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FDA versus Big Supp: Rep. Burton to the Rescue (Again)

The Dietary Supplement Health and Education Act of 1994 (DSHEA) has been aptly described here at SBM as a travesty of a mockery of a sham. The supplement industry’s slick marketing, herb adulteration due to lack of pre-market controls, Quack Miranda Warning, and the many supplements for which claims of effectiveness failed to hold up under scientific scrutiny (e.g., antioxidants, collagen, glucosamine and hoodia) have been impaled on the sharp pens of SBM posters as well.

And we’re not the only ones. Investigations of the supplement industry (or, Big Supp) by reputable institutions such as the U.S. Government Accountability Office and the Institute of Medicine have resulted in numerous recommendations to improve dietary supplement safety by, in part, strengthening the FDA’s ability to effectively regulate the industry. Many of these have gone unheeded.

A recent federal law tried to ameliorate this situation by directing the FDA to take specific steps designed to increase supplement safety. Yet the ink of President’s Obama’s signature was barely dry when a bill was proposed in Congress to gut its provisions. In fact, there are now several bills pending in Congress which would actually weaken the government’s already puny regulatory authority over supplements. Yes, things could get even worse.

DSHEA refresher

First, a bit of a refresher on DSHEA.   A 2005 article in the American Journal of Law and Medicine by Peter Cohen (1.), who holds both an M.D. and a J.D., provides what I think is an apt summary of the flawed thinking underlying DSHEA, identifying these “critical weaknesses:”

  1. “DSHEA classifies compounds as dietary supplements based on their source, rather than their pharmacologic and physiologic properties.
  2. “DSHEA assumes that components of foods cannot cause harm, even when ingested in large amounts, and that therefore supplements should be subject only to regulations dealing with foods rather with the more stringent regulations applied to drugs.”
  3. “DHSEA also assumes that since herbs and botanicals are ‘natural,’ they warrant regulation only to the same extent as food components, regardless of their pharmacologic, physiologic, or pathologic attributes, and irrespective of whether they are foods at all.”
  4. “The marketing of dietary supplements must be accompanied by a statement indicating that these substances are not intended to treat disease but rather to maintain normal bodily function. . . a meaningless distinction to most consumers.”

The dubious principles at the heart of DSHEA are exacerbated by Congress’s essentially hog-tying the Food and Drug Administration (FDA) in its ability to police the safety and effectiveness of dietary supplements, which, pre-market, is left pretty much up to the manufacturers and distributors.  It is only post-market, once the harm is done, that the FDA can come in and attempt to clean up the mess. Even then, it is hampered by lack of mandatory recall authority.  To ban a supplement, the FDA bears the burden of proving that a supplement ingredient presents a significant or unreasonable risk of illness or injury.  As the GAO report noted, this is made difficult by the fact that there is often little scientific evidence available for the supplement in question because no evidence of safety and efficacy is required by the FDA before the product can be marketed.

There is one requirement of DSHEA with the potential to improve safety but it has been largely ignored by the supplement industry and unenforced by the FDA.  Manufacturers and distributors who want to market dietary supplements containing “new dietary ingredients” must notify the FDA.  Notification must include support for their conclusion that the new dietary ingredient is reasonably expected to be safe under normal conditions of use.  Ingredients existing on or before October 15, 1994, were grandfathered in and did not have to meet this requirement.

(And guess what one of those grandfathered supplement ingredients was? Ephedra!)

FDA asks, very nicely, for evidence of safety

As noted in a recent New England Journal of Medicine article (2.), more than 100 million Americans consume dietary supplements, spending more than $28 billion annually.  Since DSHEA was passed in 1994, the number of dietary supplements has grown from an estimated 4,000 to over 55,000.  We don’t know how many of these 51,000 or so new supplements include new dietary ingredients, which should have triggered the notification requirement, but we do know that the FDA has received adequate notification for fewer than 200.

This failure of compliance and enforcement, which was noted in the 2009 GAO report, led to a requirement in the FDA Food Safety Modernization Act, effective January 4, 2011, that the Secretary of Health and Human Services publish guidance clarifying, among other things, the level of evidence needed to document the safety of new dietary ingredients.

So it came to be that the FDA, in July of last year, presented its “Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.”   As might be expected, Big Supp was not pleased.  The industry’s  response has been duly noted by SBM’s own David Kroll, Ph.D.   The usual giant strawman, Big Pharma, was trotted out, plus overblown claims to the effect that the FDA is attempting to “ban” dietary supplements.

Let us pause here to note that what the FDA issued is guidance, not actual rules, and draft guidance at that.  These are not rules anyone has to follow, nor can the FDA enforce this guidance, as is made abundantly clear in the document itself:

This draft guidance, when finalized, will represent the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the telephone number listed on the title page of this guidance.

In other words, if you don’t like what we want you to do, call us and we’ll work something out. I mean, how much more accommodating could the FDA get?

