FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.

FDA PROPOSES ADVISORY LABEL ON PRODUCTS CONTAINING AHA

FDA has announced recommendations for cosmetic manufacturers to alert consumers about the increased risk of skin sensitivity to Ultra Violet (UV) radiation that may occur when using cosmetics containing alpha hydroxy acids (AHAs).

The draft guidance, published in the Federal Register, recommends labeling that the agency believes should be used on AHA-containing cosmetic products to warn consumers about the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 minimizing these risks.

The draft guidance recommends that the following statement appear on the label of cosmetic products containing AHAs.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 sensitivity to sunburn. Use a sunscreen and limit sun exposure while using this product and for a week afterwards."

The proposed guidance was prompted by studies performed by the Cosmetic, Toiletry and Fragrance Association 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 CFTA filed a citizen petition after the release of these findings, requesting FDA guidance on sun alert labeling for AHA-containing products.

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.

####

This is a mirror of the page at http://www.fda.gov/bbs/topics/ANSWERS/2002/ANS01180.html

Draft Guidance for Industry: Labeling for Topically Applied Cosmetic Products Containing Alpha Hydroxy Acids as Ingredients December 2, 2002

Information about AHAs and BHAs