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FDA Sees Nanotech Challenges In Every Product Category

Zonk posted more than 6 years ago | from the little-tiny-bugs-everywhere dept.

Biotech 21

An anonymous reader writes "The Food and Drug Administration's Nanotechnology Task Force has passed on its first report into the ever-growing field of nanotech products. As a result, the FDA is implementing changes that will allow it to oversee nanotech products in every category withinin its purview. Nanotech products are 'estimated to grow to $2.6 trillion in manufactured goods globally by 2014. As the Task Force report highlights, nanotechnology impacts every area of FDA responsibility--drugs, drug delivery systems, cosmetics, medical devices, and food products. Overall, the agency regulates products that are worth nearly $1.5 trillion annually and that account for almost 25 percent of US consumer spending.'"

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21 comments

Who's Surprised... (2, Insightful)

StealthyRoid (1019620) | more than 6 years ago | (#20021465)

That the FDA found an excuse to stick its dick where it doesn't belong? The entire article reads like one great big FDA power grab. Lines about expanding the FDA's authority and jurisdiction to areas where it doesn't currently exist, and strengthening it where it's weak because the shibboleth of nanotechnology will provide them a FUD cover don't exactly fill me with joy. The FDA is already the single largest impediment to development of drugs, and allowing them to interfere with a fledgling technology under the banner of "safety" is only going to hurt future development and us, the consumers.

Of course, these new regulatory powers will necessitate budget increases for the FDA. Is there a single government agency that has ever, in the history of time, said "You know what guys? We actually have more money than we need. Go ahead and take this back, use it somewhere else, maybe give it back to the people."? Of course not. Government agencies ALWAYS try to increase their funding and power base, and it's silly that we let them just because they use big words and imply that, if they don't get what they want, Borg devices will make their way into everyone's bodies via a carrot or something. Remember, the government relies on the fact that most people are too stupid to tie their shoes, let alone parse the rhetoric they spit out.

We have to protect research and development of new tech, including nanotech, and suffocating the ability of companies to produce commercially profitable nanotechnology through over-regulation and intervention will only hold back advances in the tech and decreases in the cost.

Re:Who's Surprised... (1)

rickb928 (945187) | more than 6 years ago | (#20022567)

Well, after the German scare, which turned out to be http://www.nanowerk.com/spotlight/spotid=726.php/ [nanowerk.com] misguided, we may actually want to look over the whole nano- thing.

Not http://www.cnn.com/2006/TECH/science/09/01/nanotec h/index.html/ [cnn.com]everyone is willing to take it on faith that nanotech is harmless or should be assumed to be safe. And I'm guessing that when some nano- product turns out to be worse than asbestos, you'll all be screaming for reform at the FDA, how could they have betrayed us? Oh, the humanity. Figures. In one breath we decry the reduction of the FDA, and the lax inspections. Next, we oppose their expanding into examining new products that plainly need to be studied. Sheesh.

Re:Who's Surprised... (1)

StealthyRoid (1019620) | more than 6 years ago | (#20024907)

Who said anything about assuming that nanotech is harmless? Of course there are risks involved with it, just like there are like any venture. But now, if it turns out that nano causes cancer or something, I _won't_ be screaming for the FDA, because I don't want them involved in much of anything, let alone areas where they don't need to be. We already have a system to handle damages of that sort through the courts, and we should continue to use it to punish companies who release harmful products _after_ they've done real harm. Nobody is helped by having a large government agency impose billions of dollars in costs to companies wishing to do R&D, especially when the process is entirely politicized and susceptible to corruption. That's punishing the innocent.

Additionally, the market is a much better force for ensuring product safety than the FDA. All the FDA's stamp of approval does is lull people into a false sense of security, and what happens when the product in question still ends up killing you? The Merck drugs that turned out to cause serious heart problems all passed the FDA, for example. I'd rather rely on a company's profit motive not to kill me, a customer, than some government bureaucracy that has no incentive to do _anything_ right because their funding is guaranteed, and it's not like people can get fired from a federal agency.

Re:Who's Surprised... (1)

fermion (181285) | more than 6 years ago | (#20024543)

Of course I have sympathy for these companies that cheat stockholders by backdating stocks options, cashing in stock options based on insider information and in general treating stockholder property as personal disposal income. Not to mention research and development product that are perfectly willing to engage in mass murder for profits. A terrorist kills a few thousand people, we go to war. A corporation kills a few tens of thousand of people we let them continue to do the same thing another day. I mean corporate balance sheets are so much more a justification for the death of humans than a desire for political change.

