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Dietary supplement industry says “no” to more information for consumers (again)

Once again, the dietary supplement industry is fighting efforts to give consumers more information about the safety and effectiveness of dietary supplements.

Big Supp is very clever. It sells consumers on the phony idea that they need dietary supplements for good health. Even as the evidence continues to mount that consumers don’t need supplements and shouldn’t take them, the industry continues to convince the public otherwise. And in 2011 they raked in $30 billion.

The state and federal governments have served as handmaidens to the industry in this clever marketing strategy. Congress’s gift to the supplement industry, the Orwellian-named Dietary Supplement Health and Education Act (DSHEA) “effectively excludes manufacturers of these products from virtually all regulations that are in place for prescription and over-the-counter drugs, and puts the requirement to demonstrate harm on the FDA, rather than the onus on the manufacturer to show a product is safe and effective,” as SBM’s Scott Gavura pointed out. DSHEA allows supplements to make “structure and function” claims, although no one seems to know what that means, including the FDA.

States have done their part in granting chiropractors and naturopaths the authority to give “nutritional” advice and recommend dietary supplements, sometimes on the basis of dubious diagnostic testing purporting to reveal imagined nutritional deficiencies. This gives them carte blanche to sell supplements to their patients, a clear conflict of interest.

And when proposed regulation threatens their profits, the dietary supplement industry and its surrogates enlist the very public it duped to join the battle. The industry convinces the public that someone is trying to take away their access to supplements they never needed in the first place. This threat is dressed up in terms designed to push all the buttons of a public already primed to be leery of “the government” – their “health freedom” may be taken away. Actually, freedom to choose among health care practices is most threatened by withholding readily-available information which would adequately inform health care decisions.

Sen. Durbin wants more information for consumers

Sen. Dick Durbin (D-IL) has (once again) introduced legislation with some perfectly reasonable requirements designed to help consumers make informed choices about whether to use supplements. (The Dietary Supplement Labeling Act, S. 1425) Sen. Richard Blumenthal (D-CT) joins him in this effort. I’ve criticized Sen. Blumenthal for his support of a Connecticut law forcing recognition of a disease that does not exist – Chronic Lyme Disease. I don’t know if he’s seen the scientific light and now wants to protect consumers or simply doesn’t realize that the dietary supplement industry and “Lyme literate” doctors are employing variations of the same marketing strategy: selling the public on a need and then selling the public products or services to fulfill that illusory need.

In support of the bill, Sen. Durbin refers to yet another government report on the health risks of supplements. A recent Government Accounting Office report noted that between 2008 and 2011, the FDA received 2,100 reports of health problems associated with dietary supplements. However, the GAO suspects underreporting of adverse events because most consumers call poison control centers, not the FDA. (To be fair, a reported adverse event may or may not be caused by taking a dietary supplement.)

The latest report is just one of many warnings about the dangers of supplements and pleas for adequate regulation. Recently, the American College of Medical Toxicology and the American Academy of Clinical Toxicology had this to say in a joint statement:

There is a lack of stringent quality control of the ingredients present in many herbal and dietary supplements. Reliable evidence that these products are effective is often lacking, but substantial evidence exists that they may produce harm. Indirect health risks also occur when these products delay or replace more effective forms of treatment or when they compromise the efficacy of conventional medicines.

Sen. Durbin’s bill would at least partially address some of these problems. Here’s what the bill would do:

  1. Beef up the registration requirements for supplement manufacturers. In addition to registering, manufacturers would be required to provide the FDA with a description of each dietary supplement they make, a list of its ingredients and a copy of the label. The companies already have all of this information – at least, I certainly hope they do. This information would be available to the public.
  2. Require the FDA to compile a list of dietary supplement ingredients (or blends of ingredients) it determines could cause potentially serious adverse events, drug interactions, contraindications or risks to subgroups such as children and pregnant or breastfeeding women. (But not to the general public.) The Institute of Medicine would evaluate dietary supplement ingredients and provide this information, at no cost to the supplement companies.
  3. Require dietary supplement manufacturers to provide substantiation for their claims of health benefits, such as “structure and function” claims. Currently, manufacturers are supposed to have substantiation but need not give it to the FDA. Again, information the companies already have in their records, or should have.
  4. Give the FDA authority to clear up the distinction between dietary supplements and food and beverages with additives.

