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Agera Tobacco, Inc. was warned for manufacturing and distributing hookah tobacco products without obtaining required premarket authorization under the Family Smoking Prevention and Tobacco Control Act. The company's hookah tobacco products, deemed subject to FDA jurisdiction as of August 8, 2016, were found to be in violation of Federal Food, Drug, and Cosmetic Act requirements that mandate new tobacco products obtain premarket approval before commercial distribution in the United States. The warning letter indicated that Agera Tobacco failed to comply with applicable regulations governing newly deemed tobacco products, specifically those products that were not commercially marketed in the U.S. as of February 15, 2007.