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Raven Route was cited for offering electronic nicotine delivery system (ENDS) products for sale on its website without required premarket authorization, violating the Federal Food, Drug, and Cosmetic Act. The company failed to comply with FDA regulations requiring "new tobacco products" to obtain a marketing authorization order before legal distribution in the United States. This violation applied to all ENDS products containing nicotine from any source, including those derived from non-tobacco sources under the expanded definition enacted in March 2022.