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FDA’s First Hearing on CBD Opens a Path to Regulation

Posted 31 May 2019 | By Ana Mulero 

FDA’s First Hearing on CBD Opens a Path to Regulation

The US Food and Drug Administration (FDA) held its first-ever public hearing Friday on products containing cannabis and cannabis-derived products, with advocates and critics calling for an efficient regulatory framework.

FDA officials, including co-chairs of the agency’s internal working group on cannabidiol (CBD), FDA principal associate commissioner for policy Lowell Schiller and principal deputy commissioner Amy Abernethy, heard from nearly 100 hearing participants by lunch time. Speakers shared data on CBD use in patients, while FDA panel members encouraged submitting additional data for the agency to review.

Speakers, coming from academia, industry and consumer groups, sought to inform FDA’s new interest in developing a framework to allow for the lawful marketing of cannabis and cannabis-derived products where appropriate.

As part of FDA’s work to explore a regulatory framework the agency looked to address unresolved questions, including safety considerations linked to greater access to CBD products and CBD intended uses, among other issues.

Speaking on behalf of the American Epileptic Society, Colorado-based pediatric specialist Kevin Chapman expressed concerns with labelling and the unknown effects of cannabis products in developing brains and children, as well as the long-term effects on adults who are regular consumers.

“We strongly support reducing regulatory barriers to research cannabis-derived products,” he said. “We also advocate for ongoing studies on the efficacy of cannabis drugs.”

Chapman’s argument centered on classifying the products and bringing them under the agency’s purview. In response to panel questions on how patients using unapproved CBD products decide what dose to take, Chapman said, “They are making it up as they go along.”

The hearing further discussed the safety and quality of hemp-derived products and CBD. Speakers made clear to the agency that they want a legal pathway for CBD products to properly enter the market.

The new call for a regulatory framework also included representatives of the hemp and agricultural communities. “There is an urgent need for an efficient regulatory framework for CBD,” said the US Hemp Roundtable’s general counsel Jonathan Miller.

Joseph Reardon of the North Carolina Department of Agriculture and Consumer Services said: “We are simply looking for regulatory framework on the extraction, production and reconstitution of CBD or cannabinoid related products, including terpenes and other constituents.” Reardon added that the CBD industry is looking for guidance to have “a uniform consistent platform” and a legal pathway.

FDA’s Abernethy took to Twiiter during the hearing to react to the comments: “Given the rapid expansion of the market, timely clarification of the path forward is critical, but it’s our responsibility to ensure that the regulatory path is scientifically sound and in the interest of public health.”

She pointed to product safety questions and argued for determining safety thresholds for CBD.

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