The Orphan Drug Amendments of 1988 define “medical food” 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.
The following criteria must be met for compliance to the FDA’s definition of a medical food:
- The product must be specially formulated and processed
- Enteral administered (oral, gastric feeding tube, etc)
- Efficacy/dosing/safety must be proven in peer-reviewed scientific literature
- It is intended to be used under medical supervision
- Addresses the distinct metabolic requirements of patients with a specific diagnosed disease(s) or condition(s)
- All ingredients must be Generally Recognized as Safe (G.R.A.S.) or approved food additives
Deplin® is a medical food, dispensed by prescription, for the clinical dietary management of the metabolic imbalances associated with depression and schizophrenia. Use under medical supervision.