The U.S. Food and Drug Administration (FDA) has recently published a warning letter dated April 17, 2025, concerning the sale of various food and otherwise edible products containing Delta-8 tetrahydrocannabinol (delta-8 THC). FDA determined that such products may be classified as adulterated under the Federal Food, Drug, and Cosmetic Act due to the presence of an unsafe food additive, as Delta-8 THC lacks the necessary premarket approval and is not recognized as safe for consumption in food products.

This is not the first instance of the FDA addressing concerns related to Delta-8 THC; previous warning letters have been sent to other companies for similar violations regarding the safety and legality of these products. In this latest letter, FDA again expressed serious health concerns associated with Delta-8 THC, including its psychoactive effects and potential risks to public health, particularly for children. As such, FDA has mandated that companies involved in the production or sale of these products take immediate corrective actions.

It is crucial for your company to review its compliance with federal regulations regarding the safety and marketing of cannabinoid-infused edible products, as failure to do so may result in legal action, including potential product seizures and injunctions. Buchanan’s experienced FDA & Biotechnology Team, Cannabis Industry Group and Life Sciences Industry Group are here to help.