6 ms·

Dietary supplements: Scary substances manufactured under scary conditions

23 points by derleth 14y ago

derleth 14y ago
Quotes from the article, this batch from FDA inspections of supplement factories: > Some firms don’t even have recipes, known as master manufacturing records, for their products. > Others make their supplements in unsanitary factories. New Jersey-based Quality Formulation Laboratories produced protein powder mixes and other supplements in a facility infested with rodents, rodent feces and urine, according to government records. FDA inspectors found a rodent apparently cut in half next to a scoop, according to a 2008 inspection report. And this shoddiness has a grave impact on real people: > In 2008 more than 200 people — including a 4-year-old — were poisoned by selenium after taking liquid multivitamin dietary supplements that were sold in health stores and by chiropractors, according to a medical paper published on the mass poisoning. The products, called Total Body Formula and Total Body Mega Formula, contained an average of 40,800 micrograms of selenium per serving instead of 200, according to the paper.
- anigbrowl 14y ago
  Clearly we need less regulation and government interference, and these problems will magically take care of themselves.
  - Evbn 14y ago
    Yes, evolution will clear the gene pool of chiropractor and GNC customers.
Evbn 14y ago
There was a fantastic Reddit comment last year where someone did some basic controlled chemical analysis of a very popular cheap protein supplement, and found it had no protein in it.
- Scaevolus 14y ago
  Here's the post: http://www.reddit.com/r/Fitness/comments/uva9t/big_reddit_protein_powder_measurement_results/ http://www.reddit.com/r/Fitness/comments/uva9t/big_reddit_pr... Someone offered to test samples of various protein supplements for various metrics (protein %, solubility, etc.), and discovered that American Pure Whey contained .5% protein.
Empact 14y ago
There's a misleading conflation of at least 2 issues here: If manufacturers are releasing product with substantially different contents than the label, then they are guilty of defrauding their customers. This is a crime which should be expensive for the guilty company. But giving the FDA control over what supplements are allowed in the market is a travesty waiting to happen. The FDA works dramatically slower than decentralized market action, and works under incentives favoring control over free choice. Sites like http://examine.com/ http://examine.com/ are working to bring science and facts to the supplement market, and I expect a lot more progress in this area over the next few years.
- rayiner 14y ago
  > The FDA works dramatically slower than decentralized market action, and works under incentives favoring control over free choice. The FDA was a response to massive market failure.
- derleth 14y ago
  > If manufacturers are releasing product with substantially different contents than the label, then they are guilty of defrauding their customers. This is a crime which should be expensive for the guilty company. I think it should result in prison terms for the principles, but massive fines and punitive damages are a start, at least. > But giving the FDA control over what supplements are allowed in the market is a travesty waiting to happen. How? What can be worse than pills being sold with the wrong things in them, with unknown trash in them, and pills being made in conditions that would get a McDonald's shut down? It's like going back to the pre-FDA era of snake oil. > The FDA works dramatically slower than decentralized market action, and works under incentives favoring control over free choice. Free choice only works if everyone knows what's on offer. That means people would somehow have to know what manufacturers are trustworthy. We've seen from the evidence at hand, both in this century, the previous one, and the ones prior to that, that this does not work in reality. It is utopian. It is a fantasy. You cannot expect people to out-FDA the FDA. Theory must give way to evidence, and we have evidence in this matter.
  - ars 14y ago
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?
praptak 14y ago
Unproven health claims are not only confined to dietary supplements. Dannon (Danone) has a track record of trying to sneak cure-all yogurt claims into their marketeering: http://www.weightymatters.ca/2009/10/european-union-doesnt-believe-in-magic.html http://www.weightymatters.ca/2009/10/european-union-doesnt-b...
narrator 14y ago
Every year there is a regulate supplements as drugs bill in congress. Every year it fails. Mainly because their is a lot of grass roots support for keeping supplements legal and the industry has developed to a point where it can effectively lobby. The constatnt onslaught of anti-supplement bills almost reminds me of the RIAAs continuous lobbying onslaught of draconian copyright bills (sopa, pipa, protectip, etc). Just like too many people are using the internet for the most disturbing copyright bills to pass, there are too many people taking nutritional supplements for the pharma industry "we're all going to die" anti-supplement fud to be effective. Interestingly enough, given all the anti-supplement fud going around in articles like these, prescription drug overdoses now kill more people now than car crashes (http://www.voanews.com/content/article/171721.html http://www.voanews.com/content/article/171721.html).
- dalke 14y ago
