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smokewonderland.com was cited for offering electronic nicotine delivery system (ENDS) products for sale on its website without the required premarket authorization from the FDA's Center for Tobacco Products. The company failed to comply with Federal Food, Drug, and Cosmetic Act requirements that mandate new tobacco products—including ENDS containing nicotine from any source—obtain premarket approval before being legally marketed in the United States. The warning addressed products listed on the company's website that were being distributed to U.S. customers without the necessary regulatory authorization.