FDA proposes tighter regulations on anti-bacterial soaps, cleansers, etc.

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Posted 12/16/2013 by busypea in NSBR Board

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PeaNut 52,817
October 2002
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Loc: Oregon

Posted: 12/16/2013 3:29:31 PM
YAY. I hope this is implemented. Double yay for the FDA proposing the phrase out antibiotics for growth enhancement in livestock.

(Reuters) - U.S. regulators on Monday issued a proposed rule that would require makers of antibacterial hand soaps and body washes to demonstrate their products are safe and more effective than soap and water in preventing infection and the spread of bacteria.

"Although consumers generally view these products as effective tools to help prevent the spread of germs, there is currently no evidence that they are any more effective at preventing illness than washing with plain soap and water," the U.S. Food and Drug Administration said in a statement.

The FDA said research has suggested long-term exposure to antibacterial chemicals, such as triclosan in liquid soaps and triclocarban in bar soaps, could have hormonal affects and allow bacteria to mutate into harder-to-control strains.

The agency said companies that fail to demonstrate the safety and effectiveness of their products would have to reformulate them to back up the product claims, or re-label them to keep them on store shelves.

Such products are widely sold and touted, and include SoftSoap products from Colgate Palmolive, Cetaphil from Galderma Laboratories, and Dial products from Henkel AG.

The FDA said the action is part of a larger ongoing review by the agency to ensure that antibacterial ingredients are safe and effective. But the proposed rule would not affect hand sanitizers, wipes or antimicrobial products used in healthcare settings, the agency said.

The move comes five days after the FDA issued new guidelines to phase out the use of antibiotics as a growth enhancer in livestock, also in an effort to stem a surge in human resistance to antibiotics.

"Due to consumers' extensive exposure to the ingredients in antibacterial soaps, we believe there should be a clearly demonstrated benefit ... to balance any potential risk," said Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.

Almost all soaps labeled "antibacterial" or "antimicrobial" contain at least one of the antibacterial ingredients addressed in the FDA's proposed rule, most notably triclosan and triclocarban, and some labeled "deodorant" may also contain these ingredients, the agency said.

The proposed rule will be available for public comment for 180 days. Concurrently, companies will be given one year to submit new data and information, followed by a 60-day rebuttal comment period.


PEAceful Pea

PeaNut 14,521
April 2001
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Posted: 12/16/2013 3:34:42 PM
That's great news.


pearl-clutching nitpicker

PeaNut 201,774
April 2005
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Posted: 12/16/2013 3:37:07 PM
Two thumbs up.

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Allons-y Alonso

PeaNut 174,150
October 2004
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Posted: 12/16/2013 3:37:38 PM
I am glad they are only going after the soaps and not the hand sanitizers. For those of us with extremely fragile immune systems antibacterial gels are a life saver literally.


PeaNut 65,877
January 2003
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Posted: 12/16/2013 4:00:13 PM
This is great but long overdue . I didn't know that deodorant soaps had bad stuff in it. I guess I need to look it up.

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PeaNut 70,239
February 2003
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Posted: 12/16/2013 4:57:27 PM
I hate that the only choice I have at work is the anti bacterial soap.

Ancient Ancestor of Pea

PeaNut 288,459
December 2006
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Posted: 12/16/2013 6:32:47 PM
I have heard some similar talk about Colgate Palmolive mouthwashes. Any one know anything about the mouthwashes?

Nicole in TX
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PeaNut 16,696
June 2001
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Posted: 12/16/2013 6:50:44 PM
I would like to see triclosan banned in the US. I believe it is in Canada.

It is also in Colgate Total toothpastes. That is something people put in their mouth!

Ancient Ancestor of Pea

PeaNut 26,836
January 2002
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Posted: 12/16/2013 7:03:36 PM
Good news.

Ancient Ancestor of Pea

PeaNut 35,782
April 2002
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Posted: 12/16/2013 7:26:09 PM
Great News! It's about time.

Debbie in MD.


PeaNut 265,261
June 2006
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Posted: 12/16/2013 7:46:17 PM
I hope it goes through. And I totally agree with this:

I would like to see triclosan banned in the US. I believe it is in Canada.

gale w
shiny farmwife

PeaNut 40,275
June 2002
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Loc: Indiana

Posted: 12/16/2013 7:51:28 PM
Maybe BBW would finally have more choices in non antibacterial soaps. Right now they have very few and they seem to cost twice as much.

Not long ago it was really hard to find non antibacterial liquid soap anywhere. Now softsoap makes several varieties of it.

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Ancient Ancestor of Pea

PeaNut 43,893
July 2002
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Posted: 12/16/2013 8:30:48 PM
For me antibacterial soap is for smelly teen boy armpits, and yes, for that, it's better than plain soap. Hands down. BUT... I would like to know they are safe for said smelly teen. So yay!!

Hand sanitizer is for when no water is available. Otherwise I go wash my hands.my in laws on the other hand forego the kitchen sink ( complete with hands free soap dispenser ) a few feet away ( in my house ) to use hand sanitizer. Makes me crazy.

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