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Two Firsts For US Hand Sanitizer Firm: False COVID-19 Claims, Revamped Monograph Violation

 
• By Malcolm Spicer

Less than a month after Congress passed legislation to comprehensively overhaul the FDA's OTC monograph program, the agency's warning to Prefense explains that its product formulation is noncompliant under amendments to the program.

Warning Rubber Stamp

An Iowa firm not only is the first hand sanitizer provider the Food and Drug Administration warned about unproven COVID-19-related claims, but also the first target of a warning about violating the agency's OTC monograph program as it was amended in recent legislation.

The agency's 23 April letter says Prefense LLC made claims for its namesake brand product including "protects you from...

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• By Lauren Nardella

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ECHA Adds Two Cosmetic/Personal Care Silicones To REACH Candidate List

 
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