And what does the FDA say supplement makers and distributors need to do?  I agree with Dr. Kroll that the guidance is “a bit complicated.”  Dr. Pieter Cohen, author of the NEJM article mentioned above, summed it up this way:

The safety of supplements would be evaluated according to three key factors: documented history of use, . . . formulation and proposed daily dose, . . . and the recommended duration of use.

In some cases, a documented history of use will be enough to meet the “reasonable expectation of safety” standard.  In others, in vitro or animal, but not human, studies would be required.

Dr. Cohen finds the guidelines a step in the right direction, but not far enough.  He does not believe the FDA should accept historical use in lieu of experimental data, nor should it allow companies to avoid human studies.  In addition, the companies can cherry-pick the evidence, as they do not need to turn over unfavorable data.

A friend to the rescue

The hyperbolic response of Big Supp was taken up by the National Health Freedom Coalition, which sent out an “Action Alert” e-mail last month:

FDA’s draft guidance for new dietary ingredients is looming and attempting to eliminate thousands of dietary supplements currently on the market . . . . FDA’s plan [is] to impose cost-prohibitive requirements on manufacturers of these life-saving products!

The FDA is doing nothing of the sort and there is no evidence I am aware of that this long-ignored requirement is “cost prohibitive.”  And “life-saving?” Please! But the “Action Alert” did actually alert me to the fact that the supplement industry was calling on an old friend in Congress to bail it out, Rep. Dan Burton (R-IN).  Rep. Burton has introduced H.R. 3380, the “Dietary Supplement Protection Act of 2011.”

The meat of the bill, in Section 3, is short and straightforward.  It creates a “new dietary ingredient definition” by amending the provision of DSHEA that grandfathered in all new dietary ingredients existing prior to October 15, 1994.  By changing that date to January 1, 2007, it grandfathers in another 12 plus years of new dietary ingredients, thereby wiping the slate clean on all those new dietary ingredients the industry didn’t provide safety information for, in violation of the law.

More interesting is Section 2, which contains Congressional findings purporting to support the bill.  I don’t know where Rep. Burton found these findings, but I found them to be somewhere between misleading and patently false.

Let’s take it claim by claim:

(1)Improving the health status of United States citizens ranks at the top of the national priorities of the Federal Government.  The importance of nutrition and the benefits of dietary supplements to health promotion and disease prevention are well known and have been documented in scientific studies.

I had no idea that my health was the federal government’s top priority.  They had me fooled on that one.  I have to agree that nutrition is important, but other than supplementation for a recognized vitamin or mineral deficiency, dietary supplements have little to do with nutrition.  Further, I would argue that the role of dietary supplements is well known only in the sense that the ability of Cialis ™ to make bathtubs pop up out of nowhere is well known, that is, based on phenomenally successful advertising rather than actual fact.  And we have seen this claim of documentation via scientific studies before in another industry-friendly bill, The Free Speech About Science Act (which is still pending), the subject of an SBM blog post by Dr. David Gorski.  He noted, quite rightly, that  “Of course I could argue that claims for the efficacy of homeopathy, reiki, and ‘energy healing’ quackery could similarly be ‘based entirely on the results of scientific studies,’ as well. That doesn’t make them any less quackery.”

(2) Since enactment of . . . DSHEA, dietary supplements have had an exemplary public health safety record.  [Warning: non-sequiter approaching!] Based on national surveys, in 1994, 50 percent of the 260,000,000 Americans regularly consumed dietary supplements.  In 2006, 232,000,000 adults over the age of 18 alone consumed dietary supplements, 53 percent of the United States adult population.

First, someone got his sums wrong.  232,000,000 is not 53% of the adult population in 2006, which only reached 300,000,000 total in October of that year.   Second, it’s hard to argue that there is an exemplary safety record when manufacturers and distributors were not required to report serious adverse events until December of 2007. (They still don’t have to report mild to moderate adverse events.)  As Dr. Pieter Cohen pointed out, quoting the IOM report, “even widespread historical use without documented ill effects is no guarantor of long-term safety.”  Nevertheless, the bill makes the unfounded  presumption that each new dietary ingredient introduced between 1994 and 2007 exhibits an “exemplary public health safety record” despite the fact that nobody had to report adverse events from these ingredients.

(3) There were 4,000 dietary supplements in the marketplace in 1994, and in 2006 an estimated 29,000 [different] dietary supplements were being consumed daily by Americans.  Since the enactment of DSHEA, there has been 17 years of additional historical use-safety experience conducted by millions of Americans.  Over 17 years, approximately 25,000 new supplements with new dietary ingredients have been approved by the Food and Drug Administration (FDA) under DSHEA and have and are being safely consumed by Americans.

This raises interesting questions: Did the health of Americans decline so over those 17 years that we required 25,000 new supplements to enhance our “structure and function?” Conversely, is there any evidence that the 29,000 we take daily have improved our health one bit? Shouldn’t we be a whole lot healthier than in 1994 if the supplements were working as advertised? Shouldn’t we be thoroughly cleansed of toxins, our immune systems boosted to the max, muscular and virile, slimmed down, impervious to cancer, with joints as supple as an acrobat’s, free of anxiety, depression, and cholesterol?  I don’t know about you, but I just don’t see any evidence this has happened.

