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Einstein Vapes LLC was warned that its e-liquid products are tobacco products subject to FDA regulation under the Family Smoking Prevention and Tobacco Control Act, as they are made from tobacco and intended for human consumption. The company failed to obtain required premarket authorization for its "new tobacco products" as mandated by section 910(a) of the Federal Food, Drug, and Cosmetic Act. The products were found to be adulterated and/or misbranded in violation of applicable tobacco regulations.