Medical foods

Medical foods are a category of foods which are formulated to be consumed or administered enterally under the supervision of a physician and which are 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.

Definition

According to the United States Food and Drug Administration (FDA), a product is a medical food if it meets the following criteria:

• It 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 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.

Regulation

In the United States, medical foods are regulated by the FDA under the Orphan Drug Act and other legislation related to food and drugs. The FDA has established specific regulations for the labeling of medical foods.

See also

• Enteral nutrition
• Parenteral nutrition
• Food and Drug Administration
• Orphan Drug Act

References

Medical foods Resources
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