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FDA Asked to Regulate Nanotechnology

ScuttleMonkey posted more than 6 years ago | from the fda-begins-regulating-ipods dept.

248

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."

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248 comments

Oh Gawds... (5, Insightful)

duerra (684053) | more than 6 years ago | (#15354240)

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.

Re:Oh Gawds... (4, Insightful)

Quaoar (614366) | more than 6 years ago | (#15354271)

Well, to be fair, what department WOULD regulate nanotechnology? I mean it's quite new, and has applications in MANY areas, including foods and drugs. Someone's going to regulate it eventually. I mean, congress COULD directly pass laws to regulate it, but that seems far less friendly to industry.

Re:Oh Gawds... (4, Insightful)

duerra (684053) | more than 6 years ago | (#15354302)

Well, to be fair, what department WOULD regulate nanotechnology? I mean it's quite new, and has applications in MANY areas, including foods and drugs. Someone's going to regulate it eventually. I mean, congress COULD directly pass laws to regulate it, but that seems far less friendly to industry.


Once you realize that "nanotechnology" plays a part in almost every part of your daily life, from the clothes you wear, to the wheels your car rides on, to the TV you watch, to, well... you get my drift.

Nanotechnology isn't some tangible thing to be regulated. It's a word that encompases a part of almost everything in our lives, because it is, simply put, technology on a small scale. If this article is accurate, this petition was submitted out of pure ignorance.

Re:Oh Gawds... (5, Insightful)

vux984 (928602) | more than 6 years ago | (#15354486)

True, however, the reach of the FDA *is* surprisingly broad. For example contact lenses and tampons are regulated by the FDA ... and they are neither food nor drugs.

Similiarly the FDA's scope reaches into approving materials (e.g. plastics) and so forth that might be used in the packaging of food or drugs, or even used in the presence of food or drugs, or even used in a facility where packaging of food or drugs is taking place.

e.g. the FDA would be interested in the presence of asbestos in a facility that makes the plastic used in the packaging of tampons. (which again are neither food nor drugs).

Anyhow, with that kind of scope its reasonable to be watching for 'harmful' elements in clothing and wheels -- as these shirts and wheels might be on staff or forklifts in facilities that manufacture or transport food and drugs...

Once you realize that "nanotechnology" plays a part in almost every part of your daily life, from the clothes you wear, to the wheels your car rides on, to the TV you watch, to, well... you get my drift.

If by getting your drift you mean that evidently the FDA also plays a part in almost every part of your daily life. ;)

Re:Oh Gawds... (1)

P3NIS_CLEAVER (860022) | more than 6 years ago | (#15354563)

So if I make some new plastic to wrap food in with some fancy nano-technolgy component the FDA is going to make an enquiry. What was the problem again?

Re:Oh Gawds... (0)

Anonymous Coward | more than 6 years ago | (#15354717)

For example ... tampons are regulated by the FDA ... and they are neither food nor drugs.

Oh... oops.

Re:Oh Gawds... (4, Insightful)

kfg (145172) | more than 6 years ago | (#15354406)

Well, to be fair, what department WOULD regulate nanotechnology?

What department regulates gelatin intended for human consumption?

That's right, the FDA.

What department regulates glue, leather and violin strings?

Not the FDA.

How about we let the relevant agencies regulate within the sphere of their mandate and expertise? And God forbid that should leave certain applications beyond the realm of the government. I really don't feel like having to bring my fiddles to some sort of inspector other than my customers, nor do I see any value in it.

KFG

Re:Oh Gawds... (2, Funny)

Ruff_ilb (769396) | more than 6 years ago | (#15354468)

Lets just create the Department of Nanotechnology.

Problem solved!

Re:Oh Gawds... (5, Funny)

ScoLgo (458010) | more than 6 years ago | (#15354502)

"Lets just create the Department of Nanotechnology..."

The only thing I like about that idea is the resulting acronym...

(D)epartment (O)f (N)ano(T)echnology

Sick of the terminology (1)

P3NIS_CLEAVER (860022) | more than 6 years ago | (#15354520)

"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?

Look into the Constitution (3, Insightful)

mangu (126918) | more than 6 years ago | (#15354688)

Well, to be fair, what department WOULD regulate nanotechnology?


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 ... among the several states", I don't see much that the Congress of the USA can legislate about in nanotechnology.

