REVIEW BOARD COULD GIVE NOD TO ALPHA-HYDROXIES BY JUNE

Byline: Joanna Ramey

WASHINGTON — The Cosmetic Ingredient Review board — the beauty industry’s self-policing arm — is expected to give alpha-hydroxy acids its seal of approval as early as June.
At the same time, it is expected to recommend that concentrations of the ingredients, which purportedly act to exfoliate the top layer of dead skin, be restricted to certain levels.
The CIR’s final decision, more than a year in the making, will be watched carefully not only by the industry, which has seen sales of AHA-based products continue to soar, but also by Food and Drug Administration officials, who are scrutinizing how the CIR handles its first review of a new generation of cosmetics.
The FDA’s director of the Office of Cosmetics and Colors, John Bailey, has been chief among the AHA skeptics. He remains wary about what he says are still unknown effects of the ingredients.
Therefore, he questions whether in the future other such products — cosmetics he says go beyond just superficially beautifying skin — should undergo some form of CIR-like review before they are actually marketed.
“I don’t think the current process is well suited for cosmaceuticals,” said Bailey, using a term that puts industry officials on edge because they view AHAs as being just cosmetics — which legally aren’t required to have any kind of premarket screening. Cosmaceuticals are defined as products that have dual roles as cosmetics and drugs and thus require FDA approval — a definition the industry says neither suits AHAs nor any of the cosmetics currently under development that utilize the latest in high technology.
Bailey says he’s not recommending at this juncture requiring that the FDA grant premarket approval for new breeds of moisturizers and treatment products. One solution, he said, might be the industry developing its own premarket review mechanism in parallel with the CIR, which was created by the Cosmetic, Toiletry and Fragrance Association 20 years ago.
“I think for this cosmaceutical area, something has to be done,” Bailey said.
As a nonvoting member of the CIR, Bailey has made his concerns known about AHAs for several years. A lingering question he has is whether by stripping away dead skin, AHAs allow the skin to absorb chemicals it normally would repel over a period of time. He is also suspect of the sun’s impact on skin treated with AHAs.
“There is no proof, and that’s the whole point,” Bailey says of the cosmetic industry’s repeated argument that, since there is no evidence that AHAs have deleterious effects, they must be safe. “The information we have is purely anecdotal at this point. If there aren’t problems in the future, we’ll quiet down,” he said. “If there are problems, we’ll do what we have to do.”
For its part, the cosmetic industry views the CIR panel’s scrutiny of AHAs — and its anticipated approval of the ingredient for use in cosmetics — as proof the current system of checks and balances in the industry is working. The process, industry officials maintain, supports the idea of having cutting-edge treatment products under development receive the same regulatory and oversight treatment as the traditional cosmetics.
“The system obviously works,” says Gerald McEwen, vice president for science at the CTFA, referring to the extensive oversight the CIR has undertaken of AHAs. This has included the scrutiny of cosmetics manufacturers’ own tests and data regarding the exfoliant, he said.
“The action of the expert panel shows this system is independent and is not subject to industry or government influence,” noted McEwen, who is also a nonvoting member of the CIR panel.
McEwen said the fact that there have been relatively few complaints about AHAs — with a good portion of those complaints stemming from products with high concentrations used in salons — is further evidence of how consumers are protected by the current system.
“The law says it is prohibited for a company to produce a cosmetic product that could be injurious to the consumer under normal use. There are criminal penalties for this. If I am a cosmetic official, and I have that as a law, why do I need some kind of review by anybody prior to marketing?” asked McEwen. “The only reason you would want to have a premarket review is you would want to stop somebody from marketing products and basically slow the use of innovation.”
The law aside, McEwen said beauty companies have their financial interests at stake to keep only safe products on the market. “If you can’t have happy, healthy consumers, you are going to lose a lot of money,” he said.
Regarding AHAs, “John [Bailey] some four years ago said these products were horrible, and more and more people would get hurt, and they have to be stopped,” McEwen said. “Where are the major problems? Where is the data to prove there are problems? There isn’t any. There aren’t millions of people being harmed by these products. These are simple, organic molecules. There is simply nothing there to cause alarm.”
Rather, McEwen promotes AHAs as therapeutic for the skin. Without the removal of dried cells that is spurred on by AHAs, the skin can crack, which leads to increased water loss and subsequent decrease of the skin’s natural protective functions, he claimed.
“AHAs are making the skin more normal and enhancing the barrier,” McEwen said, emphasizing the cosmetic nature of the product. “What these products actually do is no different than a vigorous washing and using a very good moisturizer. It’s just that the AHA products that do this well do it in a more controlled manner.”
Given the spectrum of AHA products, ranging from department store brands and mass market lines to salon and mail-order creams, McEwen expects the CIR to offer recommendations to promote standards for safe concentrations of the fruit-derived acids. The panel could also suggest guidelines for AHA use, like for consumers to avoid the sun or to use sun protection.
The seven voting members of the CIR panel who will pass judgment on AHAs are either dermatologists, pathologists or toxicologists. The panel is considered an independent arbiter of issues regarding cosmetic safety and use.
Another nonvoting member of the CIR, Mary Ellen Fise, product safety director of the Consumer Federation of America, said she is satisfied the panel is giving a thorough review of AHAs, but because she isn’t a scientist, she can’t adequately judge the safety. Her main concern with the product is what she says is a lack of information now provided consumers about what AHAs accomplish and how their varying concentrations and pH — or acidity — levels can make a difference as to the skin’s reaction.
“I think it’s important for consumers to get more information about how the product works, whether it’s right for them because of their skin or past problems and what is the best concentration and pH level,” she said.
Fise said the CIR panel’s recommendations for AHAs should spur manufacturers to convey this information in their labeling, literature and advertising.
“The whole thing is a voluntary system. A manufacturer can choose whether to follow the CIR recommendations or not,” Fise said. “I think it’s the responsibility of manufacturers to communicate this information to consumers.” — Fairchild News Service

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