Slashdot Mirror
FDA Asked to Regulate Nanotechnology
WillAffleckUW writes "According to the Washington Post, a coalition of environmental and consumer groups has asked the FDA to look at regulating nanotechnology. They point out that there are more than 100 nanotechnology products and that nanoparticles can penetrate cells and tissues, migrate through the body and brain and cause biochemical damage."
"Concerned buckyball-momites asked, 'won't someone think of the chelates?'"
"Made up/misattributed quote that makes me look smart. I am on
How about the FDA regulate... food and drugs? This is kind of broad, don'tcha think? I mean, jeez, "nanotechnology" encompases a whole load of things that have absolutely nothing to do with the FDA, including the equipment that I'm writing this message with, and the equipment you're reading this with. Hell, why not ask the FCC to regulate nanotechnology. It would make just as much sense. Or the Department of Homeland Security. Or any other government bureaucracy with interests to protect.
Or better yet, how about the government just stay the eff out of things for a change and let's see what happens, and deal with issues as they arise? That would be a novel idea, wouldn't it? The last thing I need is the FDA telling me I can't buy the latest and greatest geeky ballpoint pen because the ink might be poisonous - or, god forbid, get me high.
Of course, maybe TFA just failed to mention that they only wanted things that actually deal with F&D regulated. I guess neither would surprise me at this point.
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Personally, I'll take a pass on any pseudoscience that comes from the "Friends of the Earth"...
Slashdot, where you get modded down as redundant for stating an opposing viewpoint... Independent thought anyone?
"Wear 'em" - signed, US Government
This is probably going to end up as an excellent way to make sure that no one bothers to do nanotechnology research in the United States.
The World Wide Web is dying. Soon, we shall have only the Internet.
There are some drugs delivered via nanotech. Otherwise I believe OSHA should be regulating the industrial use of nanotech.
...of the pharmecuticals, now we know we'll only get nanotechnology that kills our kidneys and liver before causing a heart-attack.
and ask for a trillion more a year, to regulate and enforce limits on a fast breaking technology, but only when done in the USA, meaning everyone cutting edge, or sloppy, or lazy, or with imperfect tools, starts working outside the USA, blunting the edge of this countries technological advantage a little more-- and when a self-replicating oil eating VonNeumann get's loose, anyone who might have had the skills to defeat the new micro-overloads will have never developed said skills, as they had to expend too much frustration/energy/life forces learning about red-tape processes.
every day http://en.wikipedia.org/wiki/Special:Random
... can penetrate cells and tissues, migrate through the body and brain and cause biochemical damage.
...
Yeah, and so can cars, and bullets, and
Products FDA Regulates
Food
Foodborne Illness, Nutrition, Dietary Supplements...
Drugs
Prescription, Over-the-Counter, Generic...
Medical Devices
Pacemakers, Contact Lenses, Hearing Aids...
Biologics
Vaccines, Blood Products...
Animal Feed and Drugs
Livestock, Pets...
Cosmetics
Safety, Labeling...
Radiation-Emitting Products
Cell Phones, Lasers, Microwaves...
Combination Products
Intron: the portion of DNA which expresses nothing useful.
Only you can prevent Grey Goo
This is probably going to end up as an excellent way to make sure that no one bothers to do nanotechnology research in the United States.
I doubt it. Bill Gates just endowed a giant building here at the UW in Seattle, and a lot of the funding is coming from private endowments by American citizens.
We have to realize that, even if the US were to not regulate it, the likelihood of the EU regulating nanotechnology is very high, and thus most of the world market would be forced to comply.
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Now we want to regulate things that could cause problems
Hopefully, in the future we'll regulate things that could lead to technology that could cause problems.
The FDA? What logical relationship exists between a giant, inept and incompetent beaurocracy that tries to regulate foods and drugs, and nano-tech, which is mostly tech related?
Fool me once...shame on you, fool me twice...won't be fooled again (our president)
Instead of doing things on the 10-9 scale, the'll switch to 10-8 or 10-10.
I can imagine the FDA breaking out their electron microscopes, deciding if a molecule falls within their scope of focus.
As the article clearly states, based on US and Australian precedents, the FDA has a clear legal requirement based on their successful regulation of suntan lotion.
No, I am not making that up. It's in the article in the Washington Post.
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In both cases, the industry in question is regulated not at the results level but at the process level. To change the way an airplane is manufactured, you have to get your manufacturing process recertified by the FAA. It's a great way to prevent technological progress. To put this into perspective, modern piston airplanes are still using mechanical fuel injection. We're talking technology that was first put into use in the 1950s.
As a result, it takes the financial commitment of basically building an entirely new company in order to manufacture composite airplanes (as opposed to using aluminum sheetmetal and rivets). Manufacturers aren't allowed to truly compete with each other by continuously improving their products in meaningful ways because the cost of improving the product is too high. Everything has to be recertified when a real improvement is made.