So lets take the opposite extreme position. Perhaps the FDA exists to give products official government credibility. Perhaps it works closely with private firms, including the emerging nanotech industry, to create a set of rules that creates a sufficient sense of safety such that consumer can spend more time purchasing products than evaluating products, which in turn allows money to have sufficient velocity to grow the economy.

In this view the FDA is a necessary cost of doing business. The FDA does not so much provide security, but a sense of security, much like Homeland Security. This is necessary to keep the economy running and stock markets up. It is doubly necessary now that the US is dependent on foreign power, friendly and unfriendly, to finance the public debt.

Without agencies like the FDA, the products in a drug store would have as much credibility as the products on the street There would be no generic drugs as the only assurance a consumer would have is company reputation. For instance was anyone worried about buying cheap toothpaste prior to learning there was no effective regulation in China?

Back to the middle ground. My understanding is that nanotech people are trying to leverage the credibility of the FDA so as to not be in the situation of the GM industry. The GM industry got arrogant and greedy, and basically did what it wanted to do without any concern of market forces. The nanotech industry, perhaps because they tend to be hardcore scientist, understand that such behavior is counterproductive in the long run. While the nanotech is probably much safer than most other tech, and while it is likely not a danger in normal operation, there are still concerns. The FFA can help quantify those concerns, and again, create credibility for a product.

Re:Who's Surprised... (0, Flamebait)

StealthyRoid (1019620) | more than 6 years ago | (#20025131)

Of course I have sympathy for these companies that cheat stockholders by backdating stocks options, cashing in stock options based on insider information and in general treating stockholder property as personal disposal income. Not to mention research and development product that are perfectly willing to engage in mass murder for profits. A terrorist kills a few thousand people, we go to war. A corporation kills a few tens of thousand of people we let them continue to do the same thing another day. I mean corporate balance sheets are so much more a justification for the death of humans than a desire for political change.
Ooo, an anti-corporatism rant. How original. Yes, that's exactly right. Every company cheats stockholders, jacks them based on insider information, and totally screws their investors. You've nailed it! We should clearly just get rid of private enterprise and allow the government to run everything, because it's comprised of completely altruistic individuals who would never play fast and loose with taxpayer money, engage in corrupt financial dealings, and would probably give us all kisses on the cheek before we went to bed.

Look, of _course_ you'll have individual instances of corruption in ANY sector. Managing a company doesn't change someone's core proclivities any more than getting a job with Uncle Sam does. The point here is that private organizations are far less distasteful than large federal bureaucracies. For one, you can _choose_ to invest in a company, whereas you don't have a choice when it comes to investing in Uncle Sam. He's gonna take his 25% no matter what you do. Also, if a company screws up, they get punished. If the government screws up, what happens? Nothing. There's no effective feedback for the government, and don't say elections, because that's a change of, at most, a couple thousand elected officials and political appointees. There's at least _some_ check on private agencies.

If you'd really rather descend into hysteria and claim that corporations are mass murdering assholes who've killed BILLIONS of people, OK, fine. You just don't have the evidence to back that shit up. Again, yes, corporations can behave badly, but the _overwhelming_ majority of them do not, and provide valuable services to the economy via job creation and the sale of their products and services. Also, what you ignore is how many people the FDA has killed through dragging its feet on approving medical and pharm. technology, how many people either couldn't get the drugs that would save their lives, or simply couldn't afford them because insurance companies frown upon "experimental" drugs. The FDA has FAR more blood on its hands than any company does.

Perhaps the FDA exists to give products official government credibility. Perhaps it works closely with private firms, including the emerging nanotech industry, to create a set of rules that creates a sufficient sense of safety such that consumer can spend more time purchasing products than evaluating products, which in turn allows money to have sufficient velocity to grow the economy.
Cool, so, basically, you're willing to be an ignorant sheep and let Daddy Government step in and make all those difficult decisions for you? Yeah man, when I decide whether or not something is safe for me to consume, I look for the FDA stamp of approval instead of, I dunno, investigating the matter myself, doing some damn reading on the subject, and forming my own conclusions. That's really smart. I mean, if the government says it's OK, it must be, right? Because they're the government, and they know WAY more about everything than the people who actually work on these products.