But we’re talking safety here, not effectiveness.  On that point, isn’t the claim of historical use-safety experience “conducted by millions of Americans” pretty much an admission that the supplement industry has been engaged for years in a huge uncontrolled, non-IRB-approved clinical trial with all of us as unknowing subjects?  And someone should go back and read the Federal Food, Drug and Cosmetic Act, where he will learn that the FDA doesn’t “approve” supplements at all, much less 25,000 of them.

(4) Since January  2007, FDA regulations governing dietary supplement manufacturer good manufacturing practices, dietary supplement adverse event reporting, and private sector voluntary testing and auditing for supplement quality and purity have improved postmarketing consumer safety.  Before DSHEA, these mechanisms did not exist.

Whether true or not, what has may have happened since January, 2007, is totally irrelevant, as the bill addresses new dietary ingredients prior to January, 2007.

Sections (5) and (6) simply repeat, in different language, what has already been said about the presumed safety of supplements and has thus already been refuted.

So the rationale for deleting over 12 years of new dietary supplement ingredient safety reporting is wholly unconvincing.  One wonders how much federal legislation is passed based on similarly shaky reasoning.

But wait, there’s more!

We’re not through with Rep. Burton yet.  He is also a co-sponsor of two bills introduced by avowed libertarian and current Republican Presidential candidate Ron Paul (R-TX).

The first, HR 2044, is titled the “Health Freedom Act.”  Currently, supplement manufacturers and distributors are limited to claims that a dietary supplement affects the body’s “structure” or “function.”  They are not permitted to claim their supplements mitigate, treat or prevent any disease or condition.  The bill would effectively repeal this prohibition by preventing the FDA from taking any action against such claims unless a federal court, following a trial on the merits, finds clear and convincing evidence based on qualified expert opinion and published peer-reviewed scientific research that the claim is materially false and misleading and there is no less restrictive alternative, such as a disclaimer, to render the claim not misleading.

In effect, this means that supplement makers and distributors could make such claims with impunity.  First, because they don’t have to give the FDA any evidence of effectiveness prior to marketing, there is little incentive for the industry to conduct studies.  So unless the FDA could convince the NIH or another entity to fund and conduct such studies, they won’t exist.  Second, to mount a full-blown federal trial and to meet the “clear and convincing evidence” standard with this sort of evidentiary burden is hugely expensive and would require heavy outlays of staff time, including counsel, to prepare for trial.

The second bill, HR 2045, attacks the Federal Trade Commission, which is charged with regulating supplement advertising, and is entitled the “Freedom of Health Speech Act.”  Among other limitations to be imposed on the FTC, solely with regard to supplement advertising, the bill

  • prohibits the FTC from even investigating supplement advertising without possession of clear and convincing evidence that the ad is false and misleading;
  • places the burden of proof on the FTC to show, again by clear and convincing evidence, that an ad is false, that the ad actually caused consumers to be misled into believing what is false to be true and that, but for the false content, the consumer would not have made the purchase at the price paid; and
  • proof of falsity must be based on expert scientific opinion and published in peer-reviewed scientific publications.

As if that weren’t enough, bills before the House and Senate would amend the Internal Revenue Code in favor of Big Supp. Federal tax law allows individual taxpayers to deduct from income certain medical expenses, the rationale being that, if your medical expenses exceed a certain amount, the government should help out a bit by allowing you to deduct those expenses from taxable income. Deductible items include prescription drugs, physician care, medical equipment, and other expenses, as long as they are “for the diagnosis, cure, mitigation, treatment, or prevention of disease, or for the purpose of affecting any structure or function of the body.”

House Bill 2010 and Senate Bill 1098 would expand the definition of medical expenses to include, up to $1000 per year,

amounts paid to purchase herbs, vitamins, minerals, homeopathic remedies, meal replacement products, and other dietary and nutritional supplements.

Yes, just what we need. To add insult to injury, the purchase of dietary supplements and homeopathic “remedies” will have the opportunity to add to the federal deficit.

And guess who is a co-sponsor of the House bill?  Rep. Dan Burton.  And who introduced of the Senate bill? Sen. Orrin Hatch (R-UT). Naturally.

Notes 

(1.) Cohen PJ, Science, Politics, and the Regulation of Dietary Supplements: It’s Time to Repeal DSHEA, 31 Am J Law and Med 175, 176-77 (2005).

(2.) Cohen, PA, Assessing Supplement Safety – the FDA’s Controversial Proposal, 366 N Engl J Med 389 (2012).

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

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101 thoughts on “FDA versus Big Supp: Rep. Burton to the Rescue (Again)

  1. MerColOzcopy says:

    I am not a big fan of Vitamins and Supplements, but if as you say so many take them and people aren’t dropping dead, who cares. Peoples choice. Of all that are taken, how many were suggested by doctors to their patients?? If there has been deaths and or adverse affects, why are attending physicians not recording and reporting? As far as ingredients, there are some pretty reputable companys making these V&S. Actually I would feel safer buying V&S off the shelf than most food products off grocery shelves.

