FDA May Limit Skin Bleaching Products

Agency Says Ingredient May Raise Risk Of Cancer And Skin Discoloration

(WebMD)  The FDA is seeking to ban over-the-counter sales of skin bleaching drug products.

The FDA cites the possible risk of cancer and skin discoloration from hydroquinone typically found in these products. However, those cancer studies were done on rats, not people.

"The actual risk to humans from use of hydroquinone has yet to be fully determined," the FDA states in its proposal, published in the U.S. government's Federal Register.

The type of skin discoloration noted by the FDA is called exogenous ochronosis, a darkening of the skin. The FDA cites research linking the condition to hydroquinone use.

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 percent to 5 percent, 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, M.D., of Society Hill Dermatology in Philadelphia, and the Skin of Color Center in New York about the FDA's proposal.

"I feel that hydroquinones are safe and effective treatment for pigmentary disorders," Taylor says. "I feel comfortable recommending that my patients continue to use hydroquinones if they have a pigmentary disorder."

"I think the evidence is quite weak with the link between hydroquinones and cancer," Taylor tells WebMD. "Data on rats and mice cannot necessarily be extrapolated to human data.

"In Africa, people have used hyrdoquinones for long periods of time ... meaning years, 10, 20, 30, years ... and at high concentrations," Taylor says. "We've not seen a proliferation of various types of cancers reported from that population.

Exogenous ochronosis is rare in the U.S., Taylor notes.

"If you look at the case reports, it's probably less than 200," Taylor says. "So it's really not a significant problem here in the United States."

Taylor points out that "many patients have disorders that are truly disfiguring and devastating. And these conditions can be improved significantly with hydroquinone products."

"It's important therapy and it's used by millions and millions of people," Taylor says.

She says hydroquinone products are primarily used to lighten dark areas of the skin due to conditions including injury, rashes, acne, and sun damage.

"So there are real problems, and this is a real solution," Taylor says. She adds that filing new drug applications can cost millions of dollars. "My concern is that we could lose prescription products that we have," she says. "That would have major consequences, I think.

"It's safe, effective; it's the gold standard, and I think our patients would benefit from continued use for these problems. I think those three points sum it up for me," Taylor says.

SOURCES: U.S. Government Printing Office, Federal Register, Aug. 29, 2006; Vol. 71: pp. 51146-51155. Susan Taylor, M.D., Society Hill Dermatology, Philadelphia, Skin of Color Center, New York.

[marisag77]

I have vitiligo? This is a condition that makes me have white spots on my body due to lack of pigmantation. I would like to know if creams that are out there for this, could possibly cause cancer as well? Why don't the news channels do a thing of vitiligo and show what it is like to live with spots all over your body and have people look at you like your a freak. Speaking for myself, we are all unique and having vitiligo is what makes me different from the rest of the world! I wish people who have this disorder could learn to accept it and I know it is hard to. But if the media would make people aware of this condition, it would make it easier for us to live with it rather than come across as weirdos.

[wny14127]

Just what we need, the worthless FDA tackling a non-problem. Why can't they work on the tough stuff, like drug prices? Oh, I forgot they sold out to the drug industry long ago.
I've used these products for years with no doctor involved. I don't need the FDA to try to interpret rat test data as human issues and I don't need a dermatologist to give me a prescription for the same product I'm using now.
We need less government in our lives and more personal responsibility.