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Great Vapes, an e-liquid manufacturer in Texas, was found to be manufacturing and distributing tobacco products containing nicotine without the required premarket authorization mandated by the Federal Food, Drug, and Cosmetic Act. The company's e-liquid products fell under FDA jurisdiction as tobacco products under the expanded definition that includes all products containing nicotine from any source, effective April 14, 2022. Great Vapes failed to obtain premarket approval for these "new tobacco products" before offering them for commercial sale in the United States, violating section 910(a) of the FD&C Act and applicable implementing regulations.