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Custom Vapor Blends LLC was warned that its e-liquid products sold through its website were deemed tobacco products subject to FDA regulation under the Family Smoking Prevention and Tobacco Control Act, and the company failed to obtain required premarket authorization orders before marketing these products in the United States. The FDA determined that the e-liquids, as products made or derived from tobacco and intended for human consumption, constituted "new tobacco products" requiring marketing authorization under section 910 of the Federal Food, Drug, and Cosmetic Act, which the company had not obtained. The violation centered on the unlawful marketing of unapproved tobacco products without the necessary premarket compliance documentation.