FDA Cosmetics Director: ‘Sporadic’ WEN AERs Make Case For Mandatory Reporting
This article is powered by The Rose Sheet
Executive Summary
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.
You may also be interested in...
US FDA Convinced: Cosmetic Adverse Event Reports Aren’t Telling Whole Story
Linda Katz, director of the FDA’s cosmetics office, says to “stay tuned” for federal legislative developments in 2022, maintaining her position that voluntary adverse-event reporting paints an incomplete picture of consumers’ experience with cosmetic products across the US.
Cosmetics Recalls For August-October Period Have One Familiar Thing In Common: All Were Voluntary
Under current cosmetics regulations FDA does not have the authority to order product recalls, as it does in the dietary supplement space, for example. Voluntary cosmetic recalls have been typically light in recent months, most often citing microbiological issues.
FDA To Curtail Cosmetics Safety Work Under FY 2018 Budget Constraints
President Trump's budget proposal for fiscal 2018 calls for "targeted reductions to the Food Safety program, including reducing staff levels through attrition." In its justification to congressional appropriators, FDA says it will reduce funding for cosmetics safety work in order to focus on top priorities in the broad foods area.