And the same is true for medical equipment, which is one of the big reasons your out of pocket expense for a simple MRI session is several thousand dollars.
So if we want to make sure that the U.S. is dead last in nanotech, the best way to do it is to regulate it the way we regulate medical equipment and aviation.
Use 'slashdot stuff' in the subject line in any email you send me if you want to get past the spam filter.
Of course, there are other things that "can penetrate cells and tissues, migrate through the body and brain and cause biochemical damage." Many of them occur in nature. Some of those (like buckyballs in smoke) are even nanoparticles.
Lacking <sarcasm> tags,
...mutants with superpowers from taking over the world.
Sometimes they are useful. Swiss Re, a mega-insurance company, wrote this article on Nanotechnology from an interesting perspective: *their* exposure in insuring companies in this business. Sorry for the PDF link: http://www.swissre.com/INTERNET/pwsfilpr.nsf/vwFil ebyIDKEYLu/ULUR-5YNGET/$FILE/Publ04_Nanotech_en.pd f
...regulation by a government agency the likes of the FDA - one of the more damaging bureaucracies in existence. In recent years, with its political bias, industrial favoratism and snail's pace, it does more to harm than help the public health.
Lest I be accused of irrational ranting - there's more than enough information publicly available to bolster my accusations. Go search. Look for myopic approval of flawed pharmaceuticals on the one hand and irrational opposition of dietary supplementation on the other.
All in my opinion of course (what with it being this day & age).
Nanites could learn to work together, eating our computer cores in order to reproduce while they evolve into an intelligent collective life form. Won't someone think of the cores?
EVERYTHING is nanoparticulate in nature, including you. Just because these particles are being chopped up and misced better does not by any means imply that they are unhealthy. Your skin does a pretty good job protecting you from nanoparticulate oils and debris from bacteria. Just because there is better organization at the nano scale does not mean that the nano-particles will cause any sort of damage.
By placing a label on these products, consumers will irrationally be prejudiced against them. You should not do that to such a broad and beneficial industry. Mostly, these consumer groups do not understand the basic science. They just have a general technophobia and want to project that onto everyone else's lives.
Like anything, there should be health tests, but they should be data backed (as these are not). We can't assume that all these products are guilty until proven innocent.
We apologize for the inconvenience.
is micro management.
---southpaw
I know, I've sat in on about twenty nanotechnology seminars at the UW over the past six months.
My point is, this is a real news story, the FDA has been asked by multiple groups to investigate nanotechnology for those products which may - or may not - be able to cross over into humans.
Until they research it, they won't know if it's possible, and - if so - what safeguards or regulations are or should be necessary.
At that point, after input from bioethicists - and I've attended a few panels and seminars on bioethics, as well as journal clubs - recommendations would be made and model legislation would be drafted.
At that point, slashdotters would be able to publicly comment on any such proposed legislation.
It's like when autos were invented - there were no traffic rules for a long time. Then, once they reached a certain level, people created regulations concerning driving, driving ages, rules of the road, railroad crossings, brakes, horns, and so on.
Since we now have more than 100 nanotechnology patents, it's likely we are - in fact - at that point where we need to investigate whether or not we need regulations - and, if so, at what level. Perhaps we need such regulation at the creation side, perhaps at the manufacturing side, perhaps on the consumer side. We don't know yet.
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... nanoparticles can penetrate cells and tissues, migrate through the body and brain and cause biochemical damage.
Of course, so does just about everything else.
The higher the technology, the sharper that two-edged sword.
The FDA will regulate all nanotechnology which is part of either a Food or a Drug.
-- 'The' Lord and Master Bitman On High, Master Of All
Currently, many nanotech applications are in products (or proposed to be in products) that would come in direct contact with our bodies. Take sunscreen, for example. Some brands of sunscreen are being made with nanoparticles (thus making them nanotechnology) that can penetrate the blood-brain barrier. Do we have a clue what happens when those nanoparticles interact with our brain cells? Hell no! Has that stopped it from being on the market? Hell no!
The issue at stake here is that we have a whole slew of products that have a significantly larger potential impact on our health. I'm not talking about the "smart" counter-top that will make plates out of itself just before dinner (although that would be cool -- I think Popular Science came up with that gem). I'm talking about practical applications of nanotech NOW. Nanoparticle sunscreen is just the first part. You'd better bet that the whole biomedical industry is looking into more advanced, more invasive nanotech applications. The jurisdiction would fall under the FDA sooner or later. Better sooner than later so they're not caught with their pants down.
(I'm sure I'll get modded down for this one, but I think that we need to be cautionary to some degree. Otherwise we may have another DDT or thalidomide on our hands.)
Per Square Mile, a blog about density
Instead of stating 5-10 years all those Nano-Tech related Press Releases better start saying 15-20 years... :P
well, at least the ones that weren't already saying 10+ years that is.
