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Little Town Vaping d/b/a Swamp Vapor Lafayette manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization from the FDA, in violation of section 910 of the Federal Food, Drug, and Cosmetic Act. The company's e-liquid products, classified as newly deemed tobacco products under the August 8, 2016 deeming rule, required a marketing authorization order prior to commercial distribution but were sold without this approval. The FDA determined the products were adulterated and misbranded under the Family Smoking Prevention and Tobacco Control Act.