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Good Karma Cigar LLC, a pipe tobacco manufacturer based in Amarillo, Texas, was cited for manufacturing and distributing tobacco products that were not in compliance with the Federal Food, Drug, and Cosmetic Act. The company failed to obtain required premarket authorization orders for "new tobacco products" as mandated under section 910 of the FD&C Act, and did not comply with FDA regulations governing tobacco products containing nicotine from any source following the March 2022 legislative expansion of FDA jurisdiction. The inspection found that the company's pipe tobacco products lacked the legally required marketing authorization to be sold in the United States.