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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                                                                         =
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                                                                         =
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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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                                                                         =
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                                                                         =
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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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                                                                         =
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                                                                         =
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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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                                                                         =
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                                                                         =
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                                                                         =
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                                                                         =
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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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                                                                         =
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                                                                         =
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                                                                         =
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                                                                         =
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                                                                         =
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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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                                                                         =
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                                                                         =
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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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                                                                         =
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                                                                         =
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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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                                                                         =
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                                                                         =
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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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                                                                         =
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                                                                         =
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                                                                         =
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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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                                                                         =
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                                                                         =
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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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                                                                         =
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                                                                         =
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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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                                                                         =
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                                                                         =
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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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                                                                         =
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----------------------------------------------------------
Grace Welham, Pharm.D.
Drug Information Pharmacist
Dean Health System
(608) 250-1198
----------------------------------------------------------


=20

                      "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

=20





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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