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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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.
Like other hand sanitizer manufacturers, WillSpeed Technology claims its GermBloc “kills 99.99% of germs.” Plaintiffs in a proposed class action filed in Massachusetts federal court allege the claim “grossly overstates” the product’s efficacy, deceiving consumers and endangering them with false confidence.
FDA's COVID-19 Naughty List Now Includes Marketers Of Copper Germ Stoppers, ‘24-Hour’ Hand Sanitizer
Warning letters issued by the US FDA on 28 May target two companies using COVID-19 and other disease-prevention claims to market purported germ-killing products, including a rub touted as 24-hour protection and a line of copper rollers and other implements to disinfect hands and personal items.