Updated: May 26
The FDA held an important stakeholder call on Thursday, May 25, 2023, to provide information about their conclusion that a new regulatory pathway is needed to provide appropriate regulatory oversight for CBD products. This call was the third in a series of stakeholder calls outlining FDA's position on the regulation of CBD and other cannabinoid products and the need for Congress to create a new pathway. While stakeholders continue to emphasize the need for clear guidelines from the FDA on the use of CBD in food and dietary supplements, urging the agency to take action, FDA continues to have serious safety concerns about CBD and other cannabinoids. Due to the constructs of the current regulatory frameworks for food and supplements, FDA has made clear that the agency does not see how CBD products can meet the statutory requirements. This is namely because of CBD's inherent risk profile and the limited risk management options in the food and dietary supplement pathways, as well as the safety standards established for animal food. FDA would like to see a pathway that balances consumer access with regulatory oversight. FDA is asking Congress to create a new regulatory pathway that takes a "harm reduction approach" for both human and animal products. FDA will continue its approach to enforcement with warning letters. FDA will focus its enforcement efforts on products posing the greatest risks. Another key topic of discussion is the need for clear and consistent testing standards for hemp products. As many of our clients have experienced, there is a great deal of variability in the testing methods used by different labs, which can lead to inconsistent results and confusion for consumers. Stakeholders continue to emphasize the need for standardized testing protocols that can be used across the industry to ensure the safety and quality of hemp products. The stakeholders' calls demonstrated a strong commitment from FDA to working together with Congress and the industry to address these challenges and to ensure that hemp products are safe, high-quality, and legally compliant. You can read more about the FDA's January 26th, 2023 conclusion here.