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The Dietary Supplement Safety Act of 2010: A long overdue correction to the DSHEA of 1994?

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Posted in: Herbs & Supplements, Nutrition, Politics and Regulation

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110 thoughts on “The Dietary Supplement Safety Act of 2010: A long overdue correction to the DSHEA of 1994?

  1. David Gorski says:

    I didn’t say it was. Bluntly, my point was that skeptics unwittingly help create the climate of paranoia that exists within alternative medicine regarding ANY regulation.

    You sure as heck seemed to imply that it was to me.

    Bluntly, as for “unwittingly help create the climate of paranoia,” the paranoia was there. It is there. It will be there no matter what skeptics do. The reason is that people who tend to like supplements also tend to be suspicious of any sort of regulation of supplements anyway. More importantly, though, stoking this paranoid fear that the “guv’mint’s gonna take away your supplements” is a highly useful tool for marketing and politics. It’s an incredibly powerful tool to get supporters fired up, just like the claim by the National Rifle Association that the government is going to take away all our guns is a useful rallying cry whenever any sort of handgun regulation (or even regulation of assault weapons) is proposed in this country. It’s also a good sales tactic, and don’t think that supplement manufacturers don’t know it.

    Indeed, from my time in the skeptical blogosphere and my observations this paranoid fear appears to be stoked far more by those supporting supplements. Let’s face it. Any suggestion for more regulation, no matter how mild, is a convenient excuse to launch into a “They won’t get my supplements unless they pry them from my cold, dead hands” sort of reaction. NaturalNews.com is a great example. There are plenty of posts and cartoons there likening the FDA to Hitler and modern medicine to murder and concentration camps.

    No, my friend, I think your concern is misplaced, and being oh-so-concerned that stating the skeptical and science-based position will stoke the paranoia of the “other side” strikes me as the perfect prescription for inaction.

  2. pmoran says:

    “But that isn’t even part of the DSSA of 2010.”

    “I didn’t say it was”

    “You sure as heck seemed to imply that it was to me.”
    ========================================
    PM Where? I stated that I hadn’t read the bill.

    You are only partially looking at what I am saying. That’s OK. Some of my views are very exploratory, but they concern matters that medical skeptics may well overlook through an only partially justified sense of droit du seigneur over the world of medicine.

    I have been through it all. My first gut reaction to my cancer patients being bilked by obvious frauds was that some people should be lined up against the wall and shot. I still react the same to some stories. But just as we insist that medicine be judged by what it aspires to, rather than its horrible bits, there are areas where AM can be given the benefit of some doubt, especially where placebo and other possible psychosocial functions of medical care are concerned.

    When stepping into a doctor’s surgery carries so many known dangers we can also easily overplay the safety card. For debate — most everyday complaints will have much the same outcome regardless of which system the public may resort to for treatment.
    .

  3. Fifi says:

    Dr Gorski – I totally agree that the extremist paranoia is the result of astroturf “activism” and the main sources seem to be naturalnews.com, healthfreedomusa.com and Dr Rath (and the apparently ever-present Scientology that at least the first two outfits seem to be related to). That extremism, however, does tend to get diluted and make it’s way into the mainstream and a lot of the general public who aren’t extremists – and use pretty harmless herbal remedies or a bit of CAM here and there – start to wonder if maybe there is a Big Pharma/medicine plot. (Considering that Big Pharma does conspire to con people and keeps getting caught doing it, this isn’t unreasonable. What’s unreasonable is the belief that Big Pharma and medicine are the same thing.)

    While I agree with you, I also can see what pmoran is saying and agree with his observations, having observed it often myself. Extremists who only attack CAM and are uncritical of Big Pharma – one sided skeptics or simply reactionary faux skeptics – are the equal and opposite side of the coin to the astroturf “activists”. They make it seem as if SBM is one and the same as Big Pharma. That’s why I find the writing of someone such as Dr Crislip so wonderful and important. And so very necessary. It helps people to understand the complexity of medicine and how science is an ongoing attempt to understand biology and not an ideology opposing or reacting to another ideology. It’s about being human, doing the best we can, rather than pretending to be an infallible god. There are some skeptics who are extremists and evangelists (often reformed believers in religion) and some people who treat SBM like a religion. We can argue that they’re not true skeptics but that doesn’t prevent them from claiming to be and passing themselves off as such.