I'm gleefully over-joyed at this news, since we all know the Government will keep us all safe because it knows best.
*feh*
Well, nanotechnology is a pretty broad field.
The nanotechnology the article refers to is primary nanoparticles added directly to food and drugs, so it seems reasonable that the FDA might oversee this area. For instance, if they're putting nanoparticles into sunscreen or cosmetics made with Titanium or Zinc, then it seems reasonable that the FDA would make sure those are safe.
By design, nanoparticles are often far more reactive to surface chemistry than the same chemicals in other forms, so I'd want some regulations or at least basic studies. As the field evolves, there's also many very advanced medical applications for nanotechnology (such as tissue repair or targeted tumor attacks) that also should fall under their normal medical regulation and testing requirements.
That said, the FDA certainly doesn't need to regulate IT-oriented applications such as telecommunications, nanobots, quantum computers or fields like metallurgy.
It's like Arsenic. The FDA should regulate it in foods and drugs, but they don't have much to say about the GaAs semiconductor industry.
The problem is more that the cosmetic industry has embraced the nanotechnology buzzword to make their new products seem super-high-tech and this makes the FDA a natural candidate for initial regulations, but they certainly won't be the only agency regulating them!
I know Slashdot likes to blindly bash things that might prohibit technological advance. But it's been said that the effects of nanotubes could be as dangerous as asbestos.
/ 77/1/126
Here's a study conducted by researchers from NASA, Wyle Labs, UofT Medical:
http://toxsci.oxfordjournals.org/cgi/content/full
"According to the Washington Post, a coalition of environmental and consumer groups has asked the FDA to look at regulating nanotechnology. They point out that there are more than 100 nanotechnology products and that nanoparticles can penetrate cells and tissues, migrate through the body and brain and cause biochemical damage."
Replace 'nanoparticles' with 'chemicals'.
Why treat them differently?
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... they approve and allow dangerous chemicals in USA milk :/ rBGHintro.php/
http://www.vpirg.org/campaigns/geneticEngineering
It is important that one government organization (I don't know if the FDA is the right choice) be in charge otherwise you will get a large amount of cross regulation from different organizations making development a real nightmare.
Check out the http://cben.rice.edu/>Center for Biological and Environmental Technology for more details.
Also, check out the science friday podcast from April 28.
People at the FDA are just scared that Alex Krycek is going to inject one of them with some nano-bots and then kill them with his PDA unless they do as he says.
infested with jello like fishes no melotron wishes
Exactly. We tend to forget what happened in the early 1950s when the burgeoning pharmaceutical industry created a large quantity of wonder drugs, and in the then pro-business no-regulatory environment, we ended up with some rather horrific problems, as in thalidomide babies and such.
Another good source for information is here at the University of Washington, at the Center for Nanotechnology, which holds various informative seminars on campus, some of which are podcast.
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It's high past time that the FDA Steps in. For far too long have these "Molecules" gone unregulated. The government needs to take a stand against these microscopic monsters before they destroy society.
If your theory is different from practice, then your theory is wrong.
My major concern with nanotechnology is that a white supremacist group might get some rogue scientists and release nanoparticles which will influence people to wear white vests.
Give me good ratings or I will close down the internet.
Products FDA Regulates ...
...
Radiation-Emitting Products
Cell Phones, Lasers, Microwaves...
Hmmm. So, if I equip my nanobots with lasers, are you saying the FDA would regulate them?
They'd have to catch them first
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Just get them to start using guns and smoking tobacco.
...
Then the FDA won't be allowed to regulate them.
Of course, I'm not sure what impact gun-toting cigar-smoking nanobots would have, but it would sure help the miniaturized saloon and spitoon industries
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Quo usque tandem abutere, Nimbus, patientia nostra?
Shouldve checked my preview better. Center for Biological and Environmental Technology
Not to mention that the lack of regulation will enable terrorists to control them and take over the world. We're all doomed I tell ya - we're all doomed!
Want an opinion from a bioethicist? Flip a coin. Their opinions have little to do with fact and more to do with which arguments sound convincing. At least, this is my experience after taking a bioethics course taught by a professor who wrote bioethics policy for Clinton in one weekend while he was still a grad student--make it up as you go along, and as long as it sounds convincing, people will believe you are an expert.
The Constitution of the USA is very specific on exactly what the federal government can and cannot do. Among "internal" issues, i.e. everything that does not concern the relations of the USA with other countries, there is very little that the federal government has the authority to do, although no one would guess it from the way Washington acts.
Unless someone finds a way to put nanotechnology in what has been used as the mother of all catchalls in Article I, section 8, "To regulate Commerce
foil hats?
Mine has been malfunctioning -- the voices are back.
