Skin-lightening creams and lotions are a huge business in this country, used by consumers of all races and skin tones. But their over-the-counter days may be numbered.
Last week, the Food and Drug Administration declared that products containing the bleaching agent hydroquinone pose too many health risks and proposed a ban on selling them without a prescription.
The agency wants to consider all such existing cosmetic products as new drugs, requiring companies to seek approval to sell them, and then only with a doctor's OK.
The American Academy of Dermatology will be objecting to the proposal during the public comment period, said Dr. Susan Taylor, founding director of the Skin of Color Center in New York City and assistant professor of dermatology at Columbia University.
"Hydroquinone is the gold standard for treating pigmentation disorders and has been for many years," said Dr. Taylor, who is also director of Society Hill Dermatology in Philadelphia. "I consider it to be very safe and effective."
The proposed change would have wide-ranging implications. Many cosmetics companies sell over-the-counter skin-bleaching products -- often called "brighteners" -- with hydroquinone (pronounced hydro-QUIN-own) in a 2 percent solution.
These include, but are not limited to, Porcelana, Esoterica, Black Opal Fade Gel and Palmer's Skin Success. They can be found on the shelves of most drug stores.
Consumers use the products to self-treat freckles, liver spots, melasma (the so-called mask of pregnancy), and dark marks resulting from acne or burns. Hydroquinone is also one treatment for the pigmentation disorder vitiligo, which leaves white patches on various parts of the body. Doctors prescribe the agent in higher concentrations.
Now the FDA is describing hydroquinone as a possible carcinogen, and also saying it has documented links to a skin-disfiguring condition called ochronosis. The product was banned in South Africa, where advertisements portrayed lighter skin as the key to love and success; some users wound up instead with splotches, grayish spots, pebbly bumps and abnormal thickness.
But Dr. Taylor said ochronosis rarely occurs in the United States.
"Most reports have been from Africa after a prolonged period of daily use -- sometimes 10 to 40 years -- and in high concentrations. In this country, there have been maybe 200 cases out of millions of users. To me, that means it is a very infrequent problem."
As for cancer, she said, all the studies finding carcinogenic effects were done on mice and rats, and no links to cancer in humans have been found.
"Even with the population in Africa that abuses the products, there have not been reports of increased cancer."
A ban would have a negative effect on consumers, she said; there are some botanical treatments, but they're not as effective.
If companies are required to undergo FDA approval for all their hydroquinone products, Dr. Taylor added, most would probably remove them from the shelves rather than submit to the long, costly process. And any products that gained approval would probably wind up being more expensive.
Several cosmetics companies did not return calls seeking comment on the proposed ban, nor did the FDA.
Dr. Suzan Obagi, assistant professor of dermatology and director of The Cosmetic Surgery and Skin Health Center of the University of Pittsburgh Medical Center, worries that the proposal will scare consumers away from the best available treatment. She stressed that products made by reputable companies are reliable, safe and effective.
"Patients shouldn't read this and stop using this fantastic product, because for a lot of people it's been a life-changing improvement," she said.
The only reason heightened scrutiny from the FDA would make sense would be to screen out dubious products from other countries that contain mercury, steroids or other toxic chemicals that are not allowed in topical agents in the United States, Dr. Obagi said.
But even then, the target would be the other additives, not the hydroquinone.
"Some beauty supply stores in this country do carry imported products that contain illegal ingredients, but that's not the issue here," said Dr. Taylor. "The issue here is the safe products that the FDA is thinking of banning [from over-the-counter sales]."
The agency will be accepting comments on the proposed regulation through Dec. 26.
Sally Kalson can be reached at firstname.lastname@example.org or 412-263-1610.