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Executive Summary

SUNSCREEN INGREDIENT UROCANIC ACID BAN SOUGHT by the Consumer Federation of America in a March 21 citizen petition. According to the consumer group, research has indicated that the ingredient, when applied to the skin and exposed to sunlight, suppresses the immune system and promotes the growth of skin tumors. The Consumer Federation of America petition asks FDA to "declare that . . . products containing urocanic acid are adulterated under the [FD&C] Act." The consumer advocacy organization explains: "There is ample and compelling evidence that trans-urocanic acid, used as an ingredient in sunscreen and other products, can be converted to the cis isomer upon exposure to sunlight (UVB) and . . . cis- urocanic acid possesses immunosuppressive properties. Furthermore, there is also experimental evidence directly linking UVA-induced immune suppressions with skin cancer development." If the agency determines that the ingredient is present as an active ingredient in sunscreens and other OTCs, the consumer group asks that regulatory action be extended beyond cosmetics to include OTC drugs. Urocanic acid is used in cosmetics as a skin conditioning agent and a sunscreen. According to FDA, as of Jan. 1991, it is an ingredient in 11 products, of which more than half are suntan preparations; the others include foundations, makeup bases, and face, body and hand care preparations. CFA says it "suspects that urocanic acid is used primarily as an emollient and not as a sunscreen (active ingredient)" in these products. The ingredient is not approved in the U.S. as an active sunscreen. The cosmetic industry's voluntary ingredient review scientific panel, the Cosmetic Ingredient Review, tabled the review of the safety of urocanic acid in January pending the receipt of additional safety data. A preliminary determination from CIR deemed the ingredient unsafe. CFA Product Safety Director Mary Ellen Fise serves as consumer representative on the CIR board. The petition asserts that the expected research on the ingredient's immunosuppressive properties, genotoxicity and photosentization "will not be completed and analyzed before the end of 1991." However, "such additional study, reports or data are not necessary for FDA to have in order to make a finding regarding the deleterious nature of [urocanic acid]," it adds.

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