FDA issues proposed rule for OTC skin bleaching products

September 18, 2006

The FDA has issued a notice of proposed rulemaking that would establish that OTC skin bleaching drug products are not generally recognized as safe and effective and are misbranded.

The FDA has issued a notice of proposed rulemaking that would establish that OTC skin bleaching drug products are not generally recognized as safe and effective and are misbranded. The agency is issuing this proposed rule after considering new data and information on the safety of hydroquinone, the only active ingredient that had been proposed for inclusion in a monograph for these products. Written or electronic comments may be submitted by Dec. 27. Comments may be submitted at www.regulations.gov.

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