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.
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.
I understand your position, but unfortunately it has little relevance to the world we live in. Not only is there no unambiguous rule to seperate "supplements" from "food", everything you say applies to things which are unquestionably food.
You complain about vague and perhaps incorrect claims for DHEA; I can counter with vague and incorrect claims for a whole RANGE of foods. Broccoli can cure cancer, red wine makes you immortal, pineapple juice makes your semen taste good, margarine is good for the heart, margarine is bad for the heart, eggs are bad for your heart. Need I go on? Some of the claims we hear constantly are true, some are false, and many are completely unproven. But what of it? Is vague talk about how red wine might boost longevity bad? If not, does it become bad if I take some red grape skins, grind them up, put them in capsules, and sell them with, again, nothing more than vague talk about how they might boost longevity? If so, then what claim about which foods are/aren't healthy can't be challenged? Our knowledge of diet and nutrition is INCREDIBLY weak; we're still trying to figure out stuff like "is too much salt bad for you" or "is wheat bad for you" (both open questions even today, despite what you might have heard).
And things which are inarguably foods have killed orders of magniture more people than supplements ever have. Between food poisoning, allergies, adulterated ingredients, poor manufacturing processes, down to foods which are, outright, really bad for you - walk down any supermarket aisle and you'll see them all.
Also, the author did strongly endorse a law change; he has noted that laws are NOW being enforced, but were not in the past, and yet still feels there is currently a problem. His discussion of Orin Hatch related to proposed changes in the regulations, not whether current regulations were being enforced.
The studies you quote are observational studies; if you knew anything about this field you'd know they are suggestive but prove nothing. (Thought experiment: Do you suppose people who take lots of supplements are EXACTLY like other people? Or do they possibly have some ailment that makes them more interested in improving their health?) I'm sorry, but science has hard rules, and the studies your quote blatantly violate them. There's no substitute for controlled randomized studies, and you cannot draw the conclusions you - or Forbes - have drawn from studies which are neither. There's just no real room for debate. In which case...where does that leave the argument about supplements?
Your points about food bring up the main point, which is that both food AND drugs are regulated more strongly than the supplement market. When I buy red wine, I expect that it will contain alcohol and that it won't contain methanol. When I buy broccoli, I don't expect that it will be contaminated with E. coli - and when it does, I expect that it will be tracked down to the farm in Uelzei and anything else so contaminated get recalled.
When I buy pineapple juice, I don't see claims about how it make semen taste good. When I buy food in general, I don't want to see health claims at all being used as advertisement, because I know that any such claims can be cherry picked.
But that last is my own preference. The point of the article is that some 20+% of supplement manufacturers are not in compliance with the existing laws. The problems include horrible hygiene and high variability in the product, such that the consumer cannot make an informed decision about what they are buying.
I read the article again and I see that you are correct - the author does want a change. Orac wants the FDA or some other similar organization to be in charge of deciding what a drug is, and not the manufacturer. For example, is it okay for a manufacturer to decide that an industrial chelator is a supplement, and not a drug? On this, at least, the FDA has said no.
I read the article as saying that the problem is that the muli-billion dollar supplement industry has done a poor job of regulating itself, the FDA took a long time to enforce the law, the supplement industry has strong political influence, and the author is pessimistic and thinks that "any victory will be short-lived." This analysis from the Consumer Reports http://www.consumerreports.org/cro/2012/05/dangerous-supplem... corroborates that pessimistic view.
One of the studies I quoted concluded 'there's little justification for the general and widespread use of dietary supplements' in older women. The more complete quote from their paper seems to be "Based on existing evidence, we see little justification for the general and widespread use of dietary supplements. We recommend that they be used with strong medically based cause, such as symptomatic nutrient deficiency disease."
In an interview with the first author of the paper, the author is asked: Medscape: In your study, the supplement users actually had a healthier lifestyle than the nonusers at baseline. So, they were unlikely to be taking supplements to make up for a deficiency in diet, but for prevention and treatment.
