Hemp Today reports
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.
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FDA signals it will treat all CBD as drugs, heightening urgency of legislation