Big Supp doesn’t want them to have it

In sum, the bill would give consumers some of the tools necessary to do a proper risk-benefit analysis in deciding whether to take a dietary supplement. It accomplishes this with information the companies already have or which the government will provide free of charge. But the supplement industry (once again) does not want consumers to have this information. Here’s what Michael McGuffin of the American Herbal Products Association (AHPA), an industry trade group, has to say about the bill:

There are numerous authoritative references already available to provide safety information on dietary ingredients, including AHPA’s Botanical Safety Handbook for herbal ingredients . . . Instead of using taxpayer funds to reinvent the wheel, the existing resources should be recognized.

Of course, consumers would need a paid subscription to access much of this research, if it exists, including the AHPA’s Handbook, which provides information only on botanicals. As pointed out by the toxicology experts, many of these supplements have never been fully researched. And one would need a background in pharmacy or medicine to fully understand the information provided in the Handbook.

Personally (if I took supplements, which I don’t) I’d rather have the Institute of Medicine doing my research instead of a trade organization. For example, let’s compare what the AHPA says about St. John’s wort to the analysis of St. John’s wort available from Natural Medicines Comprehensive Database, which also requires a subscription. (For brevity’s sake, I’ve omitted the references.)

AHPA Handbook:

Pregnancy and Lactation

Studies on the effect of prenatal consumption of St. John’s wort on pregnancy in mice and rats were generally associated with normal gestation and offspring development. A limited number of human case reports indicated healthy pregnancies and infants when St. John’s wort was used prenatally.

In studies of nursing mothers, the compound hyperforin was detected in low concentrations in mother’s milk while the compound hypericin was not detected in milk.

Natural Medicines Comprehensive Database:

PREGNANCY: POSSIBLY UNSAFE …when used orally. Anecdotal evidence suggests that St. John’s wort might be safe for use during pregnancy; however, animal model research has produced contradictory findings. Other preliminary research suggests that constituents of St. John’s wort might have teratogenic effects. Until more is known, St. John’s wort should not be taken during pregnancy.

LACTATION: POSSIBLY UNSAFE …when used orally. Nursing infants of mothers who take St. John’s wort can experience colic, drowsiness, and lethargy; avoid using.

Whose advice would you follow?

According to Steve Mister, from another industry trade group the Council for Responsible Nutrition, the supplement industry does not support legislation

that directs FDA to require warning labels for products or ingredients that ‘could cause’ adverse events or potential risks as this is a case of the precautionary principle run amok. While the premise may be well intentioned, in practice this requirement would lead to confusing and unnecessary label instructions likely to deter consumers from using beneficial dietary supplements based on uncommon or miniscule risks.

But that’s not what this legislation says. It plainly states that labels would have to warn only of “potentially serious adverse events, drug interactions, or contraindications, or potential risks to subgroups” like pregnant women and children. And “beneficial”? If the industry has good evidence that using dietary supplements is beneficial why not share it with the public?

In other statements, Mister seems to want to shift the focus to supplement manufacturers and sellers who aren’t complying with DSHEA and urges more resources for the FDA to address those problems. I certainly agree with giving the agency more resources, but that doesn’t really address the issues raised by this legislation: insufficient information about health benefit claims all manufacturers are touting and knowing the health risks of taking any dietary supplement, not just those sold by companies who are out of line.

Sen. Durbin’s bill has been referred to the Senate Committee on Health, Education, Labor and Pensions. Unfortunately, according to GovTrack, it has zero chance of passing.

Posted in: Herbs & Supplements, Legal, Politics and Regulation, Public Health

Leave a Comment (51) ↓

51 thoughts on “Dietary supplement industry says “no” to more information for consumers (again)

  1. Leave people alone you authoritarians says:

    Please just leave freedom loving Americans alone. We don’t need you to police every aspect of our lives. If we want to buy something, we can. If we want to find trustworthy companies from whom we buy supplements, please leave us alone. There are bad apples but that is true in all aspects of life, even you MD’s (JD’s, too) aren’t god’s gift to humanity.

    If you would like to turn your state into a police state, then work to ruin your own state, don’t hijack the federal government to impose your will on others. Just live and let live. We don’t petition the government to take your rights away, don’t take ours away.

    Oh, I forgot, you are doing all this to protect us. Sorry about my earlier comment, I have just realized that I am too stupid to be free. Thank you Jann Bellamy for making the world more authoritarian! (this last paragraph was sarcastic in case it is not clear to the obtuse readers)

    1. Jann Bellamy says:

      I think it is Big Supp who is being “authoritarian.” They are deciding what is safe and effective for you, not letting you make that decision for yourself. After all, if the information is available, why not share it with the consumer?

