The Food and Drug Administration on Tuesday proposed banning over-the-counter sales of skin-lightening products, triggering a four-month comment period likely to provoke strong protests from dermatologists and other skin experts.
Publishing the proposed rule in the Federal Register, the FDA said that the creams contained hydroquinone, a drug that, according to studies on rodents, showed "some evidence" of possibly causing cancer.
"We're acting for safety reasons," said Susan Johnson, associate director of the FDA's Office of Nonprescription Products. "There is a potential for hydroquinone to be a carcinogen in humans. We are looking for additional information."
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, a condition that can cause darkening and thickening of the skin, dome-shaped yellowish bumps and grayish-brown spots. A number of patients developed this condition even after South Africa limited the concentration of hydroquinone in nonprescription products to 2% in 1983.
But because these creams are a huge part of the U.S. market -- the FDA estimates that in the United States alone about 65 companies sell more than 200 skin-bleaching products containing hydroquinone -- reaction was swift, and negative.
"Hydroquinone is the gold standard of treatment for pigmentation problems," said Dr. Susan C. Taylor, a Philadelphia dermatologist and the founding director of the Skin of Color Center at St. Luke's Roosevelt Hospital in New York. "Millions of Americans use it without [ill] effect."
In the United States, skin-lightening products sold without a prescription can contain 2% hydroquinone; products available only with a prescription have a concentration of as much as 4%.
Experts say that 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 blemishes and age spots to look more youthful. About two-thirds of the products sold in the United States are available without a prescription.
"In Asia, you can't have a skin-care line without a skin-lightening product," said Paula Begoun, author of "Don't Go to the Cosmetics Counter Without Me." "In the United States, it isn't about being lighter; it's about brown discolorations that make you look older. It's about being youthful."
In many parts of Africa and Asia, women who use skin-lightening products have reported disastrous results, including permanent disfigurement -- with alternating patches of dark and extremely pale skin -- and, sometimes, malfunctioning adrenal glands. Early studies out of Africa found high levels of mercury in women who had used hydroquinone products.
Because of this, hydroquinone has been banned in Japan, the European Union and Australia.
Dr. Jan Adams, a plastic and reconstructive surgeon in Laguna Beach, said the FDA was overreacting. "No one believes that the metabolism of a rat is the same as a human being," he said. "The bottom line is the FDA has taken it on the chin a lot lately. They have to appear to be a watchdog."
Adams, an African American physician and a host of "Plastic Surgery: Before and After" on the Discovery Health Channel, said the pigmentation of dark skin means that acne, cuts and bruises often heal even darker.
"In those circumstances, you use skin lightening to even out the skin tone," he said. "No one is suggesting we create Michael Jacksons all over the planet."
But in its announcement Tuesday, the FDA argued that much new information had surfaced since 1982, when the agency proclaimed hydroquinone "generally safe and effective." Citing studies from the Environmental Protection Agency and the National Toxicology Program, the FDA reported "some evidence" of carcinogenic action in male and female rats and in female mice, including the development of leukemia and liver lesions.
"The FDA tentatively concludes that the benefits of [over-the-counter] skin bleaching drug products are insignificant when compared to the potential risks," the proposed rule said.
In 1990, the FDA branded another skin-bleaching cream, ammoniated mercury, as unsafe.
Under the hydroquinone proposal, all skin-bleaching products, both prescription-only and over-the-counter, would be considered "new drugs" and manufacturers would have to seek FDA approval to sell them with a prescription.
"I'm thinking of sending them my 'What were you thinking?' letter," said Begoun, who argued that a ban on over-the-counter sales would only cost consumers more money because of the need for a doctor's visit to get a prescription.
"The research about problems around hair dye is much more controversial," she said. "Enough mice have dropped dead. The FDA is not looking at that because if the women of the world couldn't get rid of the gray in their hair, they would rise up."