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The FDA is seeking to ban over-the-counter sales of skin bleaching drug products.
The FDA cites the possible risk ofand 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% to 5%, 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.
WebMD spoke with dermatologist Susan Taylor, MD, 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," she says.
"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."
Millions of Users
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,, , 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," Taylor 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, MD, Society Hill Dermatology, Philadelphia, Skin of Color Center, New York.
By Miranda Hitti, WebMD, August 30, 2006
By Howard Murad, MD
Find out how spa professionals can combat cultural stress in today's society.
Unless it's continuously reapplied, sunscreen can actually attack the skin and leave it vulnerable to ultraviolet (UV) radiation, concludes a University of California, Riverside study.
The researchers found that, over time, molecules in sunscreen that block UV radiation can penetrate into the skin and leave the outer layer susceptible to UV, CBC News reported.
The study appears in an upcoming issue of the journal Free Radical Biology & Medicine.
"Sunscreens do an excellent job protecting against sunburn when used correctly," Kerry Hanson, a research scientist in the university's department of chemistry, said in a prepared statement.
"This means using a sunscreen with a high sun protection factor and applying it uniformly on the skin. Our data show, however, that if coverage at the skin surface is low, the UV filters in sunscreens that have penetrated into the epidermis can potentially do more harm than good," he said.
HealthNews Day, 8/29/06
Anthelios SX, a sunscreen that's reportedly better at blocking ultraviolet A (UVA) radiation than other sunscreens currently sold in the United States, has been approved by the U.S. Food and Drug Administration.
The product, made by the French cosmetics company L'Oreal SA, contains an ingredient called ecamsule, and has a sun protection factor (SPF) of 15, the Associated Press reported.
Ecamsule is more effective against UVA radiation than ingredients (which block mainly ultraviolet B radiation) contained in sunscreens currently sold in the United States. Ecamsule has been an ingredient in L'Oreal's sunscreens sold in Europe and Canada since 1993.
The FDA noted that UVA is a deeper penetrating radiation than UVB. There's a suspected link between UVA and long-term effects such as wrinkles, basal and squamous cell cancers and melanoma, the AP reported.
Natural cosmetic sales are booming in France, increasing 40% in 2005, according to Organic Monitor, a business research and consulting company. Due to growing awareness of chemicals in products, consumers are shying away from traditional staples and opting for natural toiletries, makeup and hair care. A new study by Organic Monitor shows that sales are continuing to rise in 2006. In addition, with more than 1,700 choices on the market, organic products account for about one-fourth of all natural cosmetic sales.
According to “Cosmeceuticals in the U.S.,” a new report from market research publisher Packaged Facts, a division of MarketResearch.com, American spa-goers have turned their attention from injectables to cosmeceutical treatments. Sales of products such as anti-wrinkle creams and home facial peel kits jumped 7% last year to more than $13.3 billion. Projections estimate that the cosmeceuticals market will surpass $17 billion in 2010, growing a total of 29.4% between 2005 and 2010.
Centre de Recherches et d’Investigations Épidermiques et Sensorielles (CE.R.I.E.S.) announces its CE.R.I.E.S. 2006 Research Award—created to honor a researcher in dermatology and help fund future research projects focused on healthy skin. This year, Masayuki Amagai, MD, PhD, of Tokyo, received this coveted award totaling $52,000. +33 (0) 1 46 43 49 00
By Ada S. Polla
Discover how to reduce the effect of iron on aging skin.
A class action lawsuit launched in Los Angeles against the five leading U.S. makers of sun protection lotions alleges that the companies lied about the effectiveness of their products in blocking harmful sun rays and protecting skin.
The lawsuit names the following brands: Coppertone (Schering-Plough); Banana Boat (Sun Pharmaceuticals and Playtex Products); Hawaiian Tropic (Tanning Research Laboratories); Neutrogena (Neutrogena Corp. and Johnson & Johnson); and Bullfrog (Chattem Inc.).
Combined, they account for 70 percent of U.S. sales of such products, Agence France Presse reported.
Mitchell Twersky, one of the lawyers involved in the legal action, said claims by these brands are "clearly misleading" insofar as they claim that "their products block all the harmful sun rays."
The lawsuit seeks to have words such as "sunblock" and "waterproof" taken off the labels of these products. It also wants the companies that make them to direct "the money that they wrongfully obtained" into a skin cancer research foundation, AFP reported.
HealthDay News, March 31, 2006
By: Craig Wenborg, MD
Learn about this new trend in skin care treatments.