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FDA calls for antibacterial evidence in soaps, body washes

Monday, Dec. 16, 2013 12:44 PM
Last updated Tuesday, Dec. 17, 2013 12:59 AM
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Antibacterial soaps may be no better than plain soap and at worse might be causing hormonal changes, the Food and Drug Administration said Monday.

The agency announced a proposed rule and comment period calling on manufacturers of antibacterial soaps and body washes to provide evidence their products actually kill bacteria. Evidence from animal studies show these products are no more effective than soap and water and might actually affect estrogen, testosterone and thyroid hormonal levels, officials said.

“While the use of antibacterial soaps and body washes has become part of many consumers’ routines, we at the FDA have not been provided with data to demonstrate that these products are any more effective at preventing people from getting sick than washing with plain soap and water,” said Dr. Sandra Kweder, deputy director of the Office of New Drugs in the Center for Drug Evaluation and Research at FDA. “To put it simply, we need to collect additional information from the companies that make these products so that consumers can be confident about their effectiveness and their safety.”

There is also evidence that these products might be aiding antibiotic resistance among bacteria, she said.

“There are laboratory data that show that bacteria exposed to these products do change their resistance patterns,” Kweder said.

Most of those products contain an ingredient called triclosan or another called triclocarban. The FDA is aware of 2,000 such products, about 93 percent of which are labeled antibacterial, Kweder said. Companies that could not provide evidence of effectiveness would have to reformulate the products or relabel them to remove the antibacterial claim, she said. The FDA is taking comments on the proposed rule for 180 days and the industry would have until December 2014 to submit data and studies. FDA would expect to finalize the rule around September 2016.

The FDA has been talking about the issue since at least 2005 so it should not be unexpected, Kweder said.

“The industry has long been aware of our concerns,” she said.

The proposed rule would not affect hand sanitizers and other sanitizers that are alcohol-based because those have been shown to be effective, Kweder said.

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Little Lamb
43986
Points
Little Lamb 12/16/13 - 04:23 pm
2
3
Kill

These government busybodies. What will they go after next?

I just went to the bathroom and picked up a bottle of antibacterial soap. Here is what it says on the front label:

Antibacterial

Hand Soap

With Light Moisturizers
Tough On Germs

Here is what it says on the back label:

Drug Facts
Active Ingredient - - - - - - - Purpose

Triclosan 0.15% - - - - - - - - Antibacterial

Uses • for handwashing to decrease bacteria on the skin

- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -

Nowhere on the label does the soap manufacturer say the soap will kill bacteria. The word "kill" does not appear anywhere.

I would think that the FDA would have bigger fish to fry.

Little Lamb
43986
Points
Little Lamb 12/16/13 - 04:25 pm
1
2
Look at the last paragraph

It would appear all the antibacterial soap manufacturers need to do is to add a small amount of alcohol to the formula. Then the FDA would have to back off.

bright idea
719
Points
bright idea 12/16/13 - 04:45 pm
2
2
Was this a hoax?

To make money? Talk big about germs so everybody will rush out and buy antibacterial hand soap. Kind of like global warming to sell Gore's book. Who do you believe, FDA or soap manufacturers? This whole announcement and comment period is a joke.

Bizkit
29293
Points
Bizkit 12/17/13 - 02:39 am
2
1
Actually they contain another

Actually they contain another compound linked with muscle weakness too. But we bathe, breathe, eat, and drink so many different compounds-now have found evidence of blood pressure meds, acetaminophen, oxycontin, birth control estrogen/progestin, and a host of other common drugs we consume and pass into waste water shows up in our drinking water.

