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FDA stalled on CBD for now: Analyst

By Steve Gelsi

The FDA may consider additional data on whether CBD produces dangerous increases in liver enzymes, as shown in some studies.

The U.S. Food and Drug Administration (FDA) is not expected to move quickly on regulating cannabinoids (CBD) from hemp, Cowen analyst Harrison Vivas said Wednesday in the wake of a special meeting.

Vivas made the prediction after the Science Board to the Food and Drug Administration met Tuesday to consider challenges in evaluating the safety of dietary supplement and food ingredients with predicted pharmacological activity, using cannabinoids as a case study.

"We are encouraged by increasing numbers of studies and greater regulatory focus relative to even five years ago, but we still do not expect to see a near-term change in the FDA's treatment of CBD in ingestible formats without pressure from Congress," Vivas said.

The FDA continues to resist moving ahead with guidelines on foods and dietary supplements because it's uncomfortable with the the lack of knowledge around toxicity, Vivas said.

The FDA cited various animal studies that show negative side effects from consistent consumption at higher levels, but signaled it could consider data from animals with more human-like metabolism of CBD.

Also Read: Cannabis stocks rocked as FDA warning undermines case for CBD investments

At Tuesdays FDA meeting, Industry participants laid out a growing body of evidence from third parties that show that CBD can be ingested without dangerous increases in liver enzymes, Vivas noted.

Despite the growing number of unregulated dietary supplements and other foods, as well as hemp-derived Delta 8, the FDA did not offer a timeline for its review of CBD.

Meanwhile, the FDA continues to educate consumers about potential hazards of CBD as it conducts more research.

CBD has been in limbo since hemp became legal in the 2018 farm bill. The bill did not legalize CBD, which is made from hemp, and moved enforcement actions on it to the FDA from the Drug Enforcement Administration.

Also Read: FDA releases guidelines for cannabis-related research, but CBD will have to wait

While the FDA has approved the prescription drug Epidiolex to treat severe forms of childhood epilepsy, it's mostly put the brakes on use of it in food and dietary supplements, despite a growing number of such products.

Jazz Pharmaceuticals Plc (JAZZ) acquired Epidiolex in 2021 as part of its $7.2 billion deal to buy GW Pharmaceuticals.

-Steve Gelsi

 

(END) Dow Jones Newswires

06-15-22 1033ET

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