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Wild Bill's Tobacco of Alpena LLC was cited for selling and distributing electronic nicotine delivery system (ENDS) products without required premarket authorization from the FDA. The company failed to comply with the Federal Food, Drug, and Cosmetic Act requirements applicable to tobacco products, which include any product containing nicotine from any source intended for human consumption. Under FDA jurisdiction established in 2022, "new tobacco products" must obtain premarket authorization orders before legal marketing in the United States, a requirement the company had not met.