Last week, the Food and Drug Administration (the “FDA”) maintained its strict and narrow position on the legality of cannabidiol (“CBD”) by rejecting two new dietary ingredient (“NDI”) notifications submitted by Charlotte’s Web and Irwin Naturals. Both companies sought agency clearance to market their full-spectrum hemp extract as “dietary supplements.”
In its letters to these two major brands, the FDA pointed to two main reasons for its rejection:
Drug Exclusion Rule: Because CBD is an active ingredient in an approved pharmaceutical drug (e., Epidiolex), CBD is excluded from the definition of “dietary supplement” under the Federal Food, Drug and Cosmetic Act (the “FDCA”); and thus, cannot also be marketed as a dietary supplement. Insufficient Data: The FDA raised safety concerns about the sufficiency of the evidence provided by both companies. The agency specifically pointed out to: (a) the “vagueness” of the preclinical and clinical studies provided, which it deemed failed to adequately compare the history of use to the proposed conditions of use for the companies’ hemp extracts; and (b) the failure to sufficiently address certain toxicity endpoints, including reproductive toxicity.
The FDA’s conclusions are disappointing because both companies:
Addressed the distinction between a full-spectrum products like