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Among four FDA regulatory items withdrawn from OMB review is “Cannabidiol Enforcement Policy; Draft Guidance for Industry,” which the agency submitted in July 2020.
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States’ histories with legalizing cannabis aren’t good models for an hemp regulatory pathway, says FDA hemp and cannabis policy chief Norman Birenbaum. Influence from those models already seen in US with ingredients including delta-8 THC marketed as hemp as defined in federal law de-scheduling it as a controlled substance.
FDA’s tolerance of sales of hemp-containing supplements isn’t the assurance industry needs for investing in development of ingredients and products which have been shown to provide various health benefits.
FDA's evaluation of NDI notifications for cannabinoids currently is pointless, say industry stakeholders asking for a rule exempting hemp-derived cannabinoids from the agency’s prohibition against using in dietary supplements any ingredient studied or approved for use as a drug.