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

 
• By Ryan Nelson

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.

Handsanitizaer and mask

The US nonprescription antiseptics industry is forging ahead with studies to support general recognition of safety and effectiveness (GRASE) for priority germ-killing agents that the US Food and Drug Administration has identified as insufficiently studied, putting them at risk of being deemed unapproved new drugs.

The FDA issued final rules for OTC consumer antiseptic washes, consumer antiseptic rubs and health care antiseptics in September 2016, April 2019 and December 2017, respectively, deferring rulemaking on six...

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