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Amazon.com distributed multiple products through its Fulfillment by Amazon service that were labeled as energy-enhancing supplements or foods but contained undeclared pharmaceutical ingredients—specifically sildenafil and tadalafil—making them unapproved new drugs and misbranded products in violation of the Federal Food, Drug, and Cosmetic Act. Products including "MANNERS Energy Boost," "Round 2," "WeFun," "Genergy," "Big Guys Male Energy Supplement," "Mens Maximum Energy Supplement," and "X Max Triple Shot Energy Honey" were confirmed through FDA laboratory analysis to contain these active pharmaceutical ingredients not listed on their labeling. The company was held responsible for introducing these products into interstate commerce without FDA approval and without proper declaration of their drug components.