Grandpa Jones
1038
Points
Grandpa Jones 12/17/13 - 03:58 am
5
0
Soaps

A couple of years ago, I got caught up in purchasing expensive soaps/body washes. I started to have a facial rash. I ended up going to the doctor. Even, the prescription cremes didn't help. After a year of fighting this rash, I switched to some cheap soap (2 bars for 99 cents from Kroger). In less than a week, the rash was gone.

iaaffg
1590
Points
iaaffg 12/17/13 - 06:54 am
2
1
mmmm....weren't the

mmmm....weren't the manufacturers of these so-called bacteria killing soaps supposed to prove that BEFORE they were given license to sell them as such? and why are we so afraid of a few germs? how did mankind survive thousands of years of existence without all these germ killing lotions and potions we now have lined up on the store shelves? also: every time someone is sick, the doc gives 'em another antibiotic to take (which most people do not take properly anyways) and now we wonder why we have so many bugs and germs that are resistant to meds. western medicine isn't aimed at curing and making you better, it's only aimed at your pocketbook and having you be a slave to some doctor, showing up faithfully to appointments every three months to see this person for three minutes, just to get another 'script. but i digress, sorry, that's a whole other point of contention.

Bulldog
1307
Points
Bulldog 12/17/13 - 10:18 am
1
1
Selective pressure

The routine use of ANY antimicrobial compound will apply selective pressure that results in the emergence of organisms resistant to that and other compounds with a similar mechanism of action. The use of hexachlorophene in soap was banned years ago for this same reason. As Pasture said, "The microbes will have the last word.". We are only a half step ahead of the worst of the bacteria now because too many physicians didn't lean the principles of selective pressure in school.

soapy_725
43555
Points
soapy_725 12/17/13 - 10:43 am
1
0
Any soap or detergent has some anti bacterial properties. Bathi
Unpublished

ng is an anti bacterial process. Arise and be clean. Be clean of what.

soapy_725
43555
Points
soapy_725 12/17/13 - 10:44 am
1
0
Does soap get rid of the B.O.? Does bacteria cause B.O.?
Unpublished

Does soap get rid of the B.O.? Does bacteria cause B.O.?

soapy_725
43555
Points
soapy_725 12/17/13 - 10:46 am
1
0
Bizkit
29293
Points
Bizkit 12/17/13 - 10:47 am
0
1
Don't blame doctors for over

Don't blame doctors for over prescribing antibiotics. Forced to as preventive measure and legal issue initially but once realized the problem and trying to resist the overuse patients now "insist"on antibiotics-even if you tell them it won't help.

soapy_725
43555
Points
soapy_725 12/17/13 - 10:47 am
0
0
If you ever visited P&G you would know about "sope".
Unpublished

f you ever visited P&G you would know about "sope".

soapy_725
43555
Points
soapy_725 12/17/13 - 10:48 am
1
0
P&G employees taught the EPA how to sample P&G effluent.
Unpublished

P&G employees taught the EPA how to sample P&G effluent.

soapy_725
43555
Points
soapy_725 12/17/13 - 10:49 am
0
0
P&G employees taught city employees how to test waste water.
Unpublished

P&G employees taught city employees how to test waste water.

Bizkit
29293
Points
Bizkit 12/17/13 - 10:52 am
1
1
The problems is the

The problems is the assumption that all germs are bad-which there are good germs and bad germs. We need to selectively learn to change skin and gut flora to healthy ones that will prevent obesity and heart disease because recent studies indicate that gut flora maybe the key to obesity and heart disease. Science is great but it is a process-so you can't put too much credence in something that may change-we've done this in past withe education and several other things and it proved disastrous because the studies were eventually disproven.

soldout
1280
Points
soldout 12/17/13 - 03:07 pm
1
0
get them out of your house

I wouldn't want anything anti-bacterial in my house because it kills the friendly bacteria that fight disease. These products are probably helping create the super bugs and weaken immune systems. When I muscle test these products to see if my body likes them they all fail. Our body will tell us through muscle testing whether something is good or bad for us. I can't imagine dealing with all we deal with today in food, drugs and chemicals without knowing how to muscle test. A few days ago I taught someone the "Wobble test" which is a form of muscle testing where the lab inside our body can determine what is good or bad for us. She tested 38 items and her body reacted correctly to each one.

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