Medical foods are an important and often complementary category of therapeutic agents known to address disease through a nutritional pathway. This class of FDA-regulated therapies has been in use since the 1950s.
As you can see below, the definition and associated regulatory framework for a medical food is long and complicated. There are, however, two central regulatory standards that must be met, they are:
- The disease or condition for which the medical food is marketed must be one that is associated with “unique nutrient needs”
- The nutritional needs of the patient cannot otherwise be managed by modification of the normal diet alone.
Hedonia meets these standards. In addition to these standards, there are three important regulatory components you should be aware of:
- There is no FDA approval required for a medical food.
- There is no prescription needed to purchase a medical food.
- Medical foods are intended to be used under medical supervision.
- 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 dietary.
- The term medical food means 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”
- FDA considers the statutory definition of medical foods to narrowly constrain the types of products that fit within this category of food.
- Medical foods are distinguished from the broader category of foods for special dietary use.
- It is a specially formulated and processed product (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, meaning 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 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.
- 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.
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