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Confer With distributed Vivant True Tone, an unapproved skin-bleaching drug containing hydroquinone (2%) and vitamin A, in violation of section 505(a) of the FD&C Act and as a misbranded product under section 502(ee). The company's website and product labeling made drug claims by marketing the product to treat hyperpigmentation, melasma, dark spots, and age spots, establishing it as a drug requiring FDA approval rather than a cosmetic. The product was introduced into interstate commerce without an approved new drug application, constituting a violation of the FD&C Act's prohibitions on unapproved drugs and misbranded products.