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The 505 Vapor Room, LLC manufactured and distributed e-liquid products without obtaining required premarket authorization from the FDA, violating the Family Smoking Prevention and Tobacco Control Act. The company's e-liquid products, which qualify as tobacco products under FDA jurisdiction as electronic nicotine delivery systems, failed to comply with FD&C Act requirements that mandate premarket approval for any "new tobacco products" not commercially marketed in the United States prior to February 15, 2007. The inspection found the company was distributing these unapproved tobacco products for commercial sale to customers throughout the United States without the necessary regulatory clearance.