Dr. Mursu: That seems to be the case, and that has been noticed in other studies as well, so usually the supplement users are the ones who do not really need them. Usually, they have healthier lifestyles and they are not taking them to make up for a dietary deficiency.
Dr. Mursu: In our study, among the supplement users, their diet was better, they were exercising more, they were less likely to be smokers, and they were better educated -- so, if you did not adjust for these factors, the findings would be that these supplements are beneficial. Taking these factors into account in the statistical models, then, is a crucial part of the study. I was surprised to see that, after adjustment for these factors, supplements seemed to be harmful. ... We cannot exclude the possibility that in some cases for some diseases, these supplements would be beneficial. The aim of our study was to take a broader look, but the main causes of mortality in this population are still cardiovascular disease and cancer. If supplements were beneficial, then you would have expected to see an effect with the simple approach that we used.
I believe that addresses your point in the negative - most people who take supplements are healthier than average, and it's not because "they possibly some ailment that makes them more interested in improving their health."
If an older woman goes to a supplement store and asks if they should take a supplement like copper, folic acid, B6, or a few of the other supplements in the study, and wants to do so in order to help prevent chronic disease, do you think that most salespeople are going to say "no"? Hardly! I mean, according to Consumer Reports: Undercover investigators from the Government Accountability Office, posing as elderly consumers, caught salespeople on tape dispensing potentially harmful medical advice. In one case, a salesperson told an investigator that a garlic supplement could be taken in lieu of high blood pressure medicine.
But the right, most medically correct answer is "no, there's no observed benefits and it seems there's some risk, so it's probably not worth it unless you have a vitamin or mineral deficiency."
As for your disdain for all but the hardest rules of sciences, how delightfully unbalanced it is that a population study with 30,000 people over a period of decades, published in the Archives of Internal Medicine, etc. is suspect while (according to Consumer Reports): Go Away Gray, a product that is claimed to "help stop your hair from turning gray." ... has not had to provide product information to the FDA. Nor did it conduct any clinical trials of the supplement, which includes a natural enzyme called catalase, before putting it on sale. Beggan pointed us to a study by European researchers published in the July 2009 issue of the Federation of American Societies for Experimental Biology Journal. The study found that gray hair had lower-than-normal levels of catalase but did not prove that taking that enzyme by mouth would stop hair from turning gray. "We are working on getting an actual clinical trial going because the results have been so amazing, and it would just be good to have some concrete data behind it," Beggan said.
Tell me, if the research blatantly violates certain hard rules of science, what are these rules? Should I request that the authors be brought up against an ethics committee? I believe you mean to say that only double-blind trials are acceptable. Why then can a supplement point to http://www.fasebj.org/content/23/7/2065 as justification, while any counter-evidence must be rejected until it has met the most exacting of standards?
The double-blind trial you asked for, which is a follow-up to the Mursu study, starts this year. It will take 5- or 10- years to get enough data. But as the researcher points out, what's been done now should be enough to determine if there's a strong indicator that those supplements are useful. Why do you disagree with that conclusion?
To close out with another quote from that Consumer Report article: we identified a group of ingredients (out of nearly 1,100 in the database) linked to serious adverse events by clinical research or case reports. To come up with our dozen finalists, we also considered factors such as whether the ingredients were effective for their purported uses and how readily available they were to consumers. We then shopped for them online and in stores near our Yonkers, N.Y., headquarters and easily found all of them for sale in June 2010. ... The dozen are aconite, bitter orange, chaparral, colloidal silver, coltsfoot, comfrey, country mallow, germanium, greater celandine, kava, lobelia, and yohimbe. The FDA has warned about at least eight of them, some as long ago as 1993.
