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FDA to require testing of antibacterial soaps

– Is the antibacterial soap sitting near your kitchen sink any better at warding off germs than plain old soap and water? And, perhaps more important, is it safe?

After years of prodding from consumer advocates, environmental groups and some lawmakers, the Food and Drug Administration said Monday that it plans to require manufacturers to provide data to answer those questions. Those that can’t make their case may have to relabel, reformulate or discontinue their products.

In proposing the new regulations, FDA officials said there’s little evidence that the heavily marketed antibacterial soaps are more effective at preventing illnesses than soap and water.

The agency also said research suggests that long-term exposure to ingredients widely found in antibacterial products, including triclosan in liquid soaps and triclocarban in bar soaps, could pose health risks such as increased 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 relatively low,” Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, said in a statement Monday.

“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 potential risk.”

The agency’s proposal does not apply to hand sanitizers, wipes or other antibacterials used in hospitals and other medical settings. But, if finalized, the rules could affect an increasing number of products used by millions of Americans.

Sandra Kweder, deputy director of FDA’s Office of New Drugs, said about 2,000 products labeled “antimicrobial” or “antibacterial” contain at least one ingredient on a list the FDA intends to oversee.

“Consumers ought to know – and we ought to know – what the benefits are,” Kweder told reporters Monday. “We want companies to actually test these products so that consumers, when they purchase them, have a sense of whether there is any benefit at all over plain soap and water.”

Beyond concerns involving truth in advertising, federal officials have spent years trying to measure potential health risks of certain chemicals, namely triclosan, which is used in products as varied as toothpaste and socks. Activists have raised concerns about whether the widespread use of antibacterial soaps is contributing to the growth of drug-resistant superbugs untreatable by some antibiotics.

The American Cleaning Institute, which represents the $30 billion cleaning product industry, said Monday it has provided the FDA with extensive information showing that antibacterial products are safe and kill germs more effectively than soap and water.

“What perplexes us is we’ve submitted a whole wealth of data on safety and effectiveness,” said Brian Sansoni, a spokesman for the group, citing a meeting with the agency in 2008. “We just want to make sure the FDA has that data in front of them. We believe there’s a lot of solid data there.”

Aaron Glatt, an infectious disease expert and executive vice president at Mercy Medical Center in Rockville Centre, N.Y., said that while the federal officials and the industry wrestle over the outcome, consumers are better off washing their hands the old-fashioned way – and often.

“It’s not like soap and water doesn’t work,” Glatt said. “Soap and water remains the gold standard.”