Former FDA Head Proposes CBD Regulation Plan

Former Food and Drug Administration (FDA) Commissioner Scott Gottlieb described a potential regulatory process for CBD on Friday, laying out steps the agency could take while final rules are developed.

While Gottlieb urged caution against the use of cannabidiol products and argued that claims about the compound’s medical potential are largely unsubstantiated, he said there are certain measures FDA can implement to ensure that such preparations meet basic safety standards.

The former commissioner linked to an article challenging claims about CBD and stated that the “hype has outpaced science” and that “there are risks.”

CBD hype has outpaced science. And there are risks. But with use widespread, the question is whether FDA can help oversee quality, purity, potency and help prevent third rate purveyors from flooding market with shoddy products outside regulatory purview https://t.co/PErCX9ZjuJ

— Scott Gottlieb, MD (@ScottGottliebMD) November 8, 2019

“But with use widespread, the question is whether FDA can help oversee quality, purity, potency and help prevent third rate purveyors from flooding market with shoddy products outside regulatory purview,” he wrote on Twitter.

To start, Gottlieb recommended targeting regulations at CBD supplements, which are not currently allowed to be marketed because FDA has yet to issue rules—but at the same time, they’ve become widely available since hemp and its derivatives were legalized under the 2018 Farm Bill.

Safety must be the first principle. And appropriate claims grounded in science. CBD is not safe and has largely unproven benefits outside a small subset of very carefully studied indications. The vast majority of claims being made by illegal producers will never be substantiated.

— Scott Gottlieb, MD (@ScottGottliebMD) November 8, 2019

Regulators could “put burden on producers to prove CBD safety at very low levels while ensuring manufacturing standards, purity, minimum levels of active ingredient during a transition period of enforcement discretion—and sweep market of non compliant products,” he said.

Multiple lawmakers, including Senate Majority Leader Mitch McConnell (R-KY), have implored FDA to use enforcement discretion when it comes to CBD and only go after those making especially exaggerated claims about their products or neglecting safety standards.

“Safety must be the first principle. And appropriate claims grounded in science,” Gottlieb said. “CBD is not safe and has largely unproven benefits outside a small subset of very carefully studied indications. The vast majority of claims being made by illegal producers will never be substantiated.”

It’s not clear when FDA will ultimately issue an interim final rule or what regulations will come out of the process, but lawmakers and industry stakeholders are holding out hope that it will happen expeditiously and support a market where the products can be sold as food items or dietary supplements.

Gottlieb previously said that it may take years before FDA releases CBD rules if Congress doesn’t get involve legislatively.

The U.S. Department of Agriculture, meanwhile, issued an interim final rule for hemp last month, and a public comment period is open for interested parties to weigh in on the draft regulations.

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Photo courtesy of YouTube/House Appropriations Committee.