FDA Bans 19 Chemicals Used In Antibacterial Soaps (nbcnews.com) 248
The Food and Drug Administration has ordered "antibacterial" ingredients to be removed from consumer soaps, citing a lack of evidence that they are effective in making soap work any better and that the industry has failed to prove they're safe. The banned chemicals include triclosan, triclocarban and 17 others (PDF) typically found in hand and body soaps. Companies have until late next year to remove the ingredients from their products, the FDA said. "Companies will no longer be able to market antibacterial washes with these ingredients because manufacturers did not demonstrate that the ingredients are both safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections," the FDA said in a statement. NBC News reports: "In 2013 FDA gave soapmakers a year to show that adding antibacterial chemicals did anything at all to help them kill germs. It made the rule final Friday. The FDA started asking about triclosan in 1978. Environmental groups and some members of Congress have been calling for limits on the use of triclosan. The Natural Resources Defense Council (NRDC) sued and the FDA agreed to do something about triclosan by 2016. There's no proof that triclosan is dangerous to people, but some animal studies suggest high doses can affect the way hormones work in the body. The proposed rule only affects hand soaps and body washes. Triclosan is often used in toothpaste and it's been shown to help kill germs that cause gum disease."
True soap (Score:5, Interesting)
Saponified oils (real soap) are high enough pH to be antibacterial on their own, most normal soaps nowadays are a small amount of SLS (sodium lauryl sulfate) and gelling agent and are only mildly antibiotic at best. If you want antibiotic soap get some sort of saponified soap, no need to contribute to the overuse of antibiotic agents in our environment that build resistance.
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But a good smelling one!
But (Score:2)
the alcohol based hand sanitzers dry my skin out too much.
I work in the 'elder-care industry, I have to wash my hands hundreds of times per shift
Re:But (Score:5, Insightful)
The whole point is that regular soap and water are just as effective as those containing these antibacterial agents.
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Fine by me (Score:5, Insightful)
Now, if only I could find a liquid hand soap that doesn't contain moisturizers...
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OIf these chemicals put in soap don't kill germs as the makers may claim, then they must be removed from those products.
Fuck that, if this has no action, but is safe, then the FDA should have no authority for an outright ban. Ghost detector can't detect shit, but it's still being sold...
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Or even harder: without perfume.
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Yeup, as pointed out by another, you make your own. It's even easier if you have a foaming soap dispenser
Original: http://wellnessmama.com/35665/... [wellnessmama.com]
Foaming: http://wellnessmama.com/8631/f... [wellnessmama.com] I prefer the Almond, but there is unscented Dr Bronners Castile soap
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I would like to believe that the fact most hand soaps have moisturizers will decrease since it was always the fucking "antibacterial" agents which caused most of the skin damage in the first place.
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I use unscented Dr. Bronner's for virtually everything; shampoo, hand soap, dishes...
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you think? (Score:2)
We knew this already.
Reporters and the FDA are incorrect (Score:5, Informative)
The press, being the idiots that they are, don't realize that the FDA doesn't have jurisdiction over "soap." The FDA isn't helping by trying to broaden their reach.
Their order says "The U.S. Food and Drug Administration today issued a final rule establishing that over-the-counter (OTC) consumer antiseptic wash products containing certain active ingredients can no longer be marketed."
That is not soap. In fact, the FDA says it has no jurisdiction over soap, which is confusing because on various webpages they say "Soap," and they do so in the title of said order as well.
Here's the FDA's explanation of Soap:
http://www.fda.gov/Cosmetics/G... [fda.gov]
Here's the part that's relevant.
"Not every product marketed as soap meets FDA's definition of the term. FDA interprets the term "soap" to apply only when
the bulk of the nonvolatile matter in the product consists of an alkali salt of fatty acids and the product's detergent properties are due to the alkali-fatty acid compounds, and the product is labeled, sold, and represented solely as soap [21 CFR 701.20].
Products that meet this definition of soap are regulated by the Consumer Product Safety Commission disclaimer icon (CPSC), not by FDA. Please direct questions about these products, such as safety and labeling requirements, to CPSC. "
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Re:Reporters and the FDA are incorrect (Score:5, Informative)
The press, being the idiots that they are, don't realize that the FDA doesn't have jurisdiction over "soap." The FDA isn't helping by trying to broaden their reach.
