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Nubilus Vapor, LLC was warned that its e-liquid products containing nicotine are tobacco products subject to FDA jurisdiction and must comply with the Federal Food, Drug, and Cosmetic Act. The company failed to obtain premarket authorization for these "new tobacco products" as required under section 910 of the FD&C Act, and was distributing e-liquid products for commercial sale without proper FDA approval. The warning noted that FDA's jurisdiction over nicotine-containing products expanded in March 2022 to include products made from non-tobacco nicotine sources, establishing that Nubilus Vapor's products fell under federal tobacco product regulations regardless of their nicotine source.