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Mery Vape, a Japan-based company, was cited for offering electronic nicotine delivery system (ENDS) products for sale to U.S. customers without required premarket authorization. The company failed to comply with FDA regulations requiring "new tobacco products" containing nicotine from any source to obtain marketing authorization orders before being legally sold in the United States. The FDA determined that products listed on Mery Vape's website fall under FDA jurisdiction as tobacco products and must meet all applicable requirements under the Federal Food, Drug, and Cosmetic Act.