Nikte’s Wholesale, LLC – FDA Warning Letter, Jul 5, 2023

The FDA and FTC issued a Warning Letter to Mr. Villalobos regarding products sold on www.agrodine.com and www.cbdwarehouseusa.com, charged by Nikte’s Wholesale, LLC. The agencies reviewed the websites in January, May, and June 2023.

The FDA determined that Delta-8 Gushers, Delta-8 THC Lemonade 500mg, Medicated Jolly Rancher Gummies Sour, and Delta-8 THC Hot Cheetos products are adulterated under section 402(a)(2)(C)(i) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(i), because they contain an unsafe food additive (Delta-8 THC). Introducing adulterated food into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a). Delta-8 THC is not an approved food additive, nor is it generally recognized as safe (GRAS). The FDA expressed concerns about Delta-8 THC products not being evaluated for safe use, adverse event reports, psychoactive effects, manufacturing processes, and appeal to children.

The FTC cited Section 5 of the FTC Act, prohibiting unfair or deceptive marketing. The products' packaging mimics well-known snack brands (e.g., Gushers, Cheetos, Jolly