    2. Kris says:

      Taking away which of your rights? Not to know what’s in what pills you take? You people come up with the dumbest arguments for protecting what you consider to be “your rights”.

      Tell you what, put the information on the label, and you can ignore it. Win win.

      Seriously, you’re a dope.

    3. Harriet Hall says:

      How does providing more information, the information needed to give true informed consent, equate to policing every aspect of our lives? On the contrary, it supports individual autonomy.

    4. WilliamLawrenceUtridge says:

      Does your “freedom loving” include the “freedom” to murder people for their stuff?

      Does it include the “freedom” to lie to someone about allergens in food you serve them?

      Freedom requires limitations. Freedom does not include the right to yell fire in a crowded theater.

  2. Sawyer says:

    In a state with a less-than-stellar reputation for honesty in politics, I’m always happy to see my senator Dick Durbin is one of the few people willing to defend real science and medicine. I may be mixing up senators here but I recall him being a staunch defender of expanding funding for the NSF and the NIH (sans NCCAM).

    This is the first time I’ve seen the phrase “Big Supp” used. Excellent branding! I hope it sticks.

    1. Jann Bellamy says:

      Excellent branding, indeed! I can’t take credit for the name “Big Supp.” I think another blogger at SBM created it, but I don’t know who.

  3. windriven says:

    “Sen. Durbin’s bill has been referred to the Senate Committee on Health, Education, Labor and Pensions. Unfortunately, according to GovTrack, it has zero chance of passing.”

    Four words: Committee Chairman Tom Harkin. Every time I think The Republicans have cornered the market on scientific illiteracy this dope bobs up.

    1. WilliamLawrenceUtridge says:

      Read Science Left Behind, the Republicans are very far from the only party to host scientific illiterates. Within medicine (and energy for that matter), the Democrats do not acquit themselves well.

  4. ThisGuy says:

    This could be an opportunity. Contact the senator and discuss the issue. Find out in-depth information on support and lack thereof. See if he’s found like-minded people. Start a conversation. See who else he can put you in touch with. This is science-based medicine’s chance to get into politics. No it won’t change things overnight, but maintaining a close bond between SBM supporters and politicians who agree on the issues is a first step towards establishing a more unified response. You need to build a framework.

  5. Carl says:

    Currently, manufacturers are supposed to have substantiation but need not give it to the FDA.

    This is so much funnier than if there were no official requirement at all.

    FEDS: “You better have evidence for this stuff!”
    QUACKS: “Of course we do… um, we don’t need to show it to you, do we?”
    FEDS: “Nah, we don’t wanna be a bunch of Stiffly Stiffersons about it.”
    [together]: “BUWAHAHAHAHA”

    [later that day]

    FEDS: “Hey, a bunch of d!#kwads with stethoscopes think you should have to list side effects on your products.”
    QUACKS: “But that might scare people away and they won’t enjoy all of the benefits! Better if we don’t say anything.”
    FEDS: “OK, cool. But they also want you to test your products and make sure they actually work.”
    QUACKS: “But our products are harmless, so who cares if they work?”
    FEDS: “Hey, that does make sense. It’s cool how the government and industry can work together to figure this stuff out.”
    [together]: “BUWAHAHAHAHA”

  6. lagaya1 says:

    Here’s a current case of poisoning-by-supplement that’s now going on here in Hawaii. Death, liver failure, and transplants are pretty serious stuff. More people should know about this.
    http://www.hawaiinewsnow.com/story/23544063/weight-loss-supplement-linked-to-liver-failure

    1. windriven says:

      Interesting to read the ingredients list of OxyElite Pro, the supplement fingered in the news report. What it seems to boil down to is tincture of compost heap plus a cup and a half of coffee.

      Bauhinia Purpurea L, Aegeline, Norcoclaurine HCl, Hemerocallis Fulva, Pausinystalia Johimbe and 135mg of good old caffeine.

      Apparently Norcoclaurine improves rats’ ‘wood’. (Wikipedia)

      1. lagaya1 says:

        so the rats are happy until their livers fail.

  7. I am thinking Johimbe is actually yohimbine- which according to webmd can also be used for erectile dysfunction. Fixes that via increasing blood pressure- if your liver is on the edge…increased bp will not make it happier.
    We use it in vet med to counteract xylazine (which drops the blood pressure markedly). (I personally don’t use xylazine any more because there are lots better drugs available now.)

