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Dream Vapor LLC sold and distributed electronic nicotine delivery system (ENDS) products without proper FDA authorization, violating the Family Smoking Prevention and Tobacco Control Act. The company failed to comply with requirements for new tobacco products under section 910 of the FD&C Act, which mandate premarket authorization orders before legally marketing ENDS products in the United States. This violation applied regardless of whether the nicotine was derived from tobacco or any other source, following the 2022 legislation that expanded FDA jurisdiction over all nicotine-containing products.