FDA Denies Charlotte’s Web Supplement, Reigniting CBD Debate

FDA Denies Charlotte’s Web Supplement, Reigniting CBD Debate

Denis Storey
August 13, 2021

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CBD’s meandering path to mainstream acceptance suffered a setback this week when the U.S. Food and Beverage Administration (FDA) challenged an application from Charlotte’s Web Holdings Inc. for a new CBD dietary supplement.

The FDA’s official objection revealed a nagging reluctance on the part of the agency to get involved in CBD regulation without a Congressional mandate. But the agency response also included a reference to its prior approval of Epidiolex, a CBD drug designed to ease seizures, which the agency said precludes it from authorizing CBD for dietary purposes. But the FDA added that it still harbors “concerns about the adequacy of safety evidence” that Charlotte’s Web provided.

In short, the FDA’s opposition suggested that without Congressional intervention, the CBD market will stay unregulated. 

“While we disagree with FDA’s reasoning, believing we provided extensive and credible scientific evidence that supported a different outcome, this decision affirms the path to regulatory clarity must come from Congress,” Charlotte’s Web Chief Executive Officer Deanie Elsner countered in a statement. 

Elsner also disputed the data the FDA cited in its rejection, adding “the conclusions drawn by the FDA do not appear to be based on the data provided.”

According to a midyear report from Brightfield Group, Charlotte’s Web is not only the top CBD brand in the United States, but it’s also the only top brand to post sales growth from the fourth quarter of 2020 to the first quarter of 2021.

“The road to a successful full-spectrum hemp extract (FSHE) or CBD New Dietary Ingredient notification (NDI) remains elusive,” United Natural Products Alliance President Loren Israelsen wrote in a member email after the FDA’s decision. “Congressional action to create a lawful pathway for FSHE/CBD is a critical step to advance the body of data to support a successful NDI for hemp/CBD products. We’re disappointed that the agency continues to take a very strict and narrow position on the general body of the data of consumer use of hemp/CBD products in the United States. Literally, billions of dosages have been consumed, yet it appears that, at least in the case of Charlotte’s Web, two years of sales data is deemed inadequate.” 

Since Congress made CBD legal in the 2018 Farm Bill, the FDA has insisted on keeping consumers safe. Still, the agency hasn’t taken any action to establish regulations governing CBD and hemp products, despite repeated requests to do so by industry stakeholders.

While regulatory approval of a consumer CBD product could have established an industry beachhead, the FDA’s denial could instigate legislative action. Several bills are pending in Congress that would force the FDA’s hand, but so far, none of them have gained any real traction.

It’s clear from talking to manufacturers, suppliers, retailers, and other industry stakeholders that there’s a growing sense of urgency to remove the legal obstacles that hinder the growth of the hemp and CBD markets.  

Companies need to stay the course and remain focused on the future. When clear regulatory guidelines finally emerge, manufacturers and brands must embrace a more refined approach to FDA communication and label claims management. Companies should prepare for impending regulation and begin production with current good manufacturing processes, established quality processes, and remain vigilant in preserving a transparent supply chain.

Check out our on-demand webinar with Maggie Cowee, economist, author, and cannabis consultant at Cowee Consulting, as we explore the evolving regulatory landscape for CBD. She provides insight on possible regulatory timelines, GMP standard development, navigating the hemp supply chain, and risk considerations for food, beverage, and supplements companies looking to capitalize on this growing trend. You don’t want to miss this webinar – watch it here.