FDA response to NDI submitting underscores CBD’s regulatory challenges

Charlotte’s Web – the leading brand of hemp-based CBD in the United States – filed a notification with the FDA earlier this year to show that their full-spectrum hemp extract is reasonably expected to be safe.

The FDA has objected to the new notification of dietary supplements for two reasons: it stated that CBD products are exempt from the definition of a dietary supplement and it raised concerns about the adequacy of the safety evidence presented.

In the fifth episode of “Brief Legal Briefs,” host Josh Long interviewed Charlotte’s Web CEO Deanie Elsner. She discussed the depth of her company’s filings with the FDA, the reasons for notifying the agency and the FDA’s response, and the current market situation and priorities for her company. Steve Mister, President and CEO of the Council for Responsible Nutrition (CRN), also participated in the program. He spoke about Charlotte’s Web’s full-spectrum hemp extract, the FDA-cited language of “drug exclusion,” and the urgent need for a legal solution to the CBD market.