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DNA Distributors, Inc. d/b/a Just Juice manufactured and sold e-liquid tobacco products containing nicotine without obtaining required premarket authorization from the FDA. The company's products, listed on their website justjuiceusa.com, failed to comply with the Federal Food, Drug, and Cosmetic Act requirements for new tobacco products, which mandate premarket approval before legal marketing in the United States. This violation occurred after March 15, 2022, when the FDA's jurisdiction expanded to cover all products containing nicotine from any source, not just tobacco-derived nicotine.