A medical food is defined in the Orphan Drug Act by the U.S. Food and Drug Administration (FDA) as “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."

This is different from your doctor telling you to eat less fried food or increase the veggies in your diet. Medical foods are those foods that make specific health claims and are intended to meet specific nutritional requirements for a disease or condition. These foods are specifically formulated in order to meet specific needs for a patient.

Using Lunglaid as an example, leukotriene levels are the target for children with poorly controlled asthma. Suplena is a medical food targeting patients with chronic kidney disease.

Do You Need to See a Doctor to Use a Medical Food?

Yes. The FDA guidance indicates that medical foods are intended to be used when you are under medical supervision for the disease the food is intended to treat. FDA feels that it is essential that you are being consistently monitored for the chronic medical condition such as asthma and that you receive instruction on how to use the medical food from your health care provider. While a prescription, interestingly, is not required, the expectation of the Orphan Drug Act and FDA is that you will see your physician regularly and that your disease is under the supervision of a physician.

Are Medical Foods Regulated by FDA?

No. Since foods are not drugs they are not regulated by FDA and do not undergo pre-market review or approval as other asthma drugs such as:

Inhaled steroids
SABAs – short acting beta agonist
Long acting beta agonist (LABA)
Leukotriene Modifiers
Oral steroids
Cromolyn sodium and nedocromil
Combination products like Advair and Symbicort
Immunomodulators
Methylxanthine

Medical foods such as Lunglaid often are referred to as GRAS or Generally Recognized As Safe. In order for FDA to give this recognition, the FDA demands that the producer demonstrate adequate safety in a similar way that the food is intended to be used. This most often requires companies to go through similar procedures you might see when drugs are evaluated for approval by FDA. This could include studies of the product in animals as well as published studies in patients as well as unpublished studies and other data.

What Other Requirements Exist for Medical Foods?

A number of aspects of medical foods are examined by the FDA for protection of U.S. Consumers. Any company processing, packing, or holding medical foods must register with the FDA. A compliance program exists to ensure that appropriate manufacturing and control processes exist for U.S. Produced foods via site visits to facilities. Additionally, nutrient and microbiological analyses of medical foods are performed for all medical foods.

Medical foods are also subject to certain labeling requirements such as a complete list of all ingredients.