> both food AND drugs are regulated more strongly than the supplement market
Incorrect. Although if you DO think that, I can see why you'd think that supplements need more regulation. :)
> When I buy red wine, I expect that it will contain alcohol and that it won't contain methanol. When I buy broccoli, I don't expect that it will be contaminated with E. coli - and when it does, I expect that it will be tracked down to the farm in Uelzei and anything else so contaminated get recalled.
Yep, just like with supplements. Mislabelled or contaminated supplements are illegal, and the FDA is charged with enforcing those regulations.
> When I buy pineapple juice, I don't see claims about how it make semen taste good.
Yep, just like with supplements. False claims are illegal, and again, the FDA is charged with enforcing those regulations.
Also - no, those studies are still crap. Observational studies simply cannot be used in the way you and the people you quote are using them, full stop. :)
(Mind you, I also agree that many supplements on the market do nothing useful, and many of the people taking supplements don't need whatever useful thing the supplement they're using might actually do. I'm just waiting to hear a good reason why we need rules beyond "it has to be whatever it says on the label, it can't actually kill people, and you can't lie about what it does". Keeping in mind, of course, that these are the rules currently in effect...)
By "are regulated" I mean that there are laws and enforcement of those laws. I don't mean only that there needs to be more regulations. (Even if we agree on that, I state it now because I see that it wasn't clear.)
Yes, the FDA is charged with enforcing those laws. I think it's done a piss-poor job in doing so, as several of the links which I and others have provided show. I think there's not enough funding for its mandate, I think there's political pressure both to minimize funding for any government oversight ("let the free market fairy decide"), and I think there's political pressure specifically regarding supplements, as described in the linked-to article.
You are disdainful of existing research but you don't say why. I've asked for clarification, but you only say that they are full of crap, without explanation. Observational studies are done all the time: with people, whales, forests, hurricanes, volcanoes, galaxies, cosmic particles, earthquakes, and more. Are you saying that all of those observational studies are inherently incorrect?
If not, what makes these specific supplement studies full-of-crap while not the ones which don't involve people? What is the methodological error?
I would say that the message of the article is "we need more regulations". My reaction was, basically, "you haven't shown that; at best you've suggested we need better enforcement of existing regulations'. So while I disagree with the original linked article, I'm not sure you and I disagree. :)
As for the studies, this is winding far afield, but there's two main ways you can do a study: Controlled and observational. Controlled is hard, but gives good data. Observational is easy, but gives unreliable data, especially when relating to people.
To a first approximation, a controlled study can prove things about human health, while an observational study can suggest areas where a controlled study would be useful.
It's not that these studies have methodological errors (as far as I know, they don't). It's that they're observational studies, and best case, they can't prove things in the way a controlled study would.
If you want a good primer on "what are observational studies and why are they problematic for human health"...I don't actually have one handy. But there was some very good discussion floating around about the "Red Meat Consumption and Mortality" recently published in the Archives of Internal Medicine.
A lot of headlines said, basically, "science proves meat will give you cancer", but again, it was an observational study, and it simply didn't show what people who didn't understand statistics thought it did. Some links discussing that:
> 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?
> Interesting how nobody's found half a rat in a factory that makes actual drugs, as opposed to "officially-not-a-drug" supplements.
Heh. You don't quite seem to be getting the argument. Supplements are officially food, and we find pieces of rats in food all the damn time. (Also bits of metal, glass, human body parts, bugs, and every other crazy damn thing you can imagine.) (Related: Food is potentially dangerous, but it's not tested. Again, what makes a vitamin C pill need clinical trials, but food not? Keep in mind, modern "food" is often just the product of a test tube, while many supplements are just lightly processed food (fish oil, for example). What's the difference?)
What you need to do is figure out why it's a huge, huge, problem for their to be half a rat ground up in Joe Slob's dietary supplements, but just one of those things for there to be a some rat in his hamburger bun.
