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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At FDLI annual meeting, attorneys cast doubt on CBD rules outlook. Paul Joseph says regulations are at least a year away while Jonathan Havens doubts FDA is even working on regulations, including GMPs, because it is still asking industry for specific safety details.
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.