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Stuff-N-Puffs 102, LLC manufactured and distributed e-liquid tobacco products containing nicotine without required FDA premarket authorization, violating the Federal Food, Drug, and Cosmetic Act and FDA regulations governing tobacco products. The company failed to comply with FDA requirements for "new tobacco products," which mandate premarket authorization before legal commercial distribution in the United States. This violation occurred under the expanded FDA jurisdiction that took effect in 2022, which extended regulatory authority to products containing nicotine from any source, not just tobacco-derived nicotine.