Medical food
Medical food is a type of 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.
Definition[edit | edit source]
According to the FDA, a product is a medical food only if:
- It is a food for oral ingestion or tube feeding (nasogastric tube)
- It is labeled for the dietary management of a specific medical disorder, disease or condition for which there are distinctive nutritional requirements and
- It is intended to be used under medical supervision.
Uses[edit | edit source]
Medical foods are used to manage a variety of conditions including, but not limited to, Alzheimer's disease, PKU, epilepsy, and cancer. They can be used in both inpatient and outpatient settings.
Regulation[edit | edit source]
In the United States, medical foods are regulated by the FDA under the Orphan Drug Act. Unlike drugs, medical foods are not subject to premarket approval by the FDA. However, all ingredients must be GRAS (Generally Recognized as Safe) ingredients.
See also[edit | edit source]
References[edit | edit source]
Medical food Resources | |
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Contributors: Prab R. Tumpati, MD