10mg ginseng, 50mg caffeine, 65mg carpet fluff

In the USA, marketing of "dietary supplements" - which pretty much means all over-the-counter edible "alternative medicines" in the USA - is regulated by the Dietary Supplement Health and Education Act of 1994, known for short as the DSHEA.

The DSHEA restricts the ability of the US Food and Drug Administration to regulate these "dietary supplements". It, essentially, means that the people who make and sell supplements do not need to demonstrate that their products are effective, or even safe. There is no pre-market testing at all. No effort whatsoever is made to determine that dietary supplements do what they're meant to do, or even that they contain what they're meant to contain.

This laissez-faire approach has had pretty much the effect you'd expect it to. Never mind debates over whether St John's Wort is actually of any use in the treatment of depression, or whether echinacea is any good against colds; it's perfectly normal for pills allegedly containing a given quantity of those substances to contain far more, or far less, or none at all. And until someone notices and makes a fuss, not a thing will be done about it. The FDA won't investigate by itself, because the DSHEA says it can't.

I present all this by way of an explanatory preface to this little Consumerist post, in which the manufacturing processes of one modern dietary supplement manufacturer are explained.

(The DSHEA is a clearly codified lack of regulation, but realistically speaking you don't seem likely to be able to buy better "supplements" in most other nations. Here in Australia, one major pill-maker was busted heavily in 2003 - but that's very much the exception rather than the rule.)

25 Responses to “10mg ginseng, 50mg caffeine, 65mg carpet fluff”

  1. rho Says:

    While I'm not thrilled about whackadoo naturalist medicines, I'm equally not thrilled about a central point of failure for beneficial drugs, i.e. the FDA. Bureaucratic lag is a crummy thing, too. Whether it's more or less dangerous than OrganoHealthPills.com (or whatever), I don't know.

  2. KD Says:

    The DSHEA was a response to attempts by the drug companies to use the FDA to block availability of alternative treatments that treaten drug company revenue. It isn't a great solution, but it is about the only one I think we could hope to get, and I was surprised that we even got it. It is the responsibility of each individual to search out suppliers that take seriously their responsibility to deliver products that contain what they say they contain and are not contaminated. They can get advice about that from their (alternative) health care providers.

    Find a way to keep the drug companies (and other threatened interests) from corrupting the system, provide funding for proper clinical trials of alternative treatments, then we can talk about regulating those products.

  3. KD Says:

    Note that the example described seems to be a very small business. I have a feeling (I'm not in the field) that an operation with any decent volume would find it far cheaper to have the capsules filled by machine by some service, which I'd expect would maintain a reasonably clean, contaminant-free work environment. I assume such services exist and are much cheaper than hand-filling, given sufficient volume. My point is that the decidedly poor manufacturing conditions described in the article probably are true for an extremely small percentage of the total volume of health supplement products.

    The point that the health effects of the desired ingredients have not been rigorously studied is not affected by that, but you shouldn't conflate the appalling manufacturing conditions of (I imagine) a very small proportion of the total supply of health supplement products with the effectiveness and safety questions.

    Choosing a trustworthy supplier probably is enough to protect you against the poor manufacturing conditions problems. For the solution to the effectiveness and safety problems, see my previous post for why we can't address that at the moment.

  4. dabrett Says:

    It's funny this should come up, as I read this article today:
    (No idea how long the link will work for)
    At least the consumers here were at least getting the active ingredient- although they probably wish they didn't.
    I guess this is what can happen when these companies are not required to even demonstrate the safety of their products.
    Mind you, it's one of those interesting situations- while I am in no way in favour of herbal quackery, clinical trials are expensive to run and no doubt many of these small supplement companies wouldn't be able to afford to have them for every product they have, which then leaves the market dominated by large companies, who aren't interested in developing anything that they can't own the intellectual property to.
    Still, surely some sort of safety testing would be appropriate. Efficacy is really too much to hope for.

  5. Daniel Rutter Says:

    It is the responsibility of each individual to search out suppliers that take seriously their responsibility to deliver products that contain what they say they contain and are not contaminated. They can get advice about that from their (alternative) health care providers.

    This is not very practical. As a matter of fact, I'd go so far as to call it almost impossible.

