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FDA PROPOSES ADVISORY LABEL ON PRODUCTS CONTAINING AHAs

FDA has announced the availability of draft guidance describing how cosmetic manufacturers can alert consumers about the increased risk of skin sensitivity to ultraviolet (UV) radiation that may occur when using cosmetics containing alpha hydroxy acids (AHAs).

The draft guidance, published in the Federal Register, includes FDA's suggested labeling statement on AHA-containing cosmetic products for use in informing consumers about the potential for increased skin sensitivity to the sun and particularly the possibility of sunburn. The proposed labeling would also include steps for avoiding these consequences.

The draft guidance suggests that the following statement appear on the label of cosmetic products containing AHAs. " Sunburn Alert: This product contains an alpha hydroxy acid (AHA) that may increase your skin's sunburn. Use a sunscreen and limit sun exposure while using this product and for a week afterwards."

The draft guidance was prompted by studies performed by the Cosmetic, Toiletry and Fragrance Association (CTFA) and FDA on the safety of topically applied AHAs in cosmetic products. The studies demonstrated that topically applied AHAs increase skin sensitivity to UV radiation during application and that the increased skin sensitivity to UV radiation diminishes a week after discontinuing application.

The CTFA filed a citizen petition after the release of these findings, requesting that FDA issue a regulation establishing sun alert labeling for AHA-containing products. FDA is issuing this draft guidance as an interim measure while awaiting the results from an ongoing study of long-term exposure to AHAs.

There will be a 60 day comment period for members of the public to submit their views on this proposed guidance. FDA will carefully review these comments and will address them when publishing a final guidance.

Those who wish to submit comments should send them by January 31, 2003 to: Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.

All comments should include docket identifier number OOP-1378.

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