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Rochester Smoke Shop Inc was warned for manufacturing and distributing e-liquid products containing nicotine without required premarket authorization, violating the Family Smoking Prevention and Tobacco Control Act. The FDA determined that the company's e-liquid products qualified as tobacco products under expanded FDA jurisdiction that includes products containing nicotine from any source (effective March 15, 2022), and therefore required premarket approval to be legally marketed in the United States. The inspection revealed that Rochester Smoke Shop Inc had failed to obtain the necessary authorization before offering these products for commercial distribution.