Study Finds Lead Contaminants in Lipstick No Cause for Alarm

10/5/2015

American consumers are very concerned about lead in their products, particularly those products which pose a chance of contact with children. One unusual and unrealized source of lead may come from a mother's tender kiss on her infant's forehead. Surprisingly, lead is an unadvertised ingredient in many types of lipstick. According to the U.S. Food and Drug Administration (FDA), "lead is an unintended contaminant or impurity that can be present at very low levels in some color additives and in other common ingredients, such as water, that are used to product cosmetics," http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194557.htm.

Nearly a decade ago, in 2007, the Campaign for Safe Cosmetics tested 33 lipstick samples and determined that 61% of the sampled lipsticks contained lead. The most lead-dense lipstick contained a concentration of 0.65 parts per million (ppm). The FDA tested 400 lipstick samples in 2010 and found even higher levels of lead in the lipsticks sampled, with a median lead concentration of 0.9 ppm and the highest-testing lipstick containing 7.19 ppm of lead. A 2013 study used high resolution atomic spectrometry to evaluate 25 samples of lipstick, and found results consistent with the FDA's 400 lipstick study. See, Investigation of lead contents in lipsticks by solid sampling high resolution continuum source electrothermal atomic absorption spectrometry, Regulatory Toxicology and Pharmacology, Vo. 65, Issue 1, February 2013, pp. 34-37.

As published on its website, "the FDA does not believe that any of the products tested pose a safety concern." The more precautious European Union has also agreed that the levels of lead found in lipsticks posed no adverse health risk. See, Lead in lipsticks: safe levels of unintentional lead contamination confirmed, at https://ec.europa.eu/jrc/en/news/lead-lipsticks-safe-levels-unintentional-lead-contamination-confirmed-9747. While contact with lead may not be concerning if it comes from a women wearing lipstick daily or a mother's lipstick stain on her child's cheek, there are other times where the lead ingestion concern could be more rational. For example, if a child finds and eats a tube of lipstick, or if a child paints a large amount of lipstick on his or her face and then ingests it an unsafe intake of lead could conceivably result. Another concern could involve whether pregnant women who wear lipstick are inadvertently causing fetal harm. Under these more extreme exposure scenarios, is there a potential health risk associated with the oral or dermal lead contact?

What remains unknown about these lipsticks is whether and by what routes of exposure any lead they may contain would be bioavailable. In other words, is there an exposure pathway for the lead to become absorbed by the body, enter the blood stream, survive in the blood stream and cause damage to the cells or organs of the person who consumed it? Some questions for exploration are whether the pigments and emollients in the lipstick change the lead's molecular structure or are processed by the body in such a way as to prevent lead contact.

One recent study evaluated the bioavailability of lead contained in lipsticks, to evaluate the potential risk to regular adult lipstick wearers and to children who may inadvertently ingest it. Researchers found that lead exposure associated with lipstick did not significantly raise blood lead levels. As the study's authors put it, in order to raise the blood lead level of an adult with average background exposure to the CDC blood lead level of interest of 5 µg/dL, "an adult would need to apply lipstick approximately 675 times per day." Similarly, a child would need to consume 247 tubes annually to raise blood lead levels to the Centers for Disease Control level of concern, and an astonishing 897 tubes annually to reach the Environmental Protection Agency actionable level for lead exposure (which is 10 µg/dL). The study is An exposure and health risk assessment of lead (Pb) in lipstick, Food and Chemical Toxicology, vol. 80, June 2015, pp. 253-260. Note the lack of a linear difference in the consumption of lipstick required to raise the blood lead level threshold from 5 µg/dL to 10 µg/dL is not a doubling but almost a quadrupling, demonstrating that there is no simple linear exposure progression.

This study thoughtfully illustrates the importance of not falling victim to fearmongering about the potential harm from ingredients in consumer products like cosmetics, instead relying upon a realistic assessment of the risk of ingestion weighing both background levels of the substance and existing health based standards related to substance exposures.

If you would like further information regarding this study or have any questions regarding lead poisoning claims, consumer product liability or about toxic tort litigation in general, please contact David Governo (dgoverno@governo.com) or Sarah O'Leary (soleary@governo.com).