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Lecig Enterprises Inc manufactured and distributed e-liquid products for electronic nicotine delivery systems without required premarket authorization, violating the Family Smoking Prevention and Tobacco Control Act. The company's e-liquid products qualified as "new tobacco products" under FDA jurisdiction but lacked the mandatory marketing authorization that has been required for such products since the August 8, 2016 deeming rule. The FDA determined the products were adulterated and misbranded under the Federal Food, Drug, and Cosmetic Act due to these missing premarket compliance requirements.