    In the absence of any effective regulation of the content of "alternative" medicines, the only way for a practitioner to be able to actually tell you which brands are any good is if they, the practitioner, have run an assay on the pills. It wouldn't be impossible for a bunch of alternative practitioners to get together to hire an analytic lab to do this at only moderate expense (although it'd be an ongoing expense - you'd have to check batch after batch), but I am aware of no evidence that any of them have ever done so. It would be strange if they did, since they're almost without exception so fanatically opposed to the government doing it for them.

    They don't seem to object to the government checking meat for salmonella or booze to see if it's got the stated amount of alcohol in it, but when it comes to the source of their own livelihood they're determined to leave it all free and easy.

    I'm sure - I really am, I'm not just saying this - that there are some alt-med practitioners out there who're competent and educated, and who even refer cases to other doctors when their pet therapy is likely to be ineffective.

    Most of them, however, can't even recognise chicken pox.

    Even if a patient spends a huge amount of time doctor-shopping to try to find a good alt-med practitioner, and is happy to drive for hours if necessary, I'm at a loss as to how that patient would even be able to consistently tell a good practitioner from a bad one.

    It's not the olden days, when a physician was more likely to do harm than good, any more. "Scientific medicine" has made incredible - and I use the word advisedly - strides. "Alternative medicine" is still stuck in the pre-Enlightenment days, pretending that the only alternative is a bunch of magicians talking about "humours" and sticking leeches on the patient.

    Since the barriers of entry to alternative-practitioner-dom are notoriously low - in many countries (and US states) you can hang out a "naturopath", "homeopath" or "nutritionist" shingle, for instance, without any actual training at all - one can only presume that the evidence of investigations like the above-linked chicken-pox one is true, and that competent alternative practitioners are a tiny minority.

  6. KD Says:

    Yes, the suggestion you made is impractical, but that isn't what I suggested. Notice I said "suppliers that take seriously their responsibility". You don't determine that via an assay.

    Someone seeking alternative treatments, must select a doctor (a true MD) who has also studied alternative treatments or a non-doctor who has had some reasonable training from such doctors and decide whether they seem trustworthy. Those people exchange information about suppliers that are trustworthy, usually determined by personal contacts, visits to manufacturing facilities, etc.

    It isn't the best possible system. Accidents can happen in the manufacturing. People can stray from being trustworthy (or sometimes can be untrustworthy from the start, but able to fool people). You do your best to try to avoid being taken in by them, but it might happen. Some of the supplements no doubt are useless, possibly even somewhat harmful. We settle for that because we know that if we allow the FDA to regulate the nutritional supplements, the drug companies will push to make all the supplements unavailable, and sooner or later, will succeed.

    It isn't a great system, but we'll defend it until someone finds a way to keep the drug companies from corrupting the official system and finds a way to fund proper clinical trials of the supplements. Then, and only then, will we agree that regulation is acceptable.

  7. Daniel Rutter Says:

    Those people exchange information about suppliers that are trustworthy, usually determined by personal contacts, visits to manufacturing facilities, etc.

    Have you any evidence that this actually happens?

    If it it is your position that only one out of a thousand (if that) alternative practitioners lives up to your high standards, then I agree, but your argument becomes one in favour of government regulation, because clearly the industry is almost completely rotten.

    If you claim that some more significant fraction of alternative practitioners have gone to the very great lengths needed to establish that the pills they're selling (and yes, most alternative practitioners do sell what they prescribe, an obvious conflict of interest that has been eliminated in most mainstream medicine...) are what they're meant to be, and do what they're meant to do, then I really must insist that you present some concrete evidence to support this claim.

    It's a truism that unregulated industries invariably end up optimising profit above everything else, and that good manufacturers and vendors are driven out of the business by the (more profitable, less scrupulous) bad ones. Industrial self-regulation is usually a joke, but the supplement industry doesn't even have that much of a fig leaf.

    if we allow the FDA to regulate the nutritional supplements, the drug companies will push to make all the supplements unavailable

    This claim has been made many times, but it makes no sense at all.

    The big drug companies already make many "supplements", and aren't much less happy about the DSHEA than are the supplement-only manufacturers. If real regulation of supplements were put in place, the drug companies might stand to gain because they've already got proper manufacturing processes (and have greased more governmental palms...), and so could compete better with the supplement-only outfits.

    But the supplement industry in the USA alone is worth tens of billions a year (which makes the lack of proper studies of the effects of many supplements, which you mention, particularly galling). The whole problem with "big pharma" is that it just does what makes money, not what's good for its customers. If you can make billions by making supplements, big pharma will, and does, make supplements, with a smile on their faces and a song in their hearts.

