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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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.”
With the rapid growth of CBD supplements, topicals and other consumer health products available in the US, FDA has found no shortage of businesses to warn about making noncompliant claims. Still, it previously hasn't found reason to warn CBD businesses about unsafe delivery formats.
A report FDA submitted to Congress earlier in March on determining an enforcement discretion policy for CBD-containing non-drug products did little to indicate it is approaching a decision. It's likely that FDA officials are reasonably confident of CBD's safety in food and supplements because the agency has allowed the market to proliferate.