FDA attempts to ban skin-bleaching creams

WASHINGTON — The Food and Drug Administration (FDA) proposed Tuesday to ban over-the-counter sales of skin-lightening products, triggering a four-month comment period.

The FDA said the creams contain hydroquinone, a drug that, according to studies on rodents, shows "some evidence" of possibly causing cancer.

Citing studies in Africa dating to 1975, the FDA also noted a link between the use of creams containing hydroquinone and the development of ochronosis, which can cause darkening and thickening of the skin, yellowish bumps and gray-brown spots.

Because these creams are a huge part of the U.S. market — the FDA estimates that in the United States, about 65 companies sell more than 200 skin-bleaching products containing hydroquinone — reaction was swift.

"Hydroquinone is the gold standard of treatment for pigmentation problems," said Dr. Susan Taylor, a dermatologist and the founding director of the Skin of Color Center at St. Luke's Roosevelt Hospital in New York.

In the United States, skin-lightening products sold without a prescription can contain 2 percent hydroquinone; products available only with a prescription have a concentration of up to 4 percent.

Experts say most patients in the United States are not interested in lightening their skin color — as is the case in Africa and Asia — but in erasing unattractive blemishes and age spots. About two-thirds of the products sold in the United States are available without a prescription.

Hydroquinone has been banned in Japan, the European Union and Australia.

Under the hydroquinone proposal, all skin-bleaching products, both prescription-only and over-the-counter, would be considered "new drugs"; manufacturers would have to seek FDA approval to sell them with a prescription.