The Food and Drug Administration (FDA) is “actively” exploring a potential regulatory framework for CBD, with plans to prioritize the issue in the next year, a top official says. Meanwhile, the agency is also investigating issues related to kratom.
FDA Deputy Commissioner for Policy, Legislation, and International Affairs Kimberlee Trzeciak discussed the agency’s cannabis and kratom interests during a webinar hosted by the Alliance for a Strong FDA this month.
Asked about issues that are “top of mind” for the agency in 2024 and where officials hope to engage with Congress, Trzeciak said that later this year or next year FDA wants to address setting up “an appropriate regulatory framework for CBD.”
Later in the conversation, the FDA official was asked specifically about how the agency is “prioritizing” its work on cannabis and kratom regulations, and she said officials are taking a number of factors into consideration as they work to address the substances.
“In almost every neighborhood you go to, you can see stores on the corners that are marketing CBD and kratom and others,” she said. “And one of the things that we have been thinking through here at FDA, using CBD as an example, is what does the regulatory framework for those products look like?”
“Based on what we know about CBD in particular, we do not think that those products would be able to meet the safety standards that we have in place for foods and dietary supplements today,” she said, referencing the agency’s position after it declined to enact regulations for the non-intoxicating cannabinoid that was legalized under the 2018 Farm Bill.
“What can we do in terms of regulatory tools to ensure that this product is going to be marketed that consumers are clearly aware of what the product is, what is in it and making sure that we have basic information about the marketplace?” Trzeciak said. “I like to think of it as the common regulatory tool that we have across the other products that we regulate.”
She added that FDA wants to “work with Congress on this effort,” including possible rulemaking around CBD product labeling and packaging.
“For example, how can we ensure that the agency knows if there are adverse events that are being reported, so we can identify those trends, making sure that the product is being manufactured or produced in a way that’s safe and quality?” she said.
Kratom reform advocates say the deputy commissioner’s comments represent a “shift” in the agency’s policy perspective on the issue. Historically, FDA hasn’t engaged in the kratom debate as actively as other agencies such as the National Institute on Drug Abuse (NIDA).
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