(Bloomberg) – The United States Food and Drug Administration has opposed a request by Charlotte’s Web Holdings Inc. for a CBD product to be sold as a dietary ingredient, leaving a cloud of uncertainty over the industry in boom in the cannabis-derived substance.
The company’s offer to sell its full-spectrum hemp extract with CBD as a dietary supplement will not be considered due to the FDA’s earlier decision to treat CBD as a drug, according to a published letter. Wednesday on the agency’s website. The move is not expected to disrupt Charlotte’s Web business or prevent other companies from continuing to sell such products, which already exist in a gray area without agency oversight.
The decision shows the agency’s continued reluctance to regulate cannabidiol, the non-psychoactive ingredient in cannabis plants better known as CBD. The market for CBD products has already reached over $ 6 billion, with consumers seeking help with everything from relaxation and focus to better sleep. Yet sales are unregulated, aside from sporadic crackdowns on companies that attempt to make unsubstantiated claims of its health benefits.
The FDA’s latest move was based in part on its pre-approval of Epidiolex, a CBD drug to reduce seizures, which the agency says prevents it from allowing CBD for dietary purposes. Even though the drug had not been approved, the FDA said in the letter to Charlotte’s Web dated July 23 that it “had concerns about the adequacy of the safety evidence” submitted by the company. The agency reportedly wanted more data on potential liver and reproductive toxicity.
“While we disagree with the reasoning of the FDA, believing that we have provided complete and credible scientific evidence that supports a different result, this decision affirms that the path to regulatory clarity must come from Congress,” Charlotte Web CEO Deanie Elsner said in a statement.
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