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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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.
Cannabis-Derived Products Data Acceleration Plan aims to avoid same conclusion already found in FDA's more-than two-year search for information on using cannabis ingredients in supplements, food and beverages and personal care topicals: too little is available to determine safety.
FDA has little in the way of good information it can list on its CBD policy agenda so far, says Principal Deputy Commissioner Amy Abernethy. At recent regulatory conference, she said, "Like it or not, there is a massive human experiment going on right now. There’s CBD in most different product categories and people of many different backgrounds with potential vulnerabilities taking CBD."