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FDA Begins Inquiry into the Effects of Antibacterial Soaps

By Esther Entin, MD

Washing your hands with antibacterial soap may actually be risky to you and bad for our health environment, according to the Food and Drug Administration. The agency wants companies that make and market the soaps to begin a major scientific investigation to determine if the benefits outweigh the risks.

The Food and Drug Administration (FDA) recently called for a major review of research on over-the-counter antibacterial soaps and body washes bought by consumers.

People use these products because they think they will prevent the spread of disease and keep them healthier. In fact, there currently is no evidence that over-the-counter (OTC) antibacterial soap products are any more effective at preventing illness than washing with plain soap and water, according to Colleen Rogers, Ph.D., a lead microbiologist at the FDA.

A Call to Update an Earlier Study

Antibacterial soaps — also known as antimicrobial and antiseptic soaps — have been around for years. The most common ingredients are the chemicals triclosan and triclocarban. But when the FDA last evaluated them in 1994, the scientific tests were less sophisticated and there wasn't much detailed information available about their impact.

Even more worrisome are the concerns that have been raised about unwanted effects of the chemical additives in the soaps. Investigators have long campaigned for additional evaluation by government regulators to determine whether the risks outweigh the benefits.

As a result, the FDA has now called for a major review of research on over-the-counter antibacterial soaps and body washes purchased by consumers.

“The risk from the use of a consumer antiseptic wash drug product must be balanced by a demonstration that it is superior to washing with non-antibacterial soap and water in reducing infection,” Rogers said. The agency is not looking at products that are used by medical professionals in the workplace or at hand sanitizers that are intended for use without water.

Some Key Questions

The FDA wants the companies making these antibacterial soaps for consumers to address several questions:

  • Do the soaps really work?
  • How do the ingredients triclosan and triclocarban affect the body?
  • How much exposure do we get to the active ingredients in our bodies?
  • Does the effect build up over time?

The FDA contends that there is not enough evidence that antibacterial soap is superior to non-antibacterial soap in preventing illness. While the studies from 1994 did show that antibacterial soaps may reduce the amount of bacteria left on the skin, they did not prove that this would decrease the occurrence of illness or prevent people from getting sick or reduce the spread of infection from one person to another.

Active Ingredients: Concerns about Antibiotic Resistance and Chemical Exposure

In addition to calling for studies to determine whether there is a direct health benefit from antimicrobials, the FDA wants investigators to evaluate if the use of antimicrobial soaps contributes to antibiotic resistance, a growing problem that threatens to make medical treatments of infection less effective.

When you wash your hands with regular, non-antibacterial soap, you simply wash off the bacteria. With antibacterial soaps, the active ingredients actually kill or decrease the growth rate of bacteria on the skin. Triclosan does help kill bacteria such as staph and strep, but tests have shown that with repeated exposure these bacteria develop resistance; and this can create resistance to medications that are important for use in humans.

Surprisingly High Levels of Exposure

Another problem is the fact that our exposure to the active ingredients in antibacterial soaps and the skin's absorption of those ingredients are higher than previously thought. Triclosan has been found in human breast milk and in urine.

Based on these findings, the FDA is asking the industry to produce data on the effects of the absorption and metabolism of active ingredients in humans, including:

  • The impact of the exposure on children's development and reproductive systems
  • The cancer risk of various levels of exposure
  • The potential hormonal effects, and
  • The impact of the active ingredients on the development of bacterial resistance in the body and in the environment.

Finally, the FDA wants the industry to examine the risk to different groups of consumers, such as infants, children and pregnant women, who might use the soaps, especially those who have increased vulnerability to toxic effects of the chemicals they contain.

What Consumers Can Do

The process will take time. The FDA will accept public comments on its proposal for the next 180 days, and companies will have a one-year period to submit data and information on their products to the agency. In the meantime, the antibacterial products will remain on the market.

While the safety of various soaps is being studied, the FDA says washing your hands often and well is one of the most important steps people can take to avoid getting sick and to prevent spreading germs to others.

If you want to avoid antibacterial products while the issue is being studied, check the labels of the soaps and other products you are concerned about. Most antibacterial products will have the word "antibacterial" on the label, according to the FDA.

A “Drug Facts” label on a soap or body wash is a sure sign a product contains antibacterial ingredients. Parents of infants and children and pregnant women may wish to discuss the risks and benefits of antibacterial product use with their health care providers.

December 31, 2013



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This information is intended for educational and informational purposes only. It should not be used in place of an individual consultation or examination or replace the advice of your health care professional and should not be relied upon to determine diagnosis or course of treatment.