After a report released in October 2007 by the Campaign for Safe Cosmetics (CSC), an advocacy group coalizing nonprofit health and environmental organizations, the U.S. Food and Drug Administration (FDA) decided that further follow-up of lead in lipstick was needed.

Lead level higher than previously reported

In order to ensure the safety of cosmetic products, FDA scientists have developed and validated a method for determining total lead content in lipstick using microwave-assisted digestion and analysis employing inductively coupled plasma-mass spectrometry (ICP-MS). This new FDA method is highly sensitive, with a detection limit estimated to be 0.04 parts per million (ppm).

“In conducting their study, FDA applied a method that determines the total lead content of each of the products tested, not the amount of lead to which a consumer who used the product would have been exposed. This rigorous method destroys the entire product and releases all of the lead present in the product for analysis,” commented the Personal Care Products Council, which represents the cosmetic and personal care products industry.

The FDA applied its method to the same selection of lipsticks evaluated by the CSC and found lead in all of the lipsticks tested, ranging from 0.09 ppm to 3.06 ppm with an average value of 0.97 ppm [1] , significantly higher than the highest lead level of 0.65 reported in the 2007 CSC study.

Not a safety concern

However, FDA does not consider the lead levels that it found in the lipsticks to be a safety concern.

“The lead levels found are within the range that would be expected from lipsticks formulated with permitted colour additives and other ingredients that had been prepared under good manufacturing practice conditions”. The agency adds that acceptable levels of lead in lipsticks cannot be compared to those settled for food products as “lipstick is a product intended for topical use, and is only ingested incidentally and in very small quantities”.

The Personal Care Products Council agreed. Lead levels detected in lipsticks are “safe and well below limits recommended by international regulatory and public health authorities,” the Council said in a statement. “Consumers who use lipstick ingest only a tiny fraction of the lipstick they apply, and much of the lead that is ingested in that tiny fraction of lipstick is not biologically available because it is trapped inside larger particles and excreted by the body”.

Dr. Sean Palfrey, a professor of pediatrics and public health at Boston University School of Medicine and medical director of Boston’s Lead Poisoning Prevention Program, agreed that the levels are still low, but wondered if they could build up to more toxic amounts, especially in foetuses and children.

The Campaign for Safe Cosmetics called on the FDA to “immediately set standards to require manufacturers to minimize lead in lipstick to the lowest achievable levels.”