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Cloud House Vape manufactured and distributed e-liquid tobacco products without required premarket authorization as mandated under the Family Smoking Prevention and Tobacco Control Act. The company failed to comply with FDA regulations for "new tobacco products," which require marketing authorization orders under section 910 of the Federal Food, Drug, and Cosmetic Act before commercial distribution in the United States. As e-liquids are deemed tobacco products under the August 8, 2016 FDA Final Rule, Cloud House Vape's products were subject to FDA jurisdiction but lacked the necessary premarket approval to legally market them.