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Tombak LLC was warned for manufacturing and selling smokeless tobacco products, specifically Tombak Loose Leaf Chewing Tobacco (unflavored), without required premarket marketing authorization. The FDA determined that these products qualified as "new tobacco products" under the Federal Food, Drug, and Cosmetic Act and therefore were adulterated and misbranded for lacking the required marketing authorization order or substantial equivalence determination. The company had failed to submit either a premarket approval application under section 910(c) of the FD&C Act or a substantial equivalence report under section 905(j) before offering these products for sale in the United States.