KOS Distribution LLC – FDA Warning Letter, Aug 12, 2025

The FDA issued a warning letter to TKO Distro, located at 2500 S Park Rd. Unit 3, Hallandale Beach, FL, on April 17, 2025, following a review of their website in March 2025. The inspection revealed that the company markets and sells human food products containing Delta-8 tetrahydrocannabinol (THC), specifically Trippy Smak’d Fuk’d Blend Gummies in watermelon, pineapple, and grape flavors. These products are deemed adulterated under section 402(a)(2)(C)(i) of the Federal Food, Drug, and Cosmetic Act because they contain an unsafe food additive.

The FDA highlighted several concerns: Delta-8 THC products have not been evaluated or approved for safe use, may pose public health risks, and have been associated with adverse events. The psychoactive effects of Delta-8 THC, along with its appealing packaging to children, further exacerbate these concerns. The FDA also noted that Delta-8 THC does not meet the Generally Recognized as Safe (GRAS) criteria and lacks premarket approval, making its use in food products unlawful.

TKO Distro is required to address these violations by notifying the FDA in writing within fifteen working days, detailing corrective actions taken to prevent recurrence. Failure to comply may result in legal actions, including seizure and injunction. The FDA also cautioned against the use of other cannabinoids in food products, as no cannabinoid is approved as a food additive or meets GRAS criteria.