So far, your argument for why supplements should be treated differently than food seems to consist entirely of "supplements are not food, legalistic tricks notwithstanding." That's...probably not going to convince anyone who doesn't already agree with you. If that's a goal of yours, you might want to rethink.
(Also: You keep saying "fraud", but fraud is already a crime. Is it your argument that supplement makers aren't being prosecuted due to some massive far-reaching conspiracy at every level of the government? Or when you say fraud do you have some special definition of the word different than everyone else? Just curious!)
> > 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.
The 'damage' described in the article is the result of mis-labeled products being sold to unwary consumers, not of properly-informed consumers experiencing negative consequences of risk judgments that they've intentionally chosen to make. This kind of damage is more likely to occur in a black market setting, in which the protections of law are unavailable, than it is to occur in an open and above-board market, in which participants have recourse against such fraud.
Consider also that suppressing supplements entirely also equally suppresses the benefit that consumers may enjoy from their use, and it's entirely plausible that the 'overall' reduction in benefit may exceed the 'overall' reduction in harm, so even if we were to use your purely utilitarian criterion as our only decision-making guide, such a policy might still be unjustified.
> This kind of damage is more likely to occur in a black market setting
But less of it, since making it illegal would greatly reduce demand. Unless you can come up with a reason why supplements are similar enough to illegal drugs it wouldn't.
> Consider also that suppressing supplements entirely also equally suppresses the benefit that consumers may enjoy from their use
Empirically, that is a very minor concern, if it is one at all.
> But less of it, since making it illegal would greatly reduce demand
It would reduce the expression of demand, certainly, but not the actual desires of individuals that produced that expression; or to put it another way, will reduce the fulfillment of demand while the underlying unfulfilled demand still exists. This yields a net reduction in total happiness, which is counter to your apparent utilitarian ethos.
> Empirically, that is a very minor concern, if it is one at all.
Empirically? What does assessment of subjective value have to do with empirical data, apart from recognizing that individuals' subjective value empirically exists and is the source of demand?
Apart from that, apart from your apparent utilitarianism - the criteria of which remain yet unsatisfied in this discussion - what's the moral basis your assertion that forcibly denying the extant happiness of many is justifiable in order to reduce the potential unhappiness of few, especially considering that the former is not strictly necessary in order to achieve the latter, and that forcing a single uniform policy indiscriminately upon all is merely a contrivance of convenience?
My moral basis is preventing fraud and punishing people who commit fraud.
> forcing a single uniform policy indiscriminately upon all is merely a contrivance of convenience
No. If you want to claim to promote health, your products need to be shown to promote health. Supplement makers have been able to get around that very basic moral law using loopholes and bought-off politicians. I want an end to that.
> My moral basis is preventing fraud and punishing people who commit fraud.
You appear to be going far beyond dealing with fraud, and instead wish to suppress activity that's being undertaken without any deceit.
> If you want to claim to promote health, your products need to be shown to promote health.
That's fine. Note, of course, that the vast majority of supplement products contain explicit disclaimers on their labels (e.g. "These statements have not been evaluated by the FDA" and "This product is not intended to diagnose, treat, cure, or prevent any disease") that make allegations of actual fraud quite spurious. And, of course, actual fraud of the kind described in the article - e.g. selling a bottle labeled "Vitamin C" that contains no actual vitamin C - is entirely illegal with or without FDA intervention.
However, if I want to purchase a bottle of foo, honestly labeled as "foo" without making any unsustainable promises, and use the contents of that bottle based upon my own understanding of the properties of "foo", that's entirely my prerogative, and it's entirely my right to assume whatever risks the use of foo entails.
(Of course, there is the issue of defining exactly what it actually means to "promote health".)
> You appear to be going far beyond dealing with fraud, and instead wish to suppress activity that's being undertaken without any deceit.
'Deceit' does not start and end with the technical definition of fraud.
> Note, of course, that the vast majority of supplement products contain explicit disclaimers on their labels
They shout their ads and whisper their disclaimers. Why should we ignore their shouting?
