FDA WARNING_LETTER - Latro Inc. - June 03, 2025

The FDA issued a Warning Letter to Venkata Sasanka Pedapudi regarding human food products containing Delta-8 tetrahydrocannabinol (THC) sold on puredozo.com. The FDA reviewed the website in May and December 2024, and January 2025.

The primary violation is that the "Dozo D9 Smashers Peach Mango Delta-8" product is adulterated under section 402(a)(2)(C)(i) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 342(a)(2)(C)(i), because it contains an unsafe food additive, Delta-8 THC. Introducing adulterated food into interstate commerce is prohibited under section 301(a) of the Act, 21 U.S.C. 331(a).

Delta-8 THC is considered a food additive as it is not generally recognized as safe (GRAS) for use in food, nor is it subject to a prior sanction or any other exception. The FDA has serious concerns about Delta-8 THC products, including lack of evaluation for safe use, reported adverse events (including for this specific product), psychoactive effects, concerns about manufacturing processes, and appeal to children. Scientific literature review indicates potential adverse effects on central nervous and cardiopulmonary systems, and neurodevelopmental interference from gestational exposure.

The letter requires a