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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.

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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

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