FDA seeks stronger regulations on antibacterial soaps, body washes

SILVER SPRING, Md. — The Food and Drug Administration may require makers of antibacterial soaps to perform clinical trials to show their products are better at preventing infections and disease than ordinary soaps, part of a larger effort by the agency to ensure the safety and efficacy of antibacterial products and slow down the rise of antibiotic-resistant bacteria.

The FDA announced the proposed rule Monday, saying it would not affect hand sanitizers, wipes or antibacterial products used in healthcare settings. Almost all soaps labeled "antibacterial" or "antimicrobial" and marketed to consumers contain ingredients such as triclosan and triclocarban, and millions of Americans use soaps and body washes that include them. But the agency said there was currently no evidence to show such products are more effective in preventing illness than plain soap and water, and some data suggest long-term exposure to those ingredients could cause bacterial resistance or hormonal effects.

"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 very low," FDA Center for Drug Evaluation and Research director Janet Woodcock said. "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 risk."

The FDA said it was prompted by scientific data and concerns from healthcare and consumer groups, but that people should still wash their hands on a regular basis with soap and water or use hand sanitizer with at least 60% alcohol.