  8. stanmrak says:

    For anyone who cares about the other side to this legislation, from the Alliance for Natural Health:

    Sen. Durbin has said his bill is designed to stop “mislabeling products and making health claims that have no scientific basis” and “marketing supplements with impure or incorrectly identified ingredients.” If that’s the case, the senator should be pleased to know that each of those things is already against the law! In fact, almost all of the bill’s provisions are already covered by existing law, and the few that aren’t covered are so vague that they could mean whatever the FDA wants them to mean.

    This bill requires that the FDA, together with the Institute of Medicine (IOM), compile a list of dietary ingredients (supplements) that might lead to adverse events, or are otherwise deemed risky in some way—based on completely arbitrary or nonexistent standards. Given the FDA’s profound bias against supplements, and the skewed, anti-science recommendations of the IOM’s vitamin D report, these are hardly trustworthy sources of guidance!

    Creating arbitrary lists of “bad” supplements or “bad” doses, especially with no scientific evidence whatsoever, is a dangerously slippery slope. This bill will give the FDA major new powers to curtail supplement sales, and neither the FDA nor the IOM will be subject to any clear standards. They can just make it all up as they go along! Even worse, once an ingredient or supplement is on the list, there is no clear process to challenge the FDA and IOM determination, not even if new or contradictory evidence comes to light.

    This bill is a naked FDA power grab—an attempt to move us one step closer to a full FDA pre-approval system for supplements. That, of course, would just make supplements insanely expensive, like drugs—if you could get them at all. Since foods and supplements already occurring in nature are not generally patentable, producers faced with immense FDA approval costs (the average new drug costs $1 billion to get approved), most health foods and supplements would no longer be marketed at all.

    1. David Gorski says:

      This bill is a naked FDA power grab—an attempt to move us one step closer to a full FDA pre-approval system for supplements.

      Funny, but Stanmrak says this as though it were a bad thing. :-)

    2. WilliamLawrenceUtridge says:

      As has long been discussed here on SBM, a major downfall of the FDA is its inablity to proactively deliver on its mandate. More resources for the agency would probably help with its proactive review of drugs, as well as its ability to crack down on quacky, dangerous and/or ineffective supplements.

      Creating arbitrary lists of “bad” supplements or “bad” doses, especially with no scientific evidence whatsoever, is a dangerously slippery slope.

      I agree. Instead, supplements should be licensed like drugs. They can’t be sold until they are proven safe and effective. I’m glad we could agree on this Stan, go team!

      That, of course, would just make supplements insanely expensive, like drugs

      Not really, a large portion of drug costs are development of the molecules themselves. Don’t have to with supplements. You also seem to miss the opportunity cost – cheap supplements that don’t actually do anything help people how? I mean, they’re great for the people selling supplements, but for the consumer they would seem to be a complete waste of money.

      most health foods and supplements would no longer be marketed at all.

      How big is the market for vitamins again? They have proven benefits, they can’t be patented, but somehow manufacturers still make a profit. Well,that seems to totally undercut your point by a couple orders of magnitude!

    3. Jann Bellamy says:

      The Alliance for Natural Health is funded by the supplement industry. Their statements do not accurately reflect what is actually in the bill. They simply cherry-picked Sen. Durbin’s comments as if these were the only issues the bill addresses. Yes, these things are already against the law, and IF the FDA finds out the manufacturers are doing these things they can TRY to get them to stop. As Scott Gavura pointed out, DSHEA puts the FDA at a disadvantage in doing this. What the bill is trying to do is to be proactive, not reactive, and give consumers information so they can make informed decisions about whether to take a supplement, information that the supplement industry could supply if it wanted to, but does not.

      Who says the IOM will evaluate the supplements based on “no scientific evidence whatsoever”? Arbitrary and capricious decision-making is legally a basis for challenging agency action. The supplement companies will be all over it if they think there is “no scientific evidence whatsoever.” Besides, if that is their objection, why not just seek to amend the bill to add a specific standard?

      It is simply unconscionable that an industry making billions of dollars from selling supplements doesn’t want pregnant women, parents of children, and other vulnerable groups to know of “potentially serious adverse events.” Honestly, Big Supp is starting to make Big Pharma look good.

  9. stanmrak says:

    Oh, BTW, can we see a list of Sen. Durbin’s campaign contributors?

    1. WilliamLawrenceUtridge says:

      Are you equally concerned with the campaign contributors to Senator Harkin? I mean, surely your question is inspired by a concern for the consumer, their ability to know and trust that the products they buy are safe and effective, not some sort of naked greed based on your own ability to sell worthless nostroms, or some sort of ideological commitment to a pre-concieved notion, right? Otherwise you might question just who the DSHEA is helping. Sure, it helps consumers have more choice…in products that might, or might not, cause organ failure. Great choice there.

