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Simply E-Juice was warned that its e-liquid products, which are tobacco products under FDA jurisdiction, were being manufactured and offered for sale without required premarket authorization orders. The company failed to comply with the Family Smoking Prevention and Tobacco Control Act's requirement that "new tobacco products" obtain marketing authorization before being legally sold in the United States. The FDA determined that the e-liquids listed on the company's website did not have the necessary premarket approval required under Section 910 of the Federal Food, Drug, and Cosmetic Act.