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Koi CBD, LLC was cited for manufacturing and distributing adulterated human food products, specifically Delta-8 THC gummies and related products, which violated the Federal Food, Drug, and Cosmetic Act by containing unsafe food additives that had not been evaluated or approved by FDA for safe use. The FDA's inspection of the company's Norwalk, California facility and review of its website identified serious safety concerns including the lack of FDA approval for Delta-8 THC products, reports of adverse events, psychoactive and intoxicating effects of the cannabinoid, questionable manufacturing processes used to create Delta-8 concentrations, and particular risk to children from the products' packaging and labeling. The agency determined that introducing or delivering these adulterated products into interstate commerce constituted a prohibited act under federal law.