    I was born with a heart defect, and asthma. It took 33 years for the heart condition to be diagnosed, and that was after 20 years of complaining about chest pains. I had a physical in January, doc’s office was setting up further with cardio and colonoscopy, it’s been 2 months, haven’t heard a word. Some times I really don’t think Doctors understand beyond SBM, the human part.

    Been taking Vitamin D for about 4 years, haven’t had a flu nor cold since I started. And no flu shots.

  2. sarah007 says:

    David said “Investigations of the supplement industry (or, Big Supp) by reputable institutions such as the U.S. Government Accountability Office and the Institute of Medicine”.

    This idea of reputable is the funniest thing I have read here with regard to quality of evidence. How on earth can two groups with such a conflict of interest produce anything but a damming report, come on this is a silly post.

    Did you see that Wakefield’s co accused has been vindicated, shows that the GMC had conflicts of interests in their wrong decision there, now see what happens as the Texas case kicks off and the BMJ go down the pan.

    The problem David with the political direction your posts go in is that the u turn is not an option. This is unscientific, whatever you may believe.

    I, like the last poster took up the vitamin D idea from Mercola I think, and I haven’t had a cold or flu since starting some time ago, nor have my family either.

    The idea that we won’t ‘need’ medicine if we stay in good nutrative order must completely freak out the FDA, food manufacturers, doctors, so I can see why all the central dictat says no! Did you read the report by a top oncologist who said that vitamin D deficiency was the most important indicator of prognosis, even more important than the top cancer drugs. Where do you stand on that David?

    Problem is since the credit crunch most people think that centralised orders come from asses, not saints!

  3. How’s this for screwed up? The FDA finally allowed for removal of the information on statins advising doctors to do routine liver enzymes because there has never been a case of liver failure that was 100% due to statins, and we see that elevated liver enzymes always return to normal. The problem with routine liver enzyme checking (in asymptomatic patients) was that an elevated liver enzyme would scare either the practitioner or patient away from the statin, when in reality there was virtually no chance that actual liver damage would occur, but they had a high risk of cardiovascular disease. Now we remove the information from the label, but have added information from anecdotal reports of “mild, reversible memory loss” which have not been revealed in different trials that actually investigated for side effects. Not that this is necessarily a bad thing – we should be well aware of the side effects of anything we take.

    … but, why the hell isn’t there a warning on Vitamin E supplements warning of significant increase in risk of prostate cancer? That is absolutely screwed up that these supplement manufacturers can push their useless garbage without having to disclose the side effects. We have infinitely more evidence that Vitamin E causes prostate cancer than we ever did that a statin hurts your liver or causes this new “mild, reversible memory loss”, but they don’t have to even acknowledge it.

    If anyone is interested, here is a summary of different findings about different vitamins from different trials. It is by no means comprehensive, all-inclusive, or otherwise complete (these are only the negative findings, things that should be on the label):

    Vitamin A: Increases overall mortality in all adults.

    Beta-carotene: Increases incidence of lung cancers and overall mortality in smokers. Increases overall mortality in all adults.

    Vitamin B(1): Does not lower the risk of recurrent cardiovascular disease after acute myocardial infarction. Nonsignificantly increases risk of both cardiovascular events and cancer.

    Vitamin B(6): Does not lower the risk of recurrent cardiovascular disease after acute myocardial infarction. Nonsignificantly increases risk of both cardiovascular events and cancer. Increases overall mortality in older women. No decrease or increase risk of total invasive cancer or breast cancer among women.

    Vitamin B(12): Does not lower the risk of recurrent cardiovascular disease after acute myocardial infarction. Nonsignificantly increases risk of both cardiovascular events and cancer. No decrease or increase risk of total invasive cancer or breast cancer among women.

    Vitamin C: Does not reduce risk of cardiovascular events in middle-aged and older men. Detreimentally affects therapeutic response to cancer treatment.

    Vitamin E: Significantly increases risk of prostate cancer in men. Increased risk of death from hemorrhagic stroke. Does not reduce risk of cardiovascular events in middle-aged and older men. Increases overall mortality in all adults.

    Multivitamins: Increases overall mortality in older women. Does not decrease risk of cardiovascular disease or cancer.

    Selenium: Nonsignificantly increases risk of type 2 diabetes mellitus.

    Folate: Increases overall mortality in older women. Increases frequency of overall cancer. Significantly increases risk of prostate cancer. No decrease or increase risk of total invasive cancer or breast cancer among women.

    Iron, Magnesium, Zinc, Copper: Increases overall mortality in older women.

    Calcium: Decreases risk of total mortality in adults.

  4. sarah007 says:

    Skeptical health there is too much bull in your post to refute the poorly quoted research but here is one:

    “Beta-carotene: Increases incidence of lung cancers and overall mortality in smokers. Increases overall mortality in all adults.”

