What is a Prescription Medical Food?
FDA & MEDICAL FOOD
A medical food, as defined in section 5(b)(3) of the Orphan Drug Act (21 U.S.C. 360ee(b)(3)), is “a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific diet.
This guidance has been prepared by the Office of Nutrition and Food Labeling in the Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration. Contains non-binding recommendations for management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.”
FDA considers the statutory definition of medical foods to narrowly constrain the types of products that fit within this category of food (21 CFR 101.9(j)(8)).
Medical foods are distinguished from the broader category of foods for special dietary use by the requirement that medical foods be intended to meet distinctive nutritional requirements of a disease or condition, used under medical supervision, and intended for the specific dietary management of a disease or condition. Medical foods are not those simply recommended by a physician as part of an overall diet to manage the symptoms or reduce the risk of a disease or condition.
Not all foods fed to patients with a disease, including diseases that require dietary management, are medical foods. Instead, medical foods are foods that are specially formulated and processed (as opposed to a naturally occurring foodstuff used in a natural state) for a patient who requires use of the product as a major component of a disease or condition’s specific dietary management.
EBM Medical Food Criteria
It is a specially formulated and processed product for the partial or exclusive feeding of a patient by means of oral intake or by a tube or catheter that delivers nutrients beyond the oral cavity directly into the stomach or small intestine.
It is intended for the dietary management of a patient who, because of therapeutic or chronic medical needs, has limited or impaired capacity to ingest, digest, absorb, or metabolize nutrients, or who has other special medically determined nutrient requirements.
Medical Evaluation & Supervision
It provides nutritional support specified for the management of the unique nutrient needs that result from the specific disease or condition, as determined by medical evaluation and ongoing medical supervision wherein the patient requires medical care on a recurring basis for, among other things, instructions on the use of the medical food.