Applications by Charlotte’s Web Holdings Inc. and Irwin Naturals seeking to sell CBD hemp extracts as dietary supplements have been denied by the U.S. Food and Drug Administration.
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.”
“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,” said Steve Mister President and CEO of The Council for Responsible Nutrition. “Meanwhile, the agency has done little to protect consumers from the unregulated marketplace it has created from more than two years of inaction.” CBD is often sold as edibles or in tincture bottles.
Mister’s argument is 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.”
“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 Chief Executive Officer Deanie Elsner said in a statement.
The market for CBD products has grown to more than $6 billion as consumers seek help with relaxation, focus, and better sleep. Aside from sporadic crackdowns on companies that try to make unsubstantiated claims about their health benefits, sales are unregulated and products inhabit a “grey area” in the marketplace.