Singing Hawk LLC d/b/a Sin City Vapor Warning Letter Details

Summary

Singing Hawk LLC d/b/a Sin City Vapor, a Nevada-based e-liquid manufacturer, was cited for manufacturing and distributing tobacco products without required premarket authorization as mandated by the Family Smoking Prevention and Tobacco Control Act. The company's e-liquid products, containing nicotine from any source, were determined to be subject to FDA jurisdiction and required compliance with the Federal Food, Drug, and Cosmetic Act, particularly following the March 2022 legislative expansion of FDA authority over all nicotine-containing products regardless of source. The warning identified that the company failed to obtain the legally required premarket authorization orders necessary for new tobacco products to be marketed in the United States.