FDA WARNING_LETTER - KOI CBD, LLC - December 15, 2022

The FDA issued a Warning Letter to Koi CBD following a website review (June-July 2023) and an inspection of their Norwalk, CA facility (December 12-15, 2022). The letter states that Koi CBD's "Delta 8 Gummies" and Hemp Living "Pot Rocks" are adulterated under section 402(a)(2)(C)(i) of the FD&C Act because they contain Delta-8 THC, an unsafe food additive.

Delta-8 THC is not approved as a food additive, nor is it generally recognized as safe (GRAS). The FDA is unaware of any prior sanction or basis for GRAS status for Delta-8 THC in food, citing concerns about potential harm to the central nervous and cardiopulmonary systems, and neurodevelopmental interference from gestational exposure. Introducing adulterated food into interstate commerce is prohibited under section 301(a) of the FD&C Act.

The FDA expressed serious concerns about Delta-8 THC products, including lack of evaluation/approval, adverse event reports, psychoactive effects, manufacturing processes, and appeal to children. Koi CBD must notify the FDA in writing within fifteen working days of receipt of the letter, detailing corrective actions taken to address violations and prevent recurrence, or provide a reason for delay and a timeline for completion. Failure to comply may result in legal action, including seizure and injunction.