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Skull and Roses Juice Co. LLC was cited for manufacturing and selling e-liquid tobacco products without required premarket authorization orders as mandated under the Family Smoking Prevention and Tobacco Control Act. The FDA determined that the company's e-liquids, offered through websites skullandrosesjuiceco.com and mellowvape.com, met the definition of tobacco products subject to FDA jurisdiction but lacked the necessary marketing authorization to be legally distributed in the United States. The violations stemmed from the company's failure to comply with section 910 of the Federal Food, Drug, and Cosmetic Act, which requires all "new tobacco products" to obtain premarket approval before commercial marketing.