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AMBI Enterprises LLC distributed unapproved skin bleaching products—AMBI® SKINCARE Fade Cream in OILY SKIN and NORMAL SKIN formulations—in violation of federal law requiring new drug approval before marketing. The products violated section 505(a) of the FD&C Act by being introduced into interstate commerce without FDA approval and were misbranded under section 502(ee), with labeling claims such as "fades dark spots" and listing hydroquinone 2% as a "skin bleaching agent" that established their intended drug use. The company marketed these products directly to consumers through its website, making claims about gradual fading of dark skin discolorations and visible results within two weeks.