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Hot Grabba LLC d/b/a Buttas Hot Grabba manufactured and distributed roll-your-own tobacco products without obtaining required premarket authorization, violating the Family Smoking Prevention and Tobacco Control Act and the Federal Food, Drug, and Cosmetic Act. The company failed to comply with FDA regulations governing newly deemed tobacco products, which require premarket authorization for any tobacco product not commercially marketed in the United States as of February 15, 2007. The inspection revealed that the products were being manufactured and offered for sale or distribution to customers without the legally mandated premarket approval in effect.