  8. sockatume Says:

    If I were a less-than-scrupulous boss of a firm in the chemical medicine business, I'd (quietly) set up a floatilla of suppliment companies as wholly-owned subsiduaries. Got a vaguely plant- or animal-derived drug in phase one which helps cut down abdominal pain in rats but carries a small-but-statistically-significant risk of kidney damage in all your other test animals? Simply misplace the evidence and release it in a low-dose flavour as a suppliment. If someone cottons onto the problem, move them onto a differently-named but essentially-identical product and (if the FDA are looking your way) discontinue the old one citing concern for your customers' welfare, or impurities, or something.

    This is unlikely to happen though - if somebody starts peeing blood the pseudomedicine fans around them will impliment all the crusty old arguments about how it's part of the healing process or you need to remove that nasty old artificial heart medicine from your system or whatever and they'll never realise you're the problem.

    Best of all, if it turns out one of the variations doesn't cause kidney failure in your customers, you've just done your compound screening for free! Heck, you could cut down the amount of animal testing you're doing in the process, winning lots of publicity points. Then you can do the FDA-required studies on the one which works and release it under a suitably medical-sounding name to the masses.

    The suppliment industry's fractured and therefore small and agile enough to get away with the sort of stuff that "big pharma" just can't. I think my "hybrid" model really takes advantage of that lack of oversight without sacrificing your ability to sell incredibly expensive molecules directly to doctors.

  9. sockatume Says:

    Reading the above discussion, I'd say that the best possible system is one where every putitively biologically active compound sold on the shelves is subject to the same high standard of oversight and investigation. I don't think "this was popular when people were burning witches" is really a get-out-of-jail-free card when it comes to demonstrating safety and efficacy. Nature doesn't give a shit (to paraphrase Feynman) so if it's going to kill you in a prescription it's going to kill you in a suppliment..

  10. rho Says:

    Have you any evidence that this actually happens?

    My uncle is an M.D. He's actually an orthopedic surgeon, but he keeps up to some extent with these sorts of things. He's also not a big fan of chiropractors, but says that if it works for you, he's not going to take you to the woodshed.

    Ideally there would be something like UL for dietary supplements. It's possible, and practical.

  11. Coderer Says:

    Here's what kills me: if you sell me a can labeled "peaches", and it in fact contains plums (or rocks, or dog shit), you can get in trouble with the government for various things. But you're saying this bit of lawyering lets you sell me a bottle labeled "Fenugreek", which actually contains fresh-mown hay, and you get off scotch-free?

    I guess it comes down to my ability to tell between peaches and plums, and my inability to tell between fenugreek and hay; if I could tell the latter two apart (powdered and put in a gelcap), I could probably sue the manufacturer the same as with the former two.

    Well, maybe the solution presents itself, then -- only buy supplements in whole, recognizable forms. My wife takes red raspberry leaf for uterine bleeding, and it has a really distinct appearance and smell if you buy it whole and dried. It'd be like if you bought a box labeled "Earl Grey" and it actually contained yerba mate -- you'd notice right away. Of course, this doesn't address the fraud that *does* go on, but at least it's a solution that works for people who actually care.

    Aside: I agree with you, Dan, that "KD"'s solution is quite impractical. "Find someone you *trust*"? Millions of people have trusted cult leaders that have killed them or milked their bank accounts dry. Shoddy new-age outfits still exist because people *trust* them, in spite of all evidence that they're fraudsters. Either buy something you can tell is real for yourself, or get it tested by an accredited independent lab; "trust" will get you screwed.

  12. Daniel Rutter Says:

    only buy supplements in whole, recognizable forms

    There's still the problem that unprocessed botanical medicines are highly variable. Superficially indistinguishable plant materials may, for reasons of strain or cultivation or age, have vastly different concentrations of active ingredients. The "strain" part is a particular problem for herbs, as it's normal for a variety of quite chemically different plants to all be described by the same common name. They may also look much the same when prepared for sale, or even when they're still growing in a field somewhere.

    But, yes, if you buy a bundle of actual leaves rather than a bottle of pills, you can at least guard against blatant fraud. Ginger capsules look the same as garlic capsules, but ginger roots and garlic bulbs are quite readily distinguishable.