Their order says "The U.S. Food and Drug Administration today issued a final rule establishing that over-the-counter (OTC) consumer antiseptic wash products containing certain active ingredients can no longer be marketed."
That is not soap. In fact, the FDA says it has no jurisdiction over soap, which is confusing because on various webpages they say "Soap," and they do so in the title of said order as well.
Unfortunately, I think you're the one who is confused, though I can understand why. The key is in the definition you quote:
FDA interprets the term "soap" to apply only when the bulk of the nonvolatile matter in the product consists of an alkali salt of fatty acids and the product's detergent properties are due to the alkali-fatty acid compounds, and the product is labeled, sold, and represented solely as soap
I'm pretty sure the vast majority of products consumers associate with "antibacterial soaps" do NOT meet that definition. Most people think of antibacterial hand soaps, for example, which almost always are based on other detergents [wikipedia.org], for example the well-known (and maligned among "natural products" fans) sodium lauryl sulfate. These other detergents are commonly produced by other chemical means, which you can look up more information on if you want. They are more common, because they generally produce superior cleaning properties than "true soap" through surfactant properties, foaming properties, etc., which also allow them to be effective under a greater variety of conditions (e.g., hard water).
Note that the FDA allows such products still to be marketed as "soap" as long as they have cleansing characteristics and purposes similar to traditional "true soap." Hence the confusion here. The FDA's announcement and reporters' use of the term "soap" was probably meant to inform consumers of the common vernacular association of the term, as well as how these products are marketed, not the technical regulatory definition.
The number of "true soap" products that are ALSO "antibacterial" is probably quite small, because most of the "true soap" products used in situations where antibacterial soaps are common are marketed to be "natural" and thus are unlikely to contain a lot of these antibacterial agents.
And even where such products exist, there is a regulatory argument to be made by the final element of the FDA definition, i.e., "the product is labeled, sold, and represented solely as soap." According to traditional definition, "soap" is not "antibacterial." These products are making a claim of additional action -- rather than just being a cleanser or detergent, they are also an active antibacterial agent, hence, I'm not sure they'd satisfy the criterion of being "represented SOLELY as soap."
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Actually I'd argue that the point of soap is cleansing, and that antibacterial action is still cleansing, by killing bacteria, not treating a disease.
"Cleansing" by "detergent" has a very specific regulatory definition. The way soap works to remove dirt is chemically and biologically different from most antibacterial agents. To use an analogy, if you made a product that was intended to "clean brick patios" but it also tended to wash off weed seeds and such (which could infiltrate the patio and grow) through its simple detergent action, that's would be one thing. But if you added a chemical "weed killer" which would target and kill off the weeds, that
The FDA does have jurisdiction (Score:2)
You may have missed the following text from the same page:
If a product....is intended not only for cleansing but also to cure, treat, or prevent disease...it is regulated as a drug, or possibly both a drug and a cosmetic. Examples include antibacterial cleansers.
From the FDA announcement: [fda.gov]
Antibacterial hand and body wash manufacturers did not provide the necessary data to establish safety and effectiveness for the 19 active ingredients addressed in this final rulemaking. For these ingredients, either no additional data were submitted or the data and information that were submitted were not sufficient for the agency to find that these ingredients are Generally Recognized as Safe and Effective (GRAS/GRAE).
Having classified these products as drugs, the FDA does have jurisdiction. The ruling was proposed in 2013, subjected to public review, subjected to congressional review and finalized last week.
The Point... (Score:5, Informative)
The point of this isn't to ban a harmless ingredient, but to ban a harmless ingredient that could eventually prove to not be so harmless. Completely putting aside the potential long term interactions on the human body - which is hugely significant, lead and arsenic don't cause their damage in one day either - "antibacterial" soaps are essentially the same thing as "antibiotic" soaps, and you may see where this is going. 99.9% of the time, killing off all these harmless bacteria doesn't yield any benefit, but it will breed stronger bacteria over time, and that can lead tro some very nasty things. Gonorrhea, for example, is an STD that was once easily curable, but is now becoming harder and harder to treat, and I believe there is a new strain popping up for which there is no cure known at the present time. When such a disease appears and is immune to our easiest form of defense, it has the potential to become an unstoppable epidemic, and again, there's no benefit at all to killing otherwise harmless bacteria (which may even help strengthen our immune systems).
