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FDA Opens CBD Regulatory Path Docket, Warns Firms On Claims Missteps

 
• By Malcolm Spicer

With public hearing scheduled May 31 and a related public comment period, FDA "is interested in whether there are particular safety concerns that we should be aware of as we consider the FDA’s regulatory oversight and monitoring" of CBD products. Also influencing FDA's consideration is that CBD and other cannabis-derived substances are approved and being studied as drugs products, making their use as dietary ingredients noncompliant with agency regulations.

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FDA wants public input on allowing cannabidiol's use in dietary supplements marketed with compliant claims, unlike the disease claims for CBD supplements made by three firms the agency recently warned.

"I believe these are egregious, over-the-line claims and we won’t tolerate this kind of deceptive marketing to vulnerable patients," FDA Commissioner Scott Gottlieb said of the claims listed in the agency's warning letters to Advanced Spine and Pain

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