    Yes for synthetic but no for non synthetic. Funny how a ‘medical trial’, again doesn’t use the actual thing it is supposed to be testing but produces a negative result anyway! Raw grass/Hay springs to mind, corn/grain.

    “Multivitamins: Increases overall mortality in older women. Does not decrease risk of cardiovascular disease or cancer.”

    Pure Mcdonalds thinking, totally brilliant. According to you all vitamins and minerals are lethal and therefore should be banned. Problem here SH is there are no bodies for the crime so your suppositions are exactly that – suppositories.

    The point about vitamins and minerals laddy, is not about specifics or artificial supplements for a crap diet per se. Your post is a bit like be saying “Eating bricks contributes to overall mortality”

    It is criminal that people like you are posting anecdotal tosh about vitamin C being no good for CV disease.

    “Calcium: Decreases risk of total mortality in adults.” Shit me not, this has to be a joke, let’s start eating chalk then.

    You have to get off your medical head and engage with the issue.

  5. sarah007 says:

    The Boston Medical School has completed a great many research studies on vitamin D. Professor Hollick, “If women obtained adequate levels of vitamin D there would be 25 per cent less deaths from breast cancer.” Professor Hollick

  6. sarah007 says:

    SH said “Selenium: Nonsignificantly increases risk of type 2 diabetes mellitus.”

    Eating a refined diet full of processed sugar and corn syrup in everything certainly does! There should be a health tax on sugar that is added to food, this is endemic in the US.

  7. Janet Camp says:

    I don’t take any supplements and I haven’t had a cold or flu for at least eight years. Take that, sarah007. Oh yeah, I get a flu shot every year, eat a normal balanced diet, walk daily, and wash my hands a lot.

    I know we’re supposed to ignore trolls, and sarah007 seems close to illiterate, but I think my anecdotes are way more pertinent than hers so I can’t resist the odd rebuttal.

  8. Dile E. Tante says:

    It is well known that the thinking of all people is subject to various types of biases and distortions. That is why I suggest people periodically review this article: Why Bogus Therapies Often Seem to Work

  9. ebohlman says:

    Burton is (was, as of this coming winter as he isn’t running for re-election, thank goodness) from Indiana, not Illinois. Please don’t inflict collateral damage on us Illinoisans.

    Indications of Burton’s mental stability (or lack thereof):

    1) He refused to use the House gym after Barney Frank (also retiring this year) came out of the closet.

    2) Allegedly, he won’t eat soup in restaurants out of fear that a server or cook might have ejaculated in it (sorry, you’ll have to supply your own brain bleach).

    3) One of his grandsons is autistic, and he’s Absolutely Certain that it was caused by vaccines.

    4) He shot a pumpkin in his back yard in an attempt to demonstrate that White House aide Vincent Foster had been murdered.

    5) His brother, an Indiana state legislator, rushed through a bill to prevent gay couples from adopting kids. This was at the behest of a constituent, who was the foster parent of a girl who was one of several siblings who were about to be placed with a gay couple for adoption. The constituent is now serving a 40-year sentence for raping the girl.

  10. Jann Bellamy says:

    @ ebohlman

    Very sorry about slandering Illinois! Corrected now.

  11. Scott says:

    I am not a big fan of Vitamins and Supplements, but if as you say so many take them and people aren’t dropping dead, who cares.

    We don’t know that people aren’t dropping dead. The manufacturers aren’t obliged to look, and without careful testing and monitoring, even COMMON side effects can’t be reliably identified, much less rare ones.

    Peoples choice.

    A choice primarily driven by the outright LIES of the supplement industry.

    Of all that are taken, how many were suggested by doctors to their patients??

    Irrelevant, except insofar as it shows that doctors can be taken in by Big Supp’s lies too.

    If there has been deaths and or adverse affects, why are attending physicians not recording and reporting?

    Because there’s no way for them to identify them as due to the supplement in general.

    As far as ingredients, there are some pretty reputable companys making these V&S. Actually I would feel safer buying V&S off the shelf than most food products off grocery shelves.

    You shouldn’t.

    I was born with a heart defect, and asthma. It took 33 years for the heart condition to be diagnosed, and that was after 20 years of complaining about chest pains. I had a physical in January, doc’s office was setting up further with cardio and colonoscopy, it’s been 2 months, haven’t heard a word. Some times I really don’t think Doctors understand beyond SBM, the human part.

    This has not the tiniest shred of a hint of anything that might someday think about being a little bit related to the topic.

    Been taking Vitamin D for about 4 years, haven’t had a flu nor cold since I started. And no flu shots.

    Are you familiar with the term post hoc ergo propter hoc?

  12. By coincidence, I blogged about weight loss supplements today. Turns out – they don’t work:http://theness.com/neurologicablog/index.php/weight-loss-supplements-dont-work/

  13. sarah007 says:

    Stevie wonderlass said “By coincidence, I blogged about weight loss supplements today. Turns out – they don’t work”

    That’s like saying we tested statins on wallpaper and it doesnt work! Not eating crap stops you gaining weight, why would anyone expect a supplement to work, supplement for what?

