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FDA Cosmetics Director: ‘Sporadic’ WEN AERs Make Case For Mandatory Reporting

 
• By Lauren Nardella

In a Q&A posting, FDA Office of Cosmetics and Colors Director Linda Katz offered perspective on how the division handles adverse event reports and makes a case for mandatory AE reporting. She also explains how FDA reacted when WEN-related AERs began rolling in.

Linda Katz
Office of Cosmetics and Colors Director Linda Katz

Without mandatory reporting of serious adverse events associated with cosmetics, reports FDA receives represent just the “tip of the iceberg” of adverse events experienced, according to Office of Cosmetics and Colors Director Linda Katz.

In a Dec. 8 question and answer

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