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.
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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.