The FDA Gets Blunt: “New Regulatory Pathway for CBD is Needed”
On January 26, the Food and Drug Administration (“FDA”) threw up its hands, concluding cannabidiol (“CBD”) products are not a good fit for the agency’s food and supplement framework. Instead, the FDA is calling on Congress to develop a new regulatory pathway for CBD “that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks.”
The development comes after the growing CBD industry pushed for the FDA to allow the products to be marketed as dietary supplements. In response, the FDA convened a high-level internal working group to evaluate such requests. Rather than finding a “place” for CBD in existing regulations, the FDA fixated on known and unknown risks associated with CBD. The agency believes its existing food and supplement regulations are ill-fit to manage such risks, and will work with Congress to find “a new way forward.”
A new regulatory pathway will likely include safeguards such as labeling requirements, content limits, quality assurance requirements related to contamination prevention, and a minimum age to purchase. The FDA acknowledges that such a pathway may extend to both human and animal CBD products.
As we have previously reported, the FDA has closely monitored the CBD industry in recent years. In its statement, the agency writes that it will remain diligent in monitoring the CBD marketplace, and will continue to take action against CBD and other cannabis-derived products as a new strategy for regulation develops.