medical food

A medical food1 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.

In general, to be considered a medical food, a product must, at a minimum, meet the following criteria (according to the Food & Drug Administration (FDA) and the U.S. Congress, as part of the Orphan Drug Act):

  • The product must be a food for oral or tube feeding
  • The product must be labeled for the dietary management of a specific medical disorder, disease, or condition for which there are distinctive nutritional requirements
  • The product must be intended to be used under medical supervision
  • Ingredients of the product must have GRAS (Generally Recognized As Safe) status or be FDA-approved as food additives
  • The product must comply with FDA regulations that pertain to labeling, product claims, and manufacturing

Adeona is developing reaZin™ as a prescription medical food for the dietary management of zinc deficiency associated with Alzheimer's disease.

Reference:

Guidance for Industry: Frequently Asked Questions About Medical Foods. U.S. Food & Drug Administration website. MedicalFoods May 1997; Revised May 2007; Accessed April 2011.