Medical Foods

Medical Foods are a specific category of therapeutic agents created under the Orphan Drug Act of 1988, which separated Medical Foods from drugs for regulatory purposes. Products in this category share the requirements that they are intended for the nutritional management of a specific disease, are used under the supervision of a physician, and contain ingredients that are generally recognized as safe (GRAS). An example of Medical Foods are formulations intended to manage patients with inborn errors in amino acid metabolism and other conditions where the nutrient requirements for a disease cannot be met from the diet alone.

The Food and Drug Administration regulates “Medical Foods” as a discrete class of therapeutic products for the dietary management of disease or medical conditions, when a nutritional or metabolic imbalance characterizing the disease or condition can be restored with nutrients, specifically formulated in an oral administration taken by patients under physician supervision. Medical Foods are foods that are specially formulated and processed (as opposed to a naturally occurring foodstuff used in a natural state) for the patient who is seriously ill or who requires the product as a major treatment modality.

Medical Foods are different from drugs in that they work on the underlying metabolic process of the disease or condition. The definition of Medical Foods is contained in Section 5(5) of the Orphan Drug Act (21 U.S.C. 360ee (b)(3) that states that a Medical Food is “a food which is formulated to be consumed or administered eternally [orally] 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.”

Medical Food products are safe because the main statutory requirement is that their ingredients have GRAS (Generally Recognized as Safe) status. Medical Foods have been distributed for decades in hospitals and physicians offices as special nutritional formulations containing vitamins, trace elements, minerals, fatty acids, flavonoids, and amino acids. Medical Foods are required to be manufactured according to FDA cGMP (current Good Manufacturing Practices). The FDA actively enforces compliance with Medical Food regulations and conducts regular inspections of Medical Food manufacturing facilities. Unlike dietary supplements that are intended for healthy populations, Medical Foods are intended to meet the specific nutritional needs of a patient population experiencing acute or chronic diseases. Patients taking Medical Food products must be under the ongoing care and supervision of a physician.

All efficacy claims for Medical Foods must be based on recognized scientific principles and sound laboratory and clinical data. Medical Foods must be comprised of components designated as GRAS. The standard for an ingredient to achieve GRAS status requires not only technical demonstration of non-toxicity and safety, but also general recognition and agreement on that safety by experts in the field. Many ingredients have been determined by the FDA to be GRAS, and are listed as such by regulation in Volume 21 Code of Federal Regulations (CRF) Sections 182, 184, and 186. Other ingredients may achieve self-affirmed GRAS status via a panel of experts who co-author a GRAS Report. Finally, a few ingredients have been specifically permitted by FDA as Medical Food ingredients, e.g., folic acid. In addition to the GRAS standard for Medical Foods, the FDA initiated a compliance program in 1988 to ensure the safety of all products being released as Medical Foods. This oversight requires that all Medical Foods be manufactured under food Current Good Manufacturing Practice (CGMP) regulations.

Link to FDA Medical Foods Guidance, published May, 2007

Medical Food products are NOT Dietary Supplements. The following is a comparison of the differences between Medical Foods and Dietary Supplements