April 21, 2019

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FDA Warns of Asbestos Contamination in Certain Cosmetics

Unlike other product categories regulated by FDA, FDA’s authority over cosmetic products marked in the United States is limited. FDA lacks mandatory recall authority for cosmetics, and manufacturers are not legally required to disclose adverse health effects reported by consumers. Ultimately, companies and individuals who market these products in the U.S. bear the responsibility for the safety and labeling of their products.

In 2017, FDA become aware of reports of asbestos contamination in certain cosmetic products sold by Claire’s and Justice retailers. On Sept. 5, 2017 Justice voluntarily recalled the suspect products, and on December 22, 2017, Claire’s removed a number of products from its stores. In a statement on March 5, 2019, former FDA Commissioner Dr. Scott Gottlieb and Dr. Susan Mayne, Ph.D., Director of the Center for Food Safety and Applied Nutrition explained that after Claire’s withdrew and Justice recalled the suspect products, FDA conducted independent tests to determine if some of these products did, in fact, contain asbestos. Those tests confirmed the presence of asbestos in three of the product samples collected from Claire’s and one of the product samples collected from Justice.

While suspect Justice products, including the one that tested positive for asbestos were previously recalled from the market, FDA noted that Claire’s has refused to comply with the Agency’s request to recall the products. Because the Agency does not have authority to mandate a recall, FDA issued a Safety Alert, warning consumers to not use three of Claire’s products because they tested positive for asbestos. In essence, the Agency utilized the statement in this case to publicly announce their alleged safety concerns with the products and to point out that Claire’s had failed to comply with FDA’s request. While not a recall, this statement represents a powerful tool for the Agency to communicate concerns with respect to cosmetics.

 

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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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