  10. stanmrak says:

    The ‘mandate’ of the FDA is not to protect us, it to protect the profits of their corporate contributors. The pharmaceutical industry, in fact, covers a big chunk of the FDA budget, including salaries of people who approve the drugs. you’re nuts if you trust anything they say. These senators arguing over the bill aren’t looking out for me and you, they’re looking out for their next re-election campaign and the welfare of big corporations.

    1. WilliamLawrenceUtridge says:

      Sure, and that’s why the FDA never withdraws medicines from the market.

      Oh, hold on, yes they do!

      But Stan, are you yet again advocating to increase the budget of the FDA so it is adequate to discharge their responsibilities independent of corporate donations? That’d be the second time today we’ve agreed on something!

      Of course, you could also advocate your congressperson to ensure the FDA to only approves applications that are registered in an initiative like Ben Goldacre’s Alltrials.org. That would be a meaningful step towards more honest scientific evidence, but you’d have to get off your ass and actually contribute in a meaningful way instead of dishonestly harping about how horrible medicine is while completely ignoring the ever-climbing life expectancy of first-world nations (and third world nations that adopt real medicine and discard traditional approaches).

  11. Jeff says:

    “That, of course, would just make supplements insanely expensive, like drugs”

    Absolutely. The drug approval process costs about $800 million. How expensive would supplements be? read about the example of FDA-approved fish oil pills:

    http://www.lef.org/magazine/mag2006/sep2006_awsi_01.htm

    Jann Bellamy writes, “A recent Government Accounting Office report noted that between 2008 and 2011, the FDA received 2,100 reports of health problems associated with dietary supplements.”

    Number of serious adverse event reports received by the FDA during that same period for drugs: 1,736,437

    http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm070461.htm

    Supplements have a track record of safety drug makers can only dream about.

    The GAO report requested by Durbin and Waxman stated: “The greatest challenge for identifying potential safety concerns from AERs is the small number of AERs that FDA receives related to dietary supplements.”

    Senator Durbin states this is evidence of massive underreporting of AERs. Of course he presents no evidence for this claim. Even Daniel Fabricant, Ph.D, director of FDA’s Division of Dietary Supplement has admitted the supplement industry embraced Mandatory Adverse Event Reporting when it came into effect in 2008. Supplement makers felt this was an opportunity to document the safety of their products. They were right.

    1. Calli Arcale says:

      Given that drugs are far more monitored than supplements (most of the time, the doctors who would make these reports aren’t even aware that their patient is taking them), I think it’s entirely unsurprising that there are far more reports of drug side effects than supplement side effects. It’s a massive selection bias.

      BTW, I have no doubt supplements are generally quite safe. So’s sugar water. I’d like to know if they actually do what they’re claiming, because otherwise they’re a waste of time and money.

    2. Jann Bellamy says:

      If the supplement industry is so sure of the safety of its products, why is it so opposed to (1) giving the public information IT ALREADY HAS on the supplements it sells, and (2) having a reputable scientific organization evaluate the evidence of “potential serious adverse events, drug interactions, or contraindications, or potential risks to subgroups such as children and pregnant or breastfeeding women”? Look at the information on St. Johns wort from Natural Medicines Comprehensive Database in the post. Why do you want to withhold this information from the public?

      In addition, the AER system is based on voluntary reporting of serious AEs by the public to either the manufacturers or the FDA. That is certainly far from documenting “the safety of their products.”

      And the fact that prescription drugs have side effects has absolutely nothing to do with whether dietary supplements are safe or effective.

    3. WilliamLawrenceUtridge says:

      Of course, when you recognize the scale of herbal medicine and the lack of formal reporting mechanisms, you might realize that the number of adverse effects linked to supplements is low, and disproportionate to the actual number of herbs. Not to mention, drugs actually do something, and since the body is inherently messy in its distribution of receptors, you get side effects. Since supplements are mostly ineffective, you get nothing (maybe a bit of fiber). So no duh that they’re safer – they’re inert. The safer something is, the less likely it has an actual effect.

      Your point about fish oil seems to undercut your point – supplements appear to be cheap to have approved compared to drugs

    4. Derek says:

      Great reply, Jeff.

      Seems interesting that people are suggesting the supplement industry needs tighter regulations and testing – Around 2,000 people reported adverse effects during a THREE year period with supplements. Pharmaceutical drugs, taken as prescribed, KILL – not adverse reactions, KILL – over 100,000 people a year.

