Experts Refute Anti-Bacterial Soap Claims

They warned manufacturers they will have to prove their products' benefits or they may be restricted from marketing them.

Dr. Alastair Wood, chairman of the panel which met Thursday to advise the Food and Drug Administration , said he saw no reason to purchase antibacterial products, given they generally cost more than soap.

The advisers also worried the potential risks of the products, particularly the common hand soaps and body washes that use synthetic chemicals, create an environmental hazard and could contribute to the growth of bacteria that are resistant to antibiotics.

"I think we're seeing a lot of sentiment against (antibacterials) being marketed to the consumer" unless they can show some added benefit over regular soap and water, said Dr. Mary E. Tinetti, a member of the panel.

Industry representatives contend their products are safe and more effective than conventional soaps, because they kill germs instead of just washing them off. They said consumers should have a right to choose their products in a free market.

Their products have grown significantly in popularity in the last decade, as consumers decided killing germs was better than simply washing them down the drain.

But the FDA said controlled studies found no significant difference in infections in households using antibacterial products and those with regular soap and water.

On Thursday, the agency's Nonprescription Drugs Advisory Panel, composed of independent experts, recommended no specific regulatory action against the manufacturers, but called on FDA to study the products' risks versus their benefits.

The agency has the authority to order warning labels on the products or place restrictions on how they are marketed to the public. Susan Johnson, associate director of nonprescription products for the FDA, said the agency would pay close attention to the panel's concerns.

FDA officials and panelists raised concerns about whether the antibacterials contribute to the growth of drug-resistant bacteria, and said the agency has not found any medical studies that definitively linked specific antibacterial products to reduced infection rates.

Dr. Stuart B. Levy, president of the Alliance for Prudent Use of Antibiotics, said laboratory studies have suggested the soaps sometimes leave behind bacteria that have a better ability to flush threatening substances — from antibacterial soap chemicals to antibiotics — from their system.

"What we're seeing is evolution in action," he said of the process.

He advocated restricting antibacterial products from consumer use, leaving them solely for hospitals and homes with very sick people.

"Bacteria are not going to be destroyed," he said. "They've seen dinosaurs come and go. They will be happy to see us come and go. Any attempt to sterilize our home is fraught with failure."

Levy said overuse of antibiotics is the main cause of bacteria developing resistance to them. He acknowledged that a yearlong study showed that homes using antibacterial soaps did not show an increase in resistant bacteria in significant numbers, but he argued the soaps will still contribute to resistance over a longer period.

Industry representatives said they would provide more information to FDA about their products safety and effectiveness.

"The importance of controlling bacteria in the home is no different than the professional setting," said Elizabeth Anderson, associate general counsel for the Cosmetic, Toiletry and Fragrance Association. "We feel strongly that consumers must continue to have the choice to use these products."

Panelists also distinguished alcohol-based hand cleansers from antibacterial soaps and washes. The cleansers are particularly useful in situations in which soap and water are not available.

Reference Source 102
October 21, 2005

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