Biden Administration Pause On Pending Trump-Era Rules Stalls FDA Cannabinoids Guidance Progress
Among four FDA regulatory items withdrawn from OMB review is “Cannabidiol Enforcement Policy; Draft Guidance for Industry,” which the agency submitted in July 2020.
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Former FDA commissioner says legislative carve-out for a regulatory pathway for cannabinoids is a better option than a rulemaking, which could take five years and “may not even work.” Cannabinoids market is “well far ahead of where the regulation is,” he says.
De-scheduling provision in 2018 farm bill wasn’t crafted by House and Senate committees with FDA oversight, making it important that legislation to make hemp-derived cannabinoids lawful for use in supplements comes through House Energy and Commerce or Senate HELP committee.
House legislation to exempt hemp-derived cannabinoids from FDA rule that an “article” previously studied or approved for use as drugs is not allowed for use in dietary supplements either resolves a conundrum or raises additional questions for the agency and the industry.