Future Of CBD In Supplements: NDI Notification Looms As Regulatory Path
Recent statement that FDA has not found evidence supporting CBD as GRAS for use in human or animal food potentially points to NDI notifications as the only option manufacturers, marketers and other businesses will have to convince agency about safety for CBD and other hemp-derived substances used in dietary supplements.
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Making lawful the use of hemp cannabinoids in supplements and food is a step in the right direction, but including food may doom it, say industry stakeholders. As well, CRN CEO Steve Mister notes FDA has stated reservations about using cannabinoids in food.
Senate bill introduced on 19 May, unlike a House bill introduced in February, would direct FDA to allow using hemp-derived cannabinoids in food products as well as supplements. However, neither bill includes language on setting a safe daily level that some industry stakeholders argue is needed.
Duffy MacKay, senior VP of scientific and regulatory affairs at CV Sciences, offers his predictions regarding the FDA’s likely course in regulating CBD’s use in dietary supplements – action that is sorely needed as the market continues to crowd with CBD products “with who-knows-what in them.”