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Neoteric Cosmetics, Incorporated distributed ALPHA® SKIN CARE Dual Action Fade Cream, a skin bleaching product containing 2% hydroquinone and 10% glycolic acid, 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, as the company made drug claims on product labeling and its website describing the product as a "skin lightener" intended to fade dark spots, freckles, age spots, and liver spots, establishing it as a drug requiring pre-market approval. The unapproved distribution of this product into interstate commerce violated the FD&C Act's prohibition on introducing new drugs without agency authorization.