FDA Squelches Hand Sanitizer Claims

So, why all the fuss? On January 22, FDA Division of Pharmaceutical Quality Operations Director of Compliance Nicholas F. Lyons sent a letter to GOJO Industries Inc., which makes Purell hand sanitizers, about making unsupported medical claims.

Regulated as a Drug?

Under federal law, products that claim to diagnose, prevent, treat or cure disease are drugs, which may not be marketed or sold without FDA approval. Makers of consumer products and supplements often flirt with these rules, implying that their products have health benefits while avoiding claims that would trigger an FDA response.

In their January 22 letter, the FDA warned that recent Purell labeling and marketing  crossed that line. The letter quotes marketing copy asserting that Purell hand sanitizers “help eliminate MRSA & VRE”; that influenza viruses “are easily killed or inactivated by alcohol”; and that use of hand sanitizers can even reduce school absenteeism.

Those claims, Lyons says, would make Purell hand sanitizer a new drug that has yet to receive FDA approval.

To avoid federal penalties, GOJO says it will change its marketing and labeling copy to remove the claims.

In this Article: FDA, Legal Action and Enforcement