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.”
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.
