NDI Notifications For CBD ‘Excluded’ On Arrival But US FDA Still Explains Where Safety Evidence Fails
CFSAN Office of Dietary Supplement Programs tells Charlotte’s Web and Irwin Naturals that not providing sufficient evidence of a reasonable assumption of safety for an NDI's intended use wasn’t the only reason each notification was rejected.
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Clarity needed to remove unlawful label for using hemp- and cannabis-derived ingredients in supplements and food available in US. Rejections of two CBD NDI notifications could sour other firms on complying with requirement for cannabinoids or other ingredients, says food and drug law attorney Kristi Wolff.
Rejection of two firms’ proposals for using hemp-derived CBD in supplement isn’t stirring US businesses selling CBD supplements to pull products from market. For one firm that filed an unsuccessful NDI notification for full-spectrum hemp extract CBD, FDA rejection was agenda item with numerous other business, regulatory and legislative developments in its latest quarter.
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.