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Meddle Vapes manufactured and distributed e-liquid tobacco products without registering its manufacturing establishment as required by the Federal Food, Drug, and Cosmetic Act. The company failed to comply with FDA regulations governing tobacco products that were deemed subject to FDA jurisdiction in 2016, specifically violating section 905(c) of the FD&C Act by operating an unregistered manufacturing facility in Irving, Texas. This violation rendered the e-liquid products misbranded under federal law.