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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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."
US Wellness Market In 2019: Farm Bill Made Cultivating Cannabidiol Policy FDA's Main Course In Supplements
As HBW Insight looks back on notable US wellness market developments and events for the previous 12 months, we find that news in the CBD space from the FDA and the industry dominated the sector throughout 2019.