FDA Reaffirms That CBD Isn’t a Dietary Supplement
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The US Food and Drug Administration has reaffirmed that CBD, in its view, should not be sold as a dietary supplement.
In a letter to the CBD company Charlotte’s Web, which was made public on August 11, the federal agency said that the company’s full spectrum hemp extract “cannot be used in dietary supplements pursuant to the dietary supplement exclusion provision [of CBD].”
The FDA’s decision was largely made because it has already approved CBD as a drug (it is the main ingredient of the anti-epileptic medication Epidiolex). And, as per US law, “The term ‘dietary supplement’ […] does […] not include an article that is approved as a new drug.”
The ruling shouldn’t dent the sales of Charlotte’s Web products, which can continue as long as they products aren’t marketed as being dietary supplements. The FDA has previously issued warning letters to companies that market their CBD products as dietary supplements.
“While we disagree with FDA’s reasoning, believing we provided extensive and credible scientific evidence that supported a different outcome,” Charlotte’s Web chief executive officer Deanie Elsner said in a statement, as reported by Bloomberg. “This decision affirms the path to regulatory clarity must come from Congress.”
Earlier this year, the FDA announced that it was planning several research projects to improve the “gaps in current CBD data.”
“Better data in these areas are needed for the FDA and other public health agencies to make informed, science-based decisions that impact public health,” the FDA’s commissioner, Stephen Hahn, and Principal Deputy Commissioner Amy Abernethy said in a statement.