The Food and Drug Administration has required that manufacturers of antibacterial hand soap and body wash prove their products are more effective than plain soap and water in preventing illness and the spread of infection.

Antibacterial soaps

Those manufacturers also will be required to prove their products are safe for long-term use, the agency said. Unless companies can do that, they would have to reformulate or re-label these products if they want to keep them on the market, the agency said.

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. 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, says Colleen Rogers, Ph.D., a lead microbiologist at FDA.

Moreover, antibacterial soap products contain chemical ingredients, such as triclosan and triclocarban, which may carry unnecessary risks given that their benefits are unproven. “New data suggest that the risks associated with long-term, daily use of antibacterial soaps may outweigh the benefits,” Rogers says. There are indications that certain ingredients in these soaps may contribute to bacterial resistance to antibiotics, and may have unanticipated hormonal effects that are of concern to FDA.

In light of these data, the agency issued a proposed rule on Dec. 16, 2013 that 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.