FDA Rejects CBD as a Dietary Supplement

Charlotte’s Web Holdings Inc. submitted paperwork to the FDA to approve its CBD product as a dietary supplement, but it was recently rejected. This blow to the booming CBD industry leaves a shadow of doubt over its future.

The FDA’s objection to Charlotte’s Web on July 23 was that of “concern about the adequacy of safety evidence,” namely possible negative effects on the liver and male reproductive organs.

CBD became federally legal under the Farm Bill Act in 2018. While the FDA says it wants to ensure CBD products are safe, it has yet to release or enforce regulations. This rejection of Charlotte’s Web’s product is one of the first statements the FDA has made about regulating the production and quality of CBD products.

Charlotte’s Web of course disagreed with the FDA and stood by its product. Charlotte’s Web Chief Executive Officer Deanie Elsner said in a statement,

“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.”

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