FDA Proposes Ban on OTC Hydroquinone

The FDA proposed a ban Tuesday on over-the-counter sales of skin-bleaching products containing hydroquinone. New animal studies indicate the drug might cause cancer, the agency said, and human studies show it can cause ochronosis, a disfiguring skin condition that causes black patients' skin to darken and thicken.

About 200 skin-lightening products containing hydroquinone are currently on the market and about two-thirds of those are sold over-the-counter, according to the agency. Under the proposed rule, these products would be considered new drugs and manufacturers would have to seek FDA approval to sell them -- and then only as prescription products.