Medical foods are formulated to meet specific nutritional needs that occur with chronic diseases and cannot be met by diet alone.
As an example, in Alzheimer’s disease the brain is not able to use glucose (i.e. sugar) as efficiently to produce energy. This deficiency cannot be met by eating regular foods or through dietary changes.
Medical foods could be thought of as something in between a prescription drug and a dietary supplement.
The FDA has provided a new guidance in May 2016 that defined medical foods:
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.”2 In the guidance, FDA indicates that it considers this definition to “narrowly constrain” this category of products, and distinguishes medical foods from what FDA considers to be a broader category of specially formulated food products, foods for special dietary use (FSDU).
Specifically, FDA states that the primary distinguishing aspect of a medical food is the requirement that a medical food be intended to meet the distinctive nutritional requirements of a disease or condition. FDA explains that “[m]edical 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.
Here are a few examples of medical foods?
– Axona® (caprylic triglyceride) is indicated for the dietary management of Alzheimer’s disease. Caprylic triglyceride is a medium-chain triglyceride that is found in coconut oil.
– Limbrel® (flavocoxid™) is indicated for osteoarthritis. Flavocoxid, which sounds remarkably similar to cyclooxygenase (COX)-2 inhibitors such as celecoxib, is a proprietary blend of flavonoids – such as baicalin and catechin.
– Foltx® (folic acid 2.5 mg, pyridoxine 25 mg, cyanocobalamin 2 mg) is marketed for hyperhomocysteinemia, which has been linked to cardiovascular disease.
Take away message:
Medical foods are for the ‘dietary management’ of a unique nutrient needs from a specific disease or condition. Medical supervision is required with medical foods. Prescription insurance may cover medical foods. Also, from the perspective of government regulation ‘medical foods’ are different than dietary supplements or prescription drugs.
His research on plant medicine has led to more than 45 publications and abstracts.This research has been presented at international meetings in the USA, France, Turkey, Peru, Israel, Austria, and Italy.
Categories: FDA, Medical Foods, Plant Medicine