A high-level internal working group that FDA convened to explore potential regulatory pathways for cannabidiol (CBD) products announced by way of a January 26, 2023 statement that existing regulatory pathways are not appropriate for CBD.  As reported on this blog, the FDA working group examined studies related to the CBD-based drug Epidiolex, published scientific literature, information submitted to a public docket, as well as studies conducted and commissioned by FDA, and concluded it is “not apparent how CBD products could meet the safety standards for dietary supplements or food additives.”  FDA’s January statement also announced that the Agency is prepared to work with Congress on legislation to create a new CBD-specific regulatory pathway that is necessary to move forward. 

On May 25, 2023, in the last of three webinars intended to address lingering questions following its January statement, FDA reiterated that it is up to Congress to create a legal status for CBD and other hemp-derived cannabinoids.  FDA’s Stakeholder Webinar: “A New Way Forward for Cannabidiol (CBD) and Other Hemp Products” outline the factors that lead FDA to conclude statutory barriers prevent the regulation of these products as a food or dietary supplement.  Specifically, FDA cited CBD’s inherent risk profile (e.g., liver injury, interactions with certain medications, and possible harm to the male reproductive system) and the limited risk management options for the food ingredient and dietary supplement pathways (i.e., the inability for FDA to weigh any potential benefits against the safety risks).  FDA’s webinars advocate for the creation of a “harm reduction” approach for regulating CBD and other hemp-derived cannabinoids that would permit the Agency to set rules addressing known issues with current products, e.g., variable CBD content, incomplete ingredient labeling, contamination, and the risk of ingestion by children.  While recognizing the growing popularity of CBD and other hemp products, FDA insists it can take the harm reduction approach only if Congress enacts legislation for a specific new regulatory framework. 

Although there has been bipartisan interest in breaking the current stalemate, the timing for any new legal framework for CBD is unclear.  For the foreseeable future, FDA will continue to monitor the market and target enforcement efforts at products that pose the greatest risks.  Examples noted in FDA’s webinar slides are unapproved new drugs that purport to contain CBD, products that have been associated with serious adverse events, and products that are packaged and labeled to resemble cereal, candy and cookies that appeal to children.