U.S. FDA demands proof antibacterial soaps safe, work

(Reuters) — Makers of antibacterial hand soaps and body washes would have to demonstrate that their products are safe and more effective than soap and water in preventing infection and the spread of bacteria, under a rule proposed by U.S. regulators.
"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 U.S. Food and Drug Administration said in a statement.

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

The agency said companies that fail to demonstrate the safety and effectiveness of their products would have to reformulate them to back up the product claims, or re-label 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.

"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 (CDER).

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

Paul Fox, a spokesman for consumer products company Procter & Gamble maker of Safeguard antibacterial liquid hand soap, declined to comment on the proposed rule, instead suggested contacting the Personal Care Products Council, an industry trade group, for comment.

The council and another industry trade group, the American Cleaning Institute, issued a joint statement saying they were "perplexed" by FDA assertions that there is no evidence antibacterial soaps are beneficial.

"A review of two dozen relevant published studies analyzing the effectiveness of antibacterial soaps showed that hand washing with these products produces statistically greater reductions in bacteria on the skin than when using non-antibacterial soap," the groups said.

Even so, the groups praised the FDA for "moving this rulemaking forward," saying they will file comments reaffirming that use of such products in the home "does not contribute to antibiotic or antibacterial resistance."

An FDA spokeswoman said the agency looks forward to receiving and evaluating the industry comments and study data.