U.S. Agency Rejects Leading Company’s Application For CBD As Dietary Supplement

The U.S. Food and Drug Administration on Wednesday rejected a request from leading CBD provider Charlotte’s Web for one its products to be sold as a dietary supplement.

The Colorado-based company’s attempt to sell its full-spectrum hemp extract with CBD as a dietary supplement went against the FDA stance that CBD is a drug, according to a release posted Wednesday on the agency’s website.

The FDA expressed concerns “about the adequacy of safety evidence” that Charlotte’s Web submitted in its application, citing a lack of data on potential liver and reproductive toxicity to consumers of the extract.

Company CEO Deanie Elsner said in a statement that Charlotte’s Web “disagrees with the FDA’s reasoning” and called on the U.S. Congress to “affirm a path to regulatory clarity.” Elsner has been a vocal critic of the 2018 U.S. Farm Bill, contending in a February interview with Benzinga that the bill’s lack of clarity hurts farmers and manufacturers while leaving consumers with “no idea what’s in the product.”

Many third-party cannabidiol manufacturers use CBD isolate, which can be extracted and synthesized. But Charlotte’s Web and other more legitimate companies in the space produce full-spectrum CBD, which adds other natural hemp compounds.

Elsner argued the full-spectrum product and the fact that Charlotte’s Web is vertically integrated – meaning it handles its own genetics, cultivation and processing – proves its products are safe.

The FDA’s decision should not affect Charlotte’s Web or any other companies selling CBD hemp products, which already exist in an unregulated area without the agency’s oversight. But the decision illustrates federal officials’ enduring reluctancy to regulate the $6 billion CBD industry, with the exception of occasional crackdowns on companies that publicize false claims about its health benefits.

Charlotte’s Web is the top-selling CBD brand in the U.S., followed by Medterra, cbdMD Inc., CBDfx and CBDistillery, according to a July 2021 report from analytics firm Brightfield Group.

The FDA has long said it wants to ensure consumer products containing CBD are safe, but hasn’t yet acted. CBD companies would almost certainly benefit from concrete regulations, which would allow consumers to distinguish high quality CBD products from those that fail to meet certain standards.

Cannabis data and analytics firm BDSA projects the American CBD market will reach $20 billion in sales by 2024. But that projection factors in supposed greater federal clarity on regulations. The Colorado-based data firm said it expected the FDA to approve CBD as a food additive by 2022.