Loading…
Dominant Vapor, LLC was cited for manufacturing and distributing e-liquid tobacco products without required premarket authorization orders, in violation of the Family Smoking Prevention and Tobacco Control Act. The FDA determined that the company's e-liquid products listed on its website met the definition of "new tobacco products" subject to FDA jurisdiction as of the August 8, 2016 deeming rule, but lacked the legally required marketing authorization to be sold in the United States. The company failed to comply with section 910 of the Federal Food, Drug, and Cosmetic Act, which mandates premarket approval for any tobacco product not commercially marketed before February 15, 2007, or any modified product marketed thereafter.