From the 1st page of www.fda.gov (2, Informative)

Intron (870560) | more than 6 years ago | (#15354320)

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

If they regulate lasers at the FDA, then (1)

WillAffleckUW (858324) | more than 6 years ago | (#15354645)

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 ...

Re:Oh Gawds... (1)

soupdevil (587476) | more than 6 years ago | (#15354330)

Many of these nanotechnologies ARE used in food and drugs. One example is nano-sized titanium particles that are used in over-the-counter sunscreens.

Re:Oh Gawds... (2, Informative)

mugnyte (203225) | more than 6 years ago | (#15354412)

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.

see concern story here [npr.org] and a rebuttal here [softmachines.org] for examples

Re:Oh Gawds... (1, Troll)

bunions (970377) | more than 6 years ago | (#15354425)

"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?"

Yes, this is a wonderful idea. Let's just sit back and let unrestrained industry spit out whatever they want and just wait and deal with a nanotechnology disaster when it happens.

"We at NanoCorp, Ltd. would like to express our sincere regret for those whose nasal passages exploded due to our faulty nanothingamajig. We are currently under Chapter 11 protection, so don't bother sueing us. Also, we kind of don't know how to stop that whole self-replication thing, sorry. So, you know, good luck with that. We'll be in this airtight chamber, let us know when you've figured it out. Again, our heartfelt sympathies."

Re:Oh Gawds... (1)

TheGavster (774657) | more than 6 years ago | (#15354577)

What strategy, apart from addressing issues as they arise, can identify what aspects of a new (and rather broad) technology need to be regulated? An arbitrary set of preemptive regulations would prevent lots of otherwise safe developments, and generate loopholes that allow truely dangerous things to be grandfathered along.

Re:Oh Gawds... (0, Troll)

bunions (970377) | more than 6 years ago | (#15354683)

If we aren't smart enough to have at least some vague notion what the potential danger areas might be, then maybe we shouldn't really be tinkering with this.

When you build something do you wait until you lose one eye before you put goggles on the other one? Do you wait until you lose fingers on the table saw before you put a fence on it? I'm pretty sure we can find some obviously dangerous practices when making substances that can penetrate cell walls that should be regulated.

Re:Oh Gawds... (1)

carpevita (849940) | more than 6 years ago | (#15354448)

Taking a breath before the federal-agency flogging begins...

I don't think the FDA's well-known malfeasance has escaped the notice the "environmental and consumer groups" who are proposing this. However, if one's goal is to get nano-whatsits that are already used in consumer products tested asap for health effects, the FDA would be the logical organization to conduct the testing-- it is, after all, what they already do.

Given the fact that nanometer-sized particles can be very invasive in living tissues, I personally would prefer that ~someone~ check this stuff out, sooner rather than later.

Re:Oh Gawds... (1)

grungy hamster (970187) | more than 6 years ago | (#15354455)

I would suggest making an all new federal agency. Indeed, I do agree that nano particles can penetrate cells. They can be quite dangerous. Regulation would seem to fix this issue. You see, you say "let's deal with issues as they come", and there's already one to resolve. It's simply a suggested solution.

Re:Oh Gawds... (0, Troll)

HolyMonkey (966570) | more than 6 years ago | (#15354505)

"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?"

Yeah let's just let people start dying before we start taking even the most basic precautions...

Re:Oh Gawds... (1)

Moofie (22272) | more than 6 years ago | (#15354541)

"How about the FDA regulate... food and drugs?"

Things that are ingested...right. Regulating nanomachines isn't that far of a stretch, is it?

Re:Oh Gawds... (4, Insightful)

dbrower (114953) | more than 6 years ago | (#15354561)

RTFA. The suit "petitioned the Food and Drug Administration yesterday to beef up its regulation of nanoparticle-containing sunscreens and cosmetics and recall some products." These are things over which it already has jurisdiction.

This is NOT a request for blanket regulation, as some of the more knee-jerk replies suggest.

-dB

Re:Oh Gawds... (3, Insightful)

syphax (189065) | more than 6 years ago | (#15354564)

From TFA:

Among the FDA-regulated products being sold are sunscreens containing titanium dioxide or zinc oxide nanoparticles (which offer strong ultraviolet protection while remaining colorless) and cosmetics with nanoscale liposomes -- tiny chemical bubbles that deliver moisteners and other ingredients to the skin.