  I have tried to track down information about the statement "prescription drug overdoses now kill more people now than car crashes." What I found was "In 2007, approximately 27,000 unintentional drug overdose deaths occurred in the United States" from http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6101a3.htm http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6101a3.htm . I then found "According to the National Highway Traffic Safety Administration's (NHTSA) early projections, the number of traffic fatalities fell three percent between 2009 and 2010, from 33,808 to 32,788." http://www.nhtsa.gov/PR/NHTSA-05-11 http://www.nhtsa.gov/PR/NHTSA-05-11 . Which means about 20% more people die from car crashes than from overdoses. The most common overdose was painkillers. "Overdoses of prescription painkillers have more than tripled in the past 20 years, leading to 14,800 deaths in the United States in 2008" says http://www.cdc.gov/injury/about/focus-rx.html http://www.cdc.gov/injury/about/focus-rx.html. Which means 1/2 of the prescription drug overdoses is from pain killers. Moreover, "Almost one-third of prescription painkiller overdose deaths involve methadone. Six times as many people died of methadone overdoses in 2009 than a decade before." from http://www.cdc.gov/Features/VitalSigns/MethadoneOverdoses/index.html http://www.cdc.gov/Features/VitalSigns/MethadoneOverdoses/in... . The problem, of course, is that there are benefits to methadone, so it's not as simple as banning methadone. BTW, acetaminophen is a relatively dangerous drug. It causes "450 deaths and 56,000 emergency-room visits a year" says http://online.wsj.com/article/SB10001424052970203577304574272292331942618.html http://online.wsj.com/article/SB1000142405297020357730457427... . While reading http://www.nature.com/ajg/journal/v102/n11/full/ajg2007481a.html http://www.nature.com/ajg/journal/v102/n11/full/ajg2007481a.... the estimate is about 650. Anyway, you say "The constant onslaught of anti-supplement bills almost reminds me of the RIAAs continuous lobbying onslaught of draconian copyright bills" and I say the defense of supplements almost reminds me of the tobacco industry's defense of selling and promoting tobacco.
raverbashing 14y ago
In the movie "Bigger Stronger Faster" they have a section on supplements, and this comes as no surprise "Supplements" are a very broad term, and a lot of things are sold under this banner: - "True" Nutritional supplements, offering a dietary value, like carbohydrates, proteins - Supplements of a specific nature like mineral supplements, creatine, other amminoacids or peptides. - Stimulants, some mild, some very heavy and with controversial substances - "Pre-hormones" which are usually actually more damaging than most of the common steroids - Other things, usually useless I guess 80%/90% of all the products are BS, real products usually go straight to the point in their advertisement, and don't try to pass for a miracle or for something they are not.
asithinketh 14y ago
Selling supplements online. The secret of the Tim Ferris "4 hour work week". ;)
Zak 14y ago
I happen to like the fact that I can get hormones like melatonin and drugs like piracetam as dietary supplements without having to go through a doctor or have them approved by the government to treat a specific disease. I don't have insomnia, but sometimes I want to go to sleep at a specific time and melatonin enables me to do it. I don't suffer from any diseases causing cognitive impairment, but sometimes piracetam helps me think more clearly. I strongly oppose any legislative efforts to make it more difficult for me to obtain these substances. That said, some companies in the supplement industry have, without a doubt behaved badly. It seems to me that there are three issues to consider. * Advertising - making false claims in product marketing is already illegal. * Purity - making false claims about what's in a product or selling a contaminated product is already illegal. * Safety - if a substance can cause dangerous effects, the packaging should say so. The first two are already the law. If there are loopholes or unreasonable barriers to enforcement, they should be patched. This doesn't require any major changes in policy - just fine-tuning to make sure existing policy can be enforced. The last one is a bit more problematic under current policy. It's my impression that dangerous supplements can be sold with no labeling even when the dangers are fairly well known. The FDA's only recourse is to remove them from the market if they're found dangerous. I think mandatory warnings on packaging when there's significant evidence a supplement may be dangerous, similar to the black-box warnings on prescription drugs would be a good middle ground.
- ZoFreX 14y ago
  > I strongly oppose any legislative efforts to make it more difficult for me to obtain these substances. The way I took the article was that, if some sane rules were applied and enforced, it would actually be easier for you to obtain them - because right now you could be knocking back selenium and rat urine for all you know.
  - Zak 14y ago
    What I took from the article is that its author would like supplements with drug-like effects regulated as drugs. That generally means they'd need clinical trials demonstrating that they're safe and effective for treating a specific disease, with extra-strong requirements to be sold without a prescription. I don't want that. In his conclusion, he advocates milder measures for enforcement of purity and policing dubious advertising claims, but his use of "at least" implies he wants more rules.

