HBW Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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


Supplements' Mandatory Adverse Event Reporting Portends Cosmetics' Potential Future

This article was originally published in The Tan Sheet

Executive Summary

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.


Related Content

2018 In Review: US Midterm Mania Stifles Cosmetics Regulatory Reform Momentum
'Real Appetite' For User Fees Among Energy & Commerce Democrats
FDA's Cosmetic AE Data Begs Question: What If Reporting Were Mandatory?
Feinstein, EWG Gunning For Spring Senate Hearing On Cosmetics Bill
Supplement Industry Offers Cautionary Tale For Mandatory Cosmetic GMPs
Supplement GMP Inspections Reveal Adverse Event Reports, Prompting Warning Letters
Supplement AER Compliance Costs Exceed FDA Estimates – Industry
FDA Says Supplement Adverse Event Under-Reporting Should Feed Growth
FDA Says Supplement AERs Will Be Subject To Lower Threshold Before Action


Related Companies




Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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