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, -0.93% Epidiolex, a treatment for severe forms of childhood epilepsy — it has told companies that they cannot not add it to food or drink or make health claims for its use in topicals.
The regulator is working to create a framework to allow companies that were hoping to launch CBD-based products bring those to market, but has cautioned that given its status as a drug, it might require clinical trials. In November, it warned that CBD could cause liver injury and other damage to the human body. The agency has cracked down on some companies, mostly for making unsubstantiated health claims.
“We recognize that there is substantial public interest in marketing and accessing CBD for a variety of products,” an FDA spokesperson said in emailed comments. “We are working toward a goal of providing additional guidance, and have made substantial progress. There are many questions to explore regarding the science, safety, effectiveness and quality of products containing CBD, and we need to do our due diligence.”
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