On November 16, 2022, the Food and Drug Administration (FDA) issued five new warning letters to various companies making edible products containing cannabidiol (CBD) and/or Delta-8-tetrahydrocannabinol (THC). The companies were directed by the FDA to respond within 15 days to defend how their products do not violate the Food, Drug, and Cosmetic Act (FDCA) and how they plan to bring their products into compliance with the FDCA. Failure to address the issue to the agency’s satisfaction could plausibly result in enforcement actions, including seizure and/or an injunction.
The FDA’s most recent set of warning letters builds upon warning letters sent earlier this year targeting CBD and Delta-8 THC products. Previously, FDA has largely focused on CBD products that made health claims. These new warning letters are not, however, limited to those prior concerns. The FDA now appears to be particularly concerned about CBD and Delta-8 THC products that appeal to children.