It would be nice if the FDA actually regulated two of the most dangerous drugs, nicotine and ethanol. (No, I don't smoke, but yes, I do drink.) Those are unfortunately consigned to the Bureau of Alcohol, Tobacco, and Firearms, who pretty much focus on making sure the federal taxes are paid.
Some mornings it's hardly worth chewing through the restraints to get out of bed.
Unless someone finds a way to put nanotechnology in what has been used as the mother of all catchalls in Article I, section 8, "To regulate Commerce ... among the several states", I don't see much that the Congress of the USA can legislate about in nanotechnology.
... hmmm, I think I'll vacation at the California border this year ...
One would presume that companies creating nanotechnology expect to sell them in states other than the one in which they are based, thus creating commerce between states in the sale of nanotechnology.
But, you raise a good point. To avoid the regulation, you merely need sell your non-motile nanotechnology for use only within your firm's state, and ensure that it won't be shipped or moved to another state. So, if you sell clothes with nanotechnology, just make sure it self-destructs when people wearing it cross the state line
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We can just claim our nanobots are a dietary supplement.
It wasn't hard to predict that the Slashdot-hive-mind reaction to this would be to attack the government, the FDA and/or make jokes about them regulating nanobots... But there is a very serious side to this. There are nanoparticles being placed into things like cleaners and other household products right now despite the fact that various studies show there is a high likelyhood that these nanoparticles can do severe, unrepairable damage to the lungs of people who are exposed to them. This story only seems ridiculous because "nanotech" is such a broad field that covers just about everything. Some aspects of regulation (making sure these nanoparticle-containing products are safe to inhale in quantities that people are likely to be exposed to if they use them, for example) absolutely should fall under the FDA.
The excerpt alludes to a painfully obvious fact that the article authors are trying to gloss over: The ingredients being complained about have been in use far longer than the concept of nanotechnology has even existed.
They are using "nanotech" as a fud smokescreen to get stricter controls over a whole bunch of ingredients. Like zinc oxide (the sunscreen ingredient refered to in the quote). The definition of nanoingredients presented in the article is deceptively vague:
That includes basically every molecule in existence other than very large things like soot, DNA strands, long nanotubes (ironically) etc.
A better definition for regulatory purposes should define "nanoparticles" (admittedly a terrible term, but we're stuck with it now) as being particles between two appropriate threshold sizes - a minimum and a maximum, and whose interactions are not completely determined by chemical properties. (i.e. there is some "engineered" attribute which is not obvious given the composition.)
argumentum ad fallacium: Fallacy of defining a fallacy which allows one to dismiss the argument in question.
Slashdroid: How dare they regulate technological progress!!
Concerned citizens of da u.s.a (CCODUSA): ehmmm, ok Dr. Moreau just because you never see the sun doesn't mean we have to risk developing heaven knows what from your high tech sunscreen.
Slashdroid: The U.S. will be dead last in nanotechnology if the government tries to regulate it's development.
CCODUSA: Better than dead.
Slashdroid: Alarmist! This is like the "Global Warming" thing you CCODUSA are trying to make people buy into!
CCODUSA: Well, hopefully not. It'd be nice if folks actually paid attention and took some reasonable preventative action this time - rather than wake up a decade from now and begin struggling to put together a coherent thought about the very possible problems of exposure to highly reactive human-engineered compounds and particulates.
Slashdroid: But we'll get beat by other countries!
CCODUSA: Go live somewhere else then, if you're that eager to sign up for uncompensated human trials. At least here with regulation you'll get your 15 bucks a day to be a guinea-pig.
With nanos in possesion of tobacco and firearms the FDA can hand their responsibilities over to the ATF
And the same is true for medical equipment, which is one of the big reasons your out of pocket expense for a simple MRI session is several thousand dollars.
... well, that's why we discuss such things, and why any such potential regulations or model legislation has an input period.
Actually, one of the problems is that we, as medical consumers, can ask for and pay for MRI sessions, and order genetics testing for incredibly rare diseases we don't have, and then when the predicatable false positive rate is higher than the disease rate (many of the tested for diseases have an incidence level of less than 1 in 10,000 but the false positive rate on the tests is frequently around 1 in 1000, or 10 times as many false positives as there are true positives), sue.
Which wastes a heck of a lot of medical resources.
Although seeing an image of the actual plaque clogging your arteries does apparently cause patients to have a twenty times higher rate of compliance with medically-prescribed diets for patients with artery-clogging plaque that could be treated more effectively with changes in diet than with medications.
So, how to balance it
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What an idiotic statement - nanotechnology has everything to do with FDA - the products of nanotechnology are active chemicals with potentially toxic effects just like food and drugs etc. FCC regulates the electromagnetic spectrum and has absolutely no expertise in biochemistry.
Just like all the existing drug/food/chemical/environmental/health regulations have kept these technology research out of the United States, you moron!