Secondly, these soaps are snake oil, and in more ways than one. Antibacterial soaps do absolutely nothing to stop viruses, so if you think this soap will help protect you from the common cold or the flu, think again. It's also no more effective than normal soap, so you're paying more for a completely useless product, and I doubt many people know this - at the very least, stronger labeling is definitely required. Bait-and-switch, along with the false sense of security, is an issue.
And if all that doesn't convince you, than consider this: we already have a product for all of this, and it's known as hand sanitizer. If there is a place or occasion where you really need to disinfect your hands, use this stuff; it's cheap, effective, usable on the go (the places where you probably need it the most), and bacteria isn't going to be adapting to alcohol anytime soon. As a result, you limit bacterial adaptability, you save money, you destroy viruses, and you don't play Russian Roulette with our ecosystem. Common sense, people.
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I would have no objection to the FDA demanding accurate labeling including "This product contains chemicals that have not been proven safe for human use and have no proven benefit" and let the people decide from there.
Personally, I avoid "antibacterial" soaps. I have known for a long time that they probably do more harm than good. But at the same time, the FDA has screwed up enough as it is without allowing it to expand it's reach ever further. Do we really want soap and foods to become as expensive as drug
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I would have no objection to the FDA demanding accurate labeling including "This product contains chemicals that have not been proven safe for human use and have no proven benefit" and let the people decide from there.
Which is blatantly false... http://arstechnica.com/science... [arstechnica.com]
Though the agency ruled years ago that triclosan and other antimicrobials are safe, it’s now revisiting claims that the chemicals make soaps and other personal care products better.
Kinda like the ATF arbitrary deciding to ban stuff overnight while it previously considered them legal for years / decades before.
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That's one reason I would like to see the FDA demoted to an advisory only capacity. It would at least limit the damage they can cause when they decide it's time for someone else to kiss their ass and lick their boots.
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Depends on whether it makes sense for soap manufacturers to challenge it.
It's not like this one is destroying a whole industry, like other FDA mandates.
Still, it could be challenged under the 10th amendment.
You could make the case that Congress would need to make a law for this, and that without one, there is no standing or interest on the part of government.
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And if we had a sensible and functional regulatory body, I would be happy to see it at work, but as long as we have bought out ass-clowns, I would prefer them toothless.
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Except that hand sanitizers are only effective in quite limited subset of situations. [cdc.gov]
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There is a legitimate concern with antibacterial soap. The problem with antibacterial soap is that it kills off the beneficial bacteria to an even greater degree than it kills off harmf
Applicability (Score:2)
From the announcement:
This rule does not affect consumer hand “sanitizers” or wipes, or antibacterial products used in health care settings.
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Antibacterial vs antibiotic (Score:2)
Antibacterials are antibiotics used to treat surfaces rather than being ingested. This article [tufts.edu] predates the ruling but the scientific explanation is still relevant. Note the following text:
Additional experiments found that some bacteria can combat triclosan and other biocides with export systems that could also pump out antibiotics. It was demonstrated that these triclosan-resistant mutants were also resistant to several antibiotics, specifically chloramphenicol, ampicillin, tetracycline and ciprofloxacin.
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I still do not believe that it is appropriate for the FDA to regulate antibacterials in soap.
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At leas to a sufficient degree as to satisfy the FDA
This is not proving harmlessness, merely running a successful marketing / lobbying campaign.
If you sell something, you should be able to show it can do what you claim it does.
The software industry has been overselling their products for ages, yet, we're all still in a lucrative business selling junk. As mentioned in another comment, homeopathic products are still on the shelf (and selling big), and you can still buy a ghost detector.
To an extend or another, there is no successful business based on a 100% truthful and honest marketing, which is an antinomy in itself, as marketing is basica
Typical Slashdot reaction (Score:5, Interesting)
Story: FDA approves X
Reaction: Waaah the government puts dangerous chemicals in everything!
Story: FDA bans Y
Reaction: Waaah the government is meddling with our harmless chemicals!
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Whoever modded this interesting applied their mod points before all the other moderators woke up as most of the current modded comments are the exact opposite of this.
