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180 Vape E-Cigs & Lounge manufactured and distributed e-liquid tobacco products without required premarket authorization, violating the Family Smoking Prevention and Tobacco Control Act. The company failed to comply with FDA regulations governing deemed tobacco products, which require "new tobacco products" (those not commercially marketed before February 15, 2007) to obtain marketing authorization before sale or distribution in the United States. The FDA determined that the e-liquid products met the definition of tobacco products subject to FDA jurisdiction but lacked the necessary premarket approval required under section 910(a) of the Federal Food, Drug, and Cosmetic Act.