FDA Issues Guidance on Lead in Cosmetics

The US Food and Drug Administration has concluded that a recommended maximum level of 10 ppm for lead as an impurity in cosmetic lip products and externally applied cosmetics would not pose a health risk. The FDA released its guidance in a new report: Lead in Cosmetic Lip Products and Externally Applied Cosmetics: Recommended Maximum Level – Guidance for Industry

The Personal Care Products Council was pleased with the move, noting that it mirrored the Council's  2011 citizen petition, that establishes a maximum level of 10ppm for lead in cosmetic lip products and externally applied cosmetics marketed in the US. As noted in the FDA guidance, this safety level is firmly grounded in sound science, and it aligns with the recommendation in industry’s petition, according to The Council.


“According to FDA, lipsticks and cosmetics that meet the 10ppm maximum lead level pose no health risk to consumers; and of the 685 cosmetic products tested by FDA, 99% of them fell at or below this level,” the Council noted in a release. “Moreover, 10ppm is also consistent with standards set by The International Cooperation on Cosmetics Regulation (ICCR), and regions such as Canada, Japan and the European Union.”


The Council reiterated that the industry’s long-standing commitment to consumer safety and quality products was the motivating factor behind its organization’s 2011 petition to FDA on this issue.  


“Consumers should be aware that lead is never used as an intentionally added ingredient in or as an additive to lipstick,” said The Council in a statement.  “However, because lead is a naturally occurring metal, it is routinely detected in the air, water and soil.  Consequently, it may be found at extremely low levels as a trace contaminant in the raw natural ingredients used to formulate cosmetics, just as it is in thousands of other products. We hope that this guidance will conclusively alleviate any public concerns about the safety of lipsticks.”


For more info on the safety of lip products, visit: http://www.cosmeticsinfo.org/products/lip-color.”