They are asking for better regulation of currently-regulated products. Seems pretty in-scope to me.

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?

Yeah, that [wikipedia.org] approach [wikipedia.org] carries [wikipedia.org] no [wikipedia.org] risks [wikipedia.org].

Is it possible that it makes more sense to conduct controlled trials with a limited number of subjects, rather than poorly controlled trials with possibly millions of subjects? That the risk of harm of the latter case might be significant?

I submit that regulation of something with plausible but poorly understood impacts on human and/or enviromental health may not be a terrible idea. The problem, of course, is that it's really hard to write regulations that achieve their ends without being painfully burdensome for the regulated. This is partly due to having to loophole-proof the regs, as history has shown that regulated parties are really good at meeting the letter of the law while butchering the spirit. Also, not all regulations have sucked: from what I can tell, SO2 trading, which has a specific target but allows flexible, market-based solutions, basically works.

Re:Oh Gawds... (2, Insightful)

blair1q (305137) | more than 6 years ago | (#15354595)

"Nanotechnology" doesn't just mean "tiny things."

It's more guided towards "tiny independent things."

So the nanometer features of your microchips aren't strictly nanotechnology, because they aren't going anywhere without the other 50 million that are there.

Luddites... (1, Redundant)

DougLorenz (964249) | more than 6 years ago | (#15354242)

Now what part of this is either "Food" or "Drug", and why should the FDA be regulating it?

Personally, I'll take a pass on any pseudoscience that comes from the "Friends of the Earth"...

Luddites...Drug delivery. (0)

Anonymous Coward | more than 6 years ago | (#15354276)

There are some drugs delivered via nanotech. Otherwise I believe OSHA should be regulating the industrial use of nanotech.

Re:Luddites... or is the FDA not for Food and Drug (1)

WillAffleckUW (858324) | more than 6 years ago | (#15354369)

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.

Re:Luddites... (1)

DragonWriter (970822) | more than 6 years ago | (#15354379)

Now what part of this is either "Food" or "Drug", and why should the FDA be regulating it?


Sunscreen (one of the areas of nanotech application in TFA), for instance, is a nonprescription drug currently regulated by the FDA, used to prevent various kinds of disease.

Re:Luddites... (2, Insightful)

cnettel (836611) | more than 6 years ago | (#15354384)

Considering nanotechnology is, so far, often just a fancy name for thin-film application of chemicals, of course it should be governed by the regulations applying to those chemicals. The FDA certainly has some say in that.

An excellent way to get nothing done! (3, Insightful)

FooAtWFU (699187) | more than 6 years ago | (#15354269)

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.

An excellent way to get nothing done, or ... (1)

WillAffleckUW (858324) | more than 6 years ago | (#15354326)

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.

Re:An excellent way to get nothing done, or ... (0)

Anonymous Coward | more than 6 years ago | (#15354351)

Oh, the developers will be more than happy to sell products into those markets. But little will be developed there. It's been a number of decades since Europe pulled its own weight with respect to technological development thanks to their socialism, compared to economically freer nations like Japan and the US.

Re:An excellent way to get nothing done! (1)

DragonWriter (970822) | more than 6 years ago | (#15354391)

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.


Yeah, just the same way that FDA regulation of prescription drugs means no one does pharmaceutical research in the US.

Re:An excellent way to get nothing done! (2, Insightful)

ch-chuck (9622) | more than 6 years ago | (#15354747)

Well, it certainly drives way up the COST of doing pharmaceutical research in the US (and hence, ala the oil companies, the profit margin, wink wink nudge nudge) - only their customers have a steep demand curve: either pay us $500 for a month of pills or go home and suffer or die.

Buy a hunting hearing enhancing amplifier [midsouthsh...supply.com] at the sporting goods store: $300 at most. Buy a regulated hearing aid from an audiologist: $5000.

Re:An excellent way to get nothing done! (1)

shdragon (1797) | more than 6 years ago | (#15354633)

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.

As an emerging technology of which the potentially harmful effects are still unkown even to those creating products based on nantech, what do you suggest be done to protect the people? Or are you really trying to argue that nanotechnology is proven to have no ill effects? Just recently in the UK, a manufacturer was forced to recall their product that contained nanotechnology when a large swath of users became ill after using the product. I'm not trying to be an alarmist, but to look at an emerging science & thumb your nose at the potential health consequences is irresponsible.

