US regulators raise concerns about antibacterial soaps

US regulators issued a proposed rule yesterday that would require makers of antibacterial hand soaps and body washes to demonstrate their products are safe and more effective than soap and water in preventing infection and the spread of bacteria.

“Although consumers generally view these products as effective tools to help prevent the spread of germs, there is currently no evidence that they are any more effective at preventing illness than washing with plain soap and water,” the US Food and Drug Administration said in a statement.

The FDA said research had suggested long-term exposure to antibacterial chemicals, such as triclosan in liquid soaps and triclocarban in bar soaps, could have hormonal effects and allow bacteria to mutate into harder-to-control strains.

The agency said companies that failed to demonstrate the safety and effectiveness of their products would have to reformulate them to back up the product claims, or relabel them to keep them on store shelves. Such products are widely sold and touted, and include SoftSoap products from Colgate Palmolive, Cetaphil from Galderma Laboratories, and Dial products from Henkel AG.

The FDA said the action was part of a larger review by the agency to ensure that antibacterial ingredients are safe and effective. But the proposed rule would not affect hand sanitisers, wipes or antimicrobial products used in healthcare settings, the agency said.

“Due to consumers’ extensive exposure to the ingredients in antibacterial soaps, we believe there should be a clearly demonstrated benefit . . . to balance any potential risk,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.

Almost all soaps labelled "antibacterial" or "antimicrobial" contain at least one of the ingredients addressed in the FDA's proposed rule, most notably triclosan and triclocarban, and some labelled "deodorant" may also contain these agents, the agency said.
– (Reuters)