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Session Supply Co. manufactured and distributed e-liquid tobacco products through its website without obtaining required premarket authorization orders, in violation of the Family Smoking Prevention and Tobacco Control Act and the Federal Food, Drug, and Cosmetic Act. The FDA determined that the company's e-liquids qualified as "new tobacco products" subject to FDA jurisdiction under section 910 of the FD&C Act, requiring premarket approval before legal U.S. marketing. The company failed to comply with applicable tobacco product regulations governing the sale and distribution of electronically heated nicotine delivery systems.