Recently, on July 21, 2021, the U.S. Food and Drug Administration (“Agency” or “FDA”) denied a new dietary ingredient (“NDI”) notification filed by Charlotte’s Web for full spectrum hemp extract containing cannabidiol (“CBD”). FDA’s rejection is based on two folds: (i) CBD is the active ingredient in Epidiolex, the only FDA-approved cannabis-derived drug; and (ii) NDI notifications were not supported by sufficient data regarding hepatotoxicity and reproductive toxicity. While this is another setback for CBD manufacturers, it also sheds light on the FDA’s regulatory stance on CBD-containing dietary supplements.
This latest decision by the Agency is in line with its narrow and strict view on the data pertaining to the safety of the use of CBD products. More specifically, the FDA indicated in a letter to Charlotte’s Web that its two-year marketing data is “evidence of history use, which is insufficient to establish the safety of [the] ingredient when used under the proposed conditions of use” and that “none of the clinical and pre-clinical studies that you provided adequately address certain reported toxicity endpoints of CBD such as hepatotoxicity and reproductive toxicity.” Most notably, in the letter, the FDA reiterated that it “has concluded that CBD products are excluded from the dietary supplement definition under 21 U.S.C. § 321(ff)(3)(B) (section 201(ff)(3)(B) of the Act).” Notwithstanding, it is worth noting that the FDA’s enforcement actions has been limited to instances where health claims were made.
How Frier Levitt Can Help
Regulation of hemp and its derivative products remains mired in a jumble of conflicting state and federal law. Stakeholders, ranging from manufacturers to retailers, must remain compliant. If your company handles hemp and its derivatives, contact Frier Levitt today to speak to an attorney.
