FDA’s OTC Program Has Changed, But Antiseptic Sector Prepares For More Of The Same
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.
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Supplement industry’s bullseye on “60 Minutes” after its June segment critical of probiotic health benefits generated the most reads for a US consumer health and overall for HBW Insight articles in 2020. Articles about COVID-19 enforcement actions weren’t as widely read as coverage of FDA’s reorganization in its OTC drug offices and its approvals of additional ingredients to be available OTC.
The US FDA has primary jurisdiction over labeling claims on OTC consumer antiseptic rubs, and state false advertising claims lodged by the plaintiff are preempted by federal law, Edgewell Personal Care argues in its motion to dismiss a proposed class action in California federal court regarding Wet Ones germ-killing claims.