Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistSweis Global LLC was warned for manufacturing and distributing hookah tobacco products without required premarket authorization as a "new tobacco product" under the Family Smoking Prevention and Tobacco Control Act. The company failed to comply with FDA regulations requiring tobacco products to obtain premarket approval before being legally marketed in the United States, a requirement that applies to hookah tobacco products containing nicotine from any source following the 2022 legislative expansion of FDA's tobacco jurisdiction. The FDA determined the products were being manufactured and offered for sale or distribution in the United States without the mandated compliance documentation and authorization.