
| **Dietary Supplement** | Contains nutrients or bioactive compounds but is not meant for disease-specific dietary management. |
| **Functional Food**  | Regular food with added benefits (e.g., fortified cereals, probiotic yogurt). |

===== Regulations =====
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**

==== Related Links ====
  * [[https://www.fda.gov/food/dietary-supplements/medical-foods|FDA Medical Foods Overview]]
  * [[https://www.ncbi.nlm.nih.gov/|PubMed - Research on Medical Foods]]