    I don’t see why acknowledging this is a prescription for inaction. One doesn’t have to be an extremist to take action – and sometimes being an extremist doesn’t do much more than provoke equally extreme reactions that result in total deadlock (and inaction). For the record, I do think that there should be better regulations regarding making health claims and having to be more accurate about what is actually in a supplement. So, I’m for regulations simply so that people can actually make informed choices about what they take – be they pharmaceuticals or herbal supplements.

  4. SD says:

    @pmoran:

    “Do you see the problem? The null hypothesis may be a needed device when scientific rigor is at stake, but it is a hopelessly unrealistic and even oppressive basis for regulations affecting public medical behavior or commerce.”

    I find it amusing that you consider the concept of a null hypothesis to be somehow associated with “scientific rigor”. Statistics dealing with homogeneous populations (electrons, countable numbers, mass, atoms, &c.) are “rigorous”, because deviations are either due to model failure (cure: get a better model) or instrument error (cure: get a better instrument). Statistics as they are used for medical science are “useful”. There is a difference. Human beings are not all of a piece, and we are nowhere *near* a level of understanding of how human biology works to permit medicine to be considered “scientific”.

    “i love the smell of hubris in the morning”
    -SD

  5. pmoran says:

    I assure you, SD, having studied these matters intensely, that human beings are MOSTLY “all of a piece”: in anatomy, physiology, biochemistry, and in the pathology and causation of their diseases. We can even describe where, and to some extent why, individuals differ, over a limited range of possibilities that are compatible with life.

    Everyone here knows that some kinds of clinical study have their limitations. But the knowledge medicine applies comes from many sources, some even from your “first principles”.

  6. Harriet Hall says:

    The DSHEA has one consequence that undermines the intent of its supporters. Paradoxically, the DSHEA sometimes means that supplements are less likely to be accepted.
    The fact that diet supplements are not regulated results in their not being recommended by conventional medicine even when there is evidence for their effectiveness. For instance, an article in American Family Physician about treatment of insomnia has this to say about valerian:

    “Valerian root causes central sedation by inhibiting the breakdown of γ-aminobutyric acid (GABA) or its metabolites. There is minimal evidence for its effectiveness in treating insomnia. Residual daytime sedation and, rarely, hepatotoxicity are adverse effects. Preparations are unregulated by the FDA and may vary in valerian content.”

    In this case, there is minimal evidence of effectiveness and some evidence of adverse effects, but even if a product were proven safe and effective, it would be hard to recommend it if you could not count on a reliable preparation with a consistent dosage and assurance that it was pure and uncontaminated. Given two equivalent products, one FDA approved and the other classified as a diet supplement, a rational doctor and a rational patient would prefer the FDA approved version.

  7. David Gorski says:

    I assure you, SD, having studied these matters intensely, that human beings are MOSTLY “all of a piece”: in anatomy, physiology, biochemistry, and in the pathology and causation of their diseases. We can even describe where, and to some extent why, individuals differ, over a limited range of possibilities that are compatible with life.

    Indeed. Yes, there is considerable biological variability, but it’s not nearly so much that science can’t be applied to the problem of understanding human physiology, genetics, and biochemistry and then using that knowledge to design treatments, measure their effectiveness, and come up with good estimates of the probability that a given treatment will work. Many aspects of physiology are stochastic in nature, so that probabilistic considerations can be used to make predictions. Human anatomy, while not invariant, is quite predictable.

    One example: The pH of human blood. It is very tightly regulated in a normal person to a narrow range, generally between 7.35 and 7.45. It is kept in this range by a set of electrolytes whose concentrations are tightly regulated as well and the effects of perturbations of which we can calculate with considerable accuracy.

    SD seems to believe that human physiology is so variable that it’s virtually impossible to make predictions or to design strategies to normalize it when it is not working correctly. He is, quite simply, incorrect.

  8. Jeff says:

    Today The Alliance for Natural Health put this post on their website:

    http://www.anh-usa.org/new_site/?p=2489

    This is a big win for nutrition science and those who use dietary supplements.

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