  13. Malcolm Says:

    There must be something in the air (orgone energy maybe) -- the Medical Journal of Australia just published a study of complementary regulation in Australia, under the title Commercialism, choice and consumer protection: regulation of complementary medicines in Australia, and it's had a bit of play in the mainstream media.

    The article blasts the government for failing to curb unsupported claims by comp med manufacturers. Perhaps the new broom in the health department will take some action.

  14. Bruce Says:

    You are all focussing on the negative aspects of alternative medicine.

    I am strongly in favour of their use in the treatment of viruses as they are equally effective as antibiotics, without the side effects.

    Sure you won't get any better, but the risk resistant bacteria are not increased so its all good for me.

  15. Pyotr Says:

    Dan, I agree with most of what you say. However, the argument that pharmaceutical companies have no interest in pushing regulators to make alternative supplements/treatments unavailable or difficult to approve (as set out in the link you provided) does not necessarily hold.
    Drug companies may make money out of selling supplements, but they would not make the same sorts of profit margins on these as they would for patented drugs - there's a lot more competition in the supply of non-patented supplements. So, if they can lobby the legislature to prevent the sale of all supplements (or just make it difficult for such supplements to be approved) the pharmaceutical companies may be able to increase demand for their more profitable patented drugs.
    Alternatively, if pharmaceutical companies lobby for more stringent testing standards for supplements, they probably stand to gain more than smaller suppliers of supplements, as it may force the other suppliers out of the market, allowing the pharmaceutical companies to increase their prices for their own supplements.
    I'm not sure if this actually reflects their thinking, but it would make some sense.

  16. KD Says:

    "if we allow the FDA to regulate the nutritional supplements, the drug companies will push to make all the supplements unavailable

    This claim has been made many times, but it makes no sense at all."

    Nice straw man, Dan. Of course the drug companies produce supplements. There is demand they can supply and make some money at it. But they can't make as much money at that as they can at selling their drugs. If the supplements were regulated and the drug companies had their hands on the regulation levers, what do you think they'd do? Block the supplements for which they had competing drugs -- they'd be stupid not to, and that is just what was threatening before 1994. You said yourself that the drug companies do what makes the most money, not what is best for their customers.

    I've already admitted that the current system is not ideal. I'd much prefer a system in which all potential treatments were carefully evaluated and the quality of products sold was assured. But we don't have that and don't have much prospect of getting that, so I think what we have is better than cutting off access to supplements. You clearly don't.

    "If it it is your position that only one out of a thousand (if that) alternative practitioners lives up to your high standards, then I agree, but your argument becomes one in favour of government regulation, because clearly the industry is almost completely rotten."

    I doubt you have any solid base for taking one of a thousand as the ratio than I have for any other figure. I only had to get appointments with five or six doctors before I found one who seems to me to be trustworthy. Perhaps I was lucky; perhaps I was fooled. Yes, he has personally investigated the manufacturers of some of the supplements he prescribes. He takes advice from other similar doctors about sources of other supplements. He sells only a few products himself -- the ones that are not pretty easy to get at stores in the area. Government regulation in the current environment would shut down the good guys along with the bad. You seem not to believe that, and maybe that is the reason we disagree. Or maybe you do believe that, but feel losing the good ones is worth it to shut down the bad ones.

    I don't like the current system. Like the old saying about democracy goes, its a bad system, but the others are worse. I can imagine a better system, but I don't see how to get there, so I'm settling for the best I think we can achieve.

  17. magetoo Says:

    Nice straw man, Dan.

    Look who's talking. For some reason in your scenario, your straw-evil drugs companies seem inable to bring supplements to market when they compete directly even with their competitors products; and yet they don't seem to have that problem now, when it comes to prescription real medicine.

    We can have a competing product on the market right now? With no need for expensive clinical trials at all? Can you say "no-brainer"?

    And there is a market for it. A market which they, in your scenario, seem willing to leave completely untapped. In short, you ask us to believe that they are completely insane, and I'm not sure why we should want to believe that.

  18. Malcolm Says:

    According to the Wikipedia entry on the pharmaceutical industry, it generated $252 billion in annual sales in the US in 2006.

    The American "dietary supplement" industry is good for about $20 billion a year. I don't know if this counts as David and Goliath.

  19. KD Says:

    To magetoo: Huh?

    I'm afraid I couldn't figure out what you are saying. You seem to say that I claimed the drug companies don't market supplements, but that isn't what I said. Perhaps you could reword your thought to make it clearer?

