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Talk to a SpecialistTalk to a SpecialistLA-ROYAL INC was cited for importing and distributing hookah tobacco products without the required premarket authorization under the Family Smoking Prevention and Tobacco Control Act. The company failed to comply with FDA regulations requiring "new tobacco products" to obtain premarket approval before being commercially marketed in the United States, with hookah tobacco products falling under FDA jurisdiction as tobacco products containing nicotine. The warning was issued following an FDA inspection that determined the company was importing these products and offering them for sale or distribution to customers in the United States without the necessary regulatory authorization.