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Cloud Dreams, Inc. dba Rx Vape manufactured and sold e-liquid tobacco products containing nicotine without obtaining required premarket authorization orders from the FDA, in violation of the Family Smoking Prevention and Tobacco Control Act. The company's products, marketed through rxvape.com, failed to comply with FDA regulations governing new tobacco products, which require premarket approval before legal U.S. distribution. This violation was particularly significant because it occurred after March 15, 2022, when FDA jurisdiction expanded to include all products containing nicotine from any source, not just tobacco-derived nicotine.