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Perhaps. But sometimes what happens at Slashdot is that someone points out hypocricy, and once that comment is modded up, other moderators realize the hypocrisy and steer the discussion away from it.
Safe (Score:2)
Safe is a negative. It's impossible to prove that something is "safe." What they should be doing is testing to see if the product is harmful. That's the bar every other type legal standard is based on.
I Agree With The Government, Almost. (Score:2)
I agree with the government that people keep using products that kill many or most of the germs, the survivors will kill us, because they would have become immune to them.
People lose track of the fact that we are living things, living in an eco system. We are made of germs, and we have germ friends in our gut, and around our body. To listen to marketing spheal, you would think we are inorganic beings that should be separate from the rest of the world.
I disagree with some of the other stated reasons.
why bother with antibacterial soap? (Score:2)
Let's say you get your hands really dirty, maybe handling rotten garbage, then you wash your hands with regular soap and water, maybe with a nail brush. Afterwards, did you ever look at your squeaky clean hands and worry that there was still bacteria on them? Me neither.
Re:overreach (Score:5, Insightful)
You're kidding right... or do you work for a soap company?
The companies were given a year to prove that their active ingredients actually did anything... If they couldn't prove it... then this is more than just a FDA issue its a FTC and possibly DOJ for false advertising
Re:overreach (Score:5, Insightful)
Re:overreach (Score:4, Interesting)
They may also increase the incidence of food allergies.
Re:overreach (Score:5, Insightful)
Sure they do something. They help the common harmless bacteria that is all around us evolve into MRSA.
The antibacterials used in the soap do not include Methicillin or other antibiotics, so no, they don't help the bacteria evolve into MRSA.
What does that is excessive use of the life-saving drugs.
Especially: Their widespread use on farm animals that live in horrible conditions which would kill the animals by disease or render them less productive, if they weren't being pumped with so many antibiotics, that higher concentrations of precious antibiotic have been found in sewage and natural bodies of water than would exist in the blood of a human being dosed with the antibiotics.....
Re:overreach (Score:5, Insightful)
The FDA should have to prove harm, rather than the soap companies proving effectiveness.
The burden of proof is always on the party making the claim.
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And they are working quite well and are detecting every ghost that ever crosses your path, where exactly is your problem?
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Last time I checked, ghost detectors were still legal to buy... What is the FTC doing !
You can't pin this one on the FDA.
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These ghost detectors usually claim to detect electromagnetic emissions from the ghosts. If the ghosts are unlicensed EM transmitters, that puts them in FCC territory.
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I like how you took one type of thing and process and migrated it to another one. We 'dotters noticed it cause, hey, that's what we do, but, with practice, I predict a bright future in politics for you.
Re: overreach (Score:4, Informative)
I don't know how things are in the US, but where I live, claims of efficacy on homeopathic products are extremely carefully worded, and usually quite vague.
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And homeopathic "medicine" is still for sale.
It's pure water, sugar, etc - it doesn't actually do anything - so it's safe [ted.com].
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Placebos can be very effective.
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The FDA should have to prove harm, rather than the soap companies proving effectiveness.
The burden of proof is always on the party making the claim.
Oh yeah? PROVE it!
I know that two and two make four - and should be glad to prove it too if I could - though I must say if by any sort of process I could convert 2 and 2 into five it would give me much greater pleasure. Lord Byron
Re:overreach (Score:5, Interesting)
This is just like saying you're "being guilty until you prove yourself innocent "... The FDA should have to prove harm, rather than the soap companies proving effectiveness.
Problem is of course, that some group of folks has used the "starve the beast" approach on the FDA. reductio al fundo
Don't get me wrong, I'm a pro GMO pro vaccine person.
But I am very concerned about the bombardment of chemicals we are hitting ourselves with. Humans have been hammering themselves with some pretty well proven nasty stuff, like estrogen mimics, and other chemicals that are being proven to have a bad effect on humans. I'll note that the estrogen mimics tend to have a worse effect on males, but let's please not turn this into an anti or pro SJW argument.
Meanwhile, make certain your children are getting enough bisphenol A in their diets. After all, manufacturers should be allowed to put anything they damn well please in the things our kids eat and drink from. Then we can find out if its really bad or not. Otherwise they'd have to run tests before they started. That would cost money and piss off the shareholders.
