AHA "Sun Alert" Labeling Recommended In CTFA Citizen Petition
This article was originally published in The Rose Sheet
Executive Summary
The Cosmetic, Toiletry and Fragrance Association recommends FDA propose a regulation requiring a "sun alert" labeling statement on cosmetics containing alpha hydroxy acids in a June 29 citizen petition.
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The Cosmetic, Toiletry and Fragrance Association recommends FDA propose a regulation requiring a "sun alert" labeling statement on cosmetics containing alpha hydroxy acids in a June 29 citizen petition. CTFA's proposed language to amend the FD&C Act reads: "The label and labeling of a cosmetic product that contains an alpha hydroxy acid ingredient that is intended to function as an exfoliant shall bear the following prominent and conspicuous statement." "Sun Alert: Because this product may make your skin more sensitive to the sun, be certain you have adequate sunscreen protection while using this product and for a week after you discontinue use," the petition continues. The reg would include AHA products that already contain sunscreen, the CTFA petition says, explaining this will reinforce the importance of sun protection and ensure that consumers use sunscreen for a week following discontinuation of AHA use. Potential exemptions would include cases in which AHAs are used for technical purposes, such as pH adjusters, CTFA noted. AHAs and sun sensitivity was first investigated by the Cosmetic Ingredient Review panel. In CIR's 1996 safety ruling on AHAs, the panel recommended products be "formulated to avoid increasing the skin's sensitivity to the sun" or include directions for the daily use of sun protection. Both CTFA and FDA conducted studies measuring skin's sun sensitivity to AHAs and found that while use of 10% glycolic acid increases sensitivity of normal skin to UVB radiation, it subsides within seven days of discontinuation (1 (Also see "Glycolic Acid Increases Short-Term Skin Sensitivity To UVB Rays - FDA" - HBW Insight, 13 Sep, 1999.)). CTFA and FDA have been in talks over the need for labels; the trade group initially suggested the agency form a guidance on the issue, but FDA said a regulation would be more effective (2 ). FDA Office of Cosmetics and Colors Director John Bailey, PhD, discussed the importance of AHA labeling most recently at CIR's February meeting ('The Rose Sheet" Feb. 28, p. 3). The issue also is on FDA's "A" list of priorities for fiscal year 2000 (3 (Also see "AHA Labeling Proposal Tops CFSAN's Cosmetics Priorities "A" List" - HBW Insight, 14 Feb, 2000.)). |