Industry Update on CBD Containing Dietary Supplements

As most of us know the battle for FDA to allow CBD containing dietary supplements continues to rage.  Proponents of FDA action to allow CBD containing dietary supplements have been discouraged by FDA inaction in finding a path forward on that front.  Despite such slow movement in that direction, there are certainly opportunities for the FDA to allow such use within the current framework of DSHEA.  One example might be the filing of a NDI CBD master formula with FDA that would cover the entire category for all manufacturers.  If that route was to be considered it would make sense to have it cover all non-THC cannabinoids rather than focus just on CBD.

There are other proponents that are advocating for a legislative route forward which could certainly be a faster option.  The Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act (HR 8179) has been gaining steam and could result in legislation during this congressional session.

To be sure there are risks associated with either route.  The NDI route could be time consuming and additional safety data must be identified or developed to provide FDA the necessary comfort level to grant the NDI.  The congressional route could erode consumer confidence in that it could look like an end around approach to allow an ingredient that FDA could not confirm safety for but still be introduced into the marketplace.  It could also fuel efforts to allow other ingredients to gain legal access to the market based on consumer popularity rather than scientific rigor designed to protect the public safety.

Either way, something needs to be done as FDA’s authority to regulate all supplements is being undermined with flagrant disregard for adhering to existing laws designed to protect the public.  We all should pay attention to this issue as it could have unintended consequences for the entire industry.

Rick brings over 30 years of professional experience to the SafetyCall team. His contributions are broad in the areas of clinical toxicology, pharmacology, poison control, product post-market surveillance, and drug and dietary supplement safety. He has helped to shape national policy relating to product safety in many areas and regulatory jurisdictions including, EPA, FDA, and CPSC regulated products. Rick also enjoys his academic affiliation with both the University of Minnesota College of Pharmacy and the University of Mississippi’s National Center for Natural Product Research, which is an FDA Center of Excellence. He enjoys national speaking engagements where he shares his vast knowledge of product stewardship    including best practices related to adverse event post-marketing surveillance and regulatory reporting of incident data.