FDA Continues to Take Stance That it Will Not Issue CBD Rules

The U.S. Food and Drug Administration (FDA) recently doubled down on its January 26, 2023 position that existing regulatory pathways for foods and dietary supplements are not appropriate to manage the risks of cannabidiol (CBD) and a new regulatory pathway is needed. Specifically, during an April 11, 2024 hearing before the House Oversight and Accountability Committee, FDA Commissioner Califf stated “the use of CBD raises safety concerns, especially with long-term use. Studies have shown evidence of liver toxicity, interactions with certain medications, and possible harm to the male reproductive system. CBD exposure is particularly concerning for children and during pregnancy.”

The Commissioner then reiterated the Agency is willing to work with Congress to create “a new regulatory pathway that would provide access, safeguards and oversight over products containing CBD in ways that existing pathways cannot.” Per Commissioner Califf, a new regulatory scheme is needed that could “encourage better information to inform consumers about their choices.”

Under the Federal Food, Drug, & Cosmetic Act, any substance, including CBD, must meet certain standards to be lawfully marketed as a dietary supplement or food additive. The lack of rules for CBD, which are long overdue, has been a pain point for the industry. With the FDA continuing to take the position that it cannot regulate CBD under current food additive and dietary supplement laws and looking to Congress to take action, CBD’s fate looks as though it will continue to remain in unregulated purgatory. Should the FDA change its stance, promulgation of new rules that explicitly address the Agency’s concerns regarding CBD is likely the swiftest way for the industry to finally have clarity. In light of the recent testimony, however, we do not anticipate the FDA will promulgate new rules to regulate CBD any time soon. The FDA’s continued failure to take any action forces industry stakeholders to operate in a world of regulatory uncertainty, which is harming the CBD industry and its consumers.

Foley is here to help you address the short- and long-term impacts in the wake of regulatory changes. We have the resources to help you navigate these and other important legal considerations related to business operations and industry-specific issues. Please reach out to the authors, your Foley relationship partner, our Health Care & Life Science Sector, or to our Health Care Practice Group with any questions.