House Appropriators Stoke Flames For FDA Regulation On CBD In Supplements
House Appropriations subcommittee with FDA oversight makes clear in questions for Commissioner Gottlieb they support allowing use of constituent ingredients from hemp and cannabis plants in food and dietary supplement products. Members also press for approving US firms' applications for pharmaceuticals with cannabis-derived active ingredients. Gottlieb announces working group will guide FDA decisions on potential CBD-use rulemaking.
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Associate commissioner Lowell Schiller's comments at recent trade group regulatory conference mark agency's first public statement on likely direction on CBD's use in food, supplements. Potentially allowing CBD's use also is making FDA "think about whether we have the tools and resources we need to take this on," Schiller said.
Developing rules for using CBD in supplements will prevent pharma industry from creating “sweeping monopoly” over the ingredient, CRN says. CHPA says FDA's existing NDA process is appropriate not only for Rx drugs containing CBD, but also for OTC products. NPA supports allowing an exemption for CBD in supplements by establishing a daily exposure level for a healthy population through a Health Hazard Evaluation.
CBD claim warning comes as FDA reviews more than 4,200 comments on its initiative to determine whether to open regulatory paths for firms to market non-drug products containing hemp- or cannabis-derived ingredients. From Deputy Commissioner Abernethy statement included in announcement about warning, it appears agency is getting message industry trade groups stated in comments that enforcement over non-drug products containing CBD cannot wait.