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FDA Issues Draft Guidance in Lipstick and Other Cosmetics

December 21, 2016

The U.S. Food and Drug Administration today issued draft guidance recommending a limit of no more than 10 parts per million (ppm) of lead as an impurity in cosmetic lip products (such as lipsticks, lip glosses, and lip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, compact powders, shampoos, and body lotions).
Using a test method developed by FDA scientists to test cosmetic lip products and methods appropriate to the other cosmetics covered by the draft guidance, FDA has analyzed 685 products and found that more than 99 percent of products tested contain levels of lead that are at or below FDA’s recommended maximum level for lead as an impurity as described in today’s draft guidance. The FDA posted the results of its surveys of lipsticks in 2009 and 2011, and today is posting the additional results for cosmetic lip products and from the testing of externally applied cosmetics.
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