FDA Makes Final Ruling on Antibacterial Soaps

In All, Consumer products, General by Keri Szejda

As consumers, it’s not always easy to make decisions about what products we consider safe to use on our bodies. Risk assessments, by their nature, always leave some degree of uncertainty. So when making decisions about whether to use a particular product, it’s helpful to consider whether “the benefits outweigh the risks”.

To go about our daily lives, most of us are willing to accept some degree of risk – though we all differ in terms of just how much risk we find acceptable. Thinking about risk raises important questions such as, “How likely is it to happen to me?” and, “If it does happen, how bad will it be?”

But potential benefits are also a critical factor when thinking about safety or assessing risk. The higher the potential benefit, the more risk we’re likely to accept. And if there’s no demonstrated benefit, we’re not likely to accept much risk at all.

Such is the case when thinking about whether to use certain products, like antibacterial soap.

So, What are the Benefits of Antibacterial Soap?

“Antibacterial” soap is soap that contains an added antibacterial agent. The most common antibacterial chemicals are triclosan (used in liquid soaps) and triclocarban (used in bar soaps).

Back in 2013, the FDA requested manufacturers to provide safety and efficacy data for 19 antibacterial agents used in consumer soaps and washes.

On September 2, the Federal Drug Administration issued a final ruling disallowing the sale of antibacterial soaps. And that is largely due to the fact that manufacturers failed to provide evidence that antibacterial soaps are any better at preventing infections than plain old soap. Washing with plain soap doesn’t kill bacteria, but it is really effective at removing bacteria.

In a FDA statement, Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, said:

“Consumers may think antibacterial washes are more effective at preventing the spread of germs, but we have no scientific evidence that they are any better than plain soap and water. In fact, some data suggests that antibacterial ingredients may do more harm than good over the long-term”

The FDA ban applies to triclosan, triclocarban, and 17 other ingredients used in consumer soaps and body washes. There are three more ingredients (benzalkonium chloride, benzethonium chloride and chloroxylenol) under study for an additional year.

It’s important to note that yesterday’s ruling only applies to soaps and washes that are rinsed off immediately after use. The ruling doesn’t apply to consumer hand sanitizers or wipes – nor does it apply to the antibacterial soaps used in healthcare settings. These types of products are still under study.

What’s the Harm? Why Not Just Use Them – Just in Case?

The widespread use of antibacterial agents such as triclosan and triclocarban in personal care products has raised several human and environmental health concerns.

The FDA raised concerns that these antibacterial agents could be contributing to the problem of antibacterial resistance and that they may affect hormone function.

Arizona State University scientist Rolf Halden, director of the Biodesign Center for Environmental Security, has expressed concern about the widespread use of these chemicals in personal care products. That’s because his research has shown that antimicrobial agents are found in wastewater treatments plants, human blood, urine, and breastmilk. He stated:

“Most people don’t use personal-care products correctly and are unaware of the legacy that they are leaving behind, which lasts decades or longer. The widespread use of antimicrobial compounds offers no measurable benefit for the average consumer yet creates a legacy pollution that can be traced back for half a century in the sediments of our drinking-water resources.”

Do No Harm?

In this case, when there’s no obvious benefit and there are potential risks, it seems the FDA has made a clear ruling: “do no harm”.

Consumer antibacterial soaps that use any of these 19 ingredients will be off the market within a year. Meanwhile, it’s prudent to take the CDC’s long-recommended advice about washing hands with plain soap and water. Scrub for 20 seconds, or the time it takes to sing the happy birthday song twice. And rest assured that though bacteria are not being killed in the process, they are coming off your hands and going down the drain.