"Nothing truly valuable can be achieved except by the unselfish cooperation of many individuals." - Albert Einstein
GOJO, the Makers of PURELL® Products, and Valisure, a leader in independent testing, are collaborating to accelerate independent quality assurance and help ensure that only safe and effective hand hygiene products are available in public settings.
Our partnership began in 2021, during the second year of the COVID-19 pandemic. In 2020, due to unprecedented demand, the U.S. Food and Drug Administration (FDA) issued temporary guidance for hand sanitizer production, causing the production of an FDA-regulated, over-the-counter drug by many first-time hand sanitizer manufacturers. Then on March 24, 2021, Valisure made global headlines when it announced that its routine testing of pharmacy products resulted in the detection of high levels of benzene, a known human carcinogen, in several brands and batches of hand sanitizer, none of which were PURELL® products.1
Valisure filed an FDA Citizen Petition detailing its findings2 and requesting regulatory actions, which resulted in the FDA's own testing confirming benzene contamination. The FDA’s testing led to various ongoing regulatory and industry actions on this serious public health concern, including the FDA announcing multiple national recalls.
After Valisure's findings, GOJO and Valisure partnered to conduct additional research and found potential health risks associated with refilling hand sanitizer dispensers in community settings and using inferior products. Unfortunately, in 2020, to meet demand, some businesses turned to open or refillable "bulk" style dispensers, which are easily refilled with any gallon bottle of hand sanitizer. This practice has grown considerably during the last two years. As no one had studied the risks associated with this new practice, our two companies conducted a research study published in a leading independent open-access scientific journal, PLOS One.3 The study found:
- Some community hand sanitizers contain toxic impurities, which could pose a health risk to people who use them. In the study, 30% of samples had potentially dangerous chemicals like acetal (a respiratory tract irritant) and acetaldehyde (a potential carcinogen) above interim FDA guidelines that were withdrawn in October 2021.
- Some community hand sanitizers had low alcohol content, which could create a product that does not kill germs. 9% of samples from community settings4 had alcohol levels less than the FDA required, and CDC recommended a minimum concentration of 60%.5 The use of "bulk-style" or refillable dispensers were linked to alcohol evaporation – and thus lower levels of alcohol – either due to the design itself and/or the misuse of the dispenser (failure to seal the reservoir).
- Many community hand sanitizers do not have appropriate labels, so it's hard to know what you're using on your hands. The FDA regulates alcohol-based hand sanitizers as an over-the-counter (OTC) drug and has strict manufacturing regulations, including labeling. As many as 70% of dispensers sampled lacked FDA-compliant labeling, including Drug Facts, Manufacturer, Lot, and Expiration Date (it was not present on the inside or outside of the dispenser). Many dispensers simply read "hand sanitizer" on the front of the dispenser.
Since the GOJO and Valisure study was published, the FDA has withdrawn the temporary guidances for alcohol-based hand sanitizers for manufacturers.6 However, hand sanitizer products produced under the temporary guidance continue to be sold, distributed, and donated to our most vulnerable populations, including our schools, places of worship, and food banks. This led to an additional collaboration with GOJO and Valisure, where both companies offered sampling and testing of hand sanitizer products in schools.
To improve and protect public health, it is essential to partner, collaborate and drive change together. GOJO and Valisure continue to work together to find innovative ways to improve supply chain resiliency, investigate raw materials that may be sources of contamination, and generally reinforce our shared mission of improving and protecting public health.