FDA’s 2nd CBD Hearing Won’t Be the One the Industry Wants

November conference will focus on differing effects on each gender
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WASHINGTON — A public hearing next month by U.S. Food and Drug Administration (FDA) won’t be the resolution of regulation of ingestible CBD products that many industry watchers had hoped.

The FDA announced in September that it would hold the public meeting on cannabidiol (CBD) and other cannabinoids to discuss the differing way these ingredients effect each gender.

The Nov. 19 event titled CBD and Other Cannabinoids: Sex and Gender Difference in Use and Responses will be hosted by the FDA’s Office of Women’s Health and is described as a “multidisciplinary scientific conference.”

Intended topics of discussion include:

  • Sex differences in the effects of CBD and other cannabinoids
  • Use of CBD and other cannabinoids in pregnancy
  • Government agency perspectives on CBD research

Jonathan Havens, a partner in Washington, D.C., and Baltimore-based Saul Ewing Arnstein & Lehr LLP, took note of the specificity of the November meeting announcement and expressed caution for anyone hoping the event would provide insight into future ingestible CBD product regulations.

“It sounds to me like this is a listening session for researchers, educators, clinicians and patients to talk to FDA about the studies they’ve undertaken, the data they’ve reviewed, the patients they’ve treated, their personal experience, and the like,” Havens told CSP Daily News. “While the conference will be interesting and suggests FDA continues to be focused on cannabis and CBD, I don’t expect that we’ll be able to glean additional insight into how FDA might regulate ingestible CBD products.”

Havens, a former regulatory counsel at the FDA, took note of a statement the agency made about why it was seeking to address these questions of sex and gender.

“Conditions for which CBD is often marketed, such as chronic pain, anxiety, depression and sleep disturbances, are more prevalent in women than men,” the agency said in the event announcement. “Therefore, consideration of issues pertaining to the safety of CBD products may be particularly important to address in women.”

“Beyond the conclusions FDA has drawn about these ailments being more prevalent in women than men, it’s also interesting to note that at least some of them are considered by FDA to be medical conditions,” Havens said. “This suggests to me that the conference will focus mostly if not exclusively on drug products as opposed to dietary supplements.”

The drug positioning and streamlined agenda marks a stark difference between the first CBD meeting the FDA held in May 2019. While the substance’s therapeutic potential was certainly discussed during the agency’s first-ever public hearing on CBD, the agency also heard from manufacturers, retailers, the agricultural industry and state and local regulators.

“Given the wide-ranging feedback FDA sought at its hearing last May, we were able to better understand the agency’s policy questions and priorities,” Havens said.  “The November hearing is being billed as a scientific conference, one that will likely be research- and data-driven, so I don’t expect we’ll have a better understanding of FDA’s thinking on consumer (i.e., non-drug) CBD products after it.”

A research note by New York-based Cowen Washington Research Group agreed with this assessment, noting the meeting is “unlikely to provide a definitive conclusion on how the agency will regulate the CBD industry” but it “could provide important clues. The meeting suggests that the FDA is at least still moving the ball on CBD and it could provide an update on the agency's perspectives on CBD research and evaluation.”

Many manufacturers, retailers and consumers are anxious for the FDA to address the marketing and sale of edible CBD products as they believe those products will become the most popular segment of the category.

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