FDA TO REVIEW ACID ITEMS, POSSIBLY FOR REGULATION

Byline: Joanna Ramey

WASHINGTON — Although alpha-hydroxy acid ingredients continue to give beauty companies a facelift in the profits arena, they remain unpopular with the Food and Drug Administration, whose officials are wary of the products’ powers to slough off fine lines and wrinkles.
The FDA’s cosmetics industry regulators have now begun weighing whether alpha-hydroxy acids should be regulated as drugs. If that happens, treatment products with the exfoliating ingredients would be yanked from stores until they pass agency muster and undergo the same process prescription drugs must endure before being introduced into the market.
That would be the most severe of the possible outcomes of the FDA review, which is being undertaken after a panel of scientists assembled by the beauty industry gave alpha-hydroxy acids its safety seal of approval.
The most benign action the agency could take would be to require the products to carry a warning that skin treated with alpha-hydroxy acid is more sensitive to sun and users shouldn’t leave home without applying sunscreen.
The FDA’s decision to examine the issue is the most scrutiny a cosmetics issue has received since the agency cracked down on anti-aging claims made on moisturizers in the Eighties by some firms.
At that point, companies were cited for making baseless advertising claims in which they implied that their various creams could change the physical appearance of the body — a violation under federal laws governing cosmetics.
Under the law, cosmetics are defined as products that temporarily beautify the skin. And it’s because of cosmetics’ superficial nature that federal regulators don’t require FDA approval before they can be marketed.
But alpha-hydroxy acid-based items are a new breed of cosmetics that exceed the decades-old legal definition, contends John Bailey, director of the FDA’s Office of Colors and Cosmetics.
Bailey said alpha-hydroxy acids change the structure and function of the body, using language contained in the Food, Drug and Cosmetic Act that defines such products as drugs.
He referred to alpha-hydroxy acids as “cosmeceuticals” for having quasi-pharmaceutical powers that strip away the top skin layers, in the manner of a chemical peel. As such, the FDA has to give alpha-hydroxy acids a closer look, he said.
“The FDA is here to protect the public health,” Bailey said.
Although there has been only a smattering of consumer complaints about the use of products with alpha-hydroxy acids, the potential for burning the skin from products with high concentrations of the acids is one of Bailey’s safety concerns.
The other concern is whether alpha-hydroxy acid-based products leave the skin more vulnerable to sun-related damage.
“In the past, cosmetics didn’t do anything. It was just smoke and mirrors. With alpha-hydroxy acids, we’re looking at a product’s actual effects,” Bailey said, likening the debate over whether alpha-hydroxy acids are drugs to that of nicotine and the FDA’s push to regulate cigarettes. Both are products that alter the body, he said.
“The review of alpha-hydroxy acids could very well become a test, just as the tobacco issue is a test,” Bailey said.
But the potential labeling of alpha-hydroxy acid-based skin care items isn’t a step lightly taken by the agency, nor is it something the industry, which has seen the exfoliants rejuvenate its moisturizer business, is eager to have happen.
Any such move would likely trigger a barrage of legal action from beauty companies, who contend that after five years on the market, alpha-hydroxy acids have a proven safety record.
“The FDA has to prove there is a problem,” said Gerald McEwen, vice president for science at the Cosmetic, Toiletry and Fragrance Association. “Alpha-hydroxy acids are both safe and effective, and that is why people keep buying them.”
As long as alpha-hydroxy acid-based products don’t make drug-like claims, then they are legally just cosmetics, McEwen argues.
The law states that in order to be a drug, a product must “intend” to change the structure and function of the body, a type of claim that typically alpha-hydroxy acids products don’t make, he said.
“The safety of alpha-hydroxy acids has been shown. The question now is whether the law should allow the FDA, whenever it wants to, to declare something a drug,” said McEwen.
Alan Kaplan, a Washington attorney specializing in cosmetics issues, said the debate over whether alpha-hydroxy acid-based products are drugs has to focus on how companies represent the products’ intended use.
“Even with tobacco, the legal status depends on how it is represented,” Kaplan said. The Cosmetic Industry Review, the panel that studied the safety of alpha-hydroxy acids in December, concluded that the products, in concentrations up to 10 percent, are safe for widespread retail sales.
Concentrations between 10 and 30 percent should be used only by professionals, like salon operators.
The panel did not issue a must-use-sunscreen warning to accompany alpha-hydroxy products. It left that decision up to manufacturers.
Addressing Bailey’s concerns about sun sensitivity, McEwen said the CIR adequately addressed the issue in its review of alpha-hydroxy acids, and the panel’s recommendation would be followed by the industry.
“It is a valid concern,” McEwen said. “The CIR acknowledged some alpha-hydroxy acid-based products can increase sun sensitivity, and if that happens, they can’t be safely used without directing consumers to use sun protection.”
Aside from the sun sensitivity issue and that of acid concentrations, the safety of the ingredients has been adequately addressed, and any further restrictions issued by FDA wouldn’t be based on science, he continued.
In its review of alpha-hydroxy acids, Bailey said FDA scientists will examine the data collected from companies for the CIR’s study, as well as studies commissioned by the panel. The agency will likely undertake some of its own research as well.
Bailey said he expects to know by late spring what tack the agency will take regarding the use of alpha-hydroxy acids. He likens the agency’s review to the process drugs go through before FDA allows them to be marketed.
“When you buy a drug that’s gone through approval, you know what the product does and its side effects,” Bailey said. “That process hasn’t happened yet with alpha-hydroxy acids.”

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