> However, if I want to purchase a bottle of foo, honestly labeled as "foo" without making any unsustainable promises, and use the contents of that bottle based upon my own understanding of the properties of "foo", that's entirely my prerogative, and it's entirely my right to assume whatever risks the use of foo entails.
Why should you be able to sell something that you lead others to believe is good for them when it isn't?
Selling dandelions by marketing them as pretty flowers is fine. Selling them by marketing them as wine making material is also fine, as you can, in fact, make wine out of dandelions. Selling them by claiming dandelion wine is good for what ails you is lying. Can you honestly not see that last step?
> 'Deceit' does not start and end with the technical definition of fraud.
No, but fraud does start and end within the definition of 'deceit'.
> They shout their ads and whisper their disclaimers. Why should we ignore their shouting?
I've not personally seen ads for supplements of the kind you're describing, but if they* were* advertising features that weren't actually available in the products, that is, at minimum, a bait-and-switch ad, which is already a fraudulent practice.
> Why should you be able to sell something that you lead others to believe is good for them when it isn't?
Whether it is or isn't "good for them" is, of course, determined by them - we're in the realm of value judgments here - and while it's entirely unethical and already illegal to sell someone a product on the basis of fraudulent information, selling a product with an explicit disclaimer that states that the product has not been empirically proven to fulfill any health claims made about it is perfectly legitimate.
Selling dandelions in a box marked "dandelions" without making any unprovable claims is always perfectly OK; selling dandelions as a cure for cancer is already a fraudulent activity punishable by law.
This is apparently not the case, since a large number of people continue to purchase and consume supplements, and if the article is to be believed, this has resulted in providing the producers of those supplements with sufficient resources to successfully prevent their market from being suppressed by political activity, a feat which even the alcohol industry was unable to accomplish in 1919.
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/ 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.
> 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.
> 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?
What does that have to do with pills? If people are making any kind of food at all that is filled with trash then the FDA should stop them, but it has nothing at all to do with them being supplements.
We're discussing supplements, which are usually sold in pill form.
> If people are making any kind of food at all that is filled with trash then the FDA should stop them, but it has nothing at all to do with them being supplements.
Should, yes. However, if you read the article, you'll see a very bad law that prevents the FDA from doing so in the case of supplements.
> Snake oil at least was (usually) what it said on the bottle.
Really? I don't know one way or the other for sure about historical snake oil: My usage there was 'snake oil' as a synonym for 'an untested product guaranteed to cure anything and everything, sold by a con artist'.
> However, if you read the article, you'll see a very bad law that prevents the FDA from doing so in the case of supplements.
I did read the article, and that isn't true. If the pill does not have what it says on the bottle then they can easily shut them down.
> Really? I don't know one way or the other for sure about historical snake oil: My usage there was 'snake oil' as a synonym for 'an untested product guaranteed to cure anything and everything, sold by a con artist'.
I realized that right after I said it, so I edited out that sentence. But to reply to you: If the product has what it says it has, then the FDA has no business regulating it. They should regulate fraud - a product that does not have the listed ingredients for example. Or a false claim. But they have no business telling people that they can not buy/eat this or that plant.
> But they have no business telling people that they can not buy/eat this or that plant.
Yes, they do, because part of the FDA's job is looking after idiots. That's because looking after idiots is part of society's job. It's why highways have guard rails: You can't expect everyone to be perfect all the time.
Absolutely! It's so unintuitive that preventing people from doing things you don't want might get them to not do those things, I totally fail to understand why people buy into that "myth!"
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.
> 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.
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.
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).
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 .
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 .
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. 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/in... . The problem, of course, is that there are benefits to methadone, so it's not as simple as banning methadone.
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.
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.
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.
Someone offered to test samples of various protein supplements for various metrics (protein %, solubility, etc.), and discovered that American Pure Whey contained .5% protein.
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.
"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.