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Firehouse Vapes LLC d/b/a Zaelynn's Vape & CBD manufactured and distributed e-liquid tobacco products without required premarket authorization, violating the Family Smoking Prevention and Tobacco Control Act. The company failed to comply with FDA regulations for newly deemed tobacco products (effective August 8, 2016), which require e-liquids and electronic nicotine delivery systems to obtain premarket approval before commercial distribution in the United States. The FDA's inspection and review of the company's submissions determined that the e-liquid products were being manufactured and offered for sale without the legally mandated authorizations under the Federal Food, Drug, and Cosmetic Act.