After US FDA Objects To CBD Safety As NDIs, Supplement Industry Responds, What Else Is New?
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.
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Virginia Republican Morgan Griffith has same message for FDA he’s previously stated about hemp ingredients. Agency “has dragged its feet in properly regulating CBD and hemp-derived products on the market, creating confusion about its legal uses,” he says.
Denver firm recently announced self-affirmed GRAS for proprietary hemp-derived CBD extract. “I have access now to food, beverage and I can add to a dietary supplement my extract as a food additive ingredient,” says CEO Jason Mitchell. While GRAS is a US regulatory pathway for food, currently none is available for lawful use of hemp-derived ingredients in supplements.
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.