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WELLNESS WATCH: FDA issues warning to Purell manufacturer Gojo about unproven claims of hand sanitizer effectiveness

January 31, 2020 —

Submitted by Dr. Patricia Blanchette, University Health Partners of Hawaii Chief Medical Officer
Featured photo from PURELL® official website

On January 17, 2020, the U.S. Food and Drug Administration (FDA) issued a warning letter to Gojo, the manufacturer of PURELL® hand sanitizer products against making unproven claims of effectiveness in preventing disease or infection from pathogens such as Ebola, MRSA, VRE, norovirus, flu, and Candida auris.  

The FDA indicated that they are unaware of any adequate and well-controlled clinical trials in the published literature that support a determination that PURELL® Healthcare Advanced Hand Sanitizers are generally recognized as safe and effective (GRASE) for the above-described intended uses.

The FDA did not indicate that PURELL® Healthcare Advanced Hand Sanitizers are not effective, but that the claims are unproven.  

This warning is a good reminder not to be dependent on hand sanitizers in health care settings, but to wash frequently with soap and water.

For more information on the FDA’s warning letter to Gojo: 
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/gojo-industries-inc-599132-01172020