In today’s video, we’ll talk about some more not so obvious ways that FDA can classify your dietary supplement as a drug.

Hi, I’m Michael H. Cohen, founding attorney of the Cohen Healthcare Law Group. We help healthcare industry clients just like you to navigate the very complex healthcare and FDA legal and regulatory terrain so you can launch, or continue to scale, your health and wellness product or service.

We talked before about how FDA describes ten ways in which claims being made for dietary supplement products can be implied drug claims.

Here is the fourth way, criterion 4: you have an implied disease claim because of the product name, formulation, use of pictures, or other factors.  One way this can happen is really obvious: you include the name of the disease in the name of the product.  A couple of years ago, a client came to us with a brilliant idea for product that was something like, “cancer-ease.”  This very obviously references the disease in the product name, and would create an implied drug claim, not a structure/function claim.

FDA gives as examples these product names: “CarpalHealth,” and “CircuCure.”  The latter implies cure of circulatory disorders, according to FDA—so you can’t be “too cute,” and think you’re getting away with it.

FDA also flags claims about product formulation in this criterion.  If your product uses an ingredient that has been regulated by FDA primarily as a drug, either in a prescription or over-the-counter, OTC—that is well known to consumers for its use, or claimed use, in preventing or treating a disease, then you have an implied disease claim and implied drug claim.

So for example, Aspirin:

Some time ago a client came to us with a fantastic herbal formula to help people with headaches.  That’s what they use – that was the glitch, they key ingredient was Aspirin, and that made it a drug.

Now this criterion 4 is actually chock-full of different ways that people can make implied drug claims for what might otherwise be dietary supplement products.  Let’s say for example that you do stay away from using the term “diabetes” or “COVID”; but, you reference a scientific article that mentions the disease.

You’re fine right?  After all, science is science – and you don’t write those words, the scientist did, you just referenced it.

Well, that’s wrong.  FDA says: “If the citation implies a treatment or prevention of a disease, it makes a disease claim. So, in the context of the labeling as a whole, if its presence implies treatment or prevention of disease (for example, by placement on the immediate product label or packaging, inappropriate prominence, or lack of relationship to the product’s express claims), then that citation is a disease claim.”

And FDA qualifies by saying something that’s actually very nuanced: “If the citation is used in labeling, it’s the context that determines if it is a disease claim. A citation used in the bibliography section of labeling, it’s okay if it’s included in a balanced discussion of the scientific literature, is not excessively prominent relative to other citations, and provides legitimate support for a structure/function claim, then the product would not be a disease claim.”

There’s a lot of caveats packed into that.

You can see that the issue whether or not you have a drug claim depends on the context. For that reason, it’s important to have an attorney review all of your claims, including your website and social media.

Thanks for watching. If you still have questions, click on the link below, cohenhealthcarelaw.com/contact, to send us a message or book an appointment. Here’s to the success of your healthcare venture, we look forward to speaking with you soon.