The U.S. Food and Drug Administration rejected an application from Charlotte’s Web, a hemp supplement company for a hemp-based dietary supplement, according to a Wednesday press release from the company. The FDA explained that CBD products are excluded from the dietary supplement definition. Charlotte’s Web said that this rejection shows that congressional changes need to happen in order for dietary supplements with hemp extracts to be regulated.
The press release explained that the objection to its New Dietary Ingredient notification (NDI) was “due largely to its drug preclusion provision,” specifically that the FDA has already decided to treat CBD and CBD products as a drug. Charlotte’s Web said that the NDI process is rigorous and intensive, and that an approved product is expected to be safe when used under the label’s recommendations.
The FDA reportedly determined, after collaborating with the company, that the company’s full spectrum hemp extract which has natural levels of CBD “cannot be used in dietary supplements because it is precluded and expresses safety concerns.” The company, however, explained that the safety conclusions the FDA cited are not based on the data in their application but separate data and asked the FDA to make a correction.
“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.
In its rejection, the FDA noted that legislation may be required to address this. In response, the company agreed and said that congressional action is the best avenue at this point to “properly regulate the hemp wellness category.”
Although the company was hoping to have its supplement approved by the FDA, it explained that the decision will not impact its current operations, but rather gives them guidance for how to approach the regulatory framework for hemp dietary supplements.
The rejection was reportedly filed on May 12, 2021, and notice was sent to the company in June, however, it was not scheduled to be published for the public until 90 days after it was filed on August 10.