FDA WARNING_LETTER - Delta Munchies LLC - July 05, 2023

The FDA and FTC issued a Warning Letter to Mr. Hoang for Delta-8 THC products sold on deltamunchies.com, following reviews in March and June 2023. The FDA determined that Delta-8 THC gummy products, such as "Sour Worms" and "Gummy Bears," are adulterated under 21 U.S.C. 342(a)(2)(C)(i) because Delta-8 THC is an unsafe food additive, lacking GRAS status and premarket approval. Introducing these adulterated foods into interstate commerce is prohibited by 21 U.S.C. 331(a). FDA highlighted concerns about the products' unapproved status, reported adverse events, psychoactive effects, and their appeal to children due to mimicking traditional snack foods.

The FTC identified that the marketing and packaging of these Delta-8 THC gummies, with bright colors and fruity flavors, are designed to appeal to children and imitate conventional candies. This practice constitutes unfair or deceptive acts under Section 5 of the FTC Act, posing unwarranted health and safety risks, particularly to young children.

The firm must notify FDA and FTC in writing within fifteen working days, detailing specific corrective actions taken to address all violations and prevent recurrence. This includes immediately ceasing marketing edible Delta-8 THC products that imitate conventional foods appealing to children. Failure to comply may lead to legal action, including seizure and injunction.