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HRE Investments LLC d/b/a Vaporifics manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization from the FDA, violating the Family Smoking Prevention and Tobacco Control Act. The company's e-liquid products, classified as electronic nicotine delivery systems under FDA jurisdiction since August 2016, were found to be in violation of Federal Food, Drug, and Cosmetic Act requirements for "new tobacco products" that must receive premarket approval before commercial distribution. The warning identified that these products were being manufactured and sold in the United States without the necessary compliance documentation or regulatory authorization.