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Castle Rock Vapor LLC was cited for manufacturing and selling e-liquid tobacco products without obtaining required premarket authorization orders as mandated by the Family Smoking Prevention and Tobacco Control Act. The FDA determined that e-liquids sold through the company's website were deemed tobacco products subject to FDA jurisdiction under the Federal Food, Drug, and Cosmetic Act, and as "new tobacco products," they required premarket approval before being legally marketed in the United States. The company had failed to comply with these regulatory requirements for product authorization prior to commercial distribution.