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In an August Federal Register the US Food and Drug Administration suggested that OTC skin bleaching products should require an approved new drug application. The administration decided to pass the rule because of data submitted by federal agencies since 1982 on carcinogenicity and exposure to the skin bleaching substance hydroquinone. The FDA is suggesting that hydroquinone may be a potentially damaging ingredient.
The FDA is accepting comments on the proposal until December 27, 2006. There reportedly are 200 skin bleaching products on the U.S. market containing hydroquinone in concentrations of 0.4-0.5%.