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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
Intelligent Spas has released a comprehensive report on the Australian spa industry, identifying spa numbers have grown 129% since 2002. Achieving an unprecedented 64% response rate, this third survey of spa facilities conducted in Australia by Intelligent Spas, provides a valuable tool for businesses competing in, or supporting the spa industry, to more accurately develop and plan spa-related products, services, campaigns and initiatives. The report, entitled Spa Industry Profile Australia 2002-2007, features over 1,000 quantitative statistics on the Australian spa market as well as supporting qualitative trends and observations from spa owners and
Some key industry totals and averages extracted from the report include: · Intelligent Spas identified 503 spa facilities located in Australia. · The average indoor area of spa facilities in Australia was 237 square metres. · 52% of the total spa space was allocated to treatment rooms. · Spas contained six treatment rooms on average. · 65% of spas that provided a relaxation room stated it was gender-shared, compared to 7% that provided both separate and shared rooms and 4% that offered separate rooms. · Baths with water and/or air jets were provided by 58% of respondents. · One hour body wraps were priced from $110 on average. · Herbal tea was the most common complimentary food or beverage item provided by spas, with 92% offering it to visitors. · The increase in male spa visitors was the most common, current industry trend with 29% of respondents making this observation. · Spa owners and managers noticed clients’ expectations of the spa experience were rising. · The majority of spas predicted increases in spa visits and revenue during 2006 and 2007. managers.
Some key industry totals and averages extracted from the report include:
· Intelligent Spas identified 503 spa facilities located in Australia.
· The average indoor area of spa facilities in Australia was 237 square metres.
· 52% of the total spa space was allocated to treatment rooms.
· Spas contained six treatment rooms on average.
· 65% of spas that provided a relaxation room stated it was gender-shared, compared to 7% that provided both separate and shared rooms and 4% that offered separate rooms.
· Baths with water and/or air jets were provided by 58% of respondents.
· One hour body wraps were priced from $110 on average.
· Herbal tea was the most common complimentary food or beverage item provided by spas, with 92% offering it to visitors.
· The increase in male spa visitors was the most common, current industry trend with 29% of respondents making this observation.
· Spa owners and managers noticed clients’ expectations of the spa experience were rising.
· The majority of spas predicted increases in spa visits and revenue during 2006 and 2007. managers.
By William J. Lynott
Learn how to expand your spa’s marketing plan beyond the Yellow Pages.
According to the Associated Press, the New Orleans telephone book recently came out post-Hurricane Katrina, and the "Beauty Salon" listings in the Yellow Pages declined 42% from 541 individual businesses to 316.
Botox injections can help facial wounds heal with less scarring, a small study finds.
"This is the first medication found to minimize scarring," senior author Dr. David Sherris, professor and chair of the department of otolaryngology at the University at Buffalo, said in a prepared statement.
His team published the study in the August issue of Mayo Clinic Proceedings.
The study included 31 patients who suffered wounds to the forehead or had surgery to remove skin cancers from the forehead, an area that's particularly susceptible to scarring. The patients received either an injection of Botox or saline within 24 hours after wound closure.
Photographs were taken at the time the patients received the injections and again six months later. The photographs were reviewed by two facial plastic surgeons who weren't involved in the study. They rated the patients' wound healing on a scale of zero to 10, with 10 representing the best result. The two surgeons' scores were averaged to reach a final score for each patient.
The median scores for wounds injected with Botox were 8.9, compared to 7.1 for wounds injected with saline.
"The result is of substantial interest in the field of scar treatment. When a wound occurs, especially on the face, people are always worried about the scar. We can now try to improve scars with these injections," Sherris said.
The study was funded by a clinical research grant from the Mayo Clinic.
HealthDay News, August 24, 2006
Pevonia Botanica recently partnered with Luxury SpaFinder Magazine in the fight against melanoma with the Melanoma Awareness Launch Program—an integrated strategic plan of print and online campaigns that will raise public awareness and education. 800-738-6642, firstname.lastname@example.org
San Antonio-based Watermark Hotel & Spa on the River Walk earned the prestigious Mobil Four-Star Award in Mobil Travel Guide’s 2006 America’s Best Hotels and Resort Spas. In addition, the Watermark and its sister property, Omni La Mansión del Rio, were honored on Celebrated Living magazine’s Summer 2006 Reader’s Choice Platinum List as one of the top mainland hotels. Watermark: 866-605-1212, Omni: 800-292-7300
Sutra Dental Spa in La Mesa, CA, provides relaxing dental experiences with unique amenities, such as a Zen oxygen bar, virtual reality movie glasses, aromatherapy pillows and an ambient recovery room. 619-589-6060
Geoffrey Redmond, MD, will be talking about his recent book, The Hormonally Vulnerable Woman (ReganBooks/HarperCollins), especially treatment of female hair loss. A patient will also be featured, discussing her feelings about alopecia and the boost in self-esteem she feels as a result of her successful treatment. The Today Show will be broadcast on NBC affiliates all over the United States and this segment will be aired sometime between 8:15am and 9:00am, but check for the show time in your area.