Understanding the Risks Associated with Hand Sanitizer Refilling

By Chip Manuel, Ph.D. and Antonio Quiñones-Rivera, Ph.D.

Imagine you are at a breakfast buffet at a hotel (the pandemic is over), and you see a simple glass bottle of milk for your use, with no markings. You pour some milk on your cereal and splash a bit into your coffee. Later in the day, you learn that each morning the serving staff 'tops off' that bottle with milk from other containers, without ever emptying it or washing it. Over the course of weeks, with customers taking many, many milk servings from that bottle, the staff kept topping it off. How would you feel about the milk that you had been served that morning? And the next morning, would you again put milk from that bottle on your cereal?

If you've recently ventured out to your local supermarket, restaurant, or gas station, there's a good chance you've used hand sanitizers that are maintained much like the milk in the story above. Perhaps it resulted in an unexpected or unpleasant hand sanitizer encounter. And in those instances, there is an unfortunate chance that the hand sanitizer you used did not kill the germs on your hands.

Recent Changes in the Hand Sanitizer Landscape

The global COVID-19 pandemic led to a dramatic increase in the consumption of hand sanitizers – much like surface disinfectants and toilet paper – so consumers and businesses alike experienced difficulties sourcing it.

To help increase the availability of hand sanitizer, the U.S. Food & Drug Administration (FDA), which regulates these products as Over-the-Counter (OTC) drugs, instituted several temporary guidance policies early in the pandemic. ¹ These temporary policies aimed to increase availability by two approaches: 1) allowing alcohol sourced from new suppliers, such as distilleries and fuel producers, to be used as ingredients in hand sanitizer and 2) allowing some manufacturers to make hand sanitizer for the first time, provided they follow a specific set of guidelines. ^{2, 3}

These temporary policies allowed for a rapid expansion of new products entering the market, with many smaller, regional, or local manufacturers producing hand sanitizer for the first time. Additionally, many new raw material suppliers entering the supply chain were unfamiliar with the safety and regulatory requirements for producing these materials destined for these OTC drug products. Unfortunately, some of these new market entrants formulate hand sanitizer with ingredients that can be harmful. The FDA has warned consumers that some hand sanitizers are being produced with dangerous ingredients such as methanol, which can carry health risks. To assist end users and businesses in avoiding potentially dangerous products, the FDA maintains a list of hand sanitizers to avoid. ⁴

Finally, due to the pandemic, even standard-sized bottles and pumps for hand sanitizer products were in short supply – so many of the new market entrants simply packaged and sold their products by the gallon.

Bulk-Style Hand Sanitizer in Public Settings

We are all familiar with the "bulk-style" or "open refill" soap dispensers that can be found in away-from-home settings. They are often simple plastic devices that businesses refill from a "bulk" gallon of liquid soap. Hundreds of different kinds of "bulk soap" dispensers are commonly available for purchase by businesses. (It has long been proven that "bulk soap" dispensers are public health hazards, and they are not allowed in U.S. healthcare facilities, but that is a different topic. ^{5, 6}) In fact, the Centers for Disease Control and Prevention (CDC) recently acknowledged the potential risks associated with refilling bulk hand sanitizer containers, including the potential for alcohol evaporation, skin irritation, and contamination. ⁷

As established hand sanitizer products were in short supply, the marketplace simply re-purposed the bulk-style soap dispenser to support bulk-style hand sanitizer and then hurriedly brought many to market. As off-brand, bulk-style hand sanitizer products became commonly available, some businesses also began to use this bulk hand sanitizer not just to service bulk-style dispensers and bottles but to refill packages from established brands. 

Bulk Refillable Hand Sanitizer – Breaking Down the Risks

When 89% of consumers expect hand sanitizer to be offered when visiting public spaces ⁸ and demand outpaced supply, many businesses turned to alternative solutions they might not have considered before to keep customer satisfaction high, such as bulk-style hand sanitizer dispensers. There are, however, safety and efficacy risks that business buyers were likely unaware of when they made these purchases.

• Product Mixing – A critical problem common with bulk-style sanitizer is mixing different hand sanitizer formulas in the "topping off" process, like in the opening milk scene. This is also an issue when other hand sanitizer brands are used to refill established brands' packages. There are several issues with this practice:
  
