Antibacterial Soap: Good or Bad for Your Health?

Washing hands

It seems smart to wash your hands and body with soap that claims to be antibacterial. Kills the bad bugs, right?

Maybe not.

Rather than cleansing you of germs, such products might be harming your body. That is the concern of U.S. Food and Drug Administration, which says that the health claims of antibacterial soaps are not supported by current scientific data.

FDA cites two problems with antibacterial soaps:

1. There is no evidence that antibacterial hand soap and body wash products are any more effective at preventing illness than washing with plain soap and water.

2. Long-term exposure to certain active ingredients used in antibacterial products, such as triclosan in liquid soaps and triclocarban in bar soaps, could pose health risks. Users might develop bacterial resistance, or experience hormonal effects.

"Antibacterial soaps and body washes are used widely and frequently by consumers in everyday home, work, school, and public settings, where the risk of infection is relatively low," said Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research (CDER). "Due to consumers' extensive exposure to the ingredients in antibacterial soaps, we believe there should be a clearly demonstrated benefit from using antibacterial soap to balance any potential risk."

FDA takes action to protect you

Because of widespread use of antibacterial products, scientific information, and concerns by health care and consumer groups, FDA is evaluating what it needs to classify the active ingredients as "Generally Recognized As Safe and Effective” (GRASE).

On December 16, 2013, FDA issued a proposed rule to require manufacturers of antibacterial hand soaps and body washes to demonstrate that their products are safe for long-term daily use -- and more effective than plain soap and water in preventing illness and the spread of certain infections.

Under the proposed rule, manufacturers who want to continue marketing antibacterial products will be required to provide the FDA with data from clinical studies to demonstrate that these products are superior to non-antibacterial soaps in preventing human illness or reducing infection.

This action is part of a larger, ongoing review by FDA of antibacterial active ingredients to ensure they are proven to be safe and effective.

What do you do now?

You should continue to be diligent about washing your hands. "Washing with plain soap and running water is one of the most important steps consumers can take to avoid getting sick and to prevent spreading germs to others." said Sandra Kweder, M.D., deputy director, Office of New Drugs at CDER. "While the FDA continues to collect additional information on antibacterial hand soaps and body washes, we encourage consumers to make an educated choice about what products they choose to use."

There are good and not-so-good ways to wash your hands. Here is advice from Center For Disease Control. CDC: Handwashing: Clean Hands Save Lives.

If soap and water are not available, FDA says to use an alcohol-based hand sanitizer that contains at least 60 percent alcohol. (The proposed FDA rule does not affect hand sanitizers, wipes, or antibacterial products used in health care settings.)

Almost all soaps labelled "antibacterial" or "antimicrobial" contain at least one of the antibacterial ingredients addressed in the proposed rule. Most common are triclosan and triclocarban. Some soaps labelled "deodorant" might also contain these ingredients.

The proposed rule does not require that antibacterial soap products be removed from the market at this time. But that could happen if the proposed rule is finalized. To continue selling, companies will have to provide data to support an antibacterial claim, or they will have to reformulate to remove antibacterial active ingredients, or they will have to relabel to remove antibacterial claims.

None of this will happen quickly. The proposed rule is available for public comment for 180 days, with a concurrent one year period for companies to submit new data and information, followed by a 60-day rebuttal comment period. So the earliest official impact will be in 2015. However, some companies might make product changes sooner, especially if consumers cut back on using unproven and possibly risky antibacterial soaps.