    Scott said “We don’t know that people aren’t dropping dead. ” Yes we do, I can assure you that if there was a shred of evidence linking vitamins with death we would all know about it.

    These studies that get put up to demonstrate that vitamins don’t work are laughable. Shall I test aspirins on weight loss and show that they don’t work?

    “The Boston Medical School has completed a great many research studies on vitamin D. Professor Hollick, “If women obtained adequate levels of vitamin D there would be 25 per cent less deaths from breast cancer.” Professor Hollick”

    Comments please

  14. Jeff says:

    Even then, it is hampered by lack of mandatory recall authority. To ban a supplement, the FDA bears the burden of proving that a supplement ingredient presents a significant or unreasonable risk of illness or injury.

    Wrong. On Jan 4, 2011 the FDA Food Safety Modernization Act was signed into law by President Obama. One of its key provisions gives the FDA mandatory recall authority for all food products, including dietary supplements.

  15. WilliamLawrenceUtridge says:

    MerColOzcopy, there are a variety of studies that indicate vitamin supplements actually increase the risk of death or disease in nontrivial ways but at relatively low rates. Skepticalhealth has a page on the topic, including links to various studies:

    http://www.skepticalhealth.com/2012/02/24/vitamins-the-big-picture/

    And it makes sense – the human body evolved to take in vitamins in relatively low doses diluted in food over the course of the day. A vitamin supplement is a pretty concentrated dose and is being used more like a drug, which have known risks. There’s not much reason to expect “more is better” to apply in all cases, particularly when the “more” comes in a very concentrated dose and many vitamins are antioxidants – which can become pro-oxidants at certain doses. You’re probably much better off getting your vitamins from freshly prepared, minimally processed food including lots of fresh fruits and vegetables and whole grains, as recommend by any reputable doctor and national nutritional organizations.

    I’ve been getting an annual flu shot for years, don’t take any vitamin D, and also haven’t gotten the flu. What does either of our experiences prove?

    This idea of reputable is the funniest thing I have read here with regard to quality of evidence. How on earth can two groups with such a conflict of interest produce anything but a damming report, come on this is a silly post.

    Heh, this is funny. One of the criticisms of the FDA is the considerable rotation of highly qualified staff between the agency and pharmaceutical manufacturers. On one hand the FDA gets criticized for being a toothless watchdog that doesn’t protect consumers. On the other it is criticized for being overly-harsh and determined to take away our precious, precious vitamins. Which is it, a toothless waste of money or a draconian monster who wants us all to die? Please explain in terms of a conspiracy theory that includes both options – the more elaborate and tinfoil-hatted the better.

    Not eating crap stops you gaining weight, why would anyone expect a supplement to work, supplement for what?

    Not eating crap and getting exercise are the standard recommendations for weight loss, so we agree there.

    “The Boston Medical School has completed a great many research studies on vitamin D. Professor Hollick, “If women obtained adequate levels of vitamin D there would be 25 per cent less deaths from breast cancer.” Professor Hollick” Comments please

    How’s this for a comment, you repeated “Professor Hollick”. Your quote seems to come from here, and look! The nice man will conveniently give you vitamin D in pill or liquid form! I assume he’s giving it away, because only nasty Big Pharma would ever try to make a profit from people. Not natural doctors, they survive on rainbows and live in trees, with absolutely no need to ever make or spend money.

  16. MerColOzcopy says:

    Thank you Scott for refreshing my post:))

    Few years back I met someone who was a Medical transcriptionist working in Oncology, and she was taken mega amounts of V&S. I challenged her on the safety and wisdom in doing so. She told me that she was doing so because many of the Oncologist she knew were doing the same. She also told me that some of the doctors would not expose themselves or family members to the same procedures they perform on their patients. Interesting.

  17. GLaDOS says:

    “I am not a big fan of Vitamins and Supplements, but if as you say so many take them and people aren’t dropping dead, who cares. Peoples choice. ”

    Bullsh*t is not actually a choice.

  18. Scott says:

    Oh wow. A third-hand account of a single non-physician’s opinion. I am really convinced that this is a widespread thing in medicine.

  19. Calli Arcale says:

    Jeff –

    Wrong. On Jan 4, 2011 the FDA Food Safety Modernization Act was signed into law by President Obama. One of its key provisions gives the FDA mandatory recall authority for all food products, including dietary supplements.

    Yes, but as Bellamy said in the original post, they can’t use that authority without proof that the supplement or ingredient presents a significant risk. And they have used this power to have contaminated supplements recalled. But merely being a total waste is not adequate, and they cannot compel anyone to find *out* if the supplements present a significant risk. That’s what makes this provision rather weak. They have the power to have supplements recalled, but a very high standard for actually using it.

  20. cervantes says:

    This is about the ugliest comment thread I can recall seeing here. I despair for the Enlightenment.

