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FDA Wants Tighter Rules on Antibacterial Soaps, Body Washes

FDA Wants Tighter Rules on Antibacterial Soaps, Body Washes

MONDAY, Dec. 16 (HealthDay News) -- The U.S. Food and Drug Administration said Monday that it wants makers of antibacterial hand soaps and body washes to prove their products are safe for long-term daily use and more effective than regular soaps in preventing illness and the spread of certain infections.

Unless companies can do that, they would have to reformulate or re-label these products if they want to keep them on the market, the agency said.

"Millions of Americans use antibacterial soaps and body washes," Dr. Sandra Kweder, deputy director of the FDA's Office of New Drugs, Center for Drug Evaluation and Research, said during a morning press briefing.

"They are used every day at home, at work, at schools and in other public settings where the risk of bacterial infection is relatively low," she said. "We at the FDA believe there should be clearly demonstrated benefits from using antibacterial soaps to balance any potential risk."

Kweder said the FDA has not been provided with data that shows these products are "any more effective at preventing people from getting sick than washing with plain soap and water."

The agency's proposed rule would require makers of these products to justify their health claims with firm evidence of their benefit, she said.

"Manufacturers would be required to conduct clinical trials that demonstrate that their products are more effective than plain soap and water in preventing illness or the spread of certain infections," Kweder said.

"Manufacturers would also be required to provide additional safety data for these products before they can be considered generally recognized as safe for use," she added.

There's some data that long-term exposure to certain ingredients used in these products, such as triclosan (liquid soaps) and triclocarban (bar soaps), could promote bacterial resistance or have effects on hormones. These hormones include estrogen, testosterone and thyroid hormones, Kweder explained.

She said that "reformulating would mean that companies would have to remove the antibacterial active ingredient, and relabeling would mean removal of the antibacterial claim from the product's label," she said.

The proposed rule does not require that these soaps be taken off the market now. The agency has been considering the issue since 2005 and this is not something that is going to happen immediately, Kweder said. She added that the agency hopes to issue its final rule by September 2016.

In the meantime, people should continue to be diligent about washing their hands, particularly at this time of year to help protect against the spread of colds and flu. If soap and water aren't available, an alcohol-based hand sanitizer that contains at least 60 percent alcohol should be used, the FDA said.

Several doctors said they were heartened by the FDA's proposal.

"There is no link between antibacterial products and a decline in infection rates," said Dr. Luz Fonacier, head of the allergy section at Winthrop University Hospital in Mineola, N.Y. "Simply washing thoroughly with plain soap is sufficient to reduce bacteria and is effective against viruses.

"However, there are risks and disadvantages on the use of antibacterial products, including soaps and body wash, such as the possibility of development of antibiotic resistance," she added.

Dr. Leonardo Trasande, an associate professor with the Departments of Population Health, Environmental Medicine and Pediatrics at NYU Langone Medical Center in New York City, said: "Given our emerging understanding of chemicals as hormone disruptors, this is a remarkable and positive step toward protecting children. Given suggestive evidence associating triclosan exposure with allergies and concerns about promoting antibiotic resistance, there is little justification for widespread use of triclosan when soap and water or alcohol-based hand sanitizers are available."

More information

For more on antibacterial soaps, visit the U.S. food and Drug Administration.

SOURCES: Luz Fonacier, M.D., head of the allergy section, Winthrop University Hospital, Mineola, N.Y.; Leonardo Trasande, M.D., associate professor with the Departments of Population Health, Environmental Medicine and Pediatrics, NYU Langone Medical Center, New York City; Dec. 16, 2013, press conference with Sandra Kweder, M.D., deputy director, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

 
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