FDA rules on CBD could be years away

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The head of the FDA doesn’t think it can make headway without Congressional intervention

Scott Gottlieb, who is resigning next month as the head of the Food & Drug Administration (FDA), doesn’t believe that his agency has the capability to decide on cannabis-infused edibles and cannabidiol (CBD) in food preparation. He said in an interview this past Tuesday that Congress needs to get involved in helping set the rules and, absent that participation, the FDA could take years to create the guidelines.

Gottlieb was speaking at an event held at the Brookings Institution when he made his remarks. He acknowledged that there is a push for the FDA to draft rules, but asserted that “CBD didn’t previously exist in the food supply, and it exists as a drug under the statute.”

He added, “It can’t just be put into the food supply.” Gottlieb explained that the laws currently on the books only allow the agency to “contemplate putting a drug that wasn’t previously in the food supply into the food supply if it goes through a rulemaking process.” He further stated, “We’ve never done this before. It would be a highly novel rulemaking process.”

That process, according to Gottlieb, typically takes two to three years, even for conventional products. Since CBD is, in his words, “more complex,” it could take even longer.

Gottlieb also notes that delays could come from other sources, as well. He stated that the Drug Enforcement Administration’s (DEA) position on hemp-derived CBD would need to change, stating, “I think the prevailing view is that the plain language of the statute [of the Farm Bill] intended for that, but I’m not sure that DEA has done that yet. But that’s another step that would have to take place. DEA would have to formally de-schedule CBD derived from hemp.”

Congress is already pushing, as is the marijuana industry, the FDA to move quicker on cannabis. Hopefully, Gottlieb’s successor will be more ambitious.