FW: [Pharmwaste] FDA and antibacterial soaps
Tenace, Laurie
Laurie.Tenace@dep.state.fl.us
Tue, 18 Oct 2005 14:22:29 -0400
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Thanks for forwarding this article -
Laurie=20
-----Original Message-----
From: grace.welham@deancare.com [mailto:grace.welham@deancare.com]=20
Sent: Tuesday, October 18, 2005 10:58 AM
To: Tenace, Laurie
Subject: Re: [Pharmwaste] FDA and antibacterial soaps
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FDA Questions Use of =
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Antibacterial Soaps =
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Hearing Will Probe =
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Possible Link =
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To Drug-Resistant =
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Bacteria; =
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No Clear Benefit Over =
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Plain Soap? =
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By JANE ZHANG =
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Staff Reporter of THE =
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WALL STREET JOURNAL =
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October 18, 2005 =
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The Food and Drug =
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Administration is =
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questioning the use of =
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popular antibacterial =
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cleansers, which critics =
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say may not only provide =
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little benefit for =
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healthy consumers but =
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could carry =
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environmental and =
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public-health risks. =
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In documents made public =
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yesterday, the agency =
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raised concerns about =
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the use of antibacterial =
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soaps, wipes and washes, =
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a class of products that =
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includes everything from =
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some Dial soaps to =
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Pfizer Inc.'s Purell =
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hand sanitizer. This =
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Thursday, the FDA will =
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bring the issue to an =
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outside committee of =
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experts, which will =
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examine whether the =
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agency needs to limit =
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their use by consumers. =
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The FDA could, for =
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example, recommend =
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labels that would limit =
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the circumstances in =
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which some products =
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would be used, which =
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would also restrict how =
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they could be marketed. =
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The committee is looking =
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at the use of these =
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products by healthy =
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consumers, as opposed to =
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their use by those -- =
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such as health-care =
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providers and =
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food-service employees =
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-- where the benefits =
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may more clearly =
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outweigh the risks. The =
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FDA documents state that =
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it "often is not clear =
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what contribution =
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consumer antiseptics =
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make relative to washing =
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with plain soap and =
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water." =
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(Embedded image moved to =
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file: pic21547.jpg) =
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A host of antibacterial =
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products are available =
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on store shelves. =
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Any moves by the FDA =
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could affect hundreds of =
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products that are on =
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store shelves: =
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Manufacturers have =
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introduced 253 =
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antibacterial products =
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in the U.S. so far this =
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year. Last year, there =
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were 322 new products, =
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according to =
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Datamonitor's =
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Productscan Online, a =
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new-products database. =
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Antibacterial products =
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generally cost about the =
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same as their =
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conventional =
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counterparts, though =
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prices can sometimes =
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vary widely. =
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Some doctors have =
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recommended against the =
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widespread use of =
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antibacterial products =
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for years, arguing that =
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they can lead to the =
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emergence of bacteria =
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that resist antibiotics. =
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In 2000, the American =
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Medical Association =
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recommended that the FDA =
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"expedite its =
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regulation" of =
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antibacterial consumer =
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products that have been =
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linked to resistant =
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bacteria. =
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The FDA's concerns come =
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against a backdrop of =
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heightened awareness =
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about the potential for =
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drug-resistant bacteria. =
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The incidences of deadly =
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bird flu in Asia, for =
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example, have increased =
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anxiety about infectious =
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diseases overall. =
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Earlier this year, the =
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FDA for the first time =
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banned an antibiotic =
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used in chickens and =
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turkeys because of =
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evidence that its use =
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might lead to pathogens =
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that could withstand =
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drugs used to fight =
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human illness. =
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In the documents =
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released yesterday, the =
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FDA said it found no =
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medical studies that =
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showed a link between a =
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specific consumer =
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antibacterial product =
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and a decline in =
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infection rates. Indeed, =
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one major study found =
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little difference =
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between washing with =
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soap and using an =
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antimicrobial product. =
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However, the agency said =
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that the data about =
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links to resistant =
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strains of bacteria are =
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"conflicting and =
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unclear." The worries =
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raised by researchers =
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center largely on =
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triclosan, an ingredient =
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in a number of =
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antibacterial products. =
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FROM THE ARCHIVES =
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=
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?=A0Page One: Fear of =
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Disease Has Consumers =
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Resorting to Germ =
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Warfare =
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2/7/97 =
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The agency also raised =
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concerns about the =
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environmental impact of =
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some antibacterial =
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cleansers, which may =
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hurt some algae and fish =
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and break down into a =
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harmful contaminant. =
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Another potential fear =
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-- which the FDA said =
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was "controversial" -- =
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was that using too many =
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antibacterial products =
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may prevent people from =
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being exposed to routine =
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bacteria, weakening the =
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development of their =
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immune systems and =
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leading to asthma and =
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allergies. =
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Makers of the =
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antibacterial products =
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strongly defended them =
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in filings to the =
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agency. Manufacturers =
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said that the cleansers' =
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effects on the =
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environment are limited, =
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and there is no solid =
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evidence that their =
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products lead to =
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resistant bacteria in =
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real-world conditions. =
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Moreover, they said, =
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monitoring systems are =
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in place to pick up such =
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problems if they arise. =
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Manufacturers also stood =
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by their individual =
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products. "We're not =
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aware of any evidence =
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linking the use of =
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Safeguard to drug =
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resistance in bacteria," =
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said Laurie Steuri, a =
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spokeswoman for Procter =
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& Gamble Co., which =
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makes the Safeguard line =
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of antibacterial soaps. =
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A spokeswoman for =
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Pfizer, which markets =
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Purell to consumers, =
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said, "We definitely =
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believe there is benefit =
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to consumers." =
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Still, many medical =
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experts disagree. Stuart =
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Levy, a researcher at =
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Tufts University and =
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president of the =
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Alliance for the Prudent =
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Use of Antibiotics, says =
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products with alcohol =
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and bleaches aren't =
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worrisome, but chemicals =
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that don't quickly =
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evaporate or break down =
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-- including triclosan =
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-- are. Triclosan, he =
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says, has been linked to =
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antibiotic-resistant =
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bacteria in lab tests. =
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Use of such products by =
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healthy households =
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should be limited, he =
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says, unless their =
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manufacturers can prove =
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concrete health =
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benefits. =
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----------------------------------------------------------
Grace Welham, Pharm.D.
Drug Information Pharmacist
Dean Health System
(608) 250-1198
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"Tenace, Laurie"
<Laurie.Tenace@dep.state.fl To:
<pharmwaste@lists.dep.state.fl.us>
.us> cc:
Sent by: Subject:
[Pharmwaste] FDA and antibacterial soaps
pharmwaste-admin@lists.dep.
state.fl.us
=20
=20
10/18/2005 09:21 AM
=20
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I don't have a subscription - can anyone forward this article to the =
list
serve?
"FDA questions use of antibacterial soaps" The 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. Wall Street Journal.
Laurie J. Tenace
Environmental Specialist
Florida Department of Environmental Protection
2600 Blair Stone Road, MS 4555
Tallahassee, Florida 32399-2400
PH: (850) 245-8759
FAX: (850) 245-8811
Laurie.Tenace@dep.state.fl.us
view our mercury web pages at:
http://www.dep.state.fl.us/waste/categories/mercury/default.htm
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