In today’s video, we return to one of my favorite subjects, common labeling mistakes that dietary supplement manufacturers and distributors make when creating marketing claims for their products.

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

This is one in a series of videos, and so we will pick up the thread with Criterion 4 used by FDA to determine whether a dietary supplement manufacturer or distributor has made a disease claim.

FDA says: “Criterion 4: It is an implied disease claim because of the product name, formulation, use of pictures, or other factors.”

Okay, that’s criterion 4, and there are a couple of principles here that this breaks down into.

First, the product name itself can make claims.  For example, the product name contains the name of a recognizable disease … such as, coronavirus, diabetes.  Or, the product name includes words such as “cure,” “treat,” “prevent,” or even “correct,” as all of that suggests disease care, and thus is not part of an allowable structure/function claim.

Second, the company can make claims about the product formulation, and those claims can create disease claim.  For example, if the product contains an ingredient that FDA regulates primarily as a drug, that itself can cause FDA to classify the product as a drug.

Third: are claims used in citations the company makes of publication titles?  So for example, if the dietary supplement manufacturer or distributor—and remember, that distributor can be a medical doctor, or chiropractor, or another practitioner, a nurse—if that person or company cites a publication and that publication cites a disease, like cancer, or diabetes, or arthritis, virus, FDA might say that you’ve got a drug claim.  Of course, there are nuances, because FDA looks to the labeling as a whole, and FDA also has a trump card in that it can use any statements as evidence of “intended use.” So FDA always has an enforcement discretion.

The fourth part of this criterion 4 is obvious: the product marketing claims use the term “disease” or “diseased.”

There’s a carve out here as well; FDA says, “you can make general statements about health promotion and disease prevention as long as the statement doesn’t imply that your product can diagnose, cure, mitigate, treat, or prevent a disease.”

The fifth subcategory: the use of pictures of symbols that imply a disease.  FDA again draws a boundary between permissible and impermissible uses, here of pictures and symbols: “For example, pictures of healthy organs would constitute an appropriate structure/function claim while a picture of an abnormal tissue or organ would be an implied disease claim. As with other types of implied claims, it is the overall context of the total claim that is important.”

FDA notes that there are some “symbols, like the heart symbol,” that “are so widely recognized as symbols for disease treatment and prevention that their use is ordinarily an implied disease claim.”  A similar example is an EKG tracing.

And FDA says that the symbol Rx can be misleading, so watch out for that one in supplements.

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