FDA Opens CBD Regulatory Path Docket, Warns Firms On Claims Missteps
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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Whether lawmakers will favor legislation aligning with FDA’s thinking or hemp industry’s preferences isn’t known, says Jonathan Miller, US Hemp Roundtable general counsel. “We're feeling pretty confident that something's going to happen.”
Decision, explained by Principal Deputy Commissioner Woodcock, turns page on FDA’s 2019 announcement, after hemp was de-scheduled in 2018 farm bill, it would consider rulemaking for lawful use of hemp in supplements.
Everywhere In Supplements And Food, Is Hemp Safe Enough To Be Lawful? US FDA Wants Science Board's Help Solving Regulatory Conundrum
FDA says Science Board, “utilizing cannabinoids as a case study,” will consider challenges in evaluating safety of “ingredients with predicted pharmacological activity” used in supplements and food. Other ingredients also used in supplements and food also could be on its radar, but for good reason cannabinoids are focus of Science Board discussion.