Are Medical Foods FDA Approved?

I was recently queried on a product called Deplin, which claims to have anti-depressant effects when added to a conventional anti-depressant. Not surprisingly, as a gastroenterologist, I have never prescribed this, although a psychiatrist I contacted has never prescribed it either.

Although a prescription is required, Deplin is not classified as a drug by the Food and Drug Administration (FDA). It is labeled as a medical food, an important distinction that the public should be aware of.

Years ago, a medical food product, EnteraGam, was introduced as a ‘treatment for diarrhea. This is when I first became acquainted with the medical food designation.

Let me offer readers some 'medical food' for thought.

The FDA does not assess medical foods as they do for conventional drugs and medical devices. The prescription drugs that you are taking have passed through years of intense testing under the scrutiny of the FDA, whose approvals means the medicines are both safe and effective. It is common for drug candidates to fail to gain approval for any of a number of reasons. Often, the FDA may ask drug companies to conduct additional studies to bolster the case for approval.

Deplin - No Approval Needed!

Medical foods are not considered drugs and, therefore, undergo no such testing as detailed above. These agents are foods intended to confer a health benefit for a medical condition under the supervision of a physician. They do not undergo any premarket FDA approval process for medical efficacy.

So, while I can’t categorically deny that medical foods offer benefit, they come to market without FDA approval or any scientifically robust demonstration of efficacy. Deplin, with purported antidepressant properties, is basically a form of the common vitamin folate, which is available over the counter.

For me, the claims of medical foods are a little hard to swallow. Heavy on marketing and light on evidence.

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