Kingdom Tobacco LLC – FDA Warning Letter, Mar 2, 2023

The FDA issued a Warning Letter to Kingdom Tobacco LLC on March 2, 2023, after reviewing submissions and inspection records, determining the company manufactures, imports, and distributes pipe tobacco products in the U.S. These products, including Kingdom Dokha Bahja, Farid, Dawa, Aljana Premium, Nara Premium, and Ultra Premium Wahid pipe tobaccos, are deemed "new tobacco products" under section 910(a) of the FD&C Act because they were not commercially marketed before February 15, 2007. The company lacks the required FDA marketing authorization orders or exemptions for these products. Consequently, the products are adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the absence of required premarket authorization and failure to provide necessary reports under section 905(j). The introduction of these adulterated and misbranded products into interstate commerce, and the failure to provide required reports, constitute prohibited acts under sections 301(a) and 301(p) of the FD&C Act. Kingdom Tobacco LLC must take prompt action to address these violations and bring its products into compliance. A written response detailing corrective actions, including dates of discontinued sales and a compliance plan, is required within 15 working days. Failure to comply may result in regulatory actions such as civil money penalties, seizure, or injunction, and imported products may be detained or refused admission.