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So you don't see the irony in genetically modifying a plant for the sole purpose of selling more herbicides?
So you don't see the ridiculousness of thinking that all genetically modified foods are for herbicide resistance?
Hint, Monsanto Roundup Ready does not equal all genetically modified food. And people who think genetically modified food is safe do not all think Roundup ready is da shitz.
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I know we're well on the way to a complete Nanny state, but really? You want the govt to go out and do all the research for these companies that stick shit in stuff? You must run one of these companies. You would be able to kill the R&D dept and put it all into marketing. Dollar signs beckon. After all, "innocent 'til proven guilty", right?
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This is just like saying you're "being guilty until you prove yourself innocent "... The FDA should have to prove harm, rather than the soap companies proving effectiveness.
What's to prove? Customers are being tricked into paying extra for something that's useless. That's harm, right there.
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I bet you think carrots are orange, raw bananas are edible and that wheat is a product of nature, too.
Re: overreach (Score:2)
There's a difference in kind between selective breeding and genetic engineering, if you're trying to conflate the two.
Snake Oil (Score:3, Informative)
There is no reason or justification for the FDA to regulate them
This patented Antibacterial Snake Oil Goat Weed will repel Tigers & Bears, with the added benefits of making you attractive to the opposite sex and give you rock-hard erections.
since these active ingredients are otherwise safe...
Citation needed
Re:Snake Oil (Score:5, Funny)
This patented Antibacterial Snake Oil Goat Weed will repel Tigers & Bears, with the added benefits of making you attractive to the opposite sex and give you rock-hard erections.
No, I don't think that accurately describes the scent of Axe products.
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No, I don't think that accurately describes the scent of Axe products.
I take a commuter train to work. It's amazing how many people (usually young guys, but occasionally middle-aged women) apparently think if they apply enough perfume, somehow it hides the stink of their body odor. The combination is enough to make a person wretch...
(and yes, Axe is just perfume marketed to guys)
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FTFY.
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> (and yes, Axe is just perfume marketed to guys)
Axe is nowhere near concentrated enough to be a perfume. I'm not even sure it qualifies as a cologne.
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The less concentrated it is, the more the user will consume.
Re:overreach (Score:5, Insightful)
No, you're mis-understanding. It's like the same reason for not feeding animals anti-biotics.
These chemicals worsen the situation.
So while regular soap and water might get rid of 99.0% germs, bacteria, viruses, oils and other crud you might have on your hands, that 1% not killed still hangs around in small quantities, growing and competing for all the non-killed bugs. If one of these chemicals upped that to 99.9%, that means 99.9% are killed, and the 1% that isn't killed becomes resistant to that chemical, thus making it useless in the operating room.
And that is the point. Don't use these things unless there is a medically necessary reason to (eg AID's patients)
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alcohol, hydrogen peroxide and other cellular level "shotguns" tend to have err "splash damage" issues but they work WELL.
you have to have good amour to be "immune" to a Daewoo USAS 12
in similar fashion any bacteria that can handle getting dosed with Neat Alcohol is a panic situation
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That's not true at all.
They are in fact dangerous.
Triclosan has destroyed the bacteria in municipal sewage treatment plants across the country.
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If that were the actual motivation for banning anti-microbial agents, they wouldn't be banning iodine or phenol.
(1) In the 1960's, antibacterial soaps were already half the soap market in the US.
(2) Antibacterial soaps cam
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This is what the FDA said:
Is that technically true
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these active ingredients are otherwise safe and widely used.
Tiger repelling rocks are also safe and widely used for purposes other than repelling tigers.
Much like triclosan.
Triclosan breaks open the cell walls of bacteria, killing them. But it takes several hours to do this, so it does little good in the time it takes to wash and dry hands.
And much like triclosan, one of the purposes tiger repelling rocks can be widely used for is hurting people. [wikipedia.org]
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You mean where it says "Triclosan is considered safe but is under ongoing review by the FDA."?
The only human effect is a small number of studies that find an association between triclosan use and some forms of allergies in children. The causal relationship is likely not that triclosan use causes allergies, but that allergy and eczema sufferers use triclosan because it reduces infections and symptoms.
