September 16, 2021
The acting commissioner of FDA recently acknowledged a “stalemate” between FDA and companies seeking a lawful pathway to market for CBD in dietary supplements—and Dr. Janet Woodcock suggested there’s no immediate solution on the horizon at FDA.
In a recent Q&A with Woodcock, a long-time FDA official who was named acting commissioner in January, Consumer Healthcare Products Association (CHPA) President and CEO Scott Melville said “responsible companies” would like to lawfully enter the hemp-derived CBD market.
But he noted a CBD prescription drug is on the market. According to FDA, because CBD was first studied as a drug, it is excluded from the definition of a dietary supplement.
“I’m just wondering. How do we get out of this stalemate?” Melville asked Woodcock on Sept. 9 during CHPA’s Regulatory, Scientific & Quality Conference. “Congress has expressed an interest and is looking at legislation maybe to clarify that pathway [for dietary supplements]. But is there … another way that we might be able to speed this along?”
“I’m not sure,” Woodcock responded. “In my reading, the law is fairly clear about this, and so it puts us in a stalemate position. We also need additional data on the safety of lower doses and how that might be controlled, say, in the supplement market. How could you manage exposure of consumers?”
Epidiolex—the CBD prescription drug that FDA approved in 2018—“has some toxicities, but again it’s used at a certain level to control serious disease, so that tradeoff is acceptable,” Woodcock remarked. “That kind of tradeoff may not be acceptable for your average consumers taking it for other reasons.”
Woodcock also seemed to combat the perception that FDA is opposed to CBD in dietary supplements, based on agency policy.
“I don’t know that it’s a matter of FDA policy. I think it may well be a matter of law,” she said.
Earlier in the session during prepared remarks, Woodcock emphasized FDA wants more scientific evidence on CBD to support its safety.
“We continue to underscore the need for scientific evidence to support the safety profile of CBD, especially in consideration of both the known and unknown about the science, safety and quality of products that contain CBD,” she said. “To this end, we remain steadfast in our effort to obtain research, data and other safety and public health input to inform our approach and to address consumer access in a way that protects public health and maintains incentives for cannabis drug development through established regulatory pathways.”
Woodcock said FDA welcomed “stakeholder perspectives about the important and intricate regulatory and scientific aspects of CBD and other cannabinoids.”
“As we learn more, we’ll continue to update the public about our path forward for CBD, providing information based on sound science and data, including any emerging safety concerns in working to keep unsafe products off the market consistent with our mission to protect the public,” she added.
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