23 points by derleth 14y ago

Quotes from the article, this batch from FDA inspections of supplement factories: > Some firms don’t even have recipes, known as master manufacturing records, for their products. > Others make their supplements in unsanitary factories. New Jersey-based Quality Formulation Laboratories produced protein powder mixes and other supplements in a facility infested with rodents, rodent feces and urine, according to government records. FDA inspectors found a rodent apparently cut in half next to a scoop, according to a 2008 inspection report. And this shoddiness has a grave impact on real people: > In 2008 more than 200 people — including a 4-year-old — were poisoned by selenium after taking liquid multivitamin dietary supplements that were sold in health stores and by chiropractors, according to a medical paper published on the mass poisoning. The products, called Total Body Formula and Total Body Mega Formula, contained an average of 40,800 micrograms of selenium per serving instead of 200, according to the paper.

anigbrowl 14y ago
Clearly we need less regulation and government interference, and these problems will magically take care of themselves.
- Evbn 14y ago
  Yes, evolution will clear the gene pool of chiropractor and GNC customers.

Evbn 14y ago

There was a fantastic Reddit comment last year where someone did some basic controlled chemical analysis of a very popular cheap protein supplement, and found it had no protein in it.

Scaevolus 14y ago
Here's the post: http://www.reddit.com/r/Fitness/comments/uva9t/big_reddit_protein_powder_measurement_results/ http://www.reddit.com/r/Fitness/comments/uva9t/big_reddit_pr... Someone offered to test samples of various protein supplements for various metrics (protein %, solubility, etc.), and discovered that American Pure Whey contained .5% protein.

Empact 14y ago

There's a misleading conflation of at least 2 issues here: If manufacturers are releasing product with substantially different contents than the label, then they are guilty of defrauding their customers. This is a crime which should be expensive for the guilty company. But giving the FDA control over what supplements are allowed in the market is a travesty waiting to happen. The FDA works dramatically slower than decentralized market action, and works under incentives favoring control over free choice. Sites like http://examine.com/ http://examine.com/ are working to bring science and facts to the supplement market, and I expect a lot more progress in this area over the next few years.

rayiner 14y ago
> The FDA works dramatically slower than decentralized market action, and works under incentives favoring control over free choice. The FDA was a response to massive market failure.
derleth 14y ago
> If manufacturers are releasing product with substantially different contents than the label, then they are guilty of defrauding their customers. This is a crime which should be expensive for the guilty company. I think it should result in prison terms for the principles, but massive fines and punitive damages are a start, at least. > But giving the FDA control over what supplements are allowed in the market is a travesty waiting to happen. How? What can be worse than pills being sold with the wrong things in them, with unknown trash in them, and pills being made in conditions that would get a McDonald's shut down? It's like going back to the pre-FDA era of snake oil. > The FDA works dramatically slower than decentralized market action, and works under incentives favoring control over free choice. Free choice only works if everyone knows what's on offer. That means people would somehow have to know what manufacturers are trustworthy. We've seen from the evidence at hand, both in this century, the previous one, and the ones prior to that, that this does not work in reality. It is utopian. It is a fantasy. You cannot expect people to out-FDA the FDA. Theory must give way to evidence, and we have evidence in this matter.
- ars 14y ago

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?

praptak 14y ago

Unproven health claims are not only confined to dietary supplements. Dannon (Danone) has a track record of trying to sneak cure-all yogurt claims into their marketeering: http://www.weightymatters.ca/2009/10/european-union-doesnt-believe-in-magic.html http://www.weightymatters.ca/2009/10/european-union-doesnt-b...

narrator 14y ago

Every year there is a regulate supplements as drugs bill in congress. Every year it fails. Mainly because their is a lot of grass roots support for keeping supplements legal and the industry has developed to a point where it can effectively lobby. The constatnt onslaught of anti-supplement bills almost reminds me of the RIAAs continuous lobbying onslaught of draconian copyright bills (sopa, pipa, protectip, etc). Just like too many people are using the internet for the most disturbing copyright bills to pass, there are too many people taking nutritional supplements for the pharma industry "we're all going to die" anti-supplement fud to be effective. Interestingly enough, given all the anti-supplement fud going around in articles like these, prescription drug overdoses now kill more people now than car crashes (http://www.voanews.com/content/article/171721.html http://www.voanews.com/content/article/171721.html).

