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Vapor Sense LLC manufactured and distributed e-liquid products without obtaining required premarket authorization, violating the Family Smoking Prevention and Tobacco Control Act. The company's e-liquid products, which qualify as tobacco products under FDA jurisdiction since they contain nicotine derived from tobacco, were not in compliance with Federal Food, Drug, and Cosmetic Act requirements applicable to newly deemed tobacco products as of August 8, 2016. The FDA determined that the company was distributing these products commercially in the United States without the necessary premarket authorization required for new tobacco products under section 910(a)(2) of the FD&C Act.