In today’s video, we talk about whether there is a way to promote your dietary supplement to target a certain disease.

Hi, I’m Michael H. Cohen, founding attorney of Cohen Healthcare Law Group. We help healthcare industry clients just like you, navigate the healthcare and FDA legal and regulatory terrain so you can launch or grow and scale your healthcare business.

Today, a hypothetical client asked, “how can we market our dietary supplement to help with a disease?” Let’s say kidney disease, liver disease, insomnia, depression, obesity, addiction, you name it.

The client came to us because their other attorney told them: “you can’t use the words, liver disease, cancer, pain, inflammation, osteoarthritis …”  And the list went on.

My basic answer here, don’t shoot the messenger. The lawyer is right, the federal Food, Drug and Cosmetic Act, or FDCA, prohibits dietary supplement manufacturers and distributors from making disease claims, also known as drug claims.  If you say that your dietary supplement—or cosmetic, targets a disease, you’ve made a prohibited claim.

Pretty cut and dry, right?  Pardon the pun.

But let’s say you never mention the disease, but you have a picture of a kidney, or liver, on your product label.  When about that?

FDA talks about ten different ways (and we’ve covered them in other videos) that you can make an “implied” disease claim.  One of the ten is, using a picture of an organ or medical symbol on the label, where the overall context makes an implied disease claim.  For example, FDA says that depending on the context, a picture of health organ would likely be fine, while a picture of an abnormal tissue or organ would be an implied disease claim. You get the picture, so to speak.

According to FDA: “Some symbols, like the heart symbol, are so widely recognized as symbols for disease treatment and prevention that their use is ordinarily an implied disease claim.”

Now what if you’re sure that your product has an effect on mitigating a disease.  You have the proof.  Well, if you have the proof, you might satisfy substantiation which is a different legal standard.  You have to be able to “substantiate,” or provide adequate proof of your claims.  You can satisfy substantiation over here but you’re still making a disease claim, which is prohibited.

Now, another point. Cosmetics are even trickier than dietary supplements, because with cosmetics, you can’t even make a so-called “structure/function claim.”  For example, with supplements, you can say something like, “supports immune health.”  But you can’t say that for a cosmetic because that would be claiming an effect on the structure or function of the body, which is part of the definition of a cosmetic.

The legal definition of “cosmetics” is restricted.  It’s limited to a product (except soap) intended to be applied to the human body for cleansing, beautifying, promoting attractiveness or altering the appearance.  That’s it.

We have a lot more on this healthcare and FDA law blog about dietary supplement and cosmetics claims versus disease claims.  Feel free to dive in.

Thanks for watching. As always, please contact us with questions, do a legal strategy session. We have helped hundreds, thousands of healthcare industry clients just like you build their dream.  We look forward to helping you on your journey to success!