In today’s video, we discuss how FDA regulates dietary supplement claims.

Many of our clients have asked us whether their product can be sold as a dietary supplement, or, could be classified by FDA as a drug.  If it’s drug, then the company has to file a New Drug Application, which is very costly and can take years.  This means the company has to be clear in its marketing, and have its marketing reviewed by an FDA attorney, to help ensure that FDA does not determine that the product is really a “drug.”

I’m Michael H. Cohen, founding attorney of the Cohen Healthcare Law Group. We’ve advised over a thousand healthcare industry clients on healthcare and FDA legal issues, including many companies with medical devices, dietary supplements, cosmetics, and OTC drugs. Today, I’m going to explain FDA regulatory classification.

What does that mean? When you bring a health and wellness product to market, FDA will classify your product as a prescription drug, over-the-counter (OTC) drug, food, food additive, dietary supplement, cosmetic, medical device, biologic, or radiation-emitting device.

For example: you might think you’re marketing a consumer product for general wellness, for example, but FDA might consider it a device.  One company came to us with millions of dollars in revenues for a product they marketed as a dietary supplement, but they never considered that the fact that they sold a “patch” that goes on the skin, meant the product was probably a drug.  Another had a lotion that promised to remove warts; again, FDA saw that as a drug.

By the end of this video, you’ll have a good sense as to whether you’re marketing your product illegally, or in ways that get you in FDA hot water.

When companies with health care products ask for help with “labeling,” they really need advice on several different things.  First there is the label itself, which goes on the box or bottle or both.  The FDA has highly technical rules governing what goes on the label.  For dietary supplements, many of these rules are laid out in 21 CFR 101.36.  CFR stands for the Code of Federal Regulations.  21 is the Volume Number.  And 101.36 is the number of the regulation.  That in itself tells you that there are shelves and shelves of these legal rules—or if you think digitally, lots and lots and lots of URLs.

At any rate, reviewing the label for compliance with these kinds of regulations, is what we call “technical review of the label for compliance with labeling guidelines.”

The second piece is legal review of the claims.  For example, you might say, “Supports the immune system.”  That’s what we call a “structure/function claim,” because it describes how the product affects the structure of function of the human body.  What’s interesting is that you can make a structure/function claim for a dietary supplement—in fact, much of the art of FDA legal advice here is determining whether you are making a viable structure/function claim, or, a “disease claim,” which is prohibited for dietary supplements.  If you make a disease claim, also known as a therapeutic claim, for your dietary supplement product, then FDA will classify your product as a “drug.”

The third piece is substantiation.  “Substantiation” means that you must have proof for what you say in your claim, by “competent and reliable evidence.” As we’ve said on other videos, this is a high standard of proof.

So again, you have:

(1) technical review of the label itself for compliance,

(2) FDA legal review of the claims you make for your product, and

(3) some basic legal review at the outset to assess whether you have any red-flag substantiation issues.

We can get deeper into the weeds on each of these topics in subsequent videos.  For now, we want you to get oriented to the fact that when you ask an FDA lawyer for help with labeling, we’re really talking about at least three things: technical review of the label, claims review, and substantiation guidance.

Thanks for watching. Here’s to the success of your healthcare venture, we look forward to speaking with you soon.