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
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’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.
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.
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.