Loading…
Vape NV LLC manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization, violating the Family Smoking Prevention and Tobacco Control Act and the Federal Food, Drug, and Cosmetic Act. The company failed to comply with FDA regulations for newly deemed tobacco products, which have been subject to FDA jurisdiction since August 8, 2016, and are required to obtain marketing authorization orders before commercial distribution. The products at issue were e-liquids derived from tobacco and intended for human consumption, which fall under the definition of regulated tobacco products.