The Orphan Drug Amendments of 1988 defines “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 active ingredients must be present in/derived from a food
Efficacy/dosing/safety must be proven in peer-reviewed scientific literature
It is intended to be used under medical supervision; and
Addresses the distinct metabolic requirements of patients with a specific diagnosed disease(s) or condition(s)
All ingredients must be Generally Recognized as Safe (GRAS) or be approved food additives. CNAC is a medical food because it provides the distinct nutritional requirements needed to address the underlying metabolic imbalances found in Mild Cognitive Impairment.