Updates On FDA Rulings Of Soap And Sanitizers

Certain active ingredients in antibacterial hand soaps and hand sanitizers have come under scrutiny by the U.S. Food and Drug Administration (FDA) in recent years and months. Specifically, triclosan has been banned from hand sanitizers and antibacterial hand soaps, while other ingredients, like ethanol (alcohol) and benzalkonium chloride, are currently under investigation to determine safety and efficacy.

With so many rulings, long chemical names and FDA deferrals, it can be confusing to make sense of what's in the soaps and hand sanitizers and what cleaning managers should provide in their buildings. The good news is that none of these rulings and investigations have a significant impact on the products that are available in the commercial cleaning market right now, or the foreseeable future.

As always, handwashing is of the utmost importance in protecting the health of building occupants. It continues to be the focus for government organizations and the jan/san industry to provide facilities with all the tools and products needed to ensure that handwashing is accessible to all.

"There are no immediate concerns that commercial cleaning operations managers should have as far as product or ingredient availability," says Brian Sansoni, senior vice president, communications, outreach and membership for American Cleaning Institute (ACI). "There continues to be availability for the key antibacterial soap and hand sanitizer ingredients critical for infection control at this time."

Rulings And Deferrals

Although facilities aren't being impacted, managers are keeping a close eye on FDA progress in this area.

In September 2016, the FDA banned over-the-counter/consumer antibacterial soaps containing certain active ingredients, including triclosan. The reason, according to FDA reporting, is that there is no evidence that antibacterial soaps are any more effective than plain soap and water at preventing the spread of germs, and that the use of antibacterial soap may contribute to antibiotic resistance. By April 2019, the FDA had updated a second ruling on over-the-counter (OTC) hand sanitizers to avoid using similar antibacterial ingredients.

To adjust, manufacturers of those products have replaced the banned active ingredients with new ingredients that achieve the same antibacterial claims, including benzalkonium chloride and chloroxylenol (PCMX). The FDA has deferred making a ruling on these replacement ingredients as it collects data to prove safety and efficacy.

In addition, decisions on several key ingredients in OTC hand sanitizers, including benzalkonium chloride, ethyl alcohol and isopropyl alcohol have been deferred. Like with the soap ingredients, the ruling deferral means that the FDA has asked for more intelligence before it can make any determinations on the prohibition or continued use of these specific active ingredients.

"We've reaffirmed our need for more data on three other active ingredients, including ethyl alcohol — which is the most commonly used ingredient in hand sanitizers — to help the agency ensure that these products are safe and effective for regular use by consumers," says Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "We believe the industry has made good progress toward providing data, and we will continue to provide updates to the public about the progress of collecting this data."

ACI is a lobbying organization that has been tasked with providing the FDA with the data they need to showcase the safety and efficacy of products containing all of these active ingredients. ACI members include the manufacturers and formulators of soaps, detergents, and general cleaning products used in household, commercial, industrial and institutional settings; companies that supply ingredients and finished packaging for these products; and chemical distributors. A select group of these member companies is helping ACI to conduct the scientific testing needed to collect data on these active ingredients.

"The FDA has given us year-to-year deferrals of rule making because they realize that it takes a lot of time and resources to gather the intensive data they need to make a decision," says Sansoni. "We will continue to provide the research and data that the FDA is requiring to ensure that these ingredients can stay on the market."

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How Soap, Sanitizer Regulations Impact Facilities