With such a wonderful track record... (0, Flamebait)

quincunx55555 (969721) | more than 6 years ago | (#15354282)

...of the pharmecuticals, now we know we'll only get nanotechnology that kills our kidneys and liver before causing a heart-attack.

and they say "Shure!" (3, Insightful)

way2trivial (601132) | more than 6 years ago | (#15354283)

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.

Re:and they say "Shure!" (1)

WillAffleckUW (858324) | more than 6 years ago | (#15354308)

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

I'm sorry, but contrary to any statements you may have heard from the White House, the cold hard truth is that federal funding of scientific research, even in malaria, has gone down each year in this Administration.

Blaming the FDA for wanting to regulate a technology that impacts humans is not likely to be a long-term strategy for success - the first time one of the nanobots designed to "repair cow stomach infections" invades a human host and alters the human stomach to the correct norms for a bovine, will be the day the entire industry gets sued.

The FDA is there for a reason, even if it's not doing a very good job of it.

Re:and they say "Shure!" (3, Informative)

DougLorenz (964249) | more than 6 years ago | (#15354340)

There is a major difference between nanoparticles and self-replicating nanobots...

People who are afraid that minature killer robots are going to wipe out humanity should dial back the amount of time they spend watching the SciFi channel...

Re:and they say "Shure!" or what's next (4, Insightful)

WillAffleckUW (858324) | more than 6 years ago | (#15354428)

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.

Want an opinion from a bioethicist? (1)

brian0918 (638904) | more than 6 years ago | (#15354670)

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.

Re:Want an opinion from a bioethicist? (1)

WillAffleckUW (858324) | more than 6 years ago | (#15354714)

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.

Actually, your comment is fairly accurate. We were discussing this in Medical Genetics Journal Club this morning, in fact, and one of my bosses, a dual MD/PhD who has presented a number of bioethics papers and seminars, was describing entire sections that have not been investigated in depth at all, and that the whole bioethics field is - sadly - still in its infancy in many fields that one would have suspected it would have been further ahead in.

In point of fact, many new fields are totally lacking in people with doctorates or masters in the underlying field/technology, but who are creating public policy or presenting bioethics papers, talks, and books on those fields/technologies nonetheless.

However, the lack of a long history of such people in nanotechnology does not imply that we therefore should expect it to remain unregulated just because we don't have any properly trained nanotechnology bioethicists available to comment on it, especially those with experience in the underlying technology.

One does what one can with the tools at hand. That's what posting the link to the article is about - pointing out that possible discussions on regulation are about to occur or may occur, so that people who may work in the field can wake up and smell the nano-caffiene and participate in the inevitable regulatory discussion.

Would you rather we pretended nothing was going to happen and then you wake up four years later to find Congress has passed and enacted regulatory laws without your input and thought?

Re:and they say "Shure!" (1)

powerlord (28156) | more than 6 years ago | (#15354456)


People who are afraid that minature killer robots are going to wipe out humanity should dial back the amount of time they spend watching the SciFi channel...


And people who are not at all concerned about self-replicating robots going amock have never had to debug a production system. :)

( of course, the likelyhood that the self-replication will work perfectly, while the "protect^H^H^Hdestroy all life" code malfunctions, is pushing it. I expect the bugs to go out of control, and promptly die from poorly designed replication control. ... of course with our luck that will be outsourced to competent programmers in India)

Re:and they say "Shure!" (0)

Anonymous Coward | more than 6 years ago | (#15354661)

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.

Dear way2trivial:

Congratulations! You have created a whole new category of bad grammar for us to criticize: a run-on sentence fragment.

Yours,
International Association of Grammar Nazis

Re:and they say "Shure!" (1)

macklin01 (760841) | more than 6 years ago | (#15354698)

As I understand it, the FDA regulates products sold, not research (aside from clinical trials). You can research any amazing product you want, and foreign companies can manufacture any amazing product they want. But both will run into the FDA at the point where you sell the product in the U.S. No sooner, and no later, same barrier for both. (And only if the FDA applies to that particular product category.)

In a word, that's a bogus argument. -- Paul

What will they ask for next? (1, Funny)

Anonymous Coward | more than 6 years ago | (#15354289)

... can penetrate cells and tissues, migrate through the body and brain and cause biochemical damage.

Yeah, and so can cars, and bullets, and ...

