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Label warnings proposed for products with alpha hydroxy acids

SUNDAY, Feb. 9, 2003 (HealthDayNews) -- If you're one of millions of women who use skin-care treatments and cosmetics containing the popular anti-aging ingredients known as alpha hydroxy acids, you may soon find a warning on the product labels.

The U.S. Food and Drug Administration (FDA) is proposing that manufacturers be required to print the alert. It would indicate that the very ingredients used to reduce the signs of skin aging may well be causing your skin to age, primarily by increasing your risk of sunburn.

The warning may be particularly important because sunburn increases your risk of skin cancer. However, some dermatologists are downplaying the threat posed by alpha hydroxy acids.

According to a "draft guidance" published in the December 2002 Federal Register, the FDA has proposed a labeling change that would read as follows: "Sunburn Alert: This product contains an alpha hydroxy acid (AHA) that may increase your skin's sensitivity to sunburn. Use a sunscreen and limit sun exposure while using this product and for a week afterwards."

Alpha hydroxy acids -- or fruit acids as they're sometimes called -- help the skin maintain a more youthful appearance by increasing the rate of cell turnover. This can be beneficial because, as we age, the rate at which we shed dead skin cells slows down -- a fact that contributes to an older, more wrinkled-looking skin.

Currently, there are some 1,500 different products containing AHAs, comprising a $6 billion market in the United States alone.

However, the other factor that increases skin aging is sun damage. And the FDA says AHAs contribute to that damage by increasing the rate at which skin burns.

And sunburns are one of the leading causes of skin cancer, the most common form of cancer in the United States, with more than 1 million new cases diagnosed in 2002, according to the U.S. Centers for Disease Control and Prevention.

FDA officials say the proposed label change was prompted by studies conducted by the Cosmetic, Toiletry and Fragrance Association on the safety of topically applied AHAs.

Those studies -- co-sponsored by the FDA's Office of Women's Health -- confirmed that applying an AHA to the skin increased ultra violet (UV) sensitivity by up to 18 percent, following four weeks of use. Similarly, the study found that skin sensitivity to UV-induced cellular damage doubled on average.

As worrisome as these results might seem, not all dermatologists think the findings are that significant -- or warrant a label warning.

"We in dermatology have been using AHAs -- in prescription strength -- for decades, with no increased risk of skin cancer and no dramatically increased risk of sunburn," says Dr. Ted Daly, an assistant professor of dermatology at Nassau University Medical Center in New York.

"To put this kind of warning on a label seems to me to be alarming women for no reason. I don't really see it as necessary," he says.

Adds Dr. Darrell Rigel, a professor of dermatology at the New York University School of Medicine and past president of the American Academy of Dermatology: "I don't think that AHAs are dangerous, and the new label, while an important reminder to use sunscreen, could be very misleading."

Rigel says that while an AHA may, in fact, increase your risk of sunburn, that risk is small.

"Even though an AHA may increase your risk of sunburn by 18 percent, a sunscreen with a protection factor as low as 2 decreases your risk by 50 percent," says Rigel, who says it's important to keep the study findings in the proper perspective.

Both doctors concur, however, that any time you can draw attention to the need for using sunscreen, the outcome is positive. In this respect, the proposed label change may offer an important public service.

"I think reminding people to protect their skin from the sun is a good thing, and if a label is going to remind women to use a sunscreen, then it can be helpful," Rigel says.

According to the Cosmetic Ingredient Review Panel -- the industry's self-regulating body for reviewing scientific information about cosmetic ingredients -- products containing AHAs are safe for use by consumers under the following circumstances:

  • The concentration of AHA does not exceed 10 percent;
  • The acid content, or pH, of the product is listed at 3.5 or greater (the higher the pH the lower the acid level);
  • The product either contains ingredients that protect the skin from sun damage, or directions recommending the use of sunscreens following applications of products containing AHAs.

More information

To read more about the proposed label changes and the studies that led to those recommendations, visit the U.S. Food and Drug Administration. You can also learn more about how sun ages the skin by visiting The American Academy of Dermatology.

SOURCES: Darrell Rigel, M.D., professor, dermatology, New York University School of Medicine, New York City; Ted Daly, M.D., assistant professor, dermatology, Nassau University Medical Center, and dermatologist, Garden City Dermatology, Garden City, N.Y.
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