  20. Malcolm Says:

    While I'm hunting stats, here are some from Australia circa 2004.

    According to a survey published in the Medical Journal of Australia, people in South Australia spent about A$64 each (on average) on complementary and alternative medicines, and about A$25 on visits to complementary therapists.

    Australian Government Statistics had per capita spending on pharmaceuticals on A$400 (most of which is paid through taxes via the PBS).

    As an Australian consumer, I'd like government regulation of CAM to be at least 6% as good as regulation of prescription drugs...

  21. magetoo Says:

    KD: Your main argument, as far as I can tell, is that alternative treatments would disappear if the market was regulated, since they would not be profitable for Big Pharma. I don't agree, and that's what the comment was arguing against.

    I do agree that the comment was poorly written. Sorry about that.

    So another try: There obviously is a market here. Not selling to that market, when you (the drug companies) already have the production capabilities, and when no R&D money needs to be spent, seems silly -- not to mention what your stock holders will think. (And you seem to agree.)

    You say alternative treatments compete with drug companies' products and threaten their profits. I say, from a hypothetical drug company perspective, "alternative treatments compete with our competitor's products, lets hurt their profits!". There's more than one of them, and they are already going at each other.

    And, even if they were to block every small producer from marketing supplements and alternatives, there would still be a segment of the population that would prefer something other than their main product. I'll go so far as to say they'd be missing out on a certain group of people altogether, people who won't put anything "unnatural" in their system if they can at all avoid it. They would profit from selling them the supplements you insist would not be availabe, and profit from it they will.

    So that's why I think your argument doesn't work.

  22. sockatume Says:

    I'd go as far as to say that the legitimate (as in, scientifically) pharmaceutical industry rarely has to compete with the alternative medicines field at all, as (except in a few absolutely diabolical instances) people go to their real doctors for treatment for serious ailments. Alternative medicine is mostly sitting around "voodoo-ising" minor problems caused by lifestyle, such as headaches, that odd twinge in your back, and so on (in much the same way that legitimate medicine can medicalise more serious lifestyle-caused problems). And if people put off treating conditions and use placebos instead for a few years, and the condition gets significantly more complicated, then there's all the more money for medicine-as-a-business to make off them.

  23. sockatume Says:

    Come to think of it, it seems that the medicalisation of lifestyle problems is the biggest threat to the alternative medicine industry. If people start treating overeating as a serious, pill-warranting medical issue instead of something you take some herbs for, then that's a lost customer for the pseudodocs.

  24. KD Says:

    magetoo: Thanks for the clarification. I think I understand your point of view though I'm still unclear on why you think it would be important to a drug company that supplements would compete with other drug companies' products. The supplements would compete with their own products, too. If this point is key to your reasoning, then I'm still missing the overall reasoning.

    From the drug company's point of view, they want to maximize profit. Since the profit on the drugs is much higher than the profit on the supplements, they only need to convert a small number of supplement buyers to drug buyers in order to come out ahead. So the fact that they wouldn't convert all supplement users is no reason for them to keep marketing supplements. The drug companies would make the most money if they could block supplements.

    This isn't just a theoretical fear. There were efforts to start controlling supplements, and while it is hard to be sure who was behind them, at the time several investigators turned up information linking the efforts to the drug companies -- indirectly, of course, and there were the usual denials. The fact is someone was trying to interfere with supplement availabiity. That led to the call for protection that led to the DSHEA. It has been so long ago that the details have faded from my memory.

    Let me point out again that I don't like the current situation. I just think the likely alternatives are worse, at least worse according to the measures I think important.

  25. Malcolm Says:

    KD: do you have some numbers showing that the margin on prescription pharmaceuticals is higher than on supplements?

    Big pharma may charge monopoly prices when they can get away with it, but they do have substantial R&D and regulatory compliance costs. The price gouging isn't as extreme outside the US, either, because there are saner drug pricing mechanisms.

    For the record, I'm a fan of the FDA, for all its failings. Drug approval and surveillance are looked after some very astute and rigorous people. Under the US freedom of information act (which, incidentally, makes me embarrassed that we have a piece of legislation in Australia bearing the same name) you can read the full approval package (hundreds of pages) of just about any pharmaceutical marketed in the last 20 years or so, and the level of analysis is impressive.

    If the FDA was given the legislative framework and needed money to regulate complementary and alternative medicines they'd be more than capable. I don't see much sign there's any political will to ask them to do it, though.

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