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RNJ Field Inc d/b/a Thunderhead Corporation Fife manufactured and sold e-liquid tobacco products through its website without required premarket authorization from the FDA. The company failed to comply with the Family Smoking Prevention and Tobacco Control Act by marketing "new tobacco products" that were not commercially available as of February 15, 2007, without obtaining the legally required marketing authorization orders. E-liquids, classified as tobacco products under FDA jurisdiction since the August 8, 2016 deeming rule, must meet all Federal Food, Drug, and Cosmetic Act requirements prior to commercial distribution in the United States.