The growing excitement behind the therapeutic potential of CBD oils must be tempered by a more thoughtful understanding of how these products are regulated by the FDA.
The first thing that manufacturers and marketers of need to know is that CBD is under the Dietary Supplement Health & Education Act (DSHEA). This means many things, but most importantly that CBD is considered (for regulatory purposes) as a food not a drug. This means that CBD products cannot make drug claims.
A drug claim is, “My product reduces pain.” Such claims are backed up by a New Drug Application (NDA) comprised (among other things) of clinical studies that are reviewed by the FDA, resulting in a label claim. Since CBD products aren’t approved via the NDA route, they are not allowed to make these types of claims. If they do, they are in violation of the Food, Drug, & Cosmetics Act. A majority of warning letters sent by the FDA to CBD manufacturers and marketers fall into this category. It’s also relevant to note that product web sites that share patient testimonials that refer to drug-like claims (“Your product cured my pain,” etc.) are similarly violative.
Manufacturing performance is another common way that CBD manufacturers and marketers run afoul of the FDA. Simply put, if there are substances in the product that are not listed on the label, that product is mislabeled and that is an FDA violation. Similarly, if there are ingredients listed on the label that are not in product, or in an amount other than is listed, that is also a violation.
This doesn’t mean there’s nothing manufacturers and marketers can do to promote the benefits of CBD. Responsible use of Structure/Function Claims provide ample opportunity for FDA compliant communications. According to the FDA,
“Structure/function claims may describe the role of a nutrient or dietary ingredient intended to affect the normal structure or function of the human body, for example, "calcium builds strong bones." In addition, they may characterize the means by which a nutrient or dietary ingredient acts to maintain such structure or function, for example, "fiber maintains bowel regularity," or "antioxidants maintain cell integrity." These claims are not pre-approved by FDA, but manufacturers must have substantiation that the claim is truthful and not misleading and must submit a notification with the text of the claim to FDA no later than 30 days after marketing the dietary supplement.
If a dietary supplement label includes such a claim, it must state in a "disclaimer" that FDA has not evaluated the claim. The disclaimer must also state that the dietary supplement product is not intended to "diagnose, treat, cure or prevent any disease," because only a drug can legally make such a claim. Structure/Function claims may not explicitly or implicitly link the claimed effect of the nutrient or dietary ingredient to a disease or state of health leading to a disease.
All of this is just for starters. Promoting CBD products is a new frontier and, as with any pioneering endeavor, it requires knowledge of the risks as well as the benefits. And a good place to start is with a solid understanding of FDA regulations.
Peter J. Pitts, a former FDA Associate Commissioner, is the Chief Regulatory Officer at Adherent Health, LLC.