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Clinical Formula LLC manufactured and distributed Clinical Formula™ Bleaching Lotion, an unapproved new drug product intended for skin bleaching and lightening that violated section 505(a) of the FD&C Act and was misbranded under section 502(ee). The product contained hydroquinone 2% and made explicit claims on its label for bleaching hyperpigmented skin conditions such as melasma and freckles, establishing it as a drug requiring FDA approval prior to marketing. The company introduced this unapproved drug product into interstate commerce without an approved new drug application, which is prohibited under the FD&C Act.