Remember Kids (5, Funny)

youngerpants (255314) | more than 6 years ago | (#15354321)

Only you can prevent Grey Goo

Re:Remember Kids (1)

cowboy76Spain (815442) | more than 6 years ago | (#15354543)

Only you can prevent Grey Goo

If you suspect someone you know is part or works for the Grey Goo, just tell the police.

Grey Gooers! Man, woman or child, Captain America watches you!!

Re:Remember Kids (0)

Anonymous Coward | more than 6 years ago | (#15354741)

Only you can prevent Grey Goo

Duck and cover?

Progress! (4, Insightful)

thefirelane (586885) | more than 6 years ago | (#15354342)

We used to just regulate things that caused problems

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.

Re:Progress! (1)

spun (1352) | more than 6 years ago | (#15354491)

Regulations could cause problems, therefore we should regulate regulations!

Re:Progress! (0)

Anonymous Coward | more than 6 years ago | (#15354749)

Hopefully, in the future we'll regulate things that could lead to technology that could cause problems.


Like education

Are they kidding? (1)

Susceptor (559115) | more than 6 years ago | (#15354361)

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?

Re:Are they kidding? (1)

heebus (913570) | more than 6 years ago | (#15354413)

The FDA regulates implantable medical devices. I'm thinking they are anticipating nanotechnology to be prominent in the medical field. The FDA isnt totally incompetent, just mostly.

Re:Are they kidding? (2, Insightful)

DragonWriter (970822) | more than 6 years ago | (#15354485)

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?


The FDA regulates (see their homepage [fda.gov]) things marketted to treat and to prevent disease, generally, including both drugs and (though its not part of the name) non-drug biological products and medical devices (they also regulate food -- obviously -- cosmetics, animal feed and veterinary drugs, and radiation-emitting devices.) Nanotech is sometimes currently and quite likely more in the future applied to prevent and treat disease, and to that extent comes under the FDA's scope of responsibility, as either a "drug" or a "medical device", depending on how you look at it. Expanding their brief to explicitly include nanotechnology designed for use on or in the human body would make a lot of sense even if it isn't, per se, a "drug" or "medical device".

Scientists will merely switch to another scale (1, Insightful)

PIPBoy3000 (619296) | more than 6 years ago | (#15354362)

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.

Re:Scientists will merely switch to another scale (1)

spun (1352) | more than 6 years ago | (#15354513)

I, for one, welcome our new yocto [wikipedia.org]tech underlords.

How to kill nanotech in its infancy... (5, Interesting)

kcbrown (7426) | more than 6 years ago | (#15354374)

If you want to kill off an industry, the best way to do so is to regulate it the way the medical industry and the aviation industry are regulated.

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.

Re:How to kill nanotech in its infancy... (3, Interesting)

kcbrown (7426) | more than 6 years ago | (#15354420)

I suppose I should mention an example of how to regulate an industry properly: the NHTSA.

Automobile manufacturers don't have to get their manufacturing methods certified by the NHTSA. The NHTSA doesn't care how you manufacture something. It only cares about the end results: does the resulting product pass a battery of safety tests. If it passes, all is good.

The end result is that auto manufacturers can continuously improve their product, as long as they continue to meet the result-oriented safety requirements of the NHTSA.

That's the right way to regulate an industry: test for results, not processes.

Needless to say, the FAA and the FDA don't do that, and you can see the difference in the costs and the quality.

Re:How to kill nanotech in its infancy... (1, Troll)

bunions (970377) | more than 6 years ago | (#15354442)

"If you want to kill off an industry, the best way to do so is to regulate it the way the medical industry and the aviation industry are regulated."

Yeah, that's good point, the medical and airline industries are really hurting these days.

Re:How to kill nanotech in its infancy... (0)

Anonymous Coward | more than 6 years ago | (#15354582)

"If you want to kill off an industry, the best way to do so is to regulate it the way the medical industry and the aviation industry are regulated."


"Yeah, that's good point, the medical and airline industries are really hurting these days..."


Not to put words in the GP's mouth but...

I believe the point is not that the industries are hurting. Rather that they are not regulated in the most advantageous manner; resulting in increased costs (and/or risks) for consumers of those industries.

Reading comprehension; it's catching on. Or maybe not...

