Federal regulators indicate that advertisements for the hand sanitizer Purell may be false and misleading, suggesting that it is effective at preventing Ebola, norovirus, or the flu, none of which have been established by the manufacturer.
On January 17, the FDA issued a warning letter to GOJO Industries Inc., the maker of Purell products, indicating that they must stop making claims that its products prevent a myriad diseases and illnesses.
As a result of the unproven claims that Purell can cure or treat certain disease, the agency indicates that it is reclassifying the hand sanitizer as an unapproved drug.
Marketing statements for over-the-counter Purell hand sanitizer products indicate it “kills more than 99.99% of most common germs,” including the bacteria that can cause illnesses like Methicillin-resistant Staphylococcus aureus (MRSA) and Vancomycin-resistant Enterococcus (VRE). Some statements claim Purell can lead to “100% MRSA and VRE reduction.”
MRSA is a type of staph infection that is resistant to antibiotics. It is very difficult to treat, and causes more than 80,000 infections and 11,000 deaths in the U.S. every year. VRE is another form of antibiotic resistant bacteria that is difficult to treat, causing thousands of deaths annually.
The FDA also indicates Purell advertisements have claimed it could prevent the flu and help reduce student absenteeism by 51%. In addition, some Purell ads claim the World Health Organization and the U.S. Centers for Disease Control and Prevention (CDC) recommend the use of alcohol-based hand sanitizer to prevent Ebola outbreaks.
Such claims are false or unproven, according to the FDA, and go far beyond what the manufacturer is allowed to claim about Purell in its advertising.
The FDA warning indicates GOJO’s claims violate the Food and Drug Cosmetic Act by claiming the product can cure, treat or prevent a disease. The agency said it is not aware of studies that are well-controlled that adequately show hand sanitizer kills bacteria or viruses and prevent infection or disease caused by those bacteria or virus.
“Your labeling claims that PURELL Healthcare Advanced Hand Sanitizers are effective in preventing disease or infection from pathogens such as Ebola, MRSA, VRE, norovirus, flu, and Candida auris, and in preventing the spread of infection, go beyond merely describing the general intended use of a topical antiseptic as set forth in the above-referenced relevant rulemakings,” the FDA warning letter states.
The reclassification as an unapproved drug puts Purell well under the purview of FDA enforcement. The letter calls for GOJO to fix the advertising claims and other violations promptly, and to notify the agency of how it will address the problems within 15 days of receiving the letter.
The CDC recommends using hand sanitizer only when hand-washing with soap and water is not available. Washing your hands is the best way to prevent the spread of germs and onset of illness, health experts say.