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10.1081/jas-120023580 J

by selling or distributing them as modified risk tobacco products without an FDA order in effect that permits such sale or distribution. Prior to sending the Warning Letter, the FDA reviewed testimony from the July 24-25, 2019 House Subcommittee hearing, documents from FDAs inspection of JUULs headquarters, JUULs submissions to the FDA, and JUULs website, and found that JUUL has engaged in labeling, advertising, and/or other activities directed to consumers, in which JUUL explicitly and/or implicitly has represented that JUUL products are free of a substance, have a reduced level of or exposure to a substance, and/or that JUUL products present a lower risk of tobacco-related disease or are less harmful than one or more other commercially marketed tobacco products