By Riëtte van Laack –
On December 21, FDA announced the availability of a draft guidance for lead levels in cosmetics. As further described in that draft guidance, FDA has concluded that use of lipstick and externally applied cosmetics that meet the recommended maximum lead level of 10 ppm would not pose a public health risk. The 10 ppm level is consistent with international levels.
The draft guidance is in response to a June 2011 Citizen Petition (Docket No. FDA-2011-P-0458) submitted by the Personal Care Products Council (PCPC). Congress repeatedly had directed FDA to respond to the Petition. Apparently, the delay in response was (at least partly) due to FDA’s research regarding lead levels in cosmetics and the health effects of these levels. FDA published “supporting documents” that present the details of FDA’s research, the scientific and legal background, and the Agency’s rationale for the recommended maximum level of 10 ppm.
Prior to 2011, FDA analyzed the lead content of more than 400 cosmetic lip products and updated its webpage regarding lead levels in lipstick and other cosmetics. Since then (presumably in response to the Citizen Petition), the Agency conducted two additional surveys of lip products and two surveys of externally applied cosmetics, including eye shadows and body lotions. All in all, the surveys provided results for lead content in 685 cosmetic lipand externally applied cosmetic products. In all but four externally applied cosmetics, the lead level was below 10 ppm. After completing testing of cosmetics products and an exposure analysis (also described in detail in the supporting documents), FDA is granting the petition.
FDA stresses that this limit concerns the lead that is unavoidable despite adherence to good manufacturing practice and appropriate sourcing of raw materials. Companies are encouraged to keep the levels as low as possible. Moreover, FDA will take enforcement action against products that contain lead levels that may harm consumers.
Comments on the draft guidance may be submitted any time, but to be considered in finalizing the guidance, they should be submitted by February 21, 2017.