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Half Moon Mods LLC, a manufacturer of electronic nicotine delivery systems (ENDS), was found to be distributing tobacco products without required premarket authorization as mandated under the Family Smoking Prevention and Tobacco Control Act. The company failed to comply with FDA regulations requiring "new tobacco products" to obtain premarket approval before commercial distribution in the United States. As ENDS products were deemed subject to FDA jurisdiction effective August 8, 2016, Half Moon Mods LLC's continued manufacturing and sale of these products without proper authorization constituted violations of the Federal Food, Drug, and Cosmetic Act.