Portions of the “Defining Clean Skin” article (Happi, February 2017) need clarification, specifically in reference to its descriptions of Food and Drug Administration (FDA) policies governing antibacterial soaps and the science behind product and ingredient safety.


First off, the FDA did not issue a “ruling” directing the public to skip using antibacterial soaps. In September 2016, the agency did issue a final rule governing particular active ingredients that can be used in consumer antibacterial soaps and washes.


FDA’s informal statement in a public blog post urging consumers to “skip” using antibacterial soaps was, in our view, an ill-considered and misguided PR statement. The blog posting was certainly not part of any “ruling.”  


The author of “Defining Clean Skin” makes reference to research questioning antimicrobial ingredient safety and efficacy.


As we’ve written in these pages before, we are concerned that the FDA’s public blog statements following the September 2016 rule could sow consumer confusion about the amount of scientific data and research manufacturers have submitted over the years on product safety and effectiveness. Further, it can undermine what researchers are currently doing to answer new questions that have been identified by FDA.


Manufacturers stand behind the product science, research and data submitted over several decades to FDA.


Based on the newest understanding of the science and how the products are used, the industry was asked to undertake new studies. The data gaps identified by FDA are recent.


Additionally, the agency has proposed some studies which have never been conducted before relating to this category of products.


A Detailed Plan


Nonetheless, the American Cleaning Institute has laid out a detailed work plan on additional safety and efficacy data for the three major ingredients used in consumer antibacterial soaps that aligns with FDA’s requests.

Additional data will be submitted for other ingredients used in healthcare antiseptic products, consumer hand sanitizers, and food handler antiseptics that are covered under upcoming regulations.


The author spends a great deal of time questioning the safety of the antibacterial ingredient triclosan. While triclosan did have a four-decade history of safe and effective use—backed by science—many manufacturers of consumer hand washes have already transitioned to the other major ingredients referenced above: benzalkonium chloride, benzethonium chloride and chloroxylenol.


As we have written, what’s most unfortunate about FDA’s recent activity was the highly charged public statements by FDA staff that claimed using antibacterial soaps “may do more harm than good over the long-term,” particularly in trying to tie every-day use of these products to the issue of antibiotic resistance.


This ignores the agency’s own assessment of the information needed to address emerging science and the lack of any evidence that harm is actually occurring.


The author also ignores research confirming that the use of antibacterial wash products in the home environment does not contribute to antibiotic or antibacterial resistance, substantiating previous research that showcased similar findings.


A 2011 study, published in the peer-reviewed International Journal of Microbiology Research, compared the use of over-the-counter antibacterial liquid hand and body cleansers and antibacterial bar soaps against the use of non-antibacterial cleansers. Lead author Dr. Eugene Cole, who has spent 40 years in the field of environmental health research, said the study refutes claims that the use of antibacterial wash products have contributed to the selection and spread of drug-resistant bacteria on human skin.


It is important for the American public—and industry consultants—to know that manufacturers are complying with the FDA data requests, as laid out by FDA itself. It is an agency-defined road map to certainty about the safety and efficacy of antibacterial soaps and washes. The formal rulemaking is clear on this.


We believe that consumers and commercial customers can continue to use antibacterial soaps with confidence as they have for decades in millions of homes, offices, schools, daycare centers and other office settings.


It is critical that discussions around the research, safety and access to antibacterial products be fully informed so that future regulations are sound and science-based.