Targeting Antibacterial Soaps

Manufacturers of antibacterial soaps and body washes will have to show that their products are safe for everyday use and that they are more effective than ordinary soap at preventing the spread of germs. That’s according to a rule proposed today by the Food & Drug Administration. If the rule is finalized, companies that fail to show such safety and effectiveness will have to either reformulate or relabel their products.

FDA’s action comes amid growing concerns about possible health effects associated with antibacterial ingredients and their potential to lead to antibiotic resistance. Animal data suggest that daily exposure to some active ingredients used in antibacterial soaps, for example triclosan and triclocarban, could result in hormonal effects, says Sandra L. Kweder, deputy director of FDA’s Office of New Drugs. “Laboratory studies also suggest that antibacterial ingredients may contribute to changes in antibiotic susceptibility,” she notes.

“Millions of Americans use antibacterial hand soaps and body washes,” Kweder says. “They are used every day at home, work, schools, and other public settings where the risk of bacterial infections is relatively low.” Kweder estimates that there are about 2,000 antibacterial soaps and body wash products on the market today in the U.S. The use of such products is becoming increasingly prevalent, she says.

Because consumers are exposed to high levels of these antibacterial ingredients, “there should be clearly demonstrated benefit from using antibacterial soaps to balance out any potential risk,” Kweder notes. “FDA does not have data to demonstrate that these products are any more effective at preventing people from getting sick than washing with plain soap and water,” she says.

FDA’s proposed rule is part of a settlement reached last month with the environmental group Natural Resources Defense Council. The group sued FDA in 2010 for not finalizing a 1978 rule that would have banned triclosan from certain consumer products. Under the settlement, FDA committed to issuing today’s proposed rule and taking final action by 2016.

“This is a good first step toward getting unsafe triclosan off the market,” says Mae Wu, an attorney with NRDC’s health program. “Washing your hands with soap containing triclosan doesn’t make them cleaner than using regular soap and water and can carry potential health risks.”

The proposed rule does not apply to toothpaste, hand sanitizers, wipes, or antibacterial products used in health care settings or food preparation facilities. FDA is accepting comments on the rule until June 2014.