Just at the time when consumers nationwide are clearing the store shelves of Purell comes word that the Food and Drug Administration and several private lawsuits are charging the company with making unsubstantiated health claims for its products.
In January, the FDA sent a warning letter to GOJO Industries alleging that as marketed and advertised PURELL® Healthcare Advanced Hand Sanitizers are unapproved new drugs because of claims like:
“Kills more than 99.99% of most common germs that may cause illness in a healthcare setting, including MRSA & VREâ€
“In a recent study, student absenteeism was reduced by 51% when PURELL hand hygiene products were used in conjunction with a curriculum to teach kids about good hand hygiene[] . . . 10% Less Teacher Absenteeism”
“Even though norovirus is highly contagious, there are ways you can reduce the risk of its spread. … Alcohol-based hand sanitizers with at least 60% alcohol can be used in addition to handwashing . . .”
“Is PURELL® Advanced Hand Sanitizer Effective Against Ebola? … [WHO and the CDC] are recommending the use of alcohol-based hand sanitizer as a preventive measure during this outbreak . . .”
The FDA goes on to say that claims like these suggest that Purell is intended to prevent or reduce disease from Ebola, norovirus, and the flu, but the agency is not aware of any studies that correlate killing bacteria or viruses on the skin with a corresponding reduction of those diseases. As such, because Purell is intended for the “diagnosis, cure, mitigation, treatment, or prevention” of disease and thus by definition that makes it is a drug. And an unapproved new one at that. New drugs need to be FDA-approved before being sold.
The maker of Purell posted a response to the FDA on its website, saying in part:
It is our responsibility to ensure that we comply with all requirements of FDA regulations and federal law, and we take that responsibility very seriously. To that end, we have begun updating relevant website and other digital content as directed by the FDA and are taking steps to prevent a recurrence.
At least three consumer class action lawsuits (most recent one here) have been filed against GOJO claiming consumers were misled because the company made 99.99% effectiveness claims without having reliable substantiation.