But, assume you're right for a moment, that the economy does need some kind of paternalistic organization to verify what's good to eat and what isn't. Why couldn't this duty be performed by any number of private organizations? Why get the government involved? If you had private companies doing it, you could still build a feeling of trust in their ratings, the way that people trust things like the BBB or the movie ratings system, and they'd be forced to keep their approval costs down, guaranteeing a greater range of valuable and useful products reaching the market. If we can all agree that monopolies are a bad thing (which is arguable, but I think that, in the end, they are), why are we so willing to accept one in a bottleneck like this?

Also, your "people will spend time buying instead of researching" argument is stupid. Nobody forgoes purchasing something because they've spent time reading about it. Just doesn't happen.

In this view the FDA is a necessary cost of doing business. The FDA does not so much provide security, but a sense of security, much like Homeland Security. This is necessary to keep the economy running and stock markets up. It is doubly necessary now that the US is dependent on foreign power, friendly and unfriendly, to finance the public debt.
Why can't this exact same argument be applied to any overreaching federal action? Oh, well, insanely high tax rates are a cost of doing business. Oh, stupid regulations are a cost of doing business. Oh, punitive employment laws are a cost of doing business.

It seems to me like you're just arguing Security Theater Good, which is a fine position if you're an imbecile who can't think for themselves, but it's wrong to extend it to the entire economy. We got along as a nation just fine without the FDA, and we would do fine if it were abolished or replaced by a network of competing verification organizations. Plus, dude, FDA Good Because of Foreign Debt? I can think of about a billion other factors that are more important and more influential on the economy than the FDA. The two things are completely unrelated.

Without agencies like the FDA, the products in a drug store would have as much credibility as the products on the street There would be no generic drugs as the only assurance a consumer would have is company reputation. For instance was anyone worried about buying cheap toothpaste prior to learning there was no effective regulation in China?
Again, replace the FDA with a network of privately run approval organizations. Boom, problem solved. And the Chinese toothpaste argument proves my point for me. The FDA has to approve foreign products for sale in the US, including Chinese Communist Party Toothpaste (TM).

I mean, really man, would you impose ANY restrictions or limits upon federal agencies that claim to be "for the good of the people", or would you just let them continually power-grab until every aspect of our society is governed by a set of proscriptions and restrictions by government agencies? Do you really have that much faith in the state that you're just going to trust them? Seems naive to me, but whatever makes it easier for you to sleep at night, I guess. How about this as a compromise:

If you want to pay for the FDA approval process, you go right ahead and do it. It's totally binding for you, nothing changes. If I don't want to, I don't have to, because I place no value in it, and think it's bad for society and the economy. Let me opt out of the FDA, and we can both be happy.

FDA might be doing a halfway decent job? (2, Insightful)

Bondolon (1000444) | more than 6 years ago | (#20021491)

I don't necessarily see the FDA as a bad thing, since most of what they do results in me not dying from botulism. They're right to say that nanotech affects them, as nanotech is likely to go into all of the above-listed things. A bit of accountability would be nice, but I'm not expecting that any time soon from the government of the US. In any case, I just hope they don't screw it up.

Re:FDA might be doing a halfway decent job? (1)

davef139 (790691) | more than 6 years ago | (#20021945)

FDA doesn't do a great job if you ask me. While services might be improving over the last few years. Look at the current year. We had a major peanut butter mfgr initiate a nationwide recall which went back up to 2 years to indefinate, although I belive they have started to manufacturer again. Then a month later, what seemed to be the biggestpet food recall ever happened. Not to mention the whole Celebrex ordeal.

Re:FDA might be doing a halfway decent job? (1)

Qzukk (229616) | more than 6 years ago | (#20023189)

If you think that's bad, just wait til you see what happens when they're not there to issue token fines and slap people on the wrist.

Nanotech industry that big? (0)

Anonymous Coward | more than 6 years ago | (#20021549)

If nanotech is such hot shit, why don't I own a single nanotech-based consumer product? Why has nanotech impacted my life in no way whatsoever?

Sounds like a bunch of rigmarole to me.

Re:Nanotech industry that big? (1, Funny)

Anonymous Coward | more than 6 years ago | (#20021645)

you probably already have some, they're just too small for you to see.

Diagnosis (1)

mikiN (75494) | more than 6 years ago | (#20021691)

Classical case of short-sightedness.

The possible impact of nanotech on health extends much beyond just food and medical categories. Whenever life comes into contact with engineered nanostructures, there is a risk of unwanted interactions. Act [com.com] now [hazards.org].

