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FDA says Zicam enforcement routine

This article was originally published in The Rose Sheet

Executive Summary

FDA says simultaneously announcing a consumer safety alert and sending a warning letter to Matrixx Initiatives about the risks of Zicam zinc-containing intranasal homeopathic products due to potential loss of smell is not an unusual action, as some industry stakeholders suggest. Center for Drug Evaluation and Research officials say "warning letters are issued to achieve voluntary compliance," as demonstrated by the agency's June 16 communication with Matrixx about Zicam. "When it is consistent with the public protection responsibilities of the agency and depending on the nature of the violation, it is FDA's practice to give firms an opportunity to take voluntary and prompt corrective actions before it initiates an enforcement action," CDER said July 13. Matrixx voluntarily recalled the products the same day it received the warning letter (1"The Rose Sheet" June 29, 2009)

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