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


‘Vast Majority’ Of Antibac Soaps Need Reformulation Under FDA Final Rule

This article was originally published in The Pink Sheet

Executive Summary

FDA says the “vast majority” of roughly 2,100 consumer antibacterial soaps on the market contain at least one of 19 antimicrobial ingredients banned from OTC use under new final rule. Industry, which suggests the agency is overstating the rule’s impact, is focused on delivering supporting data for three active ingredients still pending before FDA for GRASE use in the category.

You may also be interested in...

ACI Still Musing On ‘Two Islands Study’ For OTC Consumer Antiseptics While Ticking GRASE Data Boxes

ACI’s James Kim, vice president of science and regulatory affairs, provides an overview of the cleaning product industry’s ongoing efforts to fill GRASE data gaps previously identified by the US FDA, which the trade group expects to be reasserted under newly legislated FDA administrative order procedures.

FDA Rule Marks Consumer Antibac Soaps A Possible Endangered Species

FDA’s rule “clarifies the mission” for manufacturers of consumer antibacterial soaps, which have a year to demonstrate that they are safe and effective or risk losing the entire OTC drug category.

FDA Says Antiseptics Need Testing Or Face Reformulation, Relabeling

FDA proposes to amend the OTC antiseptic drug product monograph to require more detailed safety and efficacy tests, pointing to mounting data that shows antibacterial wash products could pose health risks and contribute to increase antibacterial resistance.


Latest Headlines
See All



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