  
  • The potential mixing of two incompatible products could negatively impact efficacy and product, packaging, or dispenser performance, including the potential for skin irritation due to unknown product safety profiles.
  • If the FDA later identifies one of the sanitizers used in this process as ineffective or unsafe, then a questionable formula can be in the mix.
  • If an off-brand sanitizer product that uses an active ingredient that is not alcohol is mixed with an alcohol-based hand sanitizer, the resulting "formula" is quite unknown.
  • Hand sanitizer formulas are developed, manufactured, and packaged according to FDA guidance to ensure they are safe, effective, and stable – that includes materials compatibility testing to ensure the formula won't be adversely affected when it comes into contact with the packaging or pump.  
• Unknown Quality Profiles – As noted above, many off-brand hand sanitizer products that entered the market are being produced using ethanol from new suppliers who have never produced raw materials for OTC drug products. This sometimes leads to quality issues. For example, you may have noticed that many of these new hand sanitizers have a bad odor, with users reporting such odors as tequila, rotten garbage, or even stinky cheese. These odors contribute to a poor user experience, which causes end users to distrust the product.
• Evaporation – Many bulk-style dispensers are designed to be easy to open and refill. This means they are not always fully sealed and pose a risk for alcohol evaporation. If alcohol content drops below 60%, it is no longer compliant with FDA OTC drug regulations and will lose effectiveness over time (meaning it is less likely to kill the germs that can make you sick).
• Labeling Requirements – As mentioned above, hand sanitizer is regulated by the FDA as an OTC drug product with specific labeling requirements, including active ingredients and product expiration dates. Bulk-style dispensers are not always labeled appropriately and according to these regulations, put the end user at risk. The lack of labeling on these dispensers with important information such as brand, product name, and lot numbers can make traceback of contaminated or recalled product nearly impossible. Users also don't know what they're putting onto their hands.
• Open Refill Dispensing – Refillable dispensers commonly have an accessible reservoir that allows them to be easily "topped off" for servicing. This design has drawbacks that include security concerns as they present a risk for accidental or even intentional refilling with products not intended for use on hands, such as surface disinfectants. Even worse, their ease of refilling makes them risky for tampering by malicious individuals. And there is a potential risk for unwanted microbial contamination of the bulk dispenser itself over time.
• Product Dispensing Failure – Refilling a dispenser or a bottle with different hand sanitizer formula may cause the pump to clog, misdirect, or dispense too much product or too little.

Offering Safer Solutions

Businesses can provide safe and effective hand sanitizer by:

• Not mixing hand sanitizer formulas in dispensers or bottles over time.
• Not refilling branded bottles or dispensers with other formulas.
• Choosing trusted brands, like the PURELL® brand, that have a long history of using only quality ingredients and producing the most effective formulas.
• Using hand sanitizer dispensing systems with refills that are "sanitary-sealed" in production. These systems have effective dosing control and are properly labeled according to federal OTC drug requirements. Each refill comes with a new nozzle, eliminating the worry of buildup or contamination at the dispense point that comes with a permanent dispenser nozzle. Additionally, they are resistant to tampering.
• Using bottles of trusted hand sanitizer products if sanitary-sealed dispenser refills are not available.

Protecting Your Reputation

Providing quality, trusted hand sanitizer products reflect positively on the establishment's image. People are sensitive to the consistency, feel, and smell of hand sanitizers; an unpleasant hand sanitizer encounter could spoil an otherwise positive visit.

Refilling branded hand sanitizer packages with off-brand formulas can reflect badly on a business – as people reach for that trusted, familiar product and are served with something that is not appropriate for the brand. This may give people the impression they have been misled by an institution that is cutting corners.

Choosing Best-in-Class Products

Protecting the health and well-being of people around the world is at the core of what we do at GOJO and has been since our family enterprise's founding 75 years ago. As the inventors of PURELL^® instant hand sanitizers, GOJO^® and PURELL^® brand formulations result from decades of scientific innovation, using quality ingredients rigorously tested for safety and efficacy.

We're continually innovating our formulations and state-of-the-art dispensing systems to reflect the latest science. We've been offering SANITARY-SEALED™ refill technology since before we invented PURELL^® Hand Sanitizer in 1988 – we first developed the technology for our GOJO soap formulations in 1983.

Businesses can ask their GOJO distributor for information on PURELL^® brand SANITARY-SEALED™ hand sanitizer dispensing systems and specialty packaged tabletop bottles and stands that are available to meet the needs of your business now. Review products at www.GOJOInternational.com

References

1. Retrieved Jan. 11, 2021. U.S. Food & Drug Administration, "Hand Sanitizers | COVID-19." https://www.fda.gov/drugs/coronavirus-covid-19-drugs/hand-sanitizers-covid-19
2. Retrieved Jan. 11, 2021. U.S. Food & Drug Administration, "Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry." https://www.fda.gov/media/136289/download
3. Retrieved Jan. 11, 2021. U.S. Food & Drug Administration, "Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency Immediately in Effect Guidance for Industry." https://www.fda.gov/media/136118/download
4. Retrieved Jan. 11, 2021. U.S. Food & Drug Administration, "FDA updates on hand sanitizers consumers should not use." https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitizers-consumers-should-not-use#products
5. Zapka, C., et al. "Bacteria Hand Contamination and Transfer after Use of Contaminated Bulk-Soap-Refillable Dispensers." Applied and Environmental Microbiology 77(9):2898-2904, April 2011. https://aem.asm.org/content/77/9/2898
6. Centers for Disease Control and Prevention, "Guideline for Hand Hygiene in Health Care Settings," Oct. 2002. https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5116a1.htm
7. Centers for Disease Control and Prevention, "Hand Hygiene in Healthcare Settings." https://www.cdc.gov/handhygiene/providers/index.html
8. GOJO Industries, Inc., External Market Research | Internet survey, 015-096 WAVE 7, September 2020.