      This is simply another attempt by Big Pharma to try pushing natural alternatives out of the market. Their connections to the FDA border on corruption.

      Such as… as ruled by FDA regulations, if anything prevents, cures or treats an illness or disease it must be labeled as a drug.

      To all of you scholars out there:
      If you think only registered drugs carry the ability to treat, prevent or cure an illness or disease… You are demonstrating a strong lack of knowledge regarding history of effective medicine. You don’t have to be a science wiz to understand compounds and elements of nature have medicinal benefits. Even Aspirin is based off of natural compounds – the switchover to synthetic-based was to ease mass-production and allow for patenting.

      That regulation is clearly in place to benefit Big Pharma, not you or I or anyone looking for treatment. It makes it an automatic process that anything claiming to treat xyz has to be a drug; therefore highly profitable patent. Elements of nature, such as garlic, can’t be patented – which is why Pharma lobbied for this regulation. The last thing they want is people to understand the medicinal properties of plants that can be grown in their backyard. Two of its greatest, scientifically documented benefits include anti-cancer properties and strong anti-biotic properties – including killing bacterial infections that have become resistant to prescribed anti-biotics. But again, thanks to the FDA – Pharma ties if you were a health practitioner, it would be illegal for you to recommend garlic in place of patented prescribed drugs.

      At the height of their idiocy, they (FDA) have gone as far as attacking producers of walnuts and cherries – for simply sharing the scientific, documented health benefits of eating these foods.

      At what point can the corruption be removed from all this and the focus put back where it should be – HEALING people? It shouldn’t matter if it’s synthetic or natural – if it is medicinal and appropriate it should be allowed to be given to people. It shouldn’t be stone-walled due to corruption between corporate interests and government.

      1. WilliamLawrenceUtridge says:

        Seems interesting that people are suggesting the supplement industry needs tighter regulations and testing – Around 2,000 people reported adverse effects during a THREE year period with supplements. Pharmaceutical drugs, taken as prescribed, KILL – not adverse reactions, KILL – over 100,000 people a year.

        Don’t you think the two are independent? The fact that real drugs (with real effects, used to really treat real illness) have serious side effects has no bearing on whether or not herbs are safe and effective. If an herb only causes 100 cases of kidney failure, without any proven benefits, does that mean it’s OK? I would venture that it doesn’t matter if drugs cause adverse effects or even death – we should ensure herbs are at least safe before they should be sold.

        This is simply another attempt by Big Pharma to try pushing natural alternatives out of the market. Their connections to the FDA border on corruption.

        Your comment assumes that “natural alternatives” are actually “alternatives”. Seeing as most have never been tested, and are often used on the basis of the organ they most resemble (hardly evidence for efficacy), perhaps we might note that their uses are tentative at best?

        Such as… as ruled by FDA regulations, if anything prevents, cures or treats an illness or disease it must be labeled as a drug.

        “Natural” product retailers get around this by completely avoiding ever selling a compound proven to work. How is that better? You don’t know if it works, you don’t know if it’s been adulterated with drugs, heavy metals or is even the species it’s alleged to be. How is this a good thing? Do you think your herbal salesperson doesn’t have an incentive to buy cheap and skip on the testing if they don’t have to? Why not?

        To all of you scholars out there:
        If you think only registered drugs carry the ability to treat, prevent or cure an illness or disease… You are demonstrating a strong lack of knowledge regarding history of effective medicine. You don’t have to be a science wiz to understand compounds and elements of nature have medicinal benefits. Even Aspirin is based off of natural compounds – the switchover to synthetic-based was to ease mass-production and allow for patenting.

        Actually, the switch for aspirin was to reduce stomach bleeding. Aspirin is considerably easier on the mucosal lining of the gut than willow bark is.

        I don’t doubt that there are herbs that can have a physiological effect. We know about a lot of them – St. John’s wort effectively treats some depression (and interferes with AIDS drugs, and causes photosensitivity). Grapefruit enhances absorption of other drugs, often to dangerous levels. Aristolochia causes kidney failure. The trouble is – you don’t know, for the most part, what is safe or effective. You’re trusting your ancestors, and they’re idiots. They thought mandrake root was good for you because it looked like a person. Yeah, that’s way better than clinical trials.

        That regulation is clearly in place to benefit Big Pharma, not you or I or anyone looking for treatment. It makes it an automatic process that anything claiming to treat xyz has to be a drug; therefore highly profitable patent.

        Given the tremendous expense of bringing a drug to market, I would venture Pfizer would disagree that the rules benefit them.

