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Yogi's Vape Hays manufactured and distributed e-liquid tobacco products without the required premarket authorization mandated by the Family Smoking Prevention and Tobacco Control Act. The company failed to comply with FDA regulations governing newly deemed tobacco products, specifically electronic nicotine delivery systems that became subject to FDA jurisdiction as of August 8, 2016. The products were deemed adulterated and misbranded under the Federal Food, Drug, and Cosmetic Act for lacking proper marketing authorization and compliance documentation.