The Food and Drug Administration (FDA) has issued a draft guidance with a recommended maximum level of 10 parts per million (ppm) of lead as an impurity in cosmetic lip products (eg, lipsticks, lip glosses, lip liners) and externally applied cosmetics (eg, eye shadows, blushes, compact powders, shampoos, body lotions). 

This guidance serves to educate new manufacturers who wish to enter the market and to encourage current manufacturers to follow or improve on good manufacturing practices that limit lead as an impurity. The recommendation aligns with the lead level for similar products recommended by countries in the International Cooperation on Cosmetics Regulations.  

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The Personal Care Products Council had submitted a petition in 2011 requesting the action that the FDA is setting today. Scientists at the FDA created and validated a new method for analyzing lead in lipsticks and used this method to detect lead content in hundreds of cosmetic lip products on the market. After an analysis of 685 products, the FDA found that >99% of them contained levels of lead that were at or below the FDA’s recommended maximum level for lead as an impurity. 

Based on survey findings, the FDA determined that manufacturers were capable of limiting the amount of lead in cosmetic products if they were careful in selecting their ingredients and adhered to good practices. 

Using cosmetics that meet the maximum recommended level of lead will not pose a health risk and the FDA is not advising consumers to change their current cosmetics use based on lead levels. Manufacturers of lipsticks and other cosmetic products should proceed with practices that allow levels of lead <10ppm when possible. 

This guidance was issued in efforts to limit human exposure to lead in finished FDA-regulated cosmetic products. The draft guidance will be open to public comments starting December 22, 2016. 

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