Regulating nanomaterial papertowels (3, Insightful)

maggard (5579) | more than 6 years ago | (#20022511)

The thing is, nanotech enters our biosphere, and our bodies, in novel ways.

Skin doesn't really block it. And once inside us it can even pass the blood/brain barrier. That's not saying all nanotech materials are gonna do that, but I want some assurances that the nifty new coating on my paper towels isn't soaking into me.

Unless the FDA acts and gets this put within their purview then it won't be. Frankly an entire category of new materials, of a scale theyre inherently biologically interactive, being widely distributed into the market, is cause for concern for their impact. To me that justifies a little judicious oversight.

Grey goo [wikipedia.org] isn't so much a fear as industrial poisoning. I'd hate to find out in 2012 that the nano-paint on the 2010 Honda nano-flakes off and then does awful things to lung tissue resulting in asbestos-like problems. Or the nano-polish in my stovetop cleaner aerosolizes (does that apply at this scale?) and polishes corneas - from the inside.

Clearly "Bad things nobody wants to happen".

But, again, without mandates the FDA won't be able to research, perhaps regulate, or eventually react. Even though I think the FDA is a severely compromised agency, often too close to the industries they regulate and constrained by political pressure from the administration ("Coal tar? Good for the sinuses! I sniff some from the great state of _insert_ ev'ry day!") I prefer it over nothing.

Re:Regulating nanomaterial papertowels (1)

beyondkaoru (1008447) | more than 6 years ago | (#20026781)

i think what others are saying about this is that poisonous towels/paint/whatever are already regulated (nanotechnology is just potentially much more dangerous), and that this is more a power grab than anything else.

i too don't want poisonous paint (or grey goo!), but it might not need any significant change in how things are run. now, if they could just decrease the amount of corruption... and nanotech isn't only an fda thing either, so they better not be the only agency running tests.

A power-grab from... themselves? (1)

maggard (5579) | more than 6 years ago | (#20040447)

Your argument confounds itself: How can nanotech simultaneously be "...already regulated (nanotechnology is just potentially much more dangerous)" and "... this is more a power grab than anything else."

You're claiming the FDA doing a power-grab from... themselves?.

Either the FDA Has the mandate to regulate nanottech already or it doesn't.

Not to point out the obvious (though apparently it needs to be) but the point of the FDA process in question, the reports and all, is the FDA saying the FDA doesn't have a clear mandate and would like such.

You can try and debate if they should have such a mandate (just look to China for how lax oversight of food & medicine safety & efficacy works out!) but it's a little awkward to debate from the outside that the FDA is unaware of what their mandates are.

Though, perhaps, some folks posting to /. are capable of believing as many as six impossible things before breakfast, and that is your point?

Nanotech == Molecular == Already regulated (2, Insightful)

gregor-e (136142) | more than 6 years ago | (#20023781)

Anything now posing under the rubric of "nanotechnology" is just pretending to be new and different technology. So far, it's all just molecules, most of which are produced using the same old chemical processes we've always used, and which have the same inherent benefits and risks as any other new molecule. I am disturbed that this fashion trend of dubbing new molecular products "nanotech" is now being used as an excuse for specific regulatory actions. We already have laws and regulations governing testing and deployment of new molecules.

Re:Nanotech == Molecular == Already regulated (2, Interesting)

Anonymous Coward | more than 6 years ago | (#20023909)

This is not strictly correct. "Nanotechnology" refers to materials with dimensions on the order of a hundred to a few hundreds of nanometers. In general, the "nanotech" materials that are interesting (carbon nanotubes, semiconductor nanocrystals, etc.) have emergent properties that are characteristic to their size, and uniquely different from the properties of either single molecules or bulk materials. For example, CdSe nanocrystals ("Quantum dots") are highly fluorescent, but neither bulk CdSe nor CdSe "molecules" are. From a toxicology standpoint, it is possible that most nanoscale materials will behave much like individual molecules, but it is also possible that they will behave differently.

