FDA Issues Final Lead-In-Lipstick Report, Postpones Decision On Cosmetic Lead Limits
This article was originally published in The Rose Sheet
Executive Summary
FDA’s expanded survey of lead levels in lipstick examined 400 products on the market, finding an average amount of 1.11 ppm, comparable with its initial test of 20 lipsticks, which averaged 1.07 ppm lead content.
FDA’s final report on lead in lipstick finds levels consistent with its 2009 investigation and emphasizes that the agency does not believe the lead content in currently marketed lipstick presents a safety concern to consumers.
“The expanded analysis shows that lead in lipstick is an even bigger problem than previously reported, with some of the most popular brands consistently contaminated with higher levels of lead,” says CSC spokeswoman Stacy Malkan.
In a Dec. 5 update to a question-and-answer page regarding lead in lipstick on its website, FDA published the results of its in-depth study of 400 lipsticks on the market, finding lead levels ranging from 0.026 ppm to 7.19 ppm.
However, FDA has not come to a decision on whether or not to issue guidance recognizing that lead levels of 10 ppm or less are safe in cosmetics.
The Personal Care Products Council requested agency action on the matter in a June 8 citizen petition (Also see "FDA Eyes Industry-Proposed Lead Limit, With Lipstick Report Slated For Fall" - HBW Insight, 29 Aug, 2011.). An FDA-sanctioned limit would help legitimize the trade group’s position that cosmetics with trace levels of lead are safe for consumer use.
In a Dec. 1 letter to Council President and CEO Lezlee Westine, Linda Katz, director of FDA’s Office of Cosmetics and Colors, says that due to “competing priorities,” FDA was not able to reach a decision within 180 days of the Council’s petition.
“We prioritize our efforts according to public health priorities, as well as legal and administrative requirements,” an FDA spokesman said in a Dec. 7 email to “The Rose Sheet.” “Often a delay is not related to a single item added to our workload, but results when we need to coordinate work on many fronts.”
In the letter, Katz says the petition is being evaluated and FDA expects to complete its review of the request “in the near future.”
FDA has set lead limits ranging from 10ppm to 20ppm for color additives used in cosmetics, as well as in food, drugs and medical devices, and has issued guidance for maximum lead levels in “generally recognized as safe” food ingredients.
Within Expected Range
FDA initiated an investigation into the matter following a 2007 report from activist group the Campaign for Safe Cosmetics alleging dangerous levels of lead in lipstick, and the agency published its findings in the July/August 2009 issue of the Journal of Cosmetic Science (Also see "Lead Levels In Lipstick Not A Concern, FDA Says; More Testing Planned" - HBW Insight, 7 Sep, 2009.).
In testing 20 lipstick shades from 10 brands, FDA found lead levels ranging from 0.9 ppm to 3.06 ppm. The agency “concluded that the lead levels found are within the range that would be expected from lipsticks formulated with permitted color additives and other ingredients that had been prepared under good manufacturing practice conditions.”
For the second iteration of its investigation, FDA chose 400 lipsticks that reflected a variety of shades, prices and manufacturers. Specific products were selected based on the parent company’s market share, FDA says on its website.
Additionally, the agency picked some lipsticks from niche brands “in an effort to capture lipsticks with unusual characteristics,” the agency says on its website.
Lipsticks from L'Oreal SA, Shiseido Co. and Procter & Gamble Co. brands, as well as those from U.K.-based Stargazer, were among the top 10 with the highest lead content.
Testing was completed by Frontier Global Sciences, Inc., a Seattle, Wash.-based private laboratory. The lab followed “a protocol consistent with FDA’s validated method,” and was required to use specific quality control procedures to “show continued reliability of the results,” FDA says.
FDA will publish the results in the May/June 2012 issue of the Journal of Cosmetic Science, according to the agency.
As lipstick’s absorption into the body is limited, and it is ingested only in small quantities, FDA does “not consider the lead levels we found in the lipsticks to be a safety concern,” it says on its website. “The lead levels we found are within the limits recommended by other public health authorities for lead in cosmetics, including lipstick.”
Lead levels measured in the second round of testing averaged 1.11 ppm, in line with the initial survey’s average of 1.07 ppm.
“An Even Bigger Problem”
The Campaign for Safe Cosmetics disagrees with FDA’s assessment of the report.
“The expanded analysis shows that lead in lipstick is an even bigger problem than previously reported, with some of the most popular brands consistently contaminated with higher levels of lead,” Stacy Malkan, a spokeswoman for CSC, said in a Dec. 8 email to “The Rose Sheet.”
“There is no safe level of lead exposure,” she continued, citing data from the U.S. Centers for Disease Control indicating “no safe blood lead level has been identified.”
Moreover, FDA’s study fails to take into consideration the absorption of lead into the body from lipstick, she said.
The CSC recommends FDA set formal guidance for lead levels in cosmetic products “based on the lowest lead level that companies can feasibly achieve,” Malkan concluded.