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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.'"

7 of 21 comments (clear)

  1. Who's Surprised... by StealthyRoid · · Score: 2, Insightful

    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.

  2. Re:Diagnosis by Skates1616 · · Score: 2, Informative

    Check out http://www.abraxane.com/ for the first approved nano-tech drug delivery system.

  3. Regulating nanomaterial papertowels by maggard · · Score: 3, Insightful

    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.
  4. Nanotech == Molecular == Already regulated by gregor-e · · Score: 2, Insightful

    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.

    1. Re:Nanotech == Molecular == Already regulated by Anonymous Coward · · Score: 2, Interesting

      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.

    2. Re:Nanotech == Molecular == Already regulated by gregor-e · · Score: 2, Interesting

      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.

  5. Precautionary Principle by Coleon · · Score: 2, Interesting
    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

    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.