Statement by the Personal Care Products Council In Response to FDA’s Draft Guidance on The Maximum Level for Lead in Cosmetic Lip Products and Externally Applied Cosmetics
Washington, D.C. – “The Personal Care Products Council is pleased that the U.S. Food and Drug Administration (FDA) has issued draft guidance, in response to our 2011 citizen petition, that establishes a maximum level of 10 parts per million (ppm) for lead in cosmetic lip products and externally applied cosmetics marketed in the United States. 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 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. 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.
“It is important to note that our industry’s long-standing commitment to consumer safety and quality products was the motivating factor behind our organization’s 2011 petition to FDA on this issue. We appreciate that within this draft guidance the Agency acknowledges its regulatory oversight of our products.
“Consumers should be aware that lead is never used as an intentionally added ingredient in or as an additive to lipstick. 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 information on the science and safety of lip color products please visit: http://www.cosmeticsinfo.org/products/lip-color.”