5 ms·

Interesting article...mostly because it is written, throughout, with the assumption that it would be wonderful if the FDA could prevent people from selling harm

by Lazare 14y ago

Interesting article...mostly because it is written, throughout, with the assumption that it would be wonderful if the FDA could prevent people from selling harmless food items. This is masked, but consider these quotes: "the FDA can’t do anything about a harmful supplement until after it has been on the market and caused harm" and "...legislators [...] pounce, doing their best to kill or water down any legislation that strengthens the FDA’s hand in removing potentially dangerous supplements." In other words, the FDA needs to do something about dangerous supplements before it has caused any harm. But not just actually dangerous supplements, but potentially dangerous supplements too. Well, anything new is potentially dangerous. How would you prove something isn't actually dangerous? A clinic trial, one supposes, at a cost of hundreds millions of dollars? This would effectively outlaw the sale dietary supplements, none of which are profitable enough to make such a trial worthwhile. So, the author wants to shift dietary supplements from "food" to "drugs", thereby destroying the industry. But why? What's so bad about the status quo, anyhow? The author gives a few examples, but almost without exception they are issues which are already solved. That scary story about the NJ factory? Yeah, that's actually ALREADY ILLEGAL. The owners WENT TO JAIL. After being discovered by FDA inspectors, who ALREADY have the power to inspect factories. So, uh...we have an example of something admittedly bad, which is already a crime, and which is already being monitored by the relevant government department, and the owners already went to jail over it, and this is a reason why we need a law change...why? Next example, same deal. An incorrectly made product poisoned hundreds of people. If that's a reason to effectively destroy the industry, then god only knows what we should do poultry farmers after the various salmonella outbreaks over the years. Shoot them, I guess? And finally, to cap the entire piece...the author complains about the FDA not doing a good job of enforcing existing regulations. Which is...an argument for giving them more regulations to enforce. Uh....what? It's like a politician running for election with the slogan "hey, our team may have completely screwed up the economy, but that just means we know more about to fix it!" Where I come from, serious failure on someone's part is not a good argument for increasing their role and responsibilities.

derleth 14y ago
> if the FDA could prevent people from selling harmless food items No. Supplements are not food, legalistic tricks notwithstanding. > But not just actually dangerous supplements, but potentially dangerous supplements too. Well, yes. Or else you're fraudulently using your customers as test subjects. People get angry enough when video game companies do that. > This would effectively outlaw the sale dietary supplements Why would this be a bad thing? > What's so bad about the status quo, anyhow? Massive amounts of fraud. > The author gives a few examples, but almost without exception they are issues which are already solved. That scary story about the NJ factory? Yeah, that's actually ALREADY ILLEGAL. The owners WENT TO JAIL. After being discovered by FDA inspectors, who ALREADY have the power to inspect factories. Interesting how nobody's found half a rat in a factory that makes actual drugs, as opposed to "officially-not-a-drug" supplements. We need to raise the standards to make the bad things less common. Getting supplement makers up to the standards drug makers are would be good. > If that's a reason to effectively destroy the industry, then god only knows what we should do poultry farmers after the various salmonella outbreaks over the years. Shoot them, I guess? No, just raise the bar. Same as here. > And finally, to cap the entire piece...the author complains about the FDA not doing a good job of enforcing existing regulations. Which is...an argument for giving them more regulations to enforce. Uh....what? More and better regulations and more funding, yes. > Where I come from, serious failure on someone's part is not a good argument for increasing their role and responsibilities. So, given the failures of the free market to put fraudulent supplement makers out of business, why would we trust it to do so in the future?
- Gormo 14y ago
  > > This would effectively outlaw the sale dietary supplements > Why would this be a bad thing? Because people who wish to consume dietary supplements would only be able to obtain them via black markets which would likely expose them to more, not less, potential danger.
  - derleth 14y ago
    But fewer people total would consume them, leading to less damage being done overall.
dalke 14y ago
I disagree, and I believe you are reading too much into the article. It wants to distinguish between a dietary supplement, which "supplies one or more essential nutrients missing from the diet" and other supplements, including "even hormones, such as DHEA and melatonin." Where is the limit? Do you agree that an industrial chelator like OSR, untested on even animals, should not be considered a supplement? Let's take DHEA as an example: it's advertised that it "may be beneficial for a wide variety of ailments" (quoting Wikipedia), but none of those claims seem justified, based on experimental testing. While on the other hand, "High doses may cause aggressiveness, irritability, trouble sleeping, and the growth of body or facial hair on women. It also may stop menstruation and lower the levels of HDL." (again, Wikipedia). So we have something which doesn't seem to be useful, and has side effects such that a sugar pill might be better. Let's suppose a supplement has no observed benefits, and has observed and negative side effects. Note that the tests which fail to show benefits do not cost "hundreds of millions of dollars." At what point should that supplement be pulled from the market? Should ephedra be on the market? Some supplements are harmful, if only because of "because of criminally shoddy manufacturing standards." You mention the factor in NJ and implied it was only one of a few examples. The linked to article says "one in four supplement manufacturers has received a warning letter, which is considered significant." That doesn't sound like a few examples to me. Where do you see the author proposing a change to the law? The author wants the existing laws to be enforced. He complains that the supplements industry fights even these basic requirements, and bemoans that the FDA is not fast enough at upholding the law. Where do you see the argument that there should be more regulations for them to enforce? You say the author is like a politician saying "hey, our team may have completely screwed up the economy, but that just means we know more about to fix it!" I believe the claim is that the FDA has been hobbled by Orin Hatch and others, through the law, and that political reasons have meant that the FDA's oversight of the multi-billion dollar supplements industry is not the same team as its oversight of the food industry or the drug industry. So I don't believe your analogy holds - the government is not a homogenous team. Going back to human testing. Tests are done. "Jaako Murso and colleagues followed 38,772 older women for 25 years. ... the risk of death INCREASED with long term use of multivitamins, vitamin B6, folic acid, iron, magnesium, zinc, and copper." "The authors concluded that 'there's little justification for the general and widespread use of dietary supplements.'" Or, Eric Klein and colleagues studied 35,533 men over the past 10 years, looking at whether vitamin E or selenium would decrease the risk of prostate cancer. ... the risk of cancer INCREASED for the min taking vitamin E, selenium, or both. Although the increased risk is small, it is abundantly clear that neither of these supplements is helpful against prostate cancer." (Quoting Forbes.) So, okay, I can accept the idea that supplements can go on the market without being tested. What should the industry result be if subsequent testing shows that the supplement doesn't do anything useful? If the answer is "don't change and keep selling", then I wish it wouldn't associate itself so closely with health and well-being and would instead say it's more like a PEZ.