Re:Nanotech == Molecular == Already regulated (2, Interesting)

gregor-e (136142) | more than 6 years ago | (#20025565)

But we've always had materials spanning all ranges of size, from nanometer-sized molecules through tire-sized molecules (a tire being the best example). Many commonly used synthetic and biological polymers span the "nanotech" sizes you mention. Any time there is a mist of solution, the solvent evaporating will leave an airborn clump of solute that is "nanotech-sized", often having a very specific-sized population. We've always had an obligation to investigate the material properties of specific ingredients. It has always been the case that materials in specific forms can have properties different from that of their bulk or single-molecule forms. We have always had to consider whether a particular substance, say, modified to increase its surface area, or provided in the presence of other catalytic substances, will exhibit new properties, desirable or otherwise. There is nothing new in this. To claim that some molecules or clumps of molecules are suddenly more worthy of scrutiny or regulation simply because they have been marketed as "nanotech" is transparent rubbish.

Re:Nanotech == Molecular == Already regulated (0)

Anonymous Coward | more than 6 years ago | (#20031515)

Whether we've had an obligation to examine these materials or not, the fact of the matter is that it has not happened. FDA has not felt it had jurisdiction over a lot of things currently marketed as "nano", because the manufacturers claim their safety is the same as larger materials. If FDA is now recognizing that this may not be the case, and that nanoscale materials are worth examining in the same way that drugs are, that's a good thing.

Precautionary Principle (2, Interesting)

Coleon (946269) | more than 6 years ago | (#20025265)

I think there are two mayor issues with Nanotechnology.
The first is FDA or whatever Administration who has to approve it in other countries. The FDA in some way set the precedent so thats something you consider when you are testing a product to be approved in your country. "
Oh!! It was approved by FDA!! so it must be good"
As "maggard" said

Even though I think the FDA is a severely compromised agency, often too close to the industries they regulate and constrained by political pressure from the administration
So what happends if your almighty FDA fails? I will asume that guys in the FDA tries to make his best to test and to be sure that the product is not going to cause any harm.
In Europe they have something called "precautionary principle" is a moral and political principle which states that if an action or policy might cause severe or irreversible harm to the public, in the absence of a scientific consensus that harm would not ensue, the burden of proof falls on those who would advocate taking the action. http://en.wikipedia.org/wiki/Precautionary_princip le [wikipedia.org]

So this leads us to the second problem. Nanotechnologies are a trillion dollars industry, not bad for a newcommer. So what could happend if they they present false data or they put some pressure to the guys of the FDA or even to some congress men, to try to be a little more permisive on that matter. So it sets a precedent so any other Nanotech company will use to pushit even further. The company prefer to pay some millions in indemnification in the future to loose a trillion dollars market NOW.

The efect of the Nanotech are unknown as well as GMO. And not only in human beings, but any other living creature including vegetables.
It is a difficult choice but the peoples health must be first.

My doctor wanted me to take psychiatric nanotech (1)

MichaelCrawford (610140) | more than 6 years ago | (#20031347)

I have a mental illness called schizoaffective disorder [geometricvisions.com]. It's just like being schizophrenic and manic depressive at the same time.

A while back I was taking a fairly high dose of the antipsychotic Risperdal, and it was giving me symptoms of tardive dyskinesia, a form of brain damage which causes repetitive motions. In my case it was involuntary mouth movements, as if I was chewing gum, but at its worst it can put you in a wheelchair.

My doctor wanted me to be the first at the mental health clinic to try Risperdal Consta [risperdalconsta.com]. Rather than tablets taken each day, R.C. is injected once every two weeks.

How does this work? A two-week dose would normally be an overdose. But the risperidone in Risperdal Consta is encapsulated in nano-spheres that gradually dissolve in the blood, releasing the medicine. There are different grades of the capsules, so some dissolve the first day, some the next and so on.

His main reason for asking me to try it is that it requires a much lower effective dose, I think because conventional Risperdal is partially digested, diminishing its potency so you need a higher dose.

I balked at it when he told me it would cost a thousand dollars a month or so, but he said that the clinic had a fund to pay for its patients' medicine - this was in The Soviet Republic of Canuckistan.

The main reason Consta was developed though was for medication compliance. Many of those who take Risperdal suffer so much from their illnesses that they either don't remember to take it, or their paranoia leads them to believe their medicine is poison.

Because the Consta only needs to be injected every two weeks, once the injection is given, you can be sure that the patient is medicated for the two weeks.

I told my doctor that to use it on me would be an awful waste of taxpayer money, and that the Consta instead should be used on someone for whom it would keep them out of the hospital, that is, someone who on conventional Risperdal would be non-compliant.

(I have sinced switched to Zyprexa, which is more effective for me than Risperdal, so a lower dose works. I don't have the T.D. symptoms anymore.)

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