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Vapor Salon manufactured and distributed e-liquid products containing nicotine without the required premarket authorization, violating the Federal Food, Drug, and Cosmetic Act. The company failed to comply with FDA tobacco product regulations under section 901(b) of the FD&C Act, which requires "new tobacco products" to obtain premarket approval before legal marketing in the United States. The violation was particularly significant given that the March 2022 legislation expanded FDA jurisdiction to cover nicotine from any source, not just tobacco-derived nicotine, making Vapor Salon's products subject to stricter regulatory oversight.