--

Re:How to kill nanotech in its infancy... (1)

kcbrown (7426) | more than 6 years ago | (#15354625)

Yeah, that's good point, the medical and airline industries are really hurting these days.

The medical industry isn't hurting because it's essentially an infinite-demand industry. When you need treatment, you need it, period, and you usually can't go elsewhere for it. "Elsewhere" here means out of country, because that's what it would take to escape the regulatory effects of the FDA.

The airline industry just passes its costs onto the consumer. Since the entire industry is regulated by the same agency in the same way, and there are no less-regulated alternatives that can provide the same type of service to the same people, the industry can't be hurting too badly except in the face of a confidence-shaking event like 9/11.

No, if you really want to see what the FAA has done to aviation, look at the general aviation industry. Even the most basic 4-place airplane will set you back over $200K, and it's still using technology and designs that are literally over half a century old. Personal airplanes compete with both the airlines for medium size hops and automobiles for short hops. Airliners are large enough and by their nature (i.e., before accounting for certification expenses) expensive enough that the certification costs can get lost in the noise, but the same isn't true for personal airplanes.

Technological progress should be reducing the real costs of goods over time, as it reduces the amount of labor required to produce a good. Thanks to the FAA, general aviation aircraft haven't seen any real benefits there.

Great idea (1)

overshoot (39700) | more than 6 years ago | (#15354397)

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."
Makes perfect sense. Who better than the FDA to regulate skis [atomicski.com]?

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.

The FDA just wants to prevent (0)

Anonymous Coward | more than 6 years ago | (#15354400)

...mutants with superpowers from taking over the world.

Oh Good - Just What a Fledgling Industry Needs... (0)

Anonymous Coward | more than 6 years ago | (#15354408)

...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).

Not only that . . . (1)

mmell (832646) | more than 6 years ago | (#15354409)

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?

This is pure insanity (2, Interesting)

FifthRaven (701549) | more than 6 years ago | (#15354419)

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.

Re:This is pure insanity (1)

Amouth (879122) | more than 6 years ago | (#15354494)

to Quote someone i can't remember who

"Life: noun - the whim of several billon cells to be you for a while"

The last thing Nanotechnology needs... (5, Funny)

SFSouthpaw (797536) | more than 6 years ago | (#15354426)

is micro management.

Re:The last thing Nanotechnology needs... (2, Funny)

kcbrown (7426) | more than 6 years ago | (#15354460)

Nope....nanotechnology needs ... nanomangement!

*sounds of crickets*

Ah, well, I'll be here all week anyway...

Slight overreaction maybe ... (0, Redundant)

ScrewMaster (602015) | more than 6 years ago | (#15354430)

... nanoparticles can penetrate cells and tissues, migrate through the body and brain and cause biochemical damage.

Of course, so does just about everything else.

Sure thing! (1)

Lord Bitman (95493) | more than 6 years ago | (#15354443)

The FDA will regulate all nanotechnology which is part of either a Food or a Drug.

Re:Sure thing! (1)

kfg (145172) | more than 6 years ago | (#15354471)

The FDA will regulate all nanotechnology which is part of either a Food or a Drug.

They're called "elements."

KFG

Nanotech is more than tiny machines (5, Insightful)

TimmyDee (713324) | more than 6 years ago | (#15354449)

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.)

Re:Nanotech is more than tiny machines (0)

Anonymous Coward | more than 6 years ago | (#15354669)

Funny you should mention DDT...

To quote Henry V .009 from this Ask Slashdot article [slashdot.org]...

"Not using DDT kills poor Africans."

Re:Nanotech is more than tiny machines (1)

Mofassa (975528) | more than 6 years ago | (#15354748)

