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From October 21, 2005                                                                                                           

FDA Questions Use of Antibacterial Products
(Beyond Pesticides, October 21, 2005) The Food and Drug Administration (FDA) 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. U.S. Food and Drug Administration scientists and other experts said studies showed clear benefits from hand washing with plain soap, especially when people are taught when and how long to wash. Data on antibacterial soap was limited, they said during a meeting of the Nonprescription Drugs Advisory Committee.

"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.

The panel is weighing the risks of such products for consumers and whether the FDA should curb their use because they may help create drug-resistant bacteria. The FDA, which has been grappling with the issue for more than 30 years, has yet to make a final decision on how to regulate such products, which face many issues similar to antibiotic drugs, but are available over-the-counter.

The agency is asking its advisers to recommend which consumers should use such products. It is also seeking advice on how to decide whether the soaps are effective and what risks it should consider in making its final rule. The FDA, which usually follows its experts' advice, could take a variety of actions, from changing product labels to restricting marketing claims.

"We're reexamining the risks to consumers," said FDA microbiologist Colleen Rogers.
Documents released by the FDA prior to the meeting state that it "often is not clear what contribution consumer antiseptics make relative to washing with plain soap and water."

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. Numerous studies have found that triclosan promotes the emergence of bacteria that are resistant to antibiotics. Triclosan has also been linked to the formation of dioxin, a highly carcinogenic substance. Triclosan is found in hundreds of common everyday products, including nearly half of all commercial soaps. In addition to soaps, triclosan is found in deodorants, toothpastes, cosmetics, fabrics and plastics. Triclosan is used so commonly that is has made its way into the human body –it has been found in the umbilical cord blood of infants and in breast milk of mothers.

The agency also raised concerns about the environmental impact of some antibacterial cleansers, including triclosan, 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. This idea is popularly known as the hygiene hypothesis.

The panel is expected to vote at the end of the meeting on whether they believe that antibacterial cleansers are effective.

TAKE ACTION: When used in hospitals and other health care settings, or for persons with weakened immune systems, triclosan represents an important health care and sanitary tool. Outside of these settings, it is unnecessary, and the constant exposure to triclosan becomes a health and environmental hazard. The best solution to preventing infections is good old soap and water. Make sure you read all labels when buying soaps and other toiletry products to ensure that triclosan is not included. Also be on the lookout for Microban and Irgasan, which are other names for triclosan. Consult our triclosan factsheet for a list of products containing triclosan (some, like Teva sandals and kitchen knives, may surprise you) and for more detailed information on alternatives to triclosan.