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Talk to a SpecialistTalk to a Specialist5th & Nine Co. d/b/a 5th & Nine Alternatives Co. manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization from the FDA. The company's e-liquid products, which contain nicotine and fall under FDA jurisdiction as deemed tobacco products since August 2016, were found to be in violation of the Federal Food, Drug, and Cosmetic Act requirements for "new tobacco products." The FDA determined that these products lacked the necessary premarket approval required under section 901(b) of the FD&C Act before being offered for sale or distribution in the United States.