FDA Study Reaffirms The Safety Of Lipstick; Agency Says Trace Lead Levels In Lipstick Not A Safety Concern

Main Category: Cosmetic Medicine / Plastic Surgery
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 31 Aug 2009 - 0:00 PDT

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In an article published in the July/August edition of the peer-reviewed Journal of Cosmetic Science, U.S. Food and Drug Administration (FDA) scientists report that they have developed, validated and employed a highly sensitive and rigorous testing method to analyze the total lead content in a broad selection of lipsticks sold in the U.S. and found the lead levels present to be safe and well below limits recommended by international regulatory and public health authorities.

The new FDA study of lead levels in lipstick was prompted by recurring and unfounded allegations that most recently surfaced in a report released in October 2007 by the Campaign for Safe Cosmetics (CSC), an advocacy group that alleged it found unsafe lead levels in a variety of lipsticks marketed in the U.S. However, all of the lead levels the group identified were well below all established regulatory standards.

In response to the allegations, FDA scientists tested the lead content of the same selection of lipsticks evaluated by the CSC and found the lead levels present to be safe and lower than limits recommended by other public health authorities for lead in cosmetics, including the very conservative limit of 5 parts per million (ppm) set by California under Proposition 65, as well as the draft Canadian guidance of 10ppm. FDA was unable to determine if a method validated for the analysis of lipstick was used to generate the data in CSC's 2007 report because the group did not provide the details of its analytic method. This is important because the determination of trace levels of lead requires considerable skill and expertise and adherence to rigorous, validated analytic protocols.

As expected, FDA found trace levels of lead in all of the lipsticks tested, ranging from 0.09 ppm to 3.06 ppm, with an average value of 1.07 ppm, and 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 practices. FDA stated on its Web site that these results confirm that the low levels of lead found in the lipsticks are not a safety concern.

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. However, 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.

Lead is never used as an intentionally added ingredient in or as an additive to lipstick. However, because lead is found naturally in air, water, and soil, it may also be found at extremely low levels as a trace contaminant in the raw ingredients used in formulating cosmetics, just as it is in many thousands of other products.

Safety is the highest priority of personal care products companies. Cosmetic and personal care product manufacturers are required by law to substantiate the safety of all products and ingredients before they are marketed.

Council member companies employ and consult with thousands of scientists from multiple disciplines to perform sophisticated safety assessments. Those safety assessments take into account that products such as lipstick may be used daily and over the course of a lifetime.

For information on the FDA study of lead in lipstick, visit the FDA website.

Source
U.S. Food and Drug Administration