FDA Questions Use of Antibacterial Soaps

FDA Questions Use of Antibacterial Soaps

FDA Questions Use of Antibacterial Soaps

Hearing Will Probe Possible Link To Drug-Resistant Bacteria; No Clear Benefit Over Plain Soap?
By JANE ZHANG, Staff Reporter of THE WALL STREET JOURNAL, October 18, 2005; Page D1

The Food and Drug Administration is questioning the use of popular antibacterial cleansers, which critics say may not only provide little benefit for healthy consumers but could carry environmental and public-health risks.

In documents made public yesterday, the agency raised concerns about the use of antibacterial soaps, wipes and washes, a class of products that includes everything from some Dial soaps to Pfizer Inc.'s Purell hand sanitizer. This Thursday, the FDA will bring the issue to an outside committee of experts, which will examine whether the agency needs to limit their use by consumers. The FDA could, for example, recommend labels that would limit the circumstances in which some products would be used, which would also restrict how they could be marketed.

The committee is looking at the use of these products by healthy consumers, as opposed to their use by those -- such as health-care providers and food-service employees -- where the benefits may more clearly outweigh the risks. The FDA documents state that it "often is not clear what contribution consumer antiseptics make relative to washing with plain soap and water."

Any moves by the FDA could affect hundreds of products that are on store shelves: Manufacturers have introduced 253 antibacterial products in the U.S. so far this year. Last year, there were 322 new products, according to Datamonitor's Productscan Online, a new-products database. Antibacterial products generally cost about the same as their conventional counterparts, though prices can sometimes vary widely.

Some doctors have recommended against the widespread use of antibacterial products for years, arguing that they can lead to the emergence of bacteria that resist antibiotics. In 2000, the American Medical Association recommended that the FDA "expedite its regulation" of antibacterial consumer products that have been linked to resistant bacteria.

The FDA's concerns come against a backdrop of heightened awareness about the potential for drug-resistant bacteria. The incidences of deadly bird flu in Asia, for example, have increased anxiety about infectious diseases overall. Earlier this year, the FDA for the first time banned an antibiotic used in chickens and turkeys because of evidence that its use might lead to pathogens that could withstand drugs used to fight human illness.

In the documents released yesterday, the FDA said it found no medical studies that showed a link between a specific consumer antibacterial product and a decline in infection rates. Indeed, one major study found little difference between washing with soap and using an antimicrobial product. However, the agency said that the data about links to resistant strains of bacteria are "conflicting and unclear." The worries raised by researchers center largely on triclosan, an ingredient in a number of antibacterial products.

The agency also raised concerns about the environmental impact of some antibacterial cleansers, which may hurt some algae and fish and break down into a harmful contaminant. Another potential fear -- which the FDA said was "controversial" -- was that using too many antibacterial products may prevent people from being exposed to routine bacteria, weakening the development of their immune systems and leading to asthma and allergies.

Makers of the antibacterial products strongly defended them in filings to the agency. Manufacturers said that the cleansers' effects on the environment are limited, and there is no solid evidence that their products lead to resistant bacteria in real-world conditions. Moreover, they said, monitoring systems are in place to pick up such problems if they arise.

Manufacturers also stood by their individual products. "We're not aware of any evidence linking the use of Safeguard to drug resistance in bacteria," said Laurie Steuri, a spokeswoman for Procter & Gamble Co., which makes the Safeguard line of antibacterial soaps. A spokeswoman for Pfizer, which markets Purell to consumers, said, "We definitely believe there is benefit to consumers."

Still, many medical experts disagree. Stuart Levy, a researcher at Tufts University and president of the Alliance for the Prudent Use of Antibiotics, says products with alcohol and bleaches aren't worrisome, but chemicals that don't quickly evaporate or break down -- including triclosan -- are. Triclosan, he says, has been linked to antibiotic-resistant bacteria in lab tests. Use of such products by healthy households should be limited, he says, unless their manufacturers can prove concrete health benefits.

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