On April 3, former FDA (U.S. Food and Drug Administration) Commissioner Scott Gottlieb, MD, provided insights into the agency’s approach to products that contain cannabidiol (CBD) during a House Appropriations Committee hearing on FDA funding for 2020.
In two exchanges with Rep. Andy Harris (R-MD), Gottlieb reiterated that the agency considers most CBD products on the market to be unlawful. He highlighted recent FDA enforcement efforts against some companies selling those products, but noted that the agency lacks the resources to take enforcement actions against all the CBD products it considers to be unlawful.
“We see a burgeoning market,” Gottlieb said, “and we can’t boil the ocean. So we’re trying to take a risk-based approach to our enforcement, like we do in all matters. And we’re hoping by taking selective enforcement actions, you’re going to see voluntary compliance from the legitimate manufacturers and retailers, because they are marketing an unlawful product.”
Gottlieb said that at the same time, FDA is looking to create a framework where CBD can be appropriately marketed.
“I recognize Congress wants there to be a pathway here,” he said, “so we’re trying to work … expeditiously to create a viable pathway that could differentiate between potentially appropriate use of the product, if we can have scientific evidence to support its appropriate use, and use of the product that creates safety risks for the consumers.”
Gottlieb noted that additional funding would help FDA accelerate the policy-making process to create a legal framework that will form the basis of more effective enforcement action, and also put more resources behind enforcement activity.
“You don’t see a lot of legitimate food packaging companies and large stores putting CBD products into their stores and into their—into their food products right now, because they know it’s illegal,” Gottlieb said. “I think they’re all trying to work with us to see what a legal pathway would look like.”
In an exchange with Rep. Barbara Lee (D-CA), Gottlieb reiterated FDA’s intent to provide a legal framework for the lawful marketing of CBD products. He stressed that this provides a unique challenge for FDA and suggested that a legislative remedy could provide the solution.
