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FDA on cosmetic papaya extract

This article was originally published in The Rose Sheet

Executive Summary

FDA will continue to allow cosmetic use of papain, an ingredient derived from the papaya plant, according to Center for Food Safety and Applied Nutrition's Office of Cosmetics and Colors. Agency announced in a September Federal Register notice that it would take enforcement action against manufacturers of unapproved topical drug products containing papain if they did not halt production and shipping by given deadlines. Thirty-seven serious adverse events have been reported in connection with use of papain-based creams for treating wounds such as diabetic ulcers, FDA says. Papain also is used as a conditioning agent in a "relatively small number of cosmetic products" including moisturizers, cleansers, and hair preparations, according to FDA's Voluntary Cosmetic Registration Program. CFSAN has received no reports of adverse events specifically related to papain in cosmetic formulations, it says, and thus the agency plans no regulatory action against such products
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