Quality Wholesale STL, LLC – FDA Warning Letter, Oct 1, 2025

On October 23, 2025, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to Quality Wholesale STL, LLC, based on a review of their records. The company was cited for unlawfully selling and distributing electronic nicotine delivery system (ENDS) products, specifically mentioning "YOVO STARWALK WATERMELON ICE 5% 20ml," which lack the required premarket authorization.Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), particularly section 201(rr) which broadly defines tobacco products to include nicotine from any source, these ENDS items are classified as "new tobacco products." According to section 910(a) of the FD&C Act, new tobacco products must have premarket authorization to be legally marketed in the United States, as they were not commercially available before February 15, 2007, and do not possess an FDA marketing order or an exemption. The absence of this authorization renders the products adulterated and misbranded under sections 902(6)(A) and 903(a)(6) of the FD&C Act.Quality Wholesale STL, LLC must submit a written response within 15 working days. The company is required to detail actions taken to address these violations, including the dates when the sale and distribution of the non-compliant products ceased, and outline a plan for ensuring future compliance with the FD&C Act. Failure to comply could lead to further regulatory actions, such as civil money penalties, product seizure, or injunctions.