ARTICLE
21 February 2017

FDA Issues Draft Guidance On Use Of Lead In Cosmetics

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FDA has concluded that the recommended maximum lead level would not pose a health risk.
United States Food, Drugs, Healthcare, Life Sciences

In the December 22, 2016, Federal Register, FDA announced a draft guidance titled, "Lead in Cosmetic Lip Products and Externally Applied Cosmetics: Recommended Maximum Level." This draft guidance provides a recommended maximum level of 10 parts per million ("ppm") for lead as an impurity in cosmetic lip products (such as lipsticks, lip glosses, and lip liners) and externally applied cosmetics (such as eye shadows, blushes, shampoos, and body lotions) marketed in the United States. FDA considers the recommended maximum lead level to be achievable with the use of good manufacturing practices and consistent with the 10 ppm maximum lead level for similar products recommended by other countries. FDA has concluded that the recommended maximum lead level would not pose a health risk. Comments are due February 21, 2017.

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