By Chip Manuel, Ph.D.

Food Safety Science Advisor, GOJO Industries

Also By Dawn Yeomans, Ph.D.

Hygiene Sciences & Partnerships Senior Advisor, GOJO Industries

Germs are everywhere, so it also seems everywhere you go – schools, public buildings, fitness centers, restaurants, and shops – you can find hand sanitizer dispensers. Now a daily essential, consumers expect to find alcohol-based hand sanitizer available for use in public settings. In fact, 84% of people expect hand sanitizer to be offered in public places.*

With this increased expectation, more business owners and facility operators began offering hand sanitizer to help make their patrons, employees, and guests feel safe while they're visiting. However, a new study found potential health risks with a new practice related to sanitizer dispensers that arose during the pandemic – when businesses were initially having problems obtaining hand sanitizer.

To meet demand in 2020, some businesses turned to open or refillable "bulk" style dispensers, which are easily refilled with any gallon bottle of hand sanitizer, so, therefore, they were easier to source when there was limited availability of sanitizer. Unfortunately, this practice has grown considerably during the last two years. As no one has studied the risks associated with this new practice, we conducted a research study in partnership with Valisure LLC, an independent lab and leader in consumer drug product analysis.¹ 

Study finds health risks

We sampled hand sanitizers from these "bulk" dispensers in dozens of community settings across the United States – public places like schools, restaurants, and stores. The results of this study were recently published in a leading, independent open-access scientific journal, PLOS One¹. Multiple issues were found:

1. Some community hand sanitizers contained 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) in excess of interim Food and Drug Administration (FDA) guidelines. (The FDA issued temporary manufacturing guidance in 2020 when businesses and consumers had difficulty obtaining hand sanitizer due to unprecedented demand, but have recently withdrawn them, with an effective date of December 31, 2021.)²
2. Some community hand sanitizers had low alcohol content, which could create a product that does not kill germs. 9% of samples from community settings¹ had alcohol levels less than the CDC's recommended 60%.³ 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).
3. Many community hand sanitizers did 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 dispenser). Many dispensers simply read "hand sanitizer" on the front of the dispenser.

Why are these findings significant?

Consumers rely on hand sanitizer to clean their hands when they're out and about, away from sinks. It's crucial that what they reach for is safe and effective. For the past two years, consumers have heard repeatedly from public health experts and the Centers for Disease Control and Prevention (CDC) that they need to use hand sanitizer with at least 60% alcohol when sinks aren't convenient,³ and know to avoid hand sanitizers that were recalled or banned by the Food and Drug Administration (FDA) due to the presence of dangerous impurities.⁴ They expect the businesses they visit to have spent time choosing a dispenser and product that is not only effective against germs but will also be safe for themselves and their families. If they have an unpleasant experience, it may reflect poorly on your business's reputation.

What can businesses do?

Review what hand sanitizer you offer to your patrons and guests.

• Does it have "dirt" flecks, discoloration, or a weird consistency? Dispensing systems that use factory-sealed refills will help prevent contamination and the critical problem common with bulk-style sanitizer: mixing different hand sanitizer formulas in the "topping off" process.
• Does the dispenser look well-maintained? The dispenser should be clean and free of any dirt on the outside. Touch-free dispensers should be charged and in operation. Dispensers should not leak or drip.
• Is there a brand name on the front of the dispenser, so guests know what they are using (it doesn't just say "hand sanitizer")? Is it a brand name your guests would recognize and trust?
• Is there an FDA-compliant label on the product inside the dispenser (active ingredient, product manufacturer, and expiration date)? Products without these labels may not be safe to use, as the product could be expired, or the product could be on the FDA's list of hand sanitizers to avoid.

Consult your distributor if you're not happy with the answers to these questions. The supply of trusted hand sanitizer brands, including dispensers, has returned. GOJO has made significant supply chain investments to ensure ample supply for today and the future.

What to look for in alcohol-based hand sanitizers:

The hand sanitizer you offer your patrons and guests is another opportunity to show them how much you care about their well-being. Don't leave them with a bad impression. Here are some considerations when researching hand sanitizer options for your business:

1. Choose a hand sanitizer with at least 60% ethyl alcohol or 70% isopropyl alcohol for proven efficacy against germs. This will be clearly listed on the label.
2. Ensure the product is in the original packaging with appropriate labeling (including Drug Facts – e.g., ingredients; lot number; expiration date; and manufacturer contact information).
3. Check the product's expiration date, which is typically 2-3 years after the product's manufacture date.
4. Stick with well-known, proven brands. There has been a glut of off-brand hand sanitizers available during the pandemic, manufactured under the FDA's temporary guidance by first-time manufacturers unfamiliar with producing an over-the-counter drug. Unfortunately, some of these new market entrants formulated hand sanitizer with ingredients that can be harmful. Check the FDA's do-not-use list of more than 270 hand sanitizers at fda.gov/handsanitizerlist.
5. Avoid hand sanitizers with poor aesthetic qualities, such as an undesirable smell, poor product consistency, stickiness, or those that irritate or dry hands. This could have an unintended negative impact on your guests or employees.
6. Check with your distributor to make sure the product you have been using will be available after March 31, 2022, when hand sanitizer produced under the temporary policies can no longer be sold.

Next steps

In the interest of public health, we recommend businesses consider identifying and disposing of non-compliant hand sanitizer (following all local, state, and federal disposal requirements). The FDA has withdrawn its temporary hand sanitizer manufacturing policy,² which means some brands you may have been using will no longer be available. If you would like assistance transitioning to an FDA OTC compliant product, please contact your distributor.

Examples of "bulk" refillable hand sanitizer dispensers in U.S. community settings – samples were collected in the field as part of this study.

For more information on the potential risks from refilling hand sanitizer dispensers, read our blog "Understanding the Risks Associated with Hand Sanitizer Refilling."

Considering installing dispensers? Start with this article for more info.

*Results based on a nationwide online survey of 500 individuals conducted in January 2021; MR#006-102.

1. Manuel CS, Yeomans DJ, Williams JA, Fricker C, Kucera K, Light D, et al. (2022) Presence of unsafe chemical impurities, accelerated evaporation of alcohol, and lack of key labeling requirements are risks and concerns for some alcohol-based hand sanitizers and dispenser practices during the COVID-19 pandemic. PLoS ONE 17(3): e0265519. https://doi.org/10.1371/journal.pone.0265519
2. The U.S. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-brief-fda-withdrawing-temporary-guidances-alcohol-based-hand-sanitizers. Accessed Feb. 2, 2022.
3. The Centers for Disease Control and Prevention. https://www.cdc.gov/handwashing/hand-sanitizer-use.html. Accessed Feb. 2, 2022.
4. The U.S. Food and Drug Administration. https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitizers-consumers-should-not-use. Accessed Feb. 2, 2022.