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

ACI Has $10M Plan For Supporting Antibac Ingredients, If FDA Hasn’t Already Closed The Door

This article was originally published in The Rose Sheet

Executive Summary

The American Cleaning Institute is working to provide FDA with requested data to support three antibacterial agents that remain potentially viable for OTC use in consumer hand soaps following a September final rule that determined triclosan and 18 other such ingredients non-GRASE. However, FDA’s recent messaging around the issue – including that antibacterial soaps “may do more harm than good” – isn’t helping, it says.

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’s OTC Program Has Changed, But Antiseptic Sector Prepares For More Of The Same

The future of OTC antiseptic products – including antibacterial soaps and sanitizing hand rubs and wipes – came into serious question under FDA monograph actions taken in recent years. Stakeholders agree that Congress’s recently enacted CARES Act promises to transform OTC drug review, but the data requirements and uncertainty surrounding OTC germ-killing ingredients may be quickly reinstated.

CARES Act Makes Threatened Sunscreen Ingredients GRASE Again, But Next Steps Uncertain

Many questions remain following the late March enactment of the US CARES Act, which overhauls the FDA’s OTC drug regulatory framework and resets the GRASE status of long-used sunscreen drug ingredients whose safety and effectiveness have come under question at the FDA.

Related Content

Topics

UsernamePublicRestriction

Register

PS122308

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