        Elements of nature, such as garlic, can’t be patented – which is why Pharma lobbied for this regulation. The last thing they want is people to understand the medicinal properties of plants that can be grown in their backyard.

        Um…no. The company you buy your garlic pills from? They make a tidy profit. Oh, and they’re probably also the manufacturer of some sort of pharmaceutical too. Big Pharma loves supplements and vitamins, they’re cheap to produce, and they don’t have to waste money on drug testing or quality control standards.

        if you were a health practitioner, it would be illegal for you to recommend garlic in place of patented prescribed drugs.

        See, that’s funny, because I can find lots of mainstream medical source that discuss garlic. Sounds like you’re tilting at windmills.

        At the height of their idiocy, they (FDA) have gone as far as attacking producers of walnuts and cherries – for simply sharing the scientific, documented health benefits of eating these foods.

        You’re going to need a source there champ, I think you’re simply repeating whatever Gary Null sends you. Speaking of which, does he sell organic cherries, at a premium perhaps? No profit motive there!

        At what point can the corruption be removed from all this and the focus put back where it should be – HEALING people? It shouldn’t matter if it’s synthetic or natural – if it is medicinal and appropriate it should be allowed to be given to people. It shouldn’t be stone-walled due to corruption between corporate interests and government.

        The thing is, the threshold isn’t “natural” versus “synthetic”, the threshold is “proven” or “unproven”. Many natural compounds are used (digitalis comes from foxglove still, I believe, morphine from poppies, estrogens from sweet potatoes, and I’m sure there is more). But natural product retail companies don’t bother testing their compounds, because they don’t have to. For me, that’s a bit of corruption. Plus, natural compounds are often not optimized for human health, because that’s not why they evolved – they usually evolved as chemical defences to repel or kill animals trying to eat them. Plants don’t give a crap whether we live or die, we’re just lucky that a handful produce useful chemicals that can be further modified to have more optimal main and adverse effect profiles.

        Nature doesn’t care if we live or die, and neither does Big Supplement. They just want to empty your wallet before your organs give out.

  12. stanmrak says:

    Of course, hundreds of thousands of those ‘adverse’ drug events were fatal!

  13. Jeff says:

    The AER system also includes information from mandatory reporting of serious adverse events by industry:

    http://www.fdalawblog.com/2009/09/articles/miscellaneous/otc-drug-and-dietary-supplement-labeling-adverse-event-reporting-information/

    Studies done on the subject seem to indicate most adverse events relating to dietary supplements are minor:

    http://www.ncbi.nlm.nih.gov/pubmed/18570167

  14. Jeff says:

    Here’s a good explanation of The Dietary Supplement and Nonprescription Drug Consumer Protection Act:

    http://www.nixonpeabody.com/118268

    1. Harriet Hall says:

      Here’s Michael Mangano’s testimony to a senate subcommittee explaining why that Act is an inadequate safeguard to protect consumers. http://oig.hhs.gov/testimony/docs/2002/020731fin.pdf

      1. Jeff says:

        Michael Mangano’s testimony occurred in 2002, four years before The Dietary Supplement and Nonprescription Drug Consumer Protection Act was signed into law.

        1. Harriet Hall says:

          No, the transcript says 2012.

    2. Jann Bellamy says:

      Let’s just assume, for the purposes of argument, that every serious adverse event was reported during the relevant time period. That does nothing to defeat the argument that consumers are entitled to have the information supplement manufacturers are relying on to support their claims of safety and effectiveness. Let consumers decide for themselves whether to take supplements instead of having the industry decide what information they need.

      And even if we knew every single serious adverse event, what is wrong with studying the potential for adverse effects on pregnant women and children at no cost to the supplement industry? And what is the objection to giving consumers that information? Are you arguing that knowing serious adverse events that have already occurred is sufficient to exclude the possibility of other potential adverse events? That knowing the potential for serious adverse events is unnecessary?

      It is interesting that Sen. Orrin Hatch, the supplement industry’s senator-in-residence, was all for funding the study of supplement safety issues, and the use of outside scientific organizations to accomplish this, during discussion of the amendments to DSHEA you reference. Here’s what he said (Congressional Record — Senate, June 21, 2004, at p. 13139):

      “Our amendment urges the Department [of HHS] to work with outside scientific organizations . . . to develop a proposal for better adverse event reporting . . . for dietary supplements . . . [O]ur amendment restates the obvious: that adequate resources must be made available for the effective oversight of dietary supplements and second, scientific research about their benefits and/or problems.”