by Lazare 14y ago

derleth 14y ago

> if the FDA could prevent people from selling harmless food items No. Supplements are not food, legalistic tricks notwithstanding. > But not just actually dangerous supplements, but potentially dangerous supplements too. Well, yes. Or else you're fraudulently using your customers as test subjects. People get angry enough when video game companies do that. > This would effectively outlaw the sale dietary supplements Why would this be a bad thing? > What's so bad about the status quo, anyhow? Massive amounts of fraud. > The author gives a few examples, but almost without exception they are issues which are already solved. That scary story about the NJ factory? Yeah, that's actually ALREADY ILLEGAL. The owners WENT TO JAIL. After being discovered by FDA inspectors, who ALREADY have the power to inspect factories. Interesting how nobody's found half a rat in a factory that makes actual drugs, as opposed to "officially-not-a-drug" supplements. We need to raise the standards to make the bad things less common. Getting supplement makers up to the standards drug makers are would be good. > If that's a reason to effectively destroy the industry, then god only knows what we should do poultry farmers after the various salmonella outbreaks over the years. Shoot them, I guess? No, just raise the bar. Same as here. > And finally, to cap the entire piece...the author complains about the FDA not doing a good job of enforcing existing regulations. Which is...an argument for giving them more regulations to enforce. Uh....what? More and better regulations and more funding, yes. > Where I come from, serious failure on someone's part is not a good argument for increasing their role and responsibilities. So, given the failures of the free market to put fraudulent supplement makers out of business, why would we trust it to do so in the future?

Gormo 14y ago
> > This would effectively outlaw the sale dietary supplements > Why would this be a bad thing? Because people who wish to consume dietary supplements would only be able to obtain them via black markets which would likely expose them to more, not less, potential danger.
- derleth 14y ago
  But fewer people total would consume them, leading to less damage being done overall.

dalke 14y ago

I disagree, and I believe you are reading too much into the article. It wants to distinguish between a dietary supplement, which "supplies one or more essential nutrients missing from the diet" and other supplements, including "even hormones, such as DHEA and melatonin." Where is the limit? Do you agree that an industrial chelator like OSR, untested on even animals, should not be considered a supplement? Let's take DHEA as an example: it's advertised that it "may be beneficial for a wide variety of ailments" (quoting Wikipedia), but none of those claims seem justified, based on experimental testing. While on the other hand, "High doses may cause aggressiveness, irritability, trouble sleeping, and the growth of body or facial hair on women. It also may stop menstruation and lower the levels of HDL." (again, Wikipedia). So we have something which doesn't seem to be useful, and has side effects such that a sugar pill might be better. Let's suppose a supplement has no observed benefits, and has observed and negative side effects. Note that the tests which fail to show benefits do not cost "hundreds of millions of dollars." At what point should that supplement be pulled from the market? Should ephedra be on the market? Some supplements are harmful, if only because of "because of criminally shoddy manufacturing standards." You mention the factor in NJ and implied it was only one of a few examples. The linked to article says "one in four supplement manufacturers has received a warning letter, which is considered significant." That doesn't sound like a few examples to me. Where do you see the author proposing a change to the law? The author wants the existing laws to be enforced. He complains that the supplements industry fights even these basic requirements, and bemoans that the FDA is not fast enough at upholding the law. Where do you see the argument that there should be more regulations for them to enforce? You say the author is like a politician saying "hey, our team may have completely screwed up the economy, but that just means we know more about to fix it!" I believe the claim is that the FDA has been hobbled by Orin Hatch and others, through the law, and that political reasons have meant that the FDA's oversight of the multi-billion dollar supplements industry is not the same team as its oversight of the food industry or the drug industry. So I don't believe your analogy holds - the government is not a homogenous team. Going back to human testing. Tests are done. "Jaako Murso and colleagues followed 38,772 older women for 25 years. ... the risk of death INCREASED with long term use of multivitamins, vitamin B6, folic acid, iron, magnesium, zinc, and copper." "The authors concluded that 'there's little justification for the general and widespread use of dietary supplements.'" Or, Eric Klein and colleagues studied 35,533 men over the past 10 years, looking at whether vitamin E or selenium would decrease the risk of prostate cancer. ... the risk of cancer INCREASED for the min taking vitamin E, selenium, or both. Although the increased risk is small, it is abundantly clear that neither of these supplements is helpful against prostate cancer." (Quoting Forbes.) So, okay, I can accept the idea that supplements can go on the market without being tested. What should the industry result be if subsequent testing shows that the supplement doesn't do anything useful? If the answer is "don't change and keep selling", then I wish it wouldn't associate itself so closely with health and well-being and would instead say it's more like a PEZ.