FDA Releases Draft Guidance on Lead Limits in Cosmetics

FDA Releases Draft Guidance on Lead Limits in Cosmetics

In December 2016, the FDA released draft guidance in response to a 2011 Citizen Petition submitted through the Personal Care Products Council (PCPC). Following the testing of 685 cosmetic products between 2007 and 2013, the agency has issued recommendations that lead levels should not exceed 10 ppm. The guidance does not apply to topical products classified as drugs, or hair dyes containing lead acetate.

The recommended value was reached after determining that exposure through incidental ingestion and skin absorption of cosmetics was very small. This value is consistent with international accepted limits. Of the total number of products tested, over 99% were found to be less than 10 ppm, ranging from below the detection limit to a maximum of 14 ppm.

As a naturally occurring substance, traces of lead cannot be avoided completely. It is found as an impurity in the water we drink, the air we breathe, as well as in lip products, eye shadow, blush, compact powder, shampoo, body lotion, and many other cosmetics. Although pre-approval for cosmetic products or ingredients not using color additives is not required by the FDA, any products found to contain unsafe levels of lead are removed from the market.

It is the manufacturer’s responsibility to avoid potentially harmful levels of lead in products. Given the results of the FDA testing project and modern analytical capabilities for purchased ingredients and impurities introduced during the manufacturing process, it is expected that this value should be relatively easy to comply with. However, the FDA encourages manufacturers to strive to achieve levels well below the 10 ppm recommendation wherever possible.

Comments on the draft guidance should be submitted by February 21st, 2017 to be considered in its finalization.

As leading scientists in this industry and qualified Cosmetic Regulatory Consultants you can trust Focal Point Research to give you updated information within the world of Regulatory Affairs and Quality Assurance.  If you have any questions regarding this information or the impact this may have on your products, please don’t hesitate to contact us.