HBW Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

FDA's Cosmetic AE Data Begs Question: What If Reporting Were Mandatory?

This article was originally published in The Rose Sheet

Executive Summary

Infographic: According to FDA data, cosmetic-related AE reports in 2015 more than tripled what they were in 2009, but consumers still do the bulk of the reporting themselves. Proposed federal bills to update cosmetics oversight would require companies to report serious adverse events, which could propel numbers upward while providing FDA with greater insight into the marketplace.

You may also be interested in...



FDA Divulges Cosmetics Enforcement Data, Notes Hair Loss As ‘Serious’ AE

Momentum this year behind legislative proposals for cosmetics regulatory reform has prompted key Congress members to question FDA about the current oversight system. In a response to the Senate HELP Committee’s chairman, FDA provides a wealth of data on its enforcement activities and confirms hair loss as an adverse event it considers “serious,” if not one currently identified as such by MedWatch’s definition.

Supplements' Mandatory Adverse Event Reporting Portends Cosmetics' Potential Future

Supplement firms' reports of serious adverse events jump since becoming mandatory in 2008 and FDA warnings on failures to report have been on the rise as companies labor to keep up with investigations and reporting duties. Similar challenges could lie ahead for cosmetics firms under House and Senate bills.

Mandatory AE Reporting In Supplement Space Offers Glimpse Of Possible Cosmetic Future

Reports of serious adverse events in the dietary supplement industry have increased exponentially since reporting was made mandatory in 2008, and FDA warning letters citing failures to report have been on the rise as companies labor to keep up with investigations and reporting duties. Similar challenges could lie ahead for the cosmetics industry under proposed bills in the US House and Senate.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

RS019829

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel