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CBD & Cannabis

CBD a 'Hard Challenge' for Regulators: FDA Commissioner

Agency will create a working group and hold public hearings in April
Photograph: Shutterstock

WASHINGTON — Congress is pressing the U.S. Food and Drug Administration (FDA) to provide answers into what is acceptable in CBD products and what isn't, according to a CNBC report. In February, 12 lawmakers penned a bipartisan letter to FDA Commissioner Scott Gottlieb requesting a timeline for FDA guidance on CBD regulations.

“I realize this is complicated, but I just want to emphasize the need for some sense of urgency around it,” Rep. Chellie Pingree (D-Maine), one of the letters’ authors, told Gottlieb when he appeared before a House Appropriations subcommittee on Feb. 27. “CBD is being sold in a lot of places, and it’s created an enormous amount of confusion. … The role of the FDA confuses everyone, I think.”

“We’re deeply focused on this,” Gottlieb told lawmakers. “We have taken on other hard challenges before. You have my commitment I’m focused on this one.”

Gottlieb added that he heard Congress “loud and clear” when it legalized hemp products, including CBD, with the passing of the 2018 Farm Bill in December. “I understand Congress wants there to be a pathway for CBD to be available.”

To address the issue, Gottlieb said the FDA will begin the rulemaking process with a public hearing “sometime in April.” He will also form a working group of FDA experts to examine the various regulatory options.

While the agency is taking steps to regulate the growing category, Gottlieb, who has since announced he will resign from his position, warned the committee that it will not be a “straightforward” process.

Because the FDA has approved a CBD-based drug—Epidiolex, which is used to treat specific kinds of epilepsy—and is conducing clinical trials on other CBD-based drugs, the substance cannot be added to food because the manufacturing or sale of drug-infused foods is forbidden by federal law.

Gottlieb said the agency might create a framework that would have products with high CBD concentrations be regulated as drugs with stricter oversight, while products with low CBD concentrations could be regulated as food products, with an easier review process. That separation is needed “because we want to preserve the incentive to study CBD as a pharmaceutical product,” Gottlieb said.

“There is not a good proxy for us doing this through regulation,” Gottlieb said. “I will tell you that if we make a determination that the pathway here is going to be a multiyear regulatory process that could take two, three, four years, I will come back to Congress to have a discussion about whether or not there are other frameworks that could help address this.”

Gottlieb did not offer an exact date on when the public hearings would be held.

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