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Healthcare Business News

FDA challenging safety of anti-bacterial soaps

By Steven Ross Johnson
Posted: December 16, 2013 - 6:15 pm ET

Amid concerns that anti-bacterial soaps and body washes have no benefit and are nurturing anti-microbial-resistant superbugs, the Food and Drug Administration is challenging the makers of the products to prove they are safe and more effective than plain soap and water.

The FDA issued a preliminary rule on Monday that would require the manufacturers to provide evidence by the end of 2014, and the government may force them to reformulate or re-label the products to keep them on the market.

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According to the agency, some studies have suggested long-term exposure to certain chemicals within anti-bacterial products such as triclosan, which is used in liquid soaps, and triclocarban, an ingredient mostly found in bar soaps, could pose a number of health risks, including hormone alteration, and that they help develop antibiotic-resistant germs.

“I think this is a valuable step forward by the FDA,” said Dr. Pritish Tosh, an infectious diseases physician and researcher at the Mayo Clinic. “It is possible that the increasing use of anti-bacterial soaps by the public has contributed, in part, to the increasing problem we are facing with anti-microbial-resistant bacteria. Requiring further study to determine the true risk and benefits of these products is a step in the right direction.”

The FDA is targeting only anti-bacterial soaps that are used with water. Hand sanitizers, wipes and anti-bacterial products used in healthcare settings are not included.

“Anti-bacterial 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,” Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research said in a written release. “Due to consumers' extensive exposure to the ingredients in anti-bacterial soaps, we believe there should be a clearly demonstrated benefit from using antibacterial soap to balance any potential risk.”

The ruling marked a victory for health and environmental advocates, many of whom have for years warned of the potential dangers of such chemicals within anti-bacterial soaps.

“This is a good first step toward getting unsafe triclosan off the market,” Mae Wu, an attorney for the Natural Resource Defense Council said in a written release. “FDA is finally taking concerns about triclosan seriously. Washing your hands with soap containing triclosan doesn't make them cleaner than using regular soap and water and can carry potential health risks.”

Aside from soaps, triclosan is used in many other products, including clothing, kitchenware, furniture and toys. It has also been found to effectively prevent gingivitis when used in toothpaste.

The public will have 180 days for comment on the preliminary rules.

In a written statement, the American Cleaning Institute, the main trade organization for the cleaning products industry, defended the use of triclosan, arguing that data has been submitted to FDA in the past showing anti-microbial soaps were more effective at preventing the spread of germs than regular soap. “We are perplexed that the agency would suggest there is no evidence that anti-bacterial soaps are beneficial as industry has long provided data and information about the safety and efficacy of these products,” the organization said.

Follow Steven Ross Johnson on Twitter: @MHSjohnson

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