Slashdot Mirror
FDA Sees Nanotech Challenges In Every Product Category
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.'"
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.
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.
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.
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 now.
The Hacker's Guide To The Kernel: Don't panic()!
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 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.
I don't read ACs: If a post isn't worth so much as a nom de plume to its author then I wont bother either.
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.
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_princi
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.
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. 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.)
Request your free CD of my piano music.
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?
I don't read ACs: If a post isn't worth so much as a nom de plume to its author then I wont bother either.