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FDA Asked to Regulate Nanotechnology

WillAffleckUW writes "According to the Washington Post, a coalition of environmental and consumer groups has asked the FDA to look at regulating nanotechnology. They point out that there are more than 100 nanotechnology products and that nanoparticles can penetrate cells and tissues, migrate through the body and brain and cause biochemical damage."

25 of 248 comments (clear)

  1. Oh Gawds... by duerra · · Score: 5, Insightful

    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.

    1. Re:Oh Gawds... by Quaoar · · Score: 4, Insightful

      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.

      --
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    2. Re:Oh Gawds... by duerra · · Score: 4, Insightful
      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.
    3. Re:Oh Gawds... by kfg · · Score: 4, Insightful

      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

    4. Re:Oh Gawds... by vux984 · · Score: 5, Insightful

      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. ;)

    5. Re:Oh Gawds... by dbrower · · Score: 4, Insightful
      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

      --
      "It if was easy to do, we'd find someone cheaper than you to do it."
    6. Re:Oh Gawds... by syphax · · Score: 3, Insightful

      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 approach carries no risks.

      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.

      --
      Simple Unexpected Concrete Credible Emotional Stories
    7. Re:Oh Gawds... by blair1q · · Score: 2, Insightful

      "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.

    8. Re:Oh Gawds... by stressmagnetchick · · Score: 2, Insightful

      Let's hire more government bureaucrats! The FDA does such a crap job of carrying out their current duties, it's mind-boggling that anyone would seriously consider handing them a laundry list of new things to do badly.

    9. Re:Oh Gawds... by Rei · · Score: 2, Insightful

      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.

      Not really. What gives nanotech its potential is not its scale persay, but the fact that at that scale, quantum effects come into play. This gives nanoscale materials very different properties than they would have at the large scale. Nanotech materials, as a generalization, tend to be very reactive (even gold nanoparticles) and bioactive (especially since they generally can enter cells readily). These two properties make nanoscale materials, in general, pose a more significant threat to lifeforms than a random, new chemical.

      However, it's more significant than that. While most new chemicals that we create are in "families" of chemicals whose general properties are well understood, the same cannot be said about about nanotech materials which are just emerging. We don't know if we're making the next economically beneficial and harmless chemical or the next economically beneficial but bioaccumulating, slowly-degrading carcinogen.

      As a consequence, we really need to subject new nanotech products to environmental scrutiny before we approve them. Hmm, gee, what department would be good to provide scrutiny on environmental impacts? The EPA.

      I'm sure that they'd rather go with the FDA because of its stringent approval process. Unfortunately, the general case is not applicable to the FDA's role. The EPA is the organization that should be investigating emerging nanotech. If it takes extra legislation to give them the power to conduct studies before a product containing some kind of radically new nanotech material can be produced by the billions, so be it.

      --
      "You see, Government is a system that is based on weapons." -- Timster
    10. Re:Oh Gawds... by lgw · · Score: 2, Insightful

      That might work as well - I don't know much about EPA clinical trials of consumer products, are they in that business?

      In any case, TFA is talking about the FDA regulating nanomaterials in products already regulated by the FDA, which seems right. In general, raw materials which are not biologically active may become so if used as nanomaterials, and *someone* should enforce testing requirements on nanomaterials before they're allowed into consumer products. Preferably an agency which already oversees clinical trials of consumer products.

      --
      Socialism: a lie told by totalitarians and believed by fools.
  2. An excellent way to get nothing done! by FooAtWFU · · Score: 3, Insightful

    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.

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    1. Re:An excellent way to get nothing done! by ch-chuck · · Score: 2, Insightful

      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 at the sporting goods store: $300 at most. Buy a regulated hearing aid from an audiologist: $5000.

      --
      try { do() || do_not(); } catch (JediException err) { yoda(err); }
  3. and they say "Shure!" by way2trivial · · Score: 3, Insightful

    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.

    --
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  4. Progress! by thefirelane · · Score: 4, Insightful
    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.

  5. Scientists will merely switch to another scale by PIPBoy3000 · · Score: 1, Insightful

    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.

  6. Re:Luddites... by cnettel · · Score: 2, Insightful

    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.

  7. Re:and they say "Shure!" or what's next by WillAffleckUW · · Score: 4, Insightful

    I know, I've sat in on about twenty nanotechnology seminars at the UW over the past six months.

    My point is, this is a real news story, the FDA has been asked by multiple groups to investigate nanotechnology for those products which may - or may not - be able to cross over into humans.

    Until they research it, they won't know if it's possible, and - if so - what safeguards or regulations are or should be necessary.

    At that point, after input from bioethicists - and I've attended a few panels and seminars on bioethics, as well as journal clubs - recommendations would be made and model legislation would be drafted.

    At that point, slashdotters would be able to publicly comment on any such proposed legislation.

    It's like when autos were invented - there were no traffic rules for a long time. Then, once they reached a certain level, people created regulations concerning driving, driving ages, rules of the road, railroad crossings, brakes, horns, and so on.

    Since we now have more than 100 nanotechnology patents, it's likely we are - in fact - at that point where we need to investigate whether or not we need regulations - and, if so, at what level. Perhaps we need such regulation at the creation side, perhaps at the manufacturing side, perhaps on the consumer side. We don't know yet.

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  8. Nanotech is more than tiny machines by TimmyDee · · Score: 5, Insightful

    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.)

    --
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  9. Re:Are they kidding? by DragonWriter · · Score: 2, Insightful
    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) 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".

  10. Nanotechnology versus cute nanoparticles by i+am+kman · · Score: 2, Insightful

    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!

  11. Look into the Constitution by mangu · · Score: 3, Insightful
    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.

  12. puzzled by gone.fishing · · Score: 2, Insightful

    I am not going to differentiate between nano-tech and nano-particles here even though I understand there is a difference between the two, but in the case of this post, I don't think the two terms need to be differentiated. To do so would be hair-splitting.

    I can see how the FDA could regulate nano-tech if it is an ingredient in food, medicine, cosmetics or if it is a "medical device". I can not see how they would be involved if it was a more "industrial" component (say an ingredient in paint or a component in some high tech alloy).

    It is the use more than the component that really makes a difference here. I really doubt that nano-tech used in electronics will ever be considered able to be regulated by the FDA until it is incorporated into something like a pacemaker.

    I hope I am correct in this but with our current state of government in the U.S.A. it is really hard to tell. It is probably only a matter of time until the FDA comes under the umbrella of "Homeland Security" then who knows what will happen.

  13. Regulate existing ones first by vik · · Score: 2, Insightful

    It's funny, but when the nanoparticles are produced by internal combustion engines - the source of the most potent non-radioactive carcinogens known - or from plasticisers used in plastic goods etc., the US government is positively glacial in its response.

    Start developing a new technology that promises to completely revolutionise the manufacturing and supply industries as we know them, and POW! Suddenly there is activity to ban it because it might produce nasty chemicals if done in an inconsiderate manner.

    So much for US industry.

    At this rate the US will be buying its nanotechnology from Venezuela.

    Vik :v)

  14. Re:Riiight... by Anonymous Coward · · Score: 1, Insightful

    The mere existence of the FDA is proof that this is not free-market capitalism. It's State-capitlism with protections put in place to shield corporations from any liability. Your blame is sorely misplaced.