CBD may only find a legal path to market through legislation after the Food & Drug Administration (FDA) rejected two food safety applications by a pair of major U.S. sellers.
CBD makers Charlotte’s Web Holdings Inc., Louisville, Colorado, and Irwin Naturals of Los Angeles had their New Dietary Ingredients (NDI) applications rejected by FDA, which cited troubling justification in its reasoning.
First, the agency equated CBD in full-spectrum hemp supplements with concentrated CBD, such as that contained in Epidiolex, the only FDA-approved high-CBD drug. By doing so, the FDA is suggesting such CBD supplements should be available only by prescription.
The two companies had hoped their applications would help to establish CBD as a lawful dietary supplement. But FDA leaned on the “exclusionary clause” in the U.S. Food, Drug & Cosmetic Act, which prohibits supplements from containing pharmaceutical ingredients.
“CBD is the active ingredient in the approved drug product, Epidiolex. Furthermore, the existence of substantial clinical investigations involving CBD has been made public,” Cara Welch, acting director of the FDA’s Office of Dietary Supplement Programs, wrote in a letter to Charlotte’s Web. “Accordingly, your product may not be marketed as or in a dietary supplement.”
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.”
And in an 8-page response to the FDA, Charlotte’s Web pointed out differences between its full-spectrum extract and pharmaceutical CBD, an isolate that doesn’t contain other cannabinoids.
With the NDI approval process apparently putting the sector in danger, stakeholders now say that Congress should be called on to pass legislation clarifying CBD’s legal status.
The development puts into sharper focus a recently introduced bill that would make hemp-derived CBD legal as an ingredient in dietary supplements, foods and beverages. Proposed by three U.S. Senators, the Hemp Access and Consumer Safety Act would direct the FDA to update its rules accordingly.
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Published: August 16, 2021
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