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FDA Considers Restricting Antibacterial Soaps

From: Reuters
From correspondents in Silver Spring, Maryland

October 21, 2005

ANTIBACTERIAL soaps and disposable wipes have not been proven any more effective than regular soap in preventing infections among average consumers, US health experts overwhelmingly said today.

But if plain soap and water are not readily available, alcohol-based hand sanitisers are a "useful" alternative, the advisory panel said.

Alistair Wood, assistant vice chancellor at Vanderbilt University's School of Medicine, said using plain soap and water was "pretty effective".

"There was no data I saw that showed antiseptic hand washing is any better," he said.

Consumer products that include bacteria-fighting ingredients should be required to have scientific data proving they prevent infections, the advisory panel also said.

The Food and Drug Administration, which has been grappling with the issue for more than 30 years, asked the panelists to weigh the products' risks for consumers amid concerns they may create drug-resistant bacteria.

The agency has yet to make a final decision on how to regulate such over-the-counter products, which face many issues similar to prescription antibiotics.

"We're re-examining the risks to consumers," said FDA microbiologist Colleen Rogers.

FDA officials, who usually follow their experts' advice, could take various actions, from changing product labels and restricting marketing claims to pulling the products from the market.

At issue are antibacterial products that include chemicals such as triclosan, which targets a certain enzyme that bacteria need to live and may linger in the environment. Bacteria can mutate to adapt to such chemicals, scientists said.

Soaps with such bacterial-killing agents have been used for years and are now common households products.

Doctors and other experts are concerned excessive use of the products, like overuse of antibiotic medicines, will create drug-resistant "superbugs".

"Bacteria are not going to be destroyed. They've been here, they've seen dinosaurs come and go... so any attempt to sterilise our home is fraught with failure," said non-voting panelist Stuart Levy, a microbiologist at Tufts University.

FDA scientists and other experts said studies showed clear benefits from hand washing with plain soap, but data on antibacterial soap were limited.

"There is a lack of evidence that antiseptic soaps provide a benefit beyond plain soap in (the) community setting," said University of Michigan epidemiologist Allison Aiello.

Alcohol-based hand sanitisers were not a concern.

While data did not show they were better than plain soap, panelists agreed they prevent the spread of germs without triggering resistance.

Some industry representatives rejected the panel's concerns, saying antibacterial soaps were safe and effective.

"We think the evidence is crystal clear," Soap and Detergent Association spokesman Brian Sansoni said.