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

Summary

Singing Hawk LLC d/b/a Sin City Vapor II, a Las Vegas-based e-liquid manufacturer, was cited for distributing tobacco products without required premarket authorization under the Family Smoking Prevention and Tobacco Control Act. The company manufactured and sold e-liquid products (electronic nicotine delivery systems) that meet the FDA's definition of tobacco products but failed to obtain the necessary "new tobacco product" premarket approval required by the Federal Food, Drug, and Cosmetic Act as of the August 8, 2016 deeming rule. The FDA determined the products were being manufactured and distributed for commercial sale in the United States without compliance with applicable tobacco product regulations.