WASHINGTON — After reviewing public studies and data submitted by manufacturers, the Cosmetic Ingredient Review panel is scheduled to issue its preliminary findings about alpha-hydroxy acids in August.
One thing the cosmetic industry and Food and Drug Administration can agree on is that the CIR panel is the best arbiter they have to determine the safety of cosmetics.
They also agree that the panel’s findings on skin care products containing alpha-hydroxy acids (AHAs) will be one of the most crucial decisions affecting the cosmetic industry in years. What the review panel will recommend ultimately could lead to FDA regulatory action.
The bulk of the leading cosmetic companies have products with AHA ingredients, which act as exfoliants and which also have amounted to millions of dollars in add-on business for the treatment category the last few years.
Their growing popularity among age-conscious consumers who look to AHAs as a mild face peel has also led to stronger formulas, sold through infomercials and applied in salons, whose potential burning effects FDA regulators view as dangerous.
But the FDA also has questions about AHAs’ long-term effects on skin from the milder, mainstream cosmetic company formulas, most of which have AHA concentrations of under 15 percent.
Last year, the agency received 36 consumer complaints about AHAs, the majority regarding temporary skin irritation from products bought at department stores and mass retailers.
“The safety of AHAs is not a simple black or white determination,” says John Bailey, acting director of the FDA’s Office of Cosmetics and Colors, the cosmetics industry’s chief watchdog.
He is also one of three nonvoting members on the CIR panel, the others being representatives from the Cosmetic, Toiletry and Fragrance Association and the Consumer Federation of America.
The seven voting members are leading dermatologists and other medical and scientific authorities.
The cosmetics industry, which doesn’t have to get its products pre-approved, but is required under federal law to use only ingredients that are known to be safe, looks to the CIR panel to settle ingredient controversies and otherwise give its seal of approval to innovations.
And while the industry stands by its AHA formulas, given the FDA’s repeated concerns and the specter of its potential regulation, cosmetics executives thought an official inquiry into the acid was needed.
“We said we did not believe there was a problem with AHAs, but there had been questions raised by the FDA and we felt it was necessary to address these questions,” said Gerald McEwen, vice president for science at the CTFA.
“The reason we are able to exist is because, over the years, we have been able to show we can regulate ourselves better and there is no need for the FDA or Congress to be worried about the safety of our products,” McEwen said, describing the CIR panel as “the cornerstone” for safety in the industry.
Because AHAs aren’t viewed as a public health hazard, the FDA isn’t likely to channel precious funds into a costly review of their effects. That doesn’t mean the agency couldn’t take action if it were to find outside data supporting the need for banning the acid ingredients. But even then, securing action against AHAs would be a challenge.
“With cosmetics, the burden is on us to show these things are true before we can propose any action,” Bailey said. “Even if the concerns come true, we have to go through a proposal process, which pits our science against the industry’s science, so you end up with a raging debate over whose science is right. We have raised concerns. These questions have answers. I think the review by the CIR is a good effort. I don’t think it is necessarily the final word.”
Chief among Bailey’s concerns are the long-term effects of AHAs on the skin’s ability to act as a barrier. For example, he surmised that AHAs could be removing protective properties against skin cancer.
By removing skin, AHAs could also conceivably make skin more porous and thus able to more readily absorb other products and topical drugs at higher-than-normal concentrations.
“You come in contact every day with a variety of products. If your skin is made permeable to substances and absorbs more, I think it would then raise questions about the consequences,” Bailey said.
Another issue Bailey hopes the CIR will shed light on is whether the extent of exfoliation by AHAs may actually speed up the aging process. Bailey bases this concern on the fact that the body has a limited amount of cells, which reproduce slower as time goes on, producing the aging effect.
“The question is, if you are speeding up the cell removal process, are you really causing the cell reproductive cycle to expire faster?” he said.
McEwen, who emphasized that cosmetics companies have done extensive studies on the effects of AHAs, said Bailey’s concern over the aging process being speeded up is “patently absurd.”
“Your skin isn’t all of a sudden going to die,” he added. “The data that has come out is that the skin has become more of a barrier.”
He claimed AHAs sold at retail have a smoothing effect by “taking off the rough edges.”
AHAs occur naturally in sugar cane, milk, wine and fruit, and have been used in skin-treating products for centuries. They have been growing in popularity at higher concentrations as a marketable exfoliant since the Seventies.
Dermatologists have used AHAs in very high concentrations of 30 percent and more as one of several types of face peels, but most AHAs sold at retail contain concentrations of 4 to 12 percent, McEwen said, noting that the CTFA has asked the review panel to look at concentrations of 15 percent for retail cosmetics as a starting point for deciding allowable AHA levels.
But he said the panel will also have to weigh other issues in relation to concentration, since AHAs react differently when mixed with certain ingredients; it affects the potency.
“It is our feeling that there will be some kind of concentration, some qualification of some type the panel will issue, saying, ‘This is safe for retail,’ so that someone can go home and read the directions and know the product will be beneficial and won’t have significant health consequences,” McEwen said.
Levels will also likely be set for salon and dermatological use.
Regarding how much weight the review panel might give to the 36 AHA-related complaints the FDA received last year, McEwen said the number is inconsequential, given the millions of units of AHA products sold.
But Mary Ellen Fise, product safety director of the Consumer Federation of America and a nonvoting member on the cosmetic review panel, said the fact that any complaints were received is significant.
“They are cause for alarm,” Fise said, noting that Canada, while reviewing the safety of AHAs, has set an interim 10 percent AHA concentration limit. “We are concerned any time there is an ingredient out there that hasn’t been evaluated for safety either by the FDA or the CIR.”
For the cosmetics industry, the most favorable outcome of the CIR’s investigation would be one where the panel deems AHAs to be safe and sets concentration limits for products, which companies would agree to follow. The FDA would then likely decide that no regulatory action is needed, McEwen said.
The worse outcome from the industry’s point of view would be for the CIR to determine there isn’t sufficient data to make a finding on AHA safety. “That leaves you in limbo,” McEwen said.
If the industry can’t supply more convincing data, then an FDA labeling regulation would go into effect in which a product would have to carry a prominently displayed warning that its safety hasn’t been determined. Such a decision could also move the FDA into its own policing of AHA concentrations. — Fairchild News Service