About NMFC

Mission
Due to the unique niche occupied by medical foods and the (often) rare and chronic conditions/diseases managed with these products, the Nutrition and Medical Foods Coalition (NMFC) is committed to educating policymakers and the general public about medical foods and the communities they serve while advancing an annual public policy agenda focused on increasing medical research on the effect of nutritional agents on disease, improving regulation and oversight, and promoting appropriate coverage and reimbursement.

The Coalition
NMFC is comprised of medical foods companies, patient organizations, and physician societies that work collaboratively to address policy and regulatory challenges which disrupt the patient-centered development and utilization of medical foods as a medical and physician-supervised option for disease management.  

Medical Foods
As defined by the Orphan Drug Act of 1988, a medical food 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 dietary management of a chronic disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.”

  • Medical foods are specially formulated food substances intended to meet distinctive nutritional requirements in the clinical dietary management of a specific disease or condition. These products must be used under medical supervision (i.e. physician, nurse practitioner, physician assistant) [21CFR101.9(j)(8)].
  • Medical foods are intended for the specific physiological or metabolic dietary need to restore and/or maintain homeostatic processes (the state of equilibrium in the body with respect to various functions and to the chemical compositions of the fluids and tissues) for a patient receiving active and ongoing medical supervision in a health care facility or as an outpatient.
  • They are developed based on recognized scientific principles, generally undergo numerous scientific and clinical studies, which have been established by medical evaluation.  All components of a medical food must either have GRAS status (Generally Recognized as Safe) as designated by the FDA or independent review, or be an approved food additive.


Under medical supervision, medical foods are used:

  • To provide for distinctive nutritional requirements in rare inborn errors of metabolism such as phenylketonuria (PKU), maple syrup urine disease, urea cycle disorder, tyrosinemia type I, argininemia, ornithine transcarbamylase deficiency and others.
  • To manage a variety of chronic conditions and/or diseases including gastrointestinal disorders (Crohn’s disease, ulcerative colitis, functional bowel disorders); pain syndromes; osteoarthritis; osteopenia and osteoporosis; peripheral neuropathy; hypertension; chronic venous insufficiency; obesity; sleep and cognitive disorders; depression; hypertriglycerenemia; drug-induced nutrient depletion; nutritional support in cancer patients; and many others.
  • Tube feeding where patients cannot consume a normal diet due to dysphagia or gastroparesis as well as other disorders where eating is not possible.


Medical foods differ from both dietary supplements and drugs:

  • Medical foods must have recognized scientific principles, which may include, clinical trials to substantiate their intended uses. The FDA then reviews claims by medical foods after they are on the market to determine if they have met the requirements for the category, namely a distinctive nutritional requirement for a condition or disease and whether they manage a specific disease or condition.
  • Medical foods must have medical and physician supervision whereas dietary supplements are marketed over-the-counter.
  • Medical foods must be generally recognized as safe (GRAS), meaning food-like safety, whereas FDA-approved drugs must prove safety and efficacy in very narrow indications.