FDA WARNING_LETTER - STNR Creations, LLC - March 31, 2025

STNR Creations, LLC received a Warning Letter from the U.S. Food and Drug Administration (FDA) on July 16, 2025, following a website review in March 2025. The FDA found the company was marketing human food products, including gummies, candy clusters, cookies, and brownies, represented as containing Delta-8 tetrahydrocannabinol (THC). These products were deemed adulterated under section 402(a)(2)(C)(i) of the Federal Food, Drug, and Cosmetic Act because Delta-8 THC is considered an unsafe food additive. The FDA states that Delta-8 THC has not been approved for use in food, nor is it Generally Recognized As Safe (GRAS). The agency cited serious health concerns associated with Delta-8 THC, including its psychoactive effects, potential for harm to the central nervous and cardiopulmonary systems, and risks to neurodevelopment, along with concerns about marketing that could appeal to children. Introducing these adulterated foods into interstate commerce is prohibited under section 301(a) of the Act. STNR Creations, LLC is responsible for investigating these violations, ensuring compliance with the Act, and preventing their recurrence.