What Charlotte's Web’s hemp extract NDI filing means for CBD’s futureWhat Charlotte's Web’s hemp extract NDI filing means for CBD’s future
FDA’s response to Charlotte's Web's new dietary ingredient notification highlights the scope of regulatory hurdles facing the CBD industry, and according to many, the need for a legislative solution.
September 9, 2021
Charlotte’s Web—the leading brand for hemp-based CBD in the U.S.—provided a notification this year to FDA to demonstrate that its full-spectrum hemp extract is reasonably expected to be safe.
FDA objected to the new dietary ingredient notification for two reasons: it stated CBD products are excluded from the definition of a dietary supplement, and it raised concerns about the sufficiency of the safety evidence provided to it.
In the fifth episode of “short legal briefs,” host Josh Long interviewed the CEO of Charlotte’s Web, Deanie Elsner. She discussed the depth of her company’s filings with FDA, motivations for notifying the agency and FDA’s response, as well as the current state of the market and her company’s priorities. Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), also joined the program. He discussed Charlotte’s Web’s full-spectrum hemp extract, the “drug preclusion” language cited by FDA and the pressing need for a legislative solution for the CBD marketplace.
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