“We are working toward a goal of providing additional guidance”
The U.S. Food and Drug Administration released preliminary guidance on Tuesday on cannabis-related clinical research, outlining how companies seeking approval of drugs that contain cannabis or its derivatives must follow the traditional drug review and approval process involving clinical trials.
The agency is still working on rules for products that contain the cannabis ingredient CBD, which is widely held to have wellness properties but lacks research to support that view. Many companies are keen to market food, drinks and dietary supplements containing CBD, a non-psychoactive ingredient in the hemp plant, that they say can help with ailments such as anxiety.
Ever since the passage of the 2018 Farm Bill, CBD has existed in a sort of regulatory limbo. While the bill legalized hemp, it did not legalize CBD, but rather moved enforcement of the substance away from the Drug Enforcement Administration and over to the FDA. Because the FDA has approved a drug that contains the ingredient — GW Pharmaceuticals PLC’s GWPH, -1.86% Epidiolex, a treatment for severe forms of childhood epilepsy — it has told companies that they cannot add it to food or drink or make health claims for its use in topicals.
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