FDA’s publication of the draft guidance responds to a Citizen Petition submitted to the Agency by the Personal Care Products Council in 2011, which specifically requested that FDA issue guidance establishing the 10 PPM limit for lip care products and other externally applied cosmetics. Moreover, the guidance represents the first time FDA has established a regulatory tolerance for lead since the Agency issued guidance in 2005 establishing a maximum lead level of 0.1 PPM for candy likely to be frequently consumer by children.
In issuing the draft guidance, FDA noted that it has concluded, based on testing and analysis of pertinent data, that use of lipstick and externally applied cosmetics meeting the 10 ppm for lead would not pose a public health risk. Further, the 10 ppm level of lead is consistent with the maximum lead level (i.e., 10 ppm) 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 US. FDA stresses that the 10 ppm limit concerns lead that is unavoidable in the final product, despite adherence to good manufacturing practices and appropriate raw material sourcing.
Based on the Agency’s issuance of the draft guidance, we encourage product manufacturers to take reasonable steps to keep product lead levels as low as possible to avoid the possibility of enforcement action (once the guidance becomes final), should FDA become aware of marketed cosmetics containing levels of lead above the 10 ppm threshold. Further, we expect that FDA will continue to conduct spot testing of marketed cosmetics and cosmetics arriving at US Ports of Entry to help ensure industry compliance with the standard.
Arent Fox will continue to follow and report on developments involving FDA regulation of personal care products and associated safety issues. Please contact Georgia C. Ravitz or James R. Ravitz for further assistance.