FDA NewsPerspective

FDA seeks proof of effectiveness, safety of antibacterial soaps

The FDA has proposed a rule requiring the manufacturers of antibacterial hand soaps and body washes to demonstrate that their products are safe for long-term use and more effective than plain soap and water.

The rule is part of a larger, ongoing FDA review of antibacterial ingredients. The rule does not affect hand sanitizers, wipes or antibacterial products used in health care settings.

“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,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research (CDER), said in a press release. “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.”

Janet Woodcock, MD 

Janet Woodcock

According to the press release, nearly all soaps labeled as antibacterial or antimicrobial contain an antibacterial ingredient addressed in the proposed rule, such as triclosan in liquid soaps and triclocarban in bar soaps. Recent data have suggested that long-term exposure to these ingredients could pose health risks such as bacterial resistance or hormonal effects. Furthermore, there is no evidence that these products are any more effective at preventing illness than washing with plain soap and water.

The proposed rule does not require that antibacterial soaps be removed from the market at this time. When the rule is finalized, companies will be required to provide data to support the antibacterial label. If this data is not provided, they will need to reformulate the product by removing antibacterial active ingredients or re-label the product to remove the antibacterial claim.

“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,” Sandra Kweder, MD, deputy director of the Office of New Drugs at CDER, said in the press release. “Washing with plain soap and running water is one of the most important steps consumers can take to avoid getting sick and prevent spreading germs to others.”

Ebbing Lautenbach, MD, MPH

Ebbing Lautenbach

  • There are many types of antibacterial products out there, and there are very little data that suggest that they’re any better than regular soap and water in terms of prevention of infectious diseases. There are potential downsides to these products as well. The FDA is looking for better data to help both the FDA and the general public weigh the risks and benefits of using these products.

    In animal studies, there has been some suggestion that triclosan, a primary component in anbibacterial products, may have an effectson hormone levels, particularly thyroid hormone levels, but it has not been shown in humans. The impact on antibiotic resistance is also an important one. Triclosan has the potential to elicit resistance because it is a substrate for some resistance mechanisms, particularly efflux pumps. The concern is that increased exposure to triclosan will cause bacteria to upregulate efflux pumps, which will make them resistant not only to triclosan, but also other antibiotics.

    To date, there are no definitive data that these products increase the incidence of antibacterial resistance. There have been a few small studies that look at short-term effects of exposure to triclosan-containing products, but none have shown a significant increase in antibiotic-resistant bacteria. The message there is that we don’t’ have enough information to know what the long-term impact of these products is on resistance. If you use these products chronically, there may be a cumulative effect of chronic exposure, and over time there may be emergence of drug-resistant bacteria.

    Hand sanitizers, such as those used routinely in health care settings, are not included in the FDA review. As opposed to the antibacterial products being reviewed by the FDA, these sanitizers are alcohol-based and are not used with water. They play an important role in preventing transmission of infection in health care settings.  

    The take-home message is that the use of antibacterial products by consumers has increased significantly, although there is no evidence of their impact on the incidence infections. There is also concern that they may play a role in driving the further emergence of antibiotic resistance. The FDA is saying that we need more information on both sides of that equation. If they really play an important role in preventing household infections, then we need to define that role more clearly. If they don’t, and they’re not any more effective than regular soap and water, we need to know that also. Knowing this will help us weigh the risks and benefits of the products and help us give appropriate recommendations to our patients.

    • Ebbing Lautenbach, MD, MPH, MSCE
    • Professor of medicine
      Chief of infectious diseases
      University of Pennsylvania Perelman School of Medicine
  • Disclosures: Lautenbach reports no relevant financial disclosures.