What is the difference between a medical food and a dietary supplement?

It is very easy to confuse dietary supplements and medical foods.  There are a few key things to know so you can answer ‘what is the difference between a medical food and a dietary supplement?”.

Dietary supplements are intended to ‘support’ the well-being of healthy adults.

The FDA defines a dietary supplement as:

A dietary supplement is a product intended for ingestion that contains a “dietary ingredient” intended to add further nutritional value to (supplement) the diet. A “dietary ingredient” may be one, or any combination, of the following substances: a vitamin. a mineral. an herb or other botanical.

Technically a dietary supplement is not intended to diagnose, treat, cure or prevent any disease.

Medical foods have been defined by the FDA as follows:

The term medical food, as defined in section 5(b) 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 management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.”

 

Here are a few differences between dietary supplements and medical foods:

– Medical Foods and Dietary supplements have separate FDA regulatory classifications

– Medical Foods require medical supervision

– Medical Foods are for a specific disease and patient population

– Medical Foods can make medical claims

– Dietary supplements have strict labeling guidelines with a Supplement Facts box while Medical Foods have virtually no labeling regulations.

 

Here’s an example of how similar dietary supplements and medical foods can look:

  • Medical Food example – contains folic acid, pyroxidine and cyanocobalamin
  • Dietary Supplement example – contains folic acid, pyroxidine and cyanocobalamin

 

The key difference is that a medical food can make a health claim that this product can be used for ‘hyperhomocysteinia’ (high homocysteine levels) while the dietary supplement would say something like ‘supports healthy homocysteine levels’.

 

Take away message: Medical foods and dietary supplements can look very similar and can even be hard to tell apart.  One major difference between medical foods and dietary supplements is that medical foods are given under medical supervision.  In reality, you can often find dietary supplements that look just like a medical food.

Jeremy Johnson, PharmD, PhD


Categories: Dietary Supplements, Medical Foods