FDA ruling effectively bans certain ingredients
Antibacterial soap is a staple in many households and healthcare facilities. However, in 2017, due to concerns over the safety and effectiveness of antibacterial soap, the U.S. Food and Drug Administration (FDA) banned companies from using 24 active ingredients that were previously common in antibacterial soaps. 2, 4-Dichloro-3, 5-Dimethylphenol
One such ingredient, triclosan (TCS), has been linked to a variety of health issues, including thyroid dysfunction, developmental problems, and weakened immunity. These findings resulted from animal studies, though, and the potential risk of TCS to human health remains controversial.
Antibacterial soap is still available in stores, and TCS can be found in numerous personal care products, including hand sanitizer and toothpaste. Here's what you need to know about antibacterial soap and the FDA's concerns.
Antibacterial soap contains active chemicals like TCS and triclocarban (TCC), which are added to kill bacteria.
According to the Centers for Disease Control and Prevention, both antibacterial soap and plain soap are equally effective at removing bacteria from the hands. So, if regular soap is not designed to kill bacteria, how does it work?
In short, regular soap loosens and lifts bacteria from your hands so that the bacteria is easier to wash away with water. Antibacterial soap also has this effect, in addition to having TCS and TCC.
The FDA states that there isn't enough science to show that antibacterial soap is better at preventing illness than regular soap and water. And, unlike regular soap and water, antibacterial soap might have negative effects on your health.
Out of the 24 agents listed in its ruling, the FDA cited TCS and TCC as the two most commonly used active ingredients in the United States. Both have antibacterial and antifungal properties that manufacturers have long used in their products.
TCS was initially used in surgery to keep surgical sites sterile. TCS was also coated onto sutures to reduce the risk of surgical site infections. In later years, TCS and TCC found their way into consumer products, including:
By 2000, TCS or TCC could be found in nearly 75% of liquid soaps and 29% of bar soaps sold in the United States.
At a time when consumer awareness about germ transmission was growing, products like these seemed like a simple and ideal way to keep yourself and your family safe. But in most cases, manufacturer claims fell short.
In an effort to stop increasing claims that antibacterial soaps are beneficial to human health, the FDA decided to step in and set the record right. Alongside TCS and TCC, other antibacterial agents included in the FDA ruling are:
The FDA ruling does not apply to cleansers containing six ingredients (benzalkonium chloride, benzethonium chloride, chloroxylenol, ethanol, isopropyl alcohol, and povidone-iodine). Manufacturers are currently conducting human efficacy and safety trials on these ingredients.
The FDA issued its ruling in December 2017 not only because the manufacturers were unable to provide evidence that their products were any more effective than plain soap and water, but also because it is unknown how safe they are to use over the long term.
With the widespread use of TCS, TCC, and other antibacterial agents in consumer products, FDA officials became concerned that the cumulative effect of exposure may only be realized years down the road.
This is not to suggest that there has been any proof that antibacterial agents are "harmful," per se, but rather that clear clinical evidence of their long-term safety remains lacking.
Several key concerns have been raised by scientists and FDA officials.
TCC, TCS, and other antibacterial agents used in consumer washes are not fully neutralizing, meaning that some germs are able to escape. For this reason, the FDA expressed concerns that ongoing use of the products may enable bacterial strains that are resistant to antibiotics to increase rapidly.
In essence, by stripping away all but the strongest bacteria, we may be creating strains that can resist the very treatments meant to control them.
TCS is associated with an increased risk of food allergies. This may be because exposure to bacteria reduces the risk of allergy by allowing the immune system to recognize potential allergens as safe rather than overreacting to them.
TCS has also been linked to contact dermatitis in some studies.
Trace amounts of TCC have been shown to be retained in the body after use. A small study conducted by researchers at the University of California, Davis found that participants asked to wash with bar soap containing 0.6% TCC absorbed roughly 0.6% of the agent through their skin.
While TCC readily leaves the body in urine, urine analyses showed trace amounts of TCC remained in some participants. Despite the findings, it is unclear if the trace amounts of TCC would ever pose harm to users. Further research is needed.
Animal studies have also shown that TCS can be retained in tissues. The concern among scientists is that TCS and TCC are both mild endocrine disruptors, meaning that they have the potential to interfere with how certain hormones work.
There are yet to be any studies that have shown that this effect is harmful in humans. Although, a 2017 study from China reported that infants born to mothers who used TCS-containing soap had elevated levels of the male hormone testosterone in their umbilical cord bloods.
Although the elevations did not appear to cause any harm in the infants, the findings do suggest that TCS's impact on the endocrine system may be greater than presumed.
While these findings are in no way definitive—or should suggest in any way that you can "get" antibiotic resistance or food allergies by using antibacterial soap—any efforts to dispel these concerns by manufacturers have been sorely lacking.
What the FDA asserts is that antibacterial soaps, washes, cleansers, foams, and hand gels are no more effective than using plain soap and water.
In response to the ruling, many manufacturers removed TCS and TCS from their products and dropped the word "antibacterial" from labels and marketing.
It is important to understand that the FDA ruling does not apply to OTC hand sanitizers whose ingredients, like ethanol (alcohol) or povidone-iodine, are believed to be safe and effective when soap and water are not available. Pending further research, hand sanitizers like these will be allowed to be sold and marketed to the American consumer. The ban also does not apply to antibacterial soaps used in hospitals.
It is also important to note that agents like TCS have their appropriate use. In addition to TCS-infused sutures, surgical swabs, and surgical hand washes, showering with 2% triclosan has become the recommended protocol in surgical units to reduce the risk of methicillin-resistant Staphylococcus aureus (MRSA) spreading between patients.
As fast and convenient as hand sanitizer may seem, washing your hands with soap and water is still the best way to prevent common bacterial infections.
However, it is important to do so correctly. Washing your hands for at least 20 seconds is what is recommended by both the Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO).
When teaching your kids how to wash, tell them to sing the "Happy Birthday" song twice out loud, which takes roughly 20 seconds.
Finally, check that the soaps and body washes you use do not contain triclosan, triclocarban, or any other banned ingredient (other than the six currently deferred by the FDA). It is possible that these products may have been purchased before the ban went into effect.
If you're uncertain if an ingredient in a soap or body wash is safe, call the FDA at 1-888-INFO-FDA (1-888-463-6332).
According to the FDA, antibacterial soap may not be as effective as regular soap and water. It's also unknown how various ingredients used to make antibacterial soap will affect human health in the long term. For this reason, the FDA has banned at least 24 antiseptic ingredients, at least until their long term effects are clear.
It may be tempting to find products that claim to protect you from "99.9% of household germs," but don't be misled by marketing that may or may not be true. To better protect yourself and your family, simply wash your hands with regular soap and water as needed.
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By Kristina Duda, RN Kristina Duda, BSN, RN, CPN, has been working in healthcare since 2002. She specializes in pediatrics and disease and infection prevention.
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