HBW Insight is part 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

UsernamePublicRestriction
UsernamePublicRestriction

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

This article was originally published in The Rose Sheet

Executive Summary

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.

You may also be interested in...



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.

Supplement AER Numbers Could Raise False Alarm About Product Safety

CFSAN publishes data on more than 55,000 AERs received from January 2004 through September 2016 for dietary supplements, food – including food additives and color additives –and cosmetics. Quarterly updates begin in February with information from reports submitted during the 2016 fourth quarter.

Adverse Event Data Could Tip Scales In Cosmetics Regulatory Reform

FDA publishes data on AERs from January 2004 through September 2016 for food – including food additives and color additives – dietary supplements and cosmetics.

Related Content

Topics

UsernamePublicRestriction

Register

LL025498

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

Cancel