  21. Jeff says:

    Calli Arcale,

    According to the FDA’s website, mandatory recall does not require proof, merely a reasonable probability of harm:

    If the Secretary determines, based on information gathered through the reportable food registry under section 417 or through any other means, that there is a reasonable probability that an article of food (other than infant formula) is adulterated under section 402 or misbranded under section 403(w) and the use of or exposure to such article will cause serious adverse health consequences or death to humans or animals, the Secretary shall provide the responsible party (as defined in section 417) with an opportunity to cease distribution and recall such article….If the responsible party refuses to or does not voluntarily cease distribution or recall such article within the time and in the manner prescribed by the Secretary (if so prescribed), the Secretary may, by order require, as the Secretary deems necessary, such person to–
    “(A) immediately cease distribution of such article; and
    “(B) as applicable, immediately notify all persons–
    “(i) manufacturing, processing, packing, transporting, distributing, receiving, holding, or importing and selling such article; and
    “(ii) to which such article has been distributed, transported, or sold, to immediately cease distribution of such article.

  22. If Vioxx were a supplement it would still be on the market.

    We simply don’t have the kind of data with most supplements that revealed the increased risk from Vioxx. So we really cannot say that they are safe, and historical use is not enough.

    And, when we do have data that suggests a possible risk (like that for some vitamins as pointed out above) that does not seem to have any effect on marketing.

  23. Harriet Hall says:

    The FDA regulation says “adulterated or misbranded” AND probability of harm.
    What if there is a reasonable probability of harm but no adulteration or misbranding?

  24. FYI – Sarah007 has been banned from the comments for excessive troll-like behavior.

  25. Jeff says:

    As Jann Bellamy points out, since 2007 the supplement industry has been subject to mandatory reporting of serious adverse events. The FDA has finally started posting adverse event figures for dietary supplements. The numbers include serious adverse events reported by supplement companies plus reports of all adverse events, both serious and non-serious, submitted by consumers and healthcare professionals:

    http://www.accessdata.fda.gov/FDATrack/track?program=cfsan&id=CFSAN-OFDCER-Number-of-mandatory-adverse-event-reports-from-dietary-supplement-industry-entered-into-CAERS&fy=2010

    The supplement figures can be compared to those for drugs and therapeutic biologic products:

    http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm070434.htm

    Then there’s data for foodborn illness posted at the website of the Centers for Disease Control: “CDC estimates that each year roughly 1 in 6 Americans (or 48 million people) gets sick, 128,000 are hospitalized, and 3,000 die of foodborne diseases.”

    Supplement critics such as Pieter Cohen like to warn of the supposed danger to public health if the FDA is not given pre-market approval of dietary supplements. But considering that half the US population, or about 150 million Americans take supplements, the actual data paints a different picture. Supplements have a strong record of safety, especially when compared to drugs or food.

  26. jeff – you are only talking about immediate and apparent outcomes – adverse “events.” This in no way addresses long term risks that would not be apparent without study.

    In any case, safety is only half the picture. We still have a multi-billion dollar industry selling products that mostly do not work, with claims that cannot be scientifically justified, wasting resources and attention. I know many people who spend 100s of dollars a month on supplements they don’t need, sometimes instead of perscription medications they do need. Further, useless health products can distract patients away from potentially effective treatment.

    Keep in mind, I prescribe specific supplements almost every day – when they are evidence-based. Most of what we are talking about is indiscriminate use of supplements, megadosing, or using herbs as dirty drugs.

  27. rwk says:

    @ Steven Novella
    If sarah007 is banned, why don’t you just ban everyone that disagrees with this little club?

  28. MerColOzcopy says:

    Ah, this place is great. Yay, I’ve been quoted on a Science-Based Medicine Web Site:))))

    I think I am having a psychic moment; bear with me.

    I see here there are some that are true to their beliefs, and do not take any V&S, mostly Staff!!
    I see here also some that are on Staff and secretly take V&S. Possibly even having their partner take some;))
    I see here there are some who really don’t care but want you to desperately visit their failing web site:((
    I see few who fill a bowl in the morning with V&S and milk (okayyy, soymilk) and eat them like ceral:O
    I see at least one that is a lapdog, he possible is a brother-in-law to one of the Staff here and lives in their basement, is unemployed, has trouble with the women, I won’t name any (Scott) names:((( Mercola, I’am sure has a pill for that:))

    Not to bad hey!!!

    Back on topic. I see a lot of links to “studies” being thrown around. I am guessing on the internet you can a find a study to back up any position imaginable.

    What I would really like to see is the medicine cabinets, kitchen drawers of the Staff here, or vaccination records of the children of the staunch proponents of Vaccines. Those are the real studies:))

  29. lizditz says:

    Cervantes, I have a specially-trained Morton’s Demon. It automatically bypasses any communication from Sarah007. I called it “Sarah”, but now

    Huzzah! I see that it can be put out to pasture for a while. Thanks so much for banning Sarah, Dr. Novella.

    And may I suggest that you repeat this often and loudly?

