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Quality Wholesale STL, LLC was cited for selling and distributing electronic nicotine delivery system (ENDS) products without proper FDA authorization. The company failed to comply with Federal Food, Drug, and Cosmetic Act requirements, which mandate that "new tobacco products"—including ENDS products containing nicotine from any source—obtain premarket authorization orders before legal marketing in the United States. The violations fell under the Family Smoking Prevention and Tobacco Control Act and involved both adulterated and misbranded product violations.