FDA Bans Antibacterial Soaps, No Proof They Are More Effective Than Soap And Water


The Food and Drug Administration (FDA) has placed a ban on certain antibacterial soaps and body washes. According to the agency, many of these products are no more effective than simple soap and may even be harmful.

The FDA ban affects any soaps that contain one or more of 19 chemicals, including triclosan and triclocarban. While antibacterial soap makers contend these added ingredients improve the germ-fighting abilities of the product, there is no actual proof to support these claims.

“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,” said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “In fact, some data suggests that antibacterial ingredients may do more harm than good over the long-term.”

The FDA put makers of antibacterial soaps on notice over three years ago. In 2013, the agency announced a rule that would require manufacturers to substantiate data on the safety and effectiveness of triclosan and triclocarban. Once the rule was proposed, many companies opted to replace the chemicals instead of funding further research.

Most soap makers have since replaced triclosan with either benzalkonium chloride, benzethonium chloride or chloroxylenol, which are not on the FDA ban list. However, the agency has not approved these chemicals and is requesting more testing and data that support any claims they are safe and effective to use.

FDA orders soap companies prove the safety and effectiveness of antibacterial products. [Photo by Joe Raedle/Getty Images]
Antibacterial soap companies have one year to either remove the chemicals, prove their effectiveness, or take the product off the market. While the FDA ban does not affect antibacterial soaps used in hospitals or the food service industry, the agency has plans to turn its focus toward products used in these industries next.

The American Cleaning Institute, an association that represents companies that make cleaning products, plans to work with soap makers to provide the testing and information as required by the FDA to prevent any future ban on antibacterial soaps.

“In the coming year, ACI and its member companies will submit additional safety and effectiveness data on the key ingredients in use in consumer antibacterial soaps today: benzalkonium chloride, benzethonium chloride and chloroxylenol… Consumers can continue to use antibacterial soaps with confidence as they have for decades in millions of homes, offices, schools, daycare centers and other commercial settings,” said a statement from the American Cleaning Institute.

The FDA ban is only the latest in a debate about the effectiveness of antibacterial soaps that has been ongoing for years. Nearly 10 years ago, a study done to test effectiveness could not find any real health advantage to washing with antibacterial soaps containing triclosan over just using regular soap. The research even suggested antibacterial soaps could lead to the increase of dangerous drug-resistant bacteria. The final results of the study only indicated that further research is needed on the issue.

Originally used in hospitals, triclosan entered the market in the 1960s. Soon soap makers began making antibacterial products like body wash, toothpaste, and mouthwash for consumers to buy and use at home.

Despite marketing claims, antibacterial soaps with triclosan are no more effective than simple soap and water. [Photo by Joe Raedle/Getty Images]
However, it did not take long for safety concerns to surface and the FDA even considered a ban on antibacterial products in 1978. No new rules were ever implemented, and the issue was mostly forgotten until 2010. That year, the Natural Resources Defense Council requested the FDA take another look at the safety and effectiveness of antibacterial soaps and hand sanitizers. After compiling and reviewing data for the last six years, the agency has finally decided to take significant action by banning any antibacterial products that use triclosan.

According to the FDA, triclosan is used almost 2,000 products. While there are no definitive studies that prove triclosan is hazardous to humans, the FDA ban on antibacterial soaps is based on the industry’s failure to prove they are any more safe or effective than plain soap and water.

[Photo by iStock]

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