Lead in Cosmetic Lip Products and Externally Applied Cosmetics: Recommended Maximum Level; Draft Guidance for Industry; Availability

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The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled, "Lead in Cosmetic Lip Products and Externally Applied Cosmetics: Recommended Maximum Level." This draft guidance provides a recommended maximum level of 10 parts per million (ppm) for lead as an impurity in cosmetic lip products (such as lipsticks, lip glosses, and lip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. We consider 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, and we have concluded that the recommended maximum lead level would not pose a health risk.