Just like you'd pass on a 'bridge out' warning sign set up by hitler, rednecks and the illuminati. Meanwhile there are people who are able to think for themselves and reach their own conclusions without appeals to authority.
As can be logically concluded from the current state of the medical and aviation industries.
oh, here we go again - the 'all chemicals are from nature' argument - like dioxin and thalidomide - and therefore just as harmless as rainbows and kitten paws.
And what are all these anti-regulation comments implying then? That public regulation is always bad? That industry self-regulation is the solution because industry knows best and they have our interest and health at heart, don't they? I'd rather have incompetent, over-zealous, fear-mongering public interest groups raise these issues so that the industry and government have to at least pay cursory lip-service to my safety and rights rather than leave me to fend for myself alone against them. It's the way the system works - both extremes give their best shot - and usually meet in the middle with a compromise everyone can live with (pun intended)...
www.tribalnetworks.org - helping tribal people around the world to own their own means of high-tech communications
Even so, there is well-established legal precedent that the Commerce Clause together with the elastic ("...necessary and proper...") clause allows Congress to regulate activity which might effect the market for interstate commerce even where the activity itself is neither "interstate" nor "commerce", including growing agricultural products (the seminal case concerned wheat, the recent reaffirmation concerned marijuana) for personal consumption.
Keep in mind there is a current trend for cosmetics and supplements to use the word "nano" in front of all thing marketing-speak. The concern from this trend is from having the particles penetrate the subdermal layer and travel throughout the body.
Hmmm. That sounds like a Good Thing. I can't tell you how irritated I get at all those fake "nanotechnology microabrasion dermal adhesion makeup" ads I see.
If it scares off the "fake" nanotechnology and only leaves behind the "real" nanotechnology, I can live with that.
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but isn't this based on the concept that the materials that the FDA regulates, e.g. agricultural products and such, are by nature not only highly transportable (as in not a building) but easily salable and may be transhipped when persons move from one state to the next, even inside their bodies?
I know there are exemptions for alcohol, tobacco, and firearms - and also for Native American reservations.
Nanotech that could/might cross the boundary into people thus could easily cross state borders and are thus eligible for FDA regulation, no?
IANAL, but I took Business Law in grade 10, like my son is next year.
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In my chemistry class we learned about MOLECULES.
MOLECULES can affect anything anytime anywhere.
MOLECULES can wreck our DNA.
MOLECULES can poison the air land, and water.
WE ARE DOOMED!!!!!!!!!!!!!
No, it's not possible at all. Imagine a highly toxic substance, for instance Sodium Cyanide. NaCN is so toxic that, literally, a sniff can kill you. Yet it's widely used worldwide, one of the most used chemical compounds in metal plating. But very few people die from cyanide poisoning, exactly because it's so toxic that everyone knows it and acts accordingly. It's very easy to characterize NaCN as a toxic substance, mix the slightest amount of it in a rabbit's food and the rabbit will die in seconds.
On the other hand, consider a mildly toxic substance, lead. Expose a million rabbits to lead and they will have seemingly normal lives. The aqueduct that supplied water to the French city of Nimes had parts made of lead. It was operated continuously for nine centuries without obvious side effects. It was only in the second half of the twentieth century that this metal that had been used since before the Roman Empire was recognized as dangerous. How long would you conduct a controlled trial until you suspect something is wrong?
Our civilization cannot be stopped by raw fear. There are some substances that are dangerous and should be avoided. But we cannot possibly identify every single dangerous thing in advance, there is a threshold where we must assume the risk. If a set of reasonable tests have been successful we must go ahead, otherwise how can we ever be sure that polished stone axes pose no danger at all?
Yeah, but you then end up with the oposite problem. Like when Nuclear stopped being cool, they had to renamed NMRIs to MRIs or people would refuse to get scanned!
Jeremy
would make more sense for nanotech that is not designed to be consumed, while FDA would be the logical choice for medical nanotech.
A real experiment that was done with carbon nano particles:
Rats exposed to coal dust and charcoal dust sneeze, but just as you expect, they live just fine.
Rats exposed to carbon nano particles are dead in under four hours, drowning in their own blood.
The little nano particles gunked up the Nucleus in each lung cell, killing the lungs.
Ah, so do you want to buy a nano-anything yet?
I'll pass on it, thanks.
I prefer my technology to stay outside of my cell membranes, if that is OK with you.
oh. I always wondered why it was MRI, when everyone in Biochem calls it NMR.
...
That explains a lot.
I wonder if makeup in the post-WWII era was named for nuclear properties, like Cobalt Blue eyeshadow and Proton Red lipstick and Neutron Grey powder
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Don't your own links answer the question? The FDA can regulate any *food* or *drug* that might be dangerous, "nano" or otherwise, while the EPA can regulate anything else.
