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La Crosse Smokes 4 Less 1 Inc. manufactured and distributed e-liquid tobacco products containing nicotine 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, including those containing nicotine from any source following the March 2022 legislative expansion of FDA's jurisdiction. The warning specifically addressed the company's violation of section 901(b) of the FD&C Act and implementing regulations at 21 C.F.R. § 1100.1, which mandate premarket authorization before marketing new tobacco products in the United States.