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Hubbly Bubbly LLC, d/b/a Trifecta Tobacco, a hookah tobacco manufacturer in Spokane, Washington, was cited for manufacturing and distributing tobacco products without required premarket authorization under the Family Smoking Prevention and Tobacco Control Act. The company's hookah tobacco products, containing nicotine from tobacco or other sources, were found to be in violation of Federal Food, Drug, and Cosmetic Act requirements for new tobacco products, which mandate premarket approval before legal U.S. marketing. The warning emphasized that hookah tobacco products fall under FDA jurisdiction and must comply with all applicable tobacco product regulations, including the expanded definition of tobacco products that now includes those containing nicotine from any source following the 2022 legislative amendment.