While caution is needed - one of the main things we are taught in my nanotech program, and one thing you can learn from some research is much of nanotechnology that is being used now, is essencially 'old' technology. This reduced size is good (ofcourse), but it is not like TiO2 wasn't used before it was being marketed as nanotechnology in foods, its just now it is in a - lets say pure form. I think one of the main problems with "nanotechnology" (yes nanotechnology, the legendary technology covering transistors, biomedical drug delivery systems, and the amazing ability to cure wrinkles) is that the term is too broad. Where do you draw the line between what is and what isn't nanotechnology? Is everything below 100nm considered nanotechnology? If that's the case, then all these new processors/chips being produced are just that. However, in terms of production - they're basically the same as the 101nm chips. If groups are calling for special regulation on nanotechnology then we need a clear definition of what that is. But the truth is there isn't one, the term is now mostly a catch phrase. Just to show this scare, I recently read an article at (www.smalltimes.com) about a (I think German) product that was marketed as a nanospray, which you could put on walls. Wow - amazing isn't it? What happened, people said they were caughing and getting sick due to these nanoparticles. "This nanotechnology product must be removed from the market immediatly". What did it turn out? Well there were no nanoparticles in the product at all, it was simply called nano-something because the can was able to spray a coating that was 100nm thick, that consisted of oil, water, and silicon-dioxide. The actual problem, the droplets were smaller than 10micro-metres - thus could be breathed in. Now while this example shows that regulation is required, the fact that nano was in the name, meant there is an exaggeration over it. Why don't we just keep regulations consistant? Shouldn't testing and requirements be equally rigorous no matter what the product? Let's forget about this nanotechnology scare that people seem to like, and realize that chemical testing shouldn't depend on the size of a molecule, more on what that molecule is made up of.

FDA Regulation? (1)

l0ungeb0y (442022) | more than 6 years ago | (#15354473)

Instead of stating 5-10 years all those Nano-Tech related Press Releases better start saying 15-20 years...
well, at least the ones that weren't already saying 10+ years that is. :P

I'm gleefully over-joyed at this news, since we all know the Government will keep us all safe because it knows best.

*feh*

Nanotechnology versus cute nanoparticles (2, Insightful)

i am kman (972584) | more than 6 years ago | (#15354506)

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!

Re:Nanotechnology versus cute nanoparticles (1)

WillAffleckUW (858324) | more than 6 years ago | (#15354620)

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.

This could also apply to nanotechnology as used in clothing, which by virtue of its usage has close skin contact with humans, and, were it mobile nanotech (not all nanotech is mobile), could cross over into the human wearing it.

On the other hand, it's highly unlikely that chimpanzees or our other simian brethren or sistren need to worry - they can wear nanotech clothes to their heart's content, basking in their libertarian wonderland of unregulated splendor.

Hey, what's that zipper doing growing out of Curious George's head, anyway?

A Study (5, Informative)

Anonymous Coward | more than 6 years ago | (#15354514)

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.

Here's a study conducted by researchers from NASA, Wyle Labs, UofT Medical:

http://toxsci.oxfordjournals.org/cgi/content/full/ 77/1/126 [oxfordjournals.org]

This could be a good thing. (1)

tddoog (900095) | more than 6 years ago | (#15354554)

The issue is that someone should be regulating it and determining what adverse or positive health effects are caused by it. Think of asbestos and what a debacle that was. A lot of litigation time can be saved if we get the facts beforehand (or at least concurrent with development). The effects of nanosize particles compared to microsize or macro chemicals is unknown and as of yet not to much effort has been put into studying the health effects. Nanoparticles can cross the blood brain barrier. This could be used for medicine delivery or it could cause brain damage if the wrong things are entered into the blood system.

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/ [slashdot.org]>Center for Biological and Environmental Technology for more details.

Also, check out the science friday podcast from April 28.

Re:This could be a good thing (another link) (1)

WillAffleckUW (858324) | more than 6 years ago | (#15354607)

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 [washington.edu], which holds various informative seminars on campus, some of which are podcast.

Re:This could be a good thing. (1)

P3NIS_CLEAVER (860022) | more than 6 years ago | (#15354695)

You can destroy your lungs with yarn fibers. We know little particles are bad to breath, so you don't breath them! Eventually when this stuff is scaled up someone is going to make breathing apparatus that works on nanoparticles, and OSHA is going to set exposure limits. This is not the 1950s.

Alex Krycek (1, Troll)

kuwan (443684) | more than 6 years ago | (#15354573)

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.

Indeed (1)

Xeth (614132) | more than 6 years ago | (#15354609)

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.

Too late - they already have (1)

Graboid (975267) | more than 6 years ago | (#15354666)

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!

White Supremacist (1)

BoxSocial (945632) | more than 6 years ago | (#15354636)

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.

Easy solution to stop regulation of nanobots (2, Funny)

WillAffleckUW (858324) | more than 6 years ago | (#15354653)

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 ...

but when will they regulate (0)

Anonymous Coward | more than 6 years ago | (#15354729)

foil hats?

Mine has been malfunctioning -- the voices are back.
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