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Amazon was cited for distributing unapproved new drug products—specifically "MÔOYAM TCA 50%" and "Skin Beauty Solutions lactic acid skin peel 90%"—through its Fulfillment by Amazon service in violation of sections 301(d) and 505(a) of the Federal Food, Drug, and Cosmetic Act. These chemical peel products lacked FDA approval despite being intended for use affecting body structure or function, and posed significant public health risks including skin burns, wounds, pain, swelling, scarring, and in some cases requiring emergency room care or surgical intervention. The FDA had received adverse event reports documenting injuries from these products before issuing the warning.