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  1. CFSAN Constituent Updates

FDA Issues Draft Guidance Recommending a Limit on the Amount of Lead in Lipstick and Other Cosmetics

Constituent Update

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The U.S. Food and Drug Administration today issued draft guidance recommending a limit of no more than 10 parts per million (ppm) of lead as an impurity in cosmetic lip products (such as lipsticks, lip glosses, and lip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developed by FDA scientists to test cosmetic lip products and methods appropriate to the other cosmetics covered by the draft guidance, FDA has analyzed 685 products and found that more than 99 percent of products tested contain levels of lead that are at or below FDA’s recommended maximum level for lead as an impurity as described in today’s draft guidance.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.

The FDA has concluded that use of cosmetics that meet the maximum recommended lead level would not pose a health risk and is not advising consumers to change their current use of cosmetics based on lead levels. The agency also encourages manufacturers of lipsticks and other cosmetic products to follow or continue to follow manufacturing practices that allow them to achieve levels of lead lower than 10 ppm whenever feasible.

In 2011, the Personal Care Products Council, a trade association, submitted a citizen petition requesting the action FDA is taking today. After completing testing of cosmetics products and an exposure analysis, FDA is granting the petition. This guidance will educate new manufacturers who wish to enter the market and encourage current manufacturers to continue to follow or improve on voluntary good manufacturing practices that limit trace amounts of lead as an impurity.

The recommended level is also consistent with the 10 ppm maximum lead level for similar products recommended by countries represented in the International Cooperation on Cosmetics Regulations, which includes European Union member countries, Canada, and Japan, in addition to the U.S.

The FDA is accepting public comments on the draft guidance document beginning on December 22, 2016. To electronically submit comments to the docket, visit www.regulations.gov and type FDA-2014-D-2275 in the search box.

To submit comments to the docket by mail, use the following address. Be sure to include docket number FDA-2014-D-2275 on each page of your written comments.

Comments will be accepted at any time, but should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance to ensure that the FDA takes the information into consideration before making further decisions on this issue.

Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

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