FDA Announces Ban on Marketing of Some Antibacterial Soaps

Health Letter, February 2017

By Jennifer Rubio

When it comes to keeping ourselves germ-free, it seems like no amount of clean is “too clean.” Many Americans buy soaps marketed as “antibacterial,” thinking they’ll provide that extra layer of protection against harmful bacteria that might make them sick. But it turns out that antibacterial soaps are not more effective than regular soaps — and in some cases might contain harmful chemicals.

The Food and Drug Administration (FDA) announced in a September 2016 consumer update that it is issuing a rule barring the marketing of certain soaps that contain 19 antibacterial ingredients, including triclosan and triclocarban, among others.[1] The rule applies to over-the-counter products including hand soaps, bar soaps and body washes. It does not apply to hand sanitizers, hand wipes, or products used in hospitals, nursing homes and doctors’ offices.

Potentially harmful ingredients

Environmental groups and others have raised concerns about triclosan, one of the ingredients used in soaps labeled as antibacterial. There is little information about how triclosan affects humans, but animal studies have shown that the chemical may alter the way some hormones work.

According to the FDA’s consumer update, triclosan has been increasingly used in not just soaps, but also other consumer products such as clothing and toys to prevent bacterial contamination. Because of this, the human body is exposed to a great deal of triclosan over a lifetime, and there is little research to indicate what the effects of long-term exposure might be.

There is additional concern related to triclosan’s possible contribution to making bacteria resistant to antibiotics. The increase in number of antibiotic-resistant bacteria is a growing problem worldwide, mainly due to the overuse of antibiotics in circumstances that do not require them.[2] The widespread use of triclosan could contribute to that problem.

No more effective than ordinary soap

In addition to these potentially harmful effects, antibacterial soaps hold another disadvantage: They’re no more effective at preventing illness and infections than ordinary soap.[3]

In 2013, the FDA proposed a rule requiring companies marketing these products to submit safety and effectiveness data to the agency. Since then, the FDA has received very little data to suggest that the ingredients used in antibacterial soap are any more effective or safe for daily use. This finding spurred the FDA to issue its final rule banning the marketing of the products.

“If you use these products because you think they protect you more than soap and water, that’s not correct,” says the FDA’s Dr. Theresa M. Michele. “If you use them because of how they feel, there are many other products that have similar formulations but won’t expose your family to unnecessary chemicals.”

Other chemicals still under review

Although the FDA’s rule applies to most active ingredients in antibacterial soaps, three chemicals are allowed to remain on the market: benzalkonium chloride, benzethonium chloride and chloroxylenol. The manufacturers of products containing these chemicals are still developing new data about the safety and effectiveness of these ingredients, so the FDA considers them still under study.

For those products that have been banned, manufacturers have a year to comply with the new rule. They must either change the formulas of the antibacterial products by eliminating use of any of the 19 banned ingredients or stop marketing the products altogether. Many companies have already started changing the formulas of their products.

Simple soap is best

Instead of using of antibacterial soaps, what can consumers do to ensure their hands are germ-free? “Wash your hands with plain soap and water,” says the FDA’s release. “That’s still one of the most important steps you can take to avoid getting sick and to prevent spreading germs.”


References

[1] Food and Drug Administration. Antibacterial soap? You can skip it — Use plain soap and water. September 2, 2016. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm378393.htm. Accessed January 18, 2017.

[2] Centers for Disease Control and Prevention. About Antimicrobial Resistance. September 8, 2015. https://www.cdc.gov/drugresistance/about.html. Accessed January 5, 2017.

[3] Food and Drug Administration. Antibacterial soap? You can skip it — Use plain soap and water. September 2, 2016. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm378393.htm. Accessed January 17, 2017.