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Ohm Men Vape Shop LLC was warned for manufacturing and distributing e-liquid tobacco products without obtaining required premarket authorization, as e-liquids are deemed tobacco products subject to FDA regulation under the Family Smoking Prevention and Tobacco Control Act since August 8, 2016. The company failed to comply with Federal Food, Drug, and Cosmetic Act requirements applicable to "new tobacco products," which require marketing authorization before commercial distribution. The violations involved selling e-liquid products that lacked the necessary premarket approvals mandated for tobacco products not commercially marketed prior to February 15, 2007.