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.
You may also be interested in...
The American Cleaning Institute is preparing to submit a healthcare personnel hand wash study to the US FDA pending confidentiality discussions, along with results from a literature review on the topic of antimicrobial resistance. A progress report is due to the agency in October, which could stave off an administrative order under the reformed OTC drug review system.
A growing number of class action complainants allege that 99.99% germ-killing claims on hand sanitizers are false and misleading. The suits cite potentially dangerous microorganisms that, according to plaintiffs, are impervious to active ingredients used in the category, and argue that bacteria reductions do not necessarily translate to illness or infection prevention.
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.