Product Claim Guidelines [6 of 12]

Is your natural product claim actually a drug claim? [6 of 12]

The FDA provides criteria for determining whether your product claim is a structure / function claim (which is permitted provided that you have a substantiation dossier) or a drug claim. This is part six of a twelve series discussing those criteria.

[Potentially] Prohibited: Reference or link to publications which describe your product's actions or intended use.  

This guideline is more nuanced than others in this series. Linking to scientific articles, such as research studies on PubMed, is not universally prohibited. In fact, linking to scientific manuscripts which clearly define your product's role in supporting human health can help to clarify your product's role as a supplement and not a drug.

The distinction lies in the actual study or article behind the link. Everything in the scientific literature is not fair game for marketing content, which can often create confusion. After all, linking to the scientific literature is sharing scientific content. It seems like a harmless act.

However, linking to the scientific literature while also selling products is a way of making a claim. After all, that link is on your social media page or product sales page or packaging because you want your consumers to associate your product with the scientific findings.

If those scientific findings involve supporting healthy structure and function of the human body, this is a fantastic marketing approach. It builds consumer confidence and gives a preview of your product's claim substantiation dossier.

If, however, those findings involve prevention, diagnosis, treatment, or cure of a diseased state of the body, you're making a drug claim. This is the case whether the article in the manuscript describes drug activity related to your formulation as a whole or merely one or more of your formulation's ingredients. Likewise, any implication that your product or formulation is similar to what is in the literature strengthens the case that your link constitutes a drug claim.

As a general rule, be sure that the scientific studies with which you associate your product reflect the intended use of your product as a supplement which supports normal human health and not drug activity. If you do link to a study which reflects drug activity or identifies a specific disease or condition, make sure that the entirety of your links section and terminology surrounding the link clarifies your product's role as a supplement.

This nuance is why it is critical that any research you commission for your product involve experts in claim substantiation. The research question, outcome measurements, and wording related to studies you commission may constitute drug claims for your product, rendering those results unsuitable for prominent positioning in your marketing.