In response to a number of inquiries regarding reports of lead contamination in lipstick, the FDA has developed and validated a method for analyzing lead content in currently marketed lipstick.
Results do not show levels of lead in lipstick that would pose a safety concern.
The following information is drawn from responses to inquiries, along with information on our latest findings.
What is FDA’s legal authority over cosmetic safety?
The FDA regulates cosmetic safety under the authority of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FD&C Act requires that cosmetics marketed in interstate commerce be safe when used as directed in the labeling or under customary conditions of use. Cosmetics are not subject to pre-market approval by FDA. However, pre-market approval is required for the color additives used in cosmetics (including those in lipsticks), with the exception of coal-tar hair dyes.
Has FDA set limits for lead in cosmetics?
No, the FDA has not set limits for lead in cosmetics. FDA has set specifications for lead in color additives used in cosmetics. FDA approval of color additives is based on safety evaluations that consider the color additives’ intended uses and estimated consumer exposure resulting from those uses.
What Are FDA’s limits for lead in color additives?
FDA limits lead in color additives to maximum specified levels, typically no more than 20 parts per million (ppm) for color additives approved for use in cosmetics. In addition, the color additives listed under regulations in 21 CFR Parts 74 and 82 are required to be batch-certified by FDA, which includes testing each batch for lead, before they may be used in cosmetics.
Has FDA been aware of concerns about lead in lipstick?
Yes, reports about lead in lipstick are not new. In the 1990s, reports of analytical results from a commercial testing laboratory suggested that traces of lead in lipstick might be of concern. The Campaign for Safe Cosmetics (CSC), in October 2007, reported finding lead in a selection of lipsticks on the market. Because reports about lead in lipstick have surfaced periodically and because of the time that had elapsed since we last examined information on lipsticks in the marketplace, we decided that further follow-up was needed.
How did FDA follow up on the October 2007 report on lead in lipstick?
FDA scientists developed and validated a highly sensitive method for the analysis of total lead content in lipstick and applied the method to the same lipsticks, that were still available on the market, previously evaluated by the CSC. FDA scientists found lead in all of the 20 lipsticks tested, ranging from 0.09 ppm to 3.06 ppm, with an average value of 1.07 ppm. The detection limit was estimated to be 0.04 ppm. FDA 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.
How did FDA follow up on its initial survey of lead in lipstick?
FDA conducted an expanded survey of lipsticks, covering a wide variety of shades, prices, and manufacturers. Four hundred lipsticks available on the U.S. market in the spring of 2010 were tested for total lead content. The selection of lipsticks tested was based on the parent company’s market share. Also included are some lipsticks from niche markets in an effort to capture lipsticks with unusual characteristics.
Frontier Global Sciences, Inc., a private laboratory based in Seattle, WA, performed the analyses in the expanded survey, following a protocol consistent with FDA’s validated method.1 The laboratory was required to show continued reliability of the results using specific quality control procedures.
What did FDA’s expanded survey reveal about lipsticks on the market?
The expanded survey found that the average lead concentration in the 400 lipsticks tested was 1.11 ppm, very close to the average of 1.07 ppm obtained in our initial survey. The results ranged from the detection limit of 0.026 ppm to the highest value of 7.19 ppm. The expanded survey will be published in the May/June, 2012, issue of the Journal of Cosmetic Science.
Is there a safety concern about the lead levels FDA found in lipsticks?
No. The FDA has assessed the potential for harm to consumers from use of lipstick containing lead at the levels found in both rounds of testing. Lipstick, as a product intended for topical use with limited absorption, is ingested only in very small quantities. The FDA does not consider the lead levels found in the lipsticks to be a safety concern.
It has been reported that levels of lead in certain lipsticks exceed those for candy. Is this a fair comparison?
No. The FDA-recommended upper limit for lead in candy is 0.1 ppm. It is not scientifically valid to equate the risk to consumers presented by lead levels in candy, a product intended for ingestion, with that associated with lead levels in lipstick, a product intended for topical use and ingested in much smaller quantities than candy.
What are FDA’s next steps for lead in lipstick?
Although it’s not believed that the lead content found in our recent lipstick analyses poses a safety concern, the FDA is evaluating whether there may be a need to recommend an upper limit for lead in lipstick in order to further protect the health and welfare of consumers.
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