      That is, in part, exactly what this bill does.

  15. Rokujolady says:

    I totally agree that supplements should be regulated and wished this law had a prayer. However I can’t help but notice a lot of the arguments for this law presented here are the same as the recent California prop 37 for labeling GMOs, which I disagreed with. Information only enables a consumer to make an informed decision if the information is unbiased and if the consumer has the background knowledge to know what to do with it. It’s not enough to just say that more information is always better, especially if the general populace has no understanding of the information. In the case ofGMO labeling I had to conclude that the act of providing information implies danger. We label things that may be harmful. I think there is a good reason to do this for some supplements. In the case of GMO foods though, since there is a loud activist contingency but no actual evidence of harm, the act of labeling would lead the average consumer to a conclusion that was not supported by science.

    1. DugganSC says:

      Agreed on the GMO-labeling problem. As I explained to one person on Facebook who was declaring that “if GMO food is so safe, why won’t they label it as GMO?”, a decent parallel is home sales. A seller could probably advertise a given house as “in a neighborhood where only white people live” or that their house “has no black neighbors”. They might be completely factually correct, but I think everyone picks up on the ugly overtone.

    2. WilliamLawrenceUtridge says:

      The implication of danger is exactly the problem, it’s a PR issue for any company that researchers or sells it. It’s corrosive to the entire endeavour. The conclusion that uneducated consumers are led to is not “GMOs are not supported by science”, it is “GMOs are dangerous”.

      The worst aspect of that will be the impaired research on the subject. Eventually they’re going to develop seeds that are complete proteins, that pull nitrogen from the air to create their own fertilizers, and contain some if not all the essential nutrients needed for human life. It’ll just take a couple more decades, or a significant timespan of starvation. God knows the current swathe of vitamin A deficiency deaths haven’t been enough.

  16. Eclair says:

    If Sen Durbin’s office is accepting email, this constituent plans to contact him to u encourage him to proceed with this bill. Information is power.

    Too bad the “everything natural crowd is good” crowd are so keen to keep Big Supp from having to show the skeletons in their closets. They probably don’t even know what they’re not getting for what they’re overpaying.

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    1. Roman100 says:

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  18. Roman100 says:

    Maybe I’m missing something but it seems to me that Big Supp is ardently resisting having to label its products (which labelling very clearly should be required), while at the same time its promoters such as Mercola and Robbins are prodding Big Agro to label GMOs but giving Big Supp a huge free pass. Irony, anyone?

    1. Roman100 says:

      Rokujolady wrote

      I beg to differ. We label food for the information of the consumer. It is up to the latter to judge whether or not it is harmful or useful to him/her.

      1. Roman100 says:

        I was referring to this comment by Rokujolady with which I do not agree: In the case ofGMO labeling I had to conclude that the act of providing information implies danger. We label things that may be harmful. I think there is a good reason to do this for some supplements. In the case of GMO foods though, since there is a loud activist contingency but no actual evidence of harm, the act of labeling would lead the average consumer to a conclusion that was not supported by science.

        1. WilliamLawrenceUtridge says:

          The average consumer doesn’t know enough, or understand enough about GMO to grasp the safety concerns (or lack thereof). They hear that it is “unnatural”, and freak out. They hear the marketing and fearmongering of organic farmers and idiots like Mercola and don’t know enough to realize that the fears are overblown, unproven, and ultimately add nothing but expense to the cost of the food.

          It’s like telling consumers of the dangers of driving and greenhouse gasses without ever mentioning that cars are a fast, convenient way to transport yourself. Do you expect a similar statement: “Warning, this apple has been produced through a hybridization process that unpredictably alters the DNA and resulting fruit, with no way of knowing the long-term effects on human health”? Genuine experts are aware of the methods and effects of genetic manipulation, and the results of feeding experiments (and the way the human digestive tract takes apart the resulting proteins such that they aren’t a risk). They aren’t worried.

          1. windriven says:

            William, this is an unusual case where (I think) we disagree – in conclusion if not in argument. While I would certainly agree that many consumers lack the scientific knowledge to adequately assess the safety of GMO crops, I nonetheless would argue that food labels should disclose those that contain GMOs. Facts are facts and choosing to cloak some and disclose others to consumers seems at a minimum paternalistic and arguably manipulative.

            1. MadisonMD says:

              Perhaps then all foods should be labeled genetically modified, except wild game and wild berries?

              1. windriven says:

                Goddammit, I hate it when somebody makes me rethink my position.

Comments are closed.