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Heights Vapor Station was warned for manufacturing and distributing e-liquid tobacco products without the required premarket authorization under the Family Smoking Prevention and Tobacco Control Act. The FDA determined that the company's e-liquid products, as electronic nicotine delivery systems, are deemed tobacco products subject to FDA jurisdiction and must comply with Federal Food, Drug, and Cosmetic Act requirements, including obtaining premarket approval for new tobacco products before commercial distribution. The inspection and submission review revealed that Heights Vapor Station was operating without the necessary regulatory authorization to legally market these products in the United States.