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FDA objects to CBD dietary supplement as uncertainty looms over substance

August 11, 2021, 4:55 PM UTC

The U.S. Food and Drug Administration objected to an application from Charlotte’s Web Holdings Inc. for a CBD product to be sold as a dietary ingredient, leaving a cloud of uncertainty over the booming industry for the cannabis-derived substance.

The company’s bid to sell its full-spectrum hemp extract with CBD as a dietary supplement won’t be considered because of the FDA’s own prior decision to treat CBD as a drug, according to a letter posted on the agency’s website Wednesday. The decision shouldn’t disrupt the business of Charlotte’s Web or prevent other companies from continuing to sell such products, which already exist in a gray area without the agency’s oversight.

The decision shows the agency’s ongoing hesitancy to regulate cannabidiol, the non-psychoactive ingredient in cannabis plants better known as CBD. The market for CBD products has already grown to more than $6 billion as consumers seek help with everything from relaxation to focus to better sleep. Still, the sales are unregulated, aside from sporadic crackdowns on companies that try to make unsubstantiated claims about its health benefits.

The FDA’s latest decision rested in part on its prior approval of Epidiolex, a CBD drug to reduce seizures, which the agency said precludes it from authorizing CBD for dietary purposes. Even if the drug hadn’t been approved, though, the FDA said in the letter to Charlotte’s Web dated July 23 that it “has concerns about the adequacy of safety evidence” that the company submitted. The agency would have wanted more data on potential liver and reproductive toxicity.

“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 said in a statement.

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