In fact, those two agencies *do* currently regulate such things, so I don't see why some meaningless buzzword should send everyone into a panic.
I am not going to differentiate between nano-tech and nano-particles here even though I understand there is a difference between the two, but in the case of this post, I don't think the two terms need to be differentiated. To do so would be hair-splitting.
I can see how the FDA could regulate nano-tech if it is an ingredient in food, medicine, cosmetics or if it is a "medical device". I can not see how they would be involved if it was a more "industrial" component (say an ingredient in paint or a component in some high tech alloy).
It is the use more than the component that really makes a difference here. I really doubt that nano-tech used in electronics will ever be considered able to be regulated by the FDA until it is incorporated into something like a pacemaker.
I hope I am correct in this but with our current state of government in the U.S.A. it is really hard to tell. It is probably only a matter of time until the FDA comes under the umbrella of "Homeland Security" then who knows what will happen.
You sound pretty biased yourself! If that info is so available, reference some of it, but be sure it's an objective source, and not as biased in your direction as you say FDA is.
Sorry, but you hit a nerve. FDA is, as I mentioned in an above post, deliberately injected between the public and the industries it regulates. As with any government entity, its political biase is reflected by the current Administration. The Commissioner, after all, is appointed by the Pres and serves at his pleasure. And the Commissioner also runs the FDA in a pretty direct manner. He definately influences the way FDA does its job.
if you don't like it, vote for the other party next time.
Personally, I don't always like the things FDA does. I don't like the way they've sat on the morning after pill - and neither did the director of the Office of Women's Health at the FDA. She resigned - after a productive career in the government - specifically to fight that one issue!
Like I also said above - I've worked for FDA for almost thirty years, and find my fellow employees to be largely a dedicated hard working bunch. We work hard every day to ensure that your food, drugs, et. al., are safe, effective, and unadulterated. it isn't an easy job. Our budget, like the rest of the Feds, gets smaller every year, and the workload gets bigger. As our workforce gets older, its gonna get smaller, but the amount of work we do won't!
If you want that to change, lobby your congressman/woman, but if you succeed, expect your taxes to go up. Safety and effectiveness ain't cheap! You can also expect industry to continue to gripe about us - as they constantly do.
if you think we are industry flunkies - then why are FDA inspectors often required to be accompanied by US Marshalls when we seize products? We have been shot at, attacked and run out of establishments we have gone to to inspect. That doesn't sound like industry likes us much better, does it?
Like I said, we are deliberately placed between industry and the public - and its rarely possible to please both at once - and sometimes neither one!
"Money is truthful. If a man speaks of his honor, make him pay cash." Notebooks of Lazarus Long, Robert A. Heinlein
As can any megaparticle with enow momentum.
"Nanotechnology" is such an amorphous term... it can apply to anything that deals with nano-scale technologies. That includes things the tiny lasers I'm dealing with at school, and the technology that Intel uses to fabricate processors. Work is hard enough without the freakin' food and drug administration slowing me down with paperwork, defining what I can and cannot research-- I already have to deal with OSHA on a regular basis, and one government agency is quite enough for me. E The average environmentalist needs to stop jerking off to buzzwords and get a life. I'm serial.
It's funny, but when the nanoparticles are produced by internal combustion engines - the source of the most potent non-radioactive carcinogens known - or from plasticisers used in plastic goods etc., the US government is positively glacial in its response.
:v)
Start developing a new technology that promises to completely revolutionise the manufacturing and supply industries as we know them, and POW! Suddenly there is activity to ban it because it might produce nasty chemicals if done in an inconsiderate manner.
So much for US industry.
At this rate the US will be buying its nanotechnology from Venezuela.
Vik
"The Constitution of the USA is very specific on exactly what the federal government can and cannot do. Among "internal" issues, i.e. everything that does not concern the relations of the USA with other countries, there is very little that the federal government has the authority to do, although no one would guess it from the way Washington acts."
I can't wait for the regulation of food and drugs to be ruled unconstitutional. That'll show Washington.
