Josh Long, Associate editorial director, Natural Products Insider

September 16, 2021

2 Min Read
Acting FDA chief suggests no quick solution to CBD ‘stalemate’

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.

About the Author(s)

Josh Long

Associate editorial director, Natural Products Insider, Informa Markets Health and Nutrition

Josh Long directs the online news, feature and op-ed coverage at Natural Products Insider, which targets the health and wellness industry. He has been reporting on developments in the dietary supplement industry for over a decade, with a focus on regulatory issues, including at the Food and Drug Administration.

He has moderated and/or presented at industry trade shows, including SupplySide East, SupplySide West, Natural Products Expo West, NBJ Summit and the annual Dietary Supplement Regulatory Summit.

Connect with Josh on LinkedIn and ping him with story ideas at [email protected]

Education and previous experience

Josh majored in journalism and graduated from Arizona State University the same year "Jake the Snake" Plummer led the Sun Devils to the Rose Bowl against the Ohio State Buckeyes. He also holds a J.D. from the University of Wyoming College of Law, was admitted in 2008 to practice law in the state of Colorado and spent a year clerking for a state district court judge.

Over more than a quarter century, he’s written on various topics for newspapers and business-to-business publications – from the Yavapai in Arizona and a controversial plan for a nuclear-waste incinerator in Idaho to nuanced issues, including FDA enforcement of the Dietary Supplement Health and Education Act of 1994 (DSHEA).

Since the late 1990s, his articles have been published in a variety of media, including but not limited to, the Cape Cod Times (in Massachusetts), Sedona Red Rock News (in Arizona), Denver Post (in Colorado), Casper Star-Tribune (in Wyoming), now-defunct Jackson Hole Guide (in Wyoming), Colorado Lawyer (published by the Colorado Bar Association) and Nutrition Business Journal.

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