The Hidden Risks of Antibacterial Soap

FDA Ruling Effectively Bans Certain Ingredients

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Antibacterial soaps, also known as antiseptic soaps or antimicrobial soaps, contain ingredients that are purported to neutralize a broad spectrum of bacteria when used to wash your hands or body. They have long been marketed as being "better" than regular soaps, killing a wide array of germs that make you sick.

In 2013, the U.S. Food and Drug Administration (FDA), concerned about the claims and the lack of evidence supporting them, issued a directive requiring antibacterial soap manufacturers to provide clinical evidence that their products were superior to non-antibacterial soaps.

To date, no such evidence has been received. In response, the FDA ruled in 2017 that no less than 24 antibacterial agents could no longer be sold in over-the-counter (OTC) consumer antiseptic products without formal premarket approval, effectively banning them.

This leaves a lot of room for confusion regarding the efficacy and safety of those antibacterial cleansing products that still remain on store shelves.

Antibacterial Soap Ingredients

Out of the 24 agents listed in its directive, the FDA cited triclosan (TCS) and triclocarban (TCC) as the two most commonly used in the United States. Both have antibacterial and antifungal properties that manufacturers have long incorporated into their products.

TCS was initially used in surgery to keep surgical sites sterile and coated onto sutures to reduce the risk of surgical site infections. In later years, TCS and TCC found their way into consumer products, including detergents, toys, clothing, furniture, toothpaste, and consumer washes (including bar soaps, body washes, hand gels, and liquid and foam cleansers). 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 stave 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:

  • Cloflucarban
  • Fluorosalan
  • Hexachlorophene
  • Hexylresorcinol
  • Iodophors (iodine-containing ingredients)
  • Methylbenzethonium chloride
  • Phenol (greater than 1.5%)
  • Phenol (less than 1.5%)
  • Secondary amyltricresols
  • Sodium oxychlorosene
  • Tribromsalan
  • Triple dye

The FDA ruling does not apply to cleansers containing six ingredients (benzalkonium chloride, benzethonium chloride, chloroxylenol, ethanol, isopropyl alcohol, and povidone-iodine) whose manufacturers are currently conducting human efficacy and safety trials.

FDA Concerns

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 their widespread use of TCS, TCC, and other antibacterial agents in numerous 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 hard and empirical clinical evidence of their long-term safety remains lacking.

Several key concerns have been raised by scientists and FDA officials.

Antibiotic Resistance

Because TCC, TCS, and other antibacterial agents used in consumer washes are not fully neutralizing—meaning that some germs are able to escape—the FDA expressed concerns that ongoing use of the products may enable bacterial strains resistant to antibiotics to proliferate.

In essence, by stripping away all but the strongest bacteria, we may be creating strains able to resist the very treatments meant to control them.

Allergies

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.

Retention Concerns

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 is readily excreted from the body in urine, urine analyses showed that trace amounts were retained in some but not all of the participants. Despite the findings, it is unclear if the trace amounts of TCC would ever pose harm to users. Further research is needed.

Hormonal Disruption

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.

While there are yet to be any studies that have shown that this effect is harmful in humans, 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 correspond to any harm in the infants, the findings do suggest that TCS's impact on the endocrine system may be greater than presumed.

Making Sense of the Ruling

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 has been able to confidently assert 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 preemptively removed TCS and TCS from their products and dropped the word "antibacterial" from labels and marketing.

Exceptions

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 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 used in surgical units to reduce the risk of transmission in patients with methicillin-resistant Staphylococcus aureus (MRSA).

What You Can Do

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).

A Word From Verywell

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.

This includes washing before and after eating or preparing food; after using the bathroom or changing a diaper; before touching your face; and after being out in public and touching shared surfaces. Consistent and correct handwashing with soap and water is far more effective at stopping germs that any individual ingredient.

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Article Sources
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