The U.S. Food and Drug Administration (FDA) has denied two applications from companies seeking to sell CBD hemp extracts as a dietary supplement, Fortune reports. The agency said it rejected the applications because CBD is an approved drug and, therefore, excluded from the definition of a dietary supplement and that both applications failed to show that the extract meets the “reasonably expected to be safe under the conditions of use.”
The applicants were Charlotte’s Web Holdings Inc. and Irwin Naturals.
The Council for Responsible Nutrition (CRN) President and CEO Steve Mister said the organization “is extremely disappointed” by the FDA’s decision.
“FDA has wrongly mischaracterized these products as the same article as a prescription drug and has ignored, dismissed, and downplayed ample evidence that these full-spectrum hemp products can be marketed in a manner that is reasonably expected to be safe. Meanwhile, the agency has done little to protect consumers from the unregulated marketplace it has created from more than two years of inaction.”— Mister in a press release
Mister pointed out that equating the full spectrum extract to the pharmaceutical drug, Epidiolex, was incorrect because the drug “is a highly concentrated CBD isolate that contains 10 times more CBD than either of the full-spectrum hemp ingredients and plainly is not the same article supplement companies are producing.”
In a statement to Forbes, Charlotte’s Web Chief Executive Officer Deanie Elsner, said that while the company disagrees with the agency’s reasoning, the “decision affirms the path to regulatory clarity must come from Congress.”
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FDA Rejects CBD Brands Marketed as Dietary Supplements