Time for the history lesson for the historically challenged. First, I earned a master's degree in Constitutional Law, so I am at least mildly qualified to comment. The Notion that you can avoid the plenary powers of Congress merely by only doing business in a single state has not been true for over seven decades. Prior to the Great Depression the United States Supreme Court used a judical philosophy called formalism. Like a lot of 19th century ideas, it was grounded in the belief that law was in fact a science that could be proved through logical deduction. One of the effects of this judicial philosophy was that the Supreme Court took a very narrow interpretation of the commerce clause. While taking a narrow view of the commerce clause seems upon its surface to relatively easy, the net result was a series of decisions that over time did not make any sense. For example, you could legally regulate some activity that "touched" commerce but not others. It was not always easy to infer what regulations were constitutional and which weren't. Thus, you could only regulate working conditions for some employees but not for all. Federal and State minmum wage laws were frequently upheld for women, but not for men. They were upheld for "dangersous" jobs that affected public safety but not for bakers, eventhough they were prone to lung infections and disease from the flower. Finally with the great depression, formalism came to an abrupt halt, and the Supreme Court due to a variety of highly debated historical reasons switched its position. From 1933 onward, the Court essentially has given the congress plenary (complete) power over virtually all forms of commerce in the United States. In fact, by the end of the 1930s the court ruled against a farmer who was growing wheat on his farm, for his OWN consumption. The wheat in this case would NEVER leave the farm and would only be used to feed the family and livestock. The Court ruled in effect that since the farmer would not buy any wheat or hay, he would impact interstate commerce. And thus the farmer was forced to no longer grow wheat in violation of depression era price controls. Thus, the arguement that the government does not have the power to regulate nano particles is DEEPLY flawed. Regards Winston
These two industries are shining examples of why the free market is not only a bad idea, but mostly a farce perpetuated by greedy entrepreneurs looking for a quick buck without regard to the harm they cause the rest of society. Filth, I tell you.
The reasons these industries are highly regulated is because of the risks involved, which should be fucking obvious. Even with draconic regulation, there are still high levels of deaths related to faulty equipment, malpractice, and pharmaceuticals that weren't tested enough causing serious maladies in those prescribed to that medication. To do anything else would be to put human suffering below progress in the marketplace. Just go ahead and change your name to Goebbels. Similarly, airlines are only allowed to use the most trustworthy designs that go through the most rigorous certifications because of the risks to human life involved. Get a fucking clue already.
Furthermore, since just what fucking date am I supposed to believe that the US is dead last in either of the aforementioned areas?
Ex nihilo nihil fit.
1) Advertise medical MRIs to people wishing to loose weight
2) Charge them for a full MRI, but just put them through a big polo-mint shaped hole that goes "bang-bang-bang"
3) Show them a pre-shot MRI from a fat person. Talk up the arterial plaque
4) Motivated by imminent death, patient loses weight. Patient is happy.
5) Profit!
Given that nantechnology has been used in the formulation of sun screens, one could then reasonably ask:
(For the humor impaired, this is a parody of the "Pardon me, do you have any Gray Poupon?" mustard commercials.)
FTA:
The legal filing was synchronized with the release of a report by the environmental group Friends of the Earth that highlighted the growing number of personal care products with nanoingredients, defined as smaller than 100-millionths of a millimeter.
From Steven Den Beste:
Lemme see: 1/100 million == 10^-8. A millimeter is 10^-3 meter. Multiply them together and you get 10^-11 meter. So they're talking about banning particles smaller than 10 picometers.
The smallest atom is helium, which is 280 picometers in diameter. The only things smaller are elemental particles such as protons, neutrons, and electrons. I guess we have to ban everything made out of them, right?
It would be interesting to know if this is the Wapo's mistake, or if Friends of the Earth really are that clueless. I wouldn't want to bet either way.
All via Instapundit.
I rememeber reading about a problems with a "nano" a while back - just went and dug up he article. On re-reading I realized that though it talks about nan particles and health problems, the conclusion was that it was not the nanoparticles causing the health issue, it was something else in the product specific to it being an aerosol:
? story_id=6795430
http://www.economist.com/science/displayStory.cfm
Going on means going far
Going far means returning
This is great news considering the bang up job the FDA has done recently ... oh wait ....
however, you're avoiding the biological fact that wheat, by its nature, spread seeds.
in fact, we've found biological cross-crop fertilization from wheat and other such grains as far as two states away (this is from discussions I had with agricultural genetics researchers over at the other UW, the University of Wisconsin (Madison)).
thus, the courts ruled correctly, in that there is a potential, even if not common, cross-state impact on commerce.
you may not like their decision, but the same basic principle applies to nanotechnology that may (even if not by design) cross into humans and/or cross state boundaries.
-- Tigger warning: This post may contain tiggers! --
That sounds more like midichlorians to me. In which case, let them come, I'd love to control the force.
Yeah, the greenies are using the N-word to draw attention. What they meant to say was "Hey, these cosmetic products contain these funky metal oxides and other boutique molecules without making their safety studies public. Make them tell us more about their safety".
From your quote, Den Beste follows up by demonstrating his handling of powers of 10 instead of getting to the point.
EVERYTHING is nanoparticulate in nature, including you.
Yes, clearly we are all made up of atoms and molecules, however only certain of those are free agents; most are bonded together into larger pieces.
With respect to the current discussion, we are not talking about cell-sized nanotech; we're talking about particulates the size of the compounds that pass in and out of cells. Many of these compounds, when produced in a free state outside the body, are regulated by the government already--we call them drugs.
