Nursing & Healthcare News

FDA Squelches Hand Sanitizer Claims

A warning to Purell

A patient sits on a bed while a nurse in scrubs is rubbing hand sanitizer on her hands by a curtain

Although the CDC still recommends alcohol-based hand sanitizer for clinical hand hygiene, the FDA recently cautioned a leading manufacturer against making unsupported claims about their products’ ability to prevent infection.

Dispenser Panic

For nurses, hand sanitizer is as much a part of the daily routine as alarm clocks and coffee. You might have been startled, therefore, by recent news stories implying that hand sanitizer doesn’t protect against illnesses like influenza and norovirus.

If you were concerned, you can breathe easier: Although the FDA did pull certain hand sanitizer ingredients off the market last year, the CDC’s recommendations on the clinical use of alcohol-based hand sanitizers haven’t changed.

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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.

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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.

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