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.
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Latest warning letters published by FDA include not only two more about claims for supplements to prevent or treat the disease caused by the novel coronavirus, but also warnings about good manufacturing practices violations and noncompliant claims for CBD-containing products and for a detoxification line.
When businesses rapidly pivot to offering consumer health products and services, they’re likely not contemplating compliance with FDA regulations. Recent warning letters are more proof COVID-19 represents opportunities for numerous businesses that aren’t prepared to follow or simply aren’t aware of FDA regulations.
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.