(New throughout, adds FDA comment, background on prior FDA efforts, details on soaps; adds byline))
By Ransdell Pierson
Dec 16 (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 on Monday.
"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.
SOAP AND LIVESTOCK
The action comes five days after the FDA issued new voluntary guidelines to phase out the use of antibiotics as a growth enhancer in livestock, also in an effort to stem a surge in human resistance to antibiotics.
The livestock guidelines are "part of the (same) general equation of what are the benefits of using antimicrobials and how do they stack up against any risks," Sandra Kweder, deputy director of the Office of New Drugs at the FDA, said on a conference call with journalists on Monday.
Almost all soaps labeled "antibacterial" or "antimicrobial" contain at least one of the antibacterial ingredients addressed in the FDA's proposed rule, most notably triclosan and triclocarban, and some labeled "deodorant" may also contain these ingredients, the agency said.
The proposed rule will be available for public comment for 180 days. Concurrently, companies will be given one year to submit new data and information, followed by a 60-day rebuttal comment period.
Some 2,000 soap products in the United States contain antimicrobial chemicals, and 93 percent of those in liquid form contain triclosan, the FDA said.
Kweder said the proposed rule follows a longstanding public debate over antimicrobial products.
The FDA in 2005 suggested methods by which companies could test their antimicrobial products to ensure they are safe and back up their claims, Kweder said. But she noted the FDA never required companies to actually perform the tests, or submit any such data to the agency.
"We want companies to test these products so consumers will know if there is any benefit," Kweder said, following poor response from the earlier voluntary testing schemes.