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FDA Seeks Ban on OTC Skin Bleaching Products

Posted: September 5, 2006

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The FDA isn't proposing a ban on prescription skin bleaching drug products. But all such products would need to submit a new drug application for the FDA's review.

Not all skin lighteners contain hydroquinone. The FDA knows of 200 products containing hydroquinone in strengths from 0.4% to 5%, about two-thirds of which "appear to be marketed as OTC [over-the-counter] drugs," says the FDA.

The FDA is taking comments on its proposal until Dec. 27.

Expert's Views

WebMD spoke with dermatologist Susan Taylor, MD, of Society Hill Dermatology in Philadelphia, and the Skin of Color Center in New York about the FDA's proposal.