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Southbound Vapes manufactured and distributed e-liquid products without obtaining required premarket authorization as a "new tobacco product" under the Family Smoking Prevention and Tobacco Control Act, violating section 910 of the Federal Food, Drug, and Cosmetic Act. The FDA determined that the company's e-liquid products, which are derived from tobacco and intended for human consumption, qualified as deemed tobacco products subject to FDA jurisdiction since August 8, 2016, but were being sold without the mandatory marketing authorization order. The company failed to comply with applicable requirements for electronic nicotine delivery systems under FDA tobacco product regulations.