On January 8, 2021, FDA commissioner Stephen M. Hahn, M.D. released a statement entitled “Better Data for a Better Understanding of the Use and Safety Profile of Cannabidiol (CBD) Products”, which details the “knowledge gaps” that remain as the FDA works to develop a framework for the regulation of CBD products.

As many of our readers know, the 2018 Farm Bill removed “hemp” from the definition of “marijuana” under the Controlled Substance Act, thus removing one legal obstacle from marketing CBD commercially. However, CBD still needs an appropriate regulatory status for its use in conventional foods and dietary supplements. FDA has taken the position that CBD is not a lawful dietary ingredient or food ingredient based on two timing provisions found in the Federal Food, Drug, and Cosmetic Act.  While a regulatory pathway for CBD is under consideration and safety data is generated, FDA has focused its efforts on Warning Letters against companies making unsubstantiated health claims.

Dr. Hahn’s statement declared that the FDA still has a “limited understanding of the safety profile of CBD” and that important questions remain, including the risks associated with long-term use of CBD products. While acknowledging industry’s efforts to engage with and provide information to FDA, Dr. Hahn cautioned that filling the gaps “will not be a trivial exercise.” The statement describes a framework in which real-world data (RWD) can be used to answer outstanding questions on CBD products including how to understand the safety profile of CBD in the general population and potentially in specific populations. In particular, Dr. Hahn announced the following principles and goals that will guide FDA work in this area:

• Research projects should contribute to development of more sophisticated data infrastructure for understanding the safety and quality of CBD products;

• Research projects should yield information to help refine future studies, such as subpopulations that are most important to study;

• Research projects should be designed to complement the existing work of other stakeholders;

• More systematic data is needed as existing data largely comes from spontaneously reported adverse events;

• The development of specific codes in data sets is needed to identify specific CBD products;

• Longitudinal studies are needed to learn more about the long-term health effects of CBD use.

The latest statement from FDA makes clear that a lawful regulatory position for CBD will still take some time to develop and that FDA believes there are substantial safety gaps that need to be addressed. We are also awaiting FDA’s draft enforcement guidance that has been at OMB since July.