You keep demonstrating the truth
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While anti-bacterial soaps are pointless for most people, there is no reason or justification for the FDA to regulate them since these active ingredients are otherwise safe and widely used.
Watch for some of the banned antibacterials to turn up in a pricey pharma-manufactured hospital disinfectant
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The FDA only banned those antibacterials in consumer soaps; they continue to be permitted in hospital and food service soaps.
But I think you're onto the root of the problem here. Triclosan soaps are useful against body odor and for reducing allergy and eczema-related problems. So, now, instead of self-medicating with a cheap and common product, people will have to see a doctor.
I'm not sure whether tha
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Absolutely! In fact, the FDA is now hard at work trying to get people who vape to go back to smoking.
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As far as I know, tobacco products won't be banned for at least two reasons: 1- the huge amount of taxes generated for states and the federal government and 2- tobacco companies own enough congress people and state legislators to prevent the ban.
How about the complete failure of alcohol prohibition, and the War on Drugs? Is futility not enough reason by itself?
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For sure. The various government entities make more from a pack of cigarettes than the manufacturers do.
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Always? For every totalitarian government, there are dozens of ones that never became totalitarian, even more if you include local governments. And pretty much every one of them did at least something to the tragedy of the commons that involves limits people from doing what they want.
Exaggerating a danger that is otherwise real and a serious threat doesn't help people realize the danger, it helps desensitize them to warnings, exaggerated or not.
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Always? And pretty much every one of them did at least something to the tragedy of the commons that involves limits people from doing what they want.
Civilization inherently limits people's freedom. Slashdot Libertarians and anarchists might not like it, but there is a place for the rule of law.
When banning likely harmful and useless ingredients from soap trips someone's totalitarian alarm, they might consider dialing it back a little.
Re:overreach (Score:4, Informative)
Yeah, we're suffering in this socialist European country I'm in.
No, wait, the word isn't suffering... it's prospering, sorry. My bad.
Re: overreach (Score:5, Insightful)
If people toying with antibac stuff only endangered themselves, I'd be with you. Unfortunately this isn't necessarily the case. I can only HOPE that the crap doesn't work, because if it really kills "99.9% of all germs" as is often advertised, all that crap really does is to breed superbugs.
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I do not like antibacterial soap because it reduces beneficial bacteria to a greater degree than it eliminates harmful (mostly because there is a lot more benefici
Re:Scrambling! (Score:5, Insightful)
Yes, 36 years -- what speed! Thankfully, maybe our grandchildren will be able to grow up in a world without triclosan.
Re:As an observation... (Score:4, Insightful)
If they allow it in toothpaste, it's fucking stupid to ban it from soaps...
Not at all. There is demonstrably no benefit to using triclosan in hand soap, so there really is no kind of cost/benefit argument you can make justifying its use. The best you might do would be to prove that it's totally harmless, in which case there's no harm to putting it in; but then there'd still be no harm to banning it either.
In the case of toothpaste, there may be demonstrable benefit. That makes it a fundamentally different case. When we study it more we may decide that the costs outweigh the risks, but at present it's still at least possible that banning it may be a net harm.
Re: As an observation... (Score:2)
You have things backwards. If XYZ having no demonstratable benefit was a valid reason to ban XYZ, our world would be veeeery different from what it is today. Something has to be demonstratably harmful for a ban to make sense.
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Are you being wilfully obtuse? Things have to show a demonstrable benefit if they are advertised as having that benefit.
This doesn't apply to booze and smokes because they don't make such claims (though at one time they did).
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You have things backwards. If XYZ having no demonstratable benefit was a valid reason to ban XYZ, our world would be veeeery different from what it is today.
It's not a valid reason per se. But you don't make decisions based on one factor. You make decisions by balancing factors. If you had read my post carefully you would have seen that I said there's no reason to ban non-beneficial things if there is no harm.
So to recap every combination of demonstrable benefit vs. no demonstrable benefit crossed with reasonably suspected harm vs. no reasonable basis for harm is a different case. And in each case additional data may change the case a product falls under.
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The toothpaste companies were asked to prove that Triclosan was effective and were able to point out studies showing that it helped to prevent gingivitis.
The hand soap companies were given a year and weren't able point to anything.
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If you believe that I have a bridge to sell you ... made of fluoride.