FDA Denies Bid to Market CBD as Dietary Supplement

The U.S. Food and Drug Administration on Wednesday told Charlotte’s Web Holdings Inc. that its cannabidiol product cannot be sold as a dietary supplement, signaling that CBD reform may have to wait for congressional action.

“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 CEO Deanie Elsner said in a statement.

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, according to Fortune. 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.

The decision isn’t expected to impact sales of Charlotte’s Web products or prevent other companies from continuing to sell CBD products. 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, according to reports. While generally an unregulated market, the FDA will periodically crackdown on companies that try to make unsubstantiated claims about the health benefits of CBD products.

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