dalke 14y ago
I have tried to track down information about the statement "prescription drug overdoses now kill more people now than car crashes." What I found was "In 2007, approximately 27,000 unintentional drug overdose deaths occurred in the United States" from http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6101a3.htm http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6101a3.htm . I then found "According to the National Highway Traffic Safety Administration's (NHTSA) early projections, the number of traffic fatalities fell three percent between 2009 and 2010, from 33,808 to 32,788." http://www.nhtsa.gov/PR/NHTSA-05-11 http://www.nhtsa.gov/PR/NHTSA-05-11 . Which means about 20% more people die from car crashes than from overdoses. The most common overdose was painkillers. "Overdoses of prescription painkillers have more than tripled in the past 20 years, leading to 14,800 deaths in the United States in 2008" says http://www.cdc.gov/injury/about/focus-rx.html http://www.cdc.gov/injury/about/focus-rx.html. Which means 1/2 of the prescription drug overdoses is from pain killers. Moreover, "Almost one-third of prescription painkiller overdose deaths involve methadone. Six times as many people died of methadone overdoses in 2009 than a decade before." from http://www.cdc.gov/Features/VitalSigns/MethadoneOverdoses/index.html http://www.cdc.gov/Features/VitalSigns/MethadoneOverdoses/in... . The problem, of course, is that there are benefits to methadone, so it's not as simple as banning methadone. BTW, acetaminophen is a relatively dangerous drug. It causes "450 deaths and 56,000 emergency-room visits a year" says http://online.wsj.com/article/SB10001424052970203577304574272292331942618.html http://online.wsj.com/article/SB1000142405297020357730457427... . While reading http://www.nature.com/ajg/journal/v102/n11/full/ajg2007481a.html http://www.nature.com/ajg/journal/v102/n11/full/ajg2007481a.... the estimate is about 650. Anyway, you say "The constant onslaught of anti-supplement bills almost reminds me of the RIAAs continuous lobbying onslaught of draconian copyright bills" and I say the defense of supplements almost reminds me of the tobacco industry's defense of selling and promoting tobacco.

raverbashing 14y ago

In the movie "Bigger Stronger Faster" they have a section on supplements, and this comes as no surprise "Supplements" are a very broad term, and a lot of things are sold under this banner: - "True" Nutritional supplements, offering a dietary value, like carbohydrates, proteins - Supplements of a specific nature like mineral supplements, creatine, other amminoacids or peptides. - Stimulants, some mild, some very heavy and with controversial substances - "Pre-hormones" which are usually actually more damaging than most of the common steroids - Other things, usually useless I guess 80%/90% of all the products are BS, real products usually go straight to the point in their advertisement, and don't try to pass for a miracle or for something they are not.

asithinketh 14y ago

Selling supplements online. The secret of the Tim Ferris "4 hour work week". ;)

Zak 14y ago

I happen to like the fact that I can get hormones like melatonin and drugs like piracetam as dietary supplements without having to go through a doctor or have them approved by the government to treat a specific disease. I don't have insomnia, but sometimes I want to go to sleep at a specific time and melatonin enables me to do it. I don't suffer from any diseases causing cognitive impairment, but sometimes piracetam helps me think more clearly. I strongly oppose any legislative efforts to make it more difficult for me to obtain these substances. That said, some companies in the supplement industry have, without a doubt behaved badly. It seems to me that there are three issues to consider. * Advertising - making false claims in product marketing is already illegal. * Purity - making false claims about what's in a product or selling a contaminated product is already illegal. * Safety - if a substance can cause dangerous effects, the packaging should say so. The first two are already the law. If there are loopholes or unreasonable barriers to enforcement, they should be patched. This doesn't require any major changes in policy - just fine-tuning to make sure existing policy can be enforced. The last one is a bit more problematic under current policy. It's my impression that dangerous supplements can be sold with no labeling even when the dangers are fairly well known. The FDA's only recourse is to remove them from the market if they're found dangerous. I think mandatory warnings on packaging when there's significant evidence a supplement may be dangerous, similar to the black-box warnings on prescription drugs would be a good middle ground.

ZoFreX 14y ago
> I strongly oppose any legislative efforts to make it more difficult for me to obtain these substances. The way I took the article was that, if some sane rules were applied and enforced, it would actually be easier for you to obtain them - because right now you could be knocking back selenium and rat urine for all you know.
- Zak 14y ago
  What I took from the article is that its author would like supplements with drug-like effects regulated as drugs. That generally means they'd need clinical trials demonstrating that they're safe and effective for treating a specific disease, with extra-strong requirements to be sold without a prescription. I don't want that. In his conclusion, he advocates milder measures for enforcement of purity and policing dubious advertising claims, but his use of "at least" implies he wants more rules.