Loading…
TKO Distribution, LLC was cited for distributing adulterated human food products containing Delta-8 THC—specifically Trippy Smak'd Fuk'd Blend Gummies in watermelon, pineapple, and grape flavors—which the FDA determined contained unsafe food additives under the Federal Food, Drug, and Cosmetic Act. The company violated FDA regulations by introducing these unapproved cannabinoid products into interstate commerce via its website (tkodistro.com) without safety evaluation or authorization. The FDA's enforcement action reflected broader concerns about Delta-8 THC products marketed without FDA approval, potential psychoactive effects, adverse event reports, manufacturing process safety, and child-appealing packaging that poses public health risks.