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Skin Authority, L.L.C. distributed skinauthority® Hyperpigmentation Treatment, a skin bleaching drug containing 2% hydroquinone, without FDA approval in violation of section 505(a) of the FD&C Act. The product was also misbranded under section 502(ee) of the FD&C Act, with labeling claims such as "Skin Lightener" and "Whitening Agent" that established its intended use for fading spots and hyperpigmentation without regulatory authorization. The product fell under section 505G of the FD&C Act, which specifically governs nonprescription skin bleaching drugs and requires approved applications for marketing.