Background
The Food and Drug Administration’s (FDA) Center for Food Science and Applied Nutrition regulates medical foods as a distinct category of food under the Orphan Drug Act. Medical foods contain highly purified, food-based therapeutic ingredients specially formulated for dietary management of specific diseases and/or conditions. 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 disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.”
It should be noted that not all foods fed to patients with a disease, including diseases that require dietary management, are medical foods. FDA states that the distinguishing aspect of a medical food from foods for special dietary use is the requirement that a medical food be intended to meet the distinctive nutritional requirements of a disease or condition. FDA explains that “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,” but, instead, are a specially formulated food product for patients who require that product as part of a disease or condition’s dietary management.
Characteristics of a medical food as set forth by FDA include:
- It is specially formulated and processed, as opposed to a naturally occurring foodstuff used in its natural state, for the partial or exclusive feeding of a patient by means of oral intake or enteral feeding by tube (tube or catheter that delivers nutrients beyond the oral cavity 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 ordinary foodstuffs or certain nutrients, or who has other special medically determined nutrient requirements, the dietary management of which cannot be achieved by the modification of the normal diet alone;
- It provides nutritional support specifically modified for the management of the unique nutrient needs that result from the specific disease or condition, as determined by medical evaluation;
- It is intended to be used under medical supervision; and
- It is intended only for a patient receiving active 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.
Finally, the claims on medical foods must be supported by competent and reliable scientific evidence.
Issue
In its finalized guidance on medical foods in May 2016, FDA stated that it “narrowly constrain(s)” this category of products. FDA’s medical food definition is so narrow that it only considers the following products as medical foods:
- Nutritionally complete or incomplete formulas
- Formulas for metabolic (genetic) disorders in patients over 12 months of age (ie. Phenylalanine-free formulations for phenylketonuria patients); or
- Oral rehydration products
FDA’s guidance also eliminates the potential use of medical foods for the dietary management of conditions like pregnancy and diabetes. FDA believes that while there are nutrient requirements associated with these 2 states, they do not impose distinctive nutritional requirements.
Physicians use probiotics off-label at CFU quantities in the trillions for antibiotic associated diarrhea to prevent Clostridium difficile colitis. These are not considered medical foods, but yet they are probiotics found in dietary supplements and other foods. Furthermore, these probiotics can’t be obtained and ingested by modification of the normal diet because one needs high quantities of a single or combination of probiotics. These probiotics can only be ingested when manufactured and specially formulated to maintain their long-term viability.
NPA Position
NPA is committed to working with Congress and the Trump Administration in developing a broader and more transparent definition for medical foods with more examples. NPA believes the main goal should be for FDA to establish a clear path to market for this food commodity while utilizing the current state of nutritional science to benefit the health of all Americans. NPA believes there is considerable science to substantiate the use of many dietary ingredients for disease conditions, and the population would benefit greatly. Probiotics for antibiotic associated diarrhea is just one example where dietary ingredients can be used in a medical food to benefit patients, as long as the intended use and medical food claims can be substantiated in clinical trials.
