FDA Punts on CBD Regulations, Causing Status Quo to Remain

Feb 1, 2023 Chicago, IL

Last week, the US Food and Drug Administration (FDA) announced that it will not issue regulations related to cannabidiol (CBD) and its use in dietary supplements and food. According to FDA Principal Deputy Commissioner Dr. Janet Woodcock’s statement, the FDA has “not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm. Therefore, we do not intend to pursue rulemaking allowing the use of CBD in dietary supplements or conventional foods.” Rather than engage in rulemaking, the FDA says it “looks forward to working with Congress to develop a cross-agency strategy for the regulation of these products to protect the public’s health and safety.”

The FDA’s announcement is not a surprise, but is still a blow to the cannabis industry, which has been lobbying for the FDA to issue CBD rules since the 2018 Farm Bill legalized hemp. In the absence of new rules, the FDA’s stance that CBD is not “generally recognized as safe” still controls. As a result, CBD-infused foods, drinks, capsules, and other products remain unlawful, although the FDA has shown little willingness to engage in enforcement outside of warning letters to egregious violators making aggressive health claims.

It’s hard to know what will happen next for CBD regulation. While it’s possible that the FDA assists Congress with a stand-alone bill addressing CBD and other cannabinoids, it seems there is a more likely alternative. The 2018 Farm Bill expires this year, so Congress may choose to include CBD regulations in the next iteration of the bill. In the meantime, companies operating in the CBD industry, and those considering entry into it, will have to live with the murky status quo.

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FDA Punts on CBD Regulations, Causing Status Quo to Remain

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