The U.S. Food and Drug Administration (FDA) issued a consumer update on December 16 stating that it is taking a closer look at soaps purporting to be antibacterial. Every day, consumers use antibacterial soaps and body washes at home, work, school and in other public settings. Especially because so many consumers use them, FDA believes that there should be clearly demonstrated benefits to balance any potential risks. Currently, there is no evidence that over-the-counter antibacterial soap products are any more effective at preventing illness than washing with plain soap and water.

In light of these concerns, the FDA has issued a proposed rule on December 16 that would increase regulation and oversight of these “antibacterial” products. If finalized, the rule would require manufacturers to provide more substantial data to demonstrate the safety and effectiveness of antibacterial soaps. The proposed rule covers only those consumer antibacterial soaps and body washes that are used with water. It does not apply to hand sanitizers, hand wipes or antibacterial soaps that are used in health care settings such as hospitals.

According to Bloomberg Businessweek, the ingredients of particular concern are triclosan and triclocarban. Use of antibacterial soap containing triclosan and triclocarban has increased significantly in the past few decades. There are indications that certain ingredients in these soaps may contribute to bacterial resistance to antibiotics, and may have unanticipated hormonal effects, including infertility and early puberty.

The Natural Resources Defense Council (NRDC) has already criticized the FDA for failing to issue a final rule regulating the chemicals triclosan and triclocarban.  The NRDC filed a lawsuit against the FDA, noting that the FDA acknowledged soaps containing triclosan offer no additional benefit over regular soap and water.  FDA also expressed concern about the development of antibiotic resistance from using antibacterial products and about triclosan’s potential long-term health effects, but did not move ahead on the rule-making.  NRDC also said that triclosan and triclocarban showed endocrine disruptors linked to reproductive and developmental harm in laboratory studies.

In 1999, the Los Angeles Times described the progress of antibacterials. At that time, the products were already thought to be of dubious efficacy.  Despite that reputation in the scientific and regulatory communities, consumers were still buying plenty of the products.  The article also states that many experts say thorough hand washing with regular soap is still the best way to clean hands and prevent the spread of disease. Some experts are concerned that antibacterials might lead to development of antibiotic-resistant strains.