Until recently, manufactured materials did not use particle sizes that were so small, so we did not have to worry about them the same way we worried about drugs. That has changed, and the regulations must change too. Compounds that are harmless at one particle size might be highly dangerous at another, because as you go down in size, some particles begin to exhibit new biochemical effects. These can either be because it fits through barriers that used to stop it, or because the surface shape of the particle enables additional reactivity.
Just because these particles are being chopped up and misced better does not by any means imply that they are unhealthy. Your skin does a pretty good job protecting you from nanoparticulate oils and debris from bacteria. Just because there is better organization at the nano scale does not mean that the nano-particles will cause any sort of damage.
Again this is just not true; there are plenty of compounds that are absorbed through the skin--ever hear of the nicotine or birth control patches? These powerful chemicals are directly absorbed though unbroken skin, and, coincedentally, regulated by the government. The skin of the respiratory or digestive tracks offer even less of a barrier. Particle size and morphology controls what gets through most barriers in the body--skin, cell wall, blood/brain, etc.
By placing a label on these products, consumers will irrationally be prejudiced against them. You should not do that to such a broad and beneficial industry. Mostly, these consumer groups do not understand the basic science. They just have a general technophobia and want to project that onto everyone else's lives.
This is absolutely ridiculous; even in the absence of any regulation, the free market requires accurate information to solve problems. Hiding the nature of products or their possible consequences is NOT a "free market" approach. Accurate information is the minimum required for the invisible hand to work. That can be accomplished by pre-emptive regulated communication, or it can be accomplished by the public and press after any possible negative consequences have already harmed a sizable number of people. As a potential consumer (and test subject) the former approach seems better to me.
Like anything, there should be health tests, but they should be data backed (as these are not). We can't assume that all these products are guilty until proven innocent.
As which are not? I don't get what you're referring to. The FDA is a research-driven organization, interested in accurate data. It has its flaws but so does any human enterprise--lack of perfection is hardly a good reason to completely dismiss something. And accurate communication of known risks is not a verdict of "guilty." Risks either exist or not; talking about them doesn't affect the biochemistry.
Build a man a fire, he's warm for one night. Set him on fire, and he's warm for the rest of his life.
Isn't that like placing a Urologist in charge of a candy store? Or worse, George W. Bush in charge of the country.
Having to work for a living is the root of all evil.
Well, some makeup NOW is named in such a way. Manic Panic has a hair dye called atomic turquoise. Granted, they also have four different shades of electric. Plus an ultra violet and infra red. Oh yeah, lots of subculture types are kinda geeks.
I don't know if you were replying to my post or the initial post, but I was disagreeing with the above poster, and in essence agreeing with you. That being said, when the court ruled against the wheat farmer, it was basically asserting that even activity restricted to a farm, impacts interstate commerce. I agree with both this rationale and the decision. The original poster, who argued, that since nano tech did not "touch" interstate commerce was beyond scope of the Constitution and thus beyond the ability of Congress to regulate it, has a view of constitutional law that predates 1933. Regards Winston
"medical advances [should]would not be hamstrung by excessive regulation as they are today. Even former FDA Commissioner Donald Kennedy acknowledged, "...the pattern of intervention into science from a combination of local, state, and federal sources has moved from reasonable control to something close to chaotic strangulation." Better medical advances mean better overall health."
As taxpayers, we first pay government to create the problem (e.g., FDA) and then pay once again for the government-mandated solution (e.g., NIH).
Delays caused by FDA regulations cost many more lives than they save. The cure is worse than the disease. For the terminally ill, denying access to drugs that could potentially save their lives, prolong their lives, or make them more comfortable, is especially cruel.
"FDA delays mean that companies have fewer years left on their patent to recover the cost of development when a drug is finally marketed. As delays get longer, fewer drugs have enough market life to pay for themselves before going generic. Drugs that could save lives or alleviate suffering are simply not offered to the public because the cost of their development can't be recovered. In all likelihood, drugs that are never developed because of FDA regulations cost even more lives than the delays!"
"The Thalidomide tragedy was the worst drug disaster in modern history, yet it pales in comparison to the damage done by the delays of life-saving drugs. The FDA's three year delay in introducing propranolol after it was sold in Europe, cost (conservatively) 30,000 U.S. lives. In comparison, 10,000 children were affected by thalidomide. Every time the FDA delays a life-saving drug, we have the equivalent of three thalidomide tragedies.
Source:
Dr. Ruwart
http://www.theadvocates.org/ruwart/
Libertas in infinitum
Nanotechnology offers a fantastic range of possibilities to both improve and destroy our lives, but the actual scope of its effects is still shrouded in speculation. I am loathe to have a governmental agency regulate its use, especially when the members of that agency have little to no familiarity with the technology. That is the problem with the rapidly expanding tecnology and biotechnology fields - there just aren't enough competent officials in government to monitor and honestly evaluate the issues associated with the technologies.
thanks. sometimes it's hard to tell if people grok the implications.
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