Last August, we reported on the Southern District of New York’s decision granting L’Oréal’s motion to dismiss a putative class action alleging that a common pump dispense mechanism used on L’Oréal’s cosmetics bottles deceptively prevented consumers from accessing the entirety of the product. Judge Koetl disagreed, finding that consumers are familiar with pump dispensers on cosmetics packaging, and that the plaintiffs’ alleged “disappointment” did not “establish deception” or “transform [L’Oréal’s] accurate labeling of the product’s net weight into fraud by omission.” Judge Koetl also found that the plaintiffs’ claims were preempted by the Federal Food, Drug and Cosmetics Act (“FDCA”). Because federal law requires L’Oréal to label its cosmetics products with the net quantity of the product, irrespective of the amount that is accessible through the pump, Judge Koetl found that the plaintiffs’ claims were preempted.

The Second Circuit agreed. Because the plaintiffs conceded that L’Oréal’s packaging complied with the FDCA with respect to the net-quantity of the product, the court found that, in order to avoid liability under the plaintiff’s theory, L’Oréal would have to “make an additional disclosure on its packaging, indicating that some cream cannot be retrieved or that the cream that is accessible is less than the net quantity displayed on the package label.” (emphasis added). Because such a theory would “impose labeling requirements on top of those already mandated in the FDCA,” the claims were preempted.

The Second Circuit did not reach the “reasonable consumer” grounds for the District Court’s decision, and we expect that the plaintiffs’ bar will continue to try to plead around FDCA preemption in slack fill cases. But this decision will severely hinder their ability to do so—at least in the Second Circuit—and plaintiffs may start looking elsewhere to pursue these allegations.

Reports of lead in lipstick have surfaced periodically over the last several years. In 2007, the Campaign for Safe Cosmetics released a report stating that it had found lead in lipsticks on the market at that time. FDA conducted testing of 20 lipsticks in 2007 and found an average lead content of 1.07 parts per million (ppm). The highest range detected was 3.06 ppm. In 2010, FDA and expanded its testing to 400 lipsticks, resulting in an average lead concentration of 1.11 ppm. The lead levels of certain lipsticks rose significantly since the 2007 testing, however, with 7.19 ppm being the highest level detected. For a table of the results and further information, see FDA Analyses of Lead in Lipsticks – Expanded Survey. The expanded survey will be published in the May/June, 2012, issue of the Journal of Cosmetic Science.

FDA has not set an upper limit for overall lead content in lipstick. Color additives are limited to maximum specified levels, typically no more than 20 ppm for cosmetic products. However, FDA is assessing whether an overall lead limit is appropriate. The agency website states: “Although we do not believe that the lead content found in our recent lipstick analyses poses a safety concern, we are 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.”

On March 26, 2010, the Food & Drug Administration (FDA), issued a final rule titled, "Listing of Color Additives Exempt From Certification; Bismuth Citrate,” amending the color additive regulations to increase the permitted use level of bismuth citrate as a color additive in cosmetics intended for coloring hair on the scalp.

This regulation follows the initial notice published by FDA on February 25, 2008, which announced that a color additive petition (CAP 8c0286) had been filed by Combe, Inc. to amend the color additive regulations at 21 CFR 73.2110 for bismuth citrate to increase the maximum permitted use level of bismuth citrate as a color additive in cosmetics intended for coloring hair on the scalp from 0.5 percent (weight per volume (w/v)) to 2.0 percent (w/v). Bismuth citrate is commonly used as an active ingredient in hair dyes used to darken hair on the scalp.

After reviewing the data in the petition and other materials related to the safety of the use of bismuth citrate as a color additive in cosmetics intended for coloring hair on the scalp, FDA concluded that use of bismuth citrate at levels up to 2.0 percent (w/v) “is safe and…will achieve its intended technical effect.” The rule will go into effect on April 27, 2010, "except as to any provisions that may be stayed by the filing of proper objections."

More information about the regulation, including information on submitting objections or requests for hearings, is available here.