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

Summary

Singing Hawk LLC d/b/a Sin City Vapor III, a Nevada-based e-liquid manufacturer, was warned that its nicotine-containing vaping products constitute tobacco products under FDA jurisdiction and require premarket authorization to be legally marketed in the United States. The company had manufactured and distributed e-liquid products without obtaining required premarket authorization orders, violating the Federal Food, Drug, and Cosmetic Act's new tobacco product requirements. The warning came following FDA review of the company's submissions and inspection records, and notably referenced the March 2022 legislative expansion of FDA's tobacco product definition to include products containing nicotine from any source, not just tobacco-derived nicotine.