“These companies have an obligation to the public to demonstrate to the FDA that their products are safe and effective, and they have failed to do so,” said Deborah M. Autor, director of the Office of Compliance at the FDA’s Center for Drug Evaluation and Research.

Fun Express, Inc. recalls children’s face paint associated with adverse events. The Food and Drug Administration is advising consumers to stop using certain cosmetic “Face Paint” items labeled as distributed by Oriental Trading Co., Omaha, Neb., due to adverse event reports of skin reactions in children. These items were distributed nationwide.