    If Vioxx were a supplement it would still be on the market.

    We simply don’t have the kind of data with most supplements that revealed the increased risk from Vioxx. So we really cannot say that they are safe, and historical use is not enough.

    And, when we do have data that suggests a possible risk (like that for some vitamins as pointed out above) that does not seem to have any effect on marketing.

    Many people are aware of the Vioxx recall. They assume supplements are safe, and need to know that safety data are simply not collected.

  30. Scott says:

    I see that being unable to effectively respond to refutations of your claims really annoys you.

  31. rwk – she was not banned for disagreeing with anyone. Any honest person with the slightest familiarity with this blog and the comments can see that we have a very high tolerance for discussion and disagreement, and a wide range of views. Every year or so we have to ban someone for being excessively disruptive -hijacking every thread with frequent contrarion and dangerously ill-informed comments, pathologically misrepresenting the views of others, etc. Basic troll behavior.

  32. Jeff says:

    One important set of regulations not even mentioned by Jann Bellamy are GMPs for supplements.

    These extensive, stringent regs hold companies accountable for their own testing procedures. Over time strong FDA enforcement of supplement GMPs should eliminate the problem of products spiked with drugs. No longer will company executives be able to plead ignorance about any illegal ingredients their products may contain.

  33. EricG says:

    @ Dr. Novella

    Dang, now we’ll never find out what she eats for breakfast to stay so healthy and full of spunk…

  34. Harriet Hall says:

    “Over time strong FDA enforcement of supplement GMPs should eliminate the problem of products spiked with drugs.”

    Maybe. Over time. If there is strong enforcement.
    Any evidence that progress is actually being made?
    I don’t see how GMP regulations could eliminate the problem entirely. What’s to prevent unscrupulous companies from intentionally spiking their products with drugs, waiting for the letter from the FDA and then just saying “Oops, we’re sorry; we’ll recall that batch.”

  35. I’d like to re-ask my question:

    We know that dietary supplementation with vitamin E significantly increases the risk of prostate cancer in men. Why hasn’t either this supplement been taken off the market, or forced to use a safety label?

    http://www.ncbi.nlm.nih.gov/pubmed/19066370
    http://www.ncbi.nlm.nih.gov/pubmed/21990298

    Heck, if anyone reads this safety information on vitamin E, from the Mayo Clinic (which incidentally does not list prostate cancer as a “adverse effect”, it sounds pretty scary. If you replaced the word “vitamin E” with “rosuvastatin” on the same webpage, every NaturalNews-clone website on the internet would be shouting from the top of their lungs at how dangerous this “drug” is.

    http://www.mayoclinic.com/health/vitamin-e/NS_patient-vitamine/DSECTION=safety

  36. weing says:

    ” I see a lot of links to “studies” being thrown around. I am guessing on the internet you can a find a study to back up any position imaginable.”

    You have to have a method to separate the wheat from the chaff.

  37. WilliamLawrenceUtridge says:

    @MerColOzcopy

    Back on topic. I see a lot of links to “studies” being thrown around. I am guessing on the internet you can a find a study to back up any position imaginable.

    You should read Snake Oil Science by R. Barker Bausell and Trick or Treatment by Simon Singh and Edzard Ernst. If you genuinely want to criticize science and medicine, you need to understand both. That means learning why large N studies matter, why control groups matter, why randomization is important, what data quality means and what a meta-analysis is. Without a basic understanding of science, you’ll never understand why some studies are taken seriously and others are discarded without getting past the abstract. A lot of CAM believers are like creationists – ignorantly parroting buzzwords and slogans without realizing their comments aren’t even wrong. You said you’re a farmer I believe. What if I told you the best way to grow crops is to fertilize them with salt and water them with gasoline – but only while chanting Beatles songs. Backwards. And when you argue that my approach wouldn’t work, I say you’re just a shill for Big Seed. CAM promoters like to proclaim the failings of modern medicine and science when they don’t even know how either works.

    So read the books, then come back and see if you know why we trust some studies more than others. And if you don’t want to read something that might change your mind – why not? What do you have to lose?

  38. Jeff says:

    Maybe. Over time. If there is strong enforcement. Any evidence that progress is actually being made?

    Here’s a start:
    http://blog.consumerbell.com/2011/11/23/consumer-recall-safety-fda-files-injunction-against-supp/

    Here’s another article:
    The Cost of GMP Compliance

  39. Harriet Hall says:

    @Jeff,

    The link you gave is not a very good argument for the success of regulation, much less for progress:

    “The defendants had from 2007 until 2010 to comply, which they failed to do, said an FDA press release.

    ” the company has withheld adverse event reports from the FDA,” she said.

    “the manufacturer and its owner failed to report serious adverse events associated with their products. In one case an individual who consumed one of the products reported experiencing a spike in blood pressure, hospitalization and a subsequent mild heart attack.”

    “No recall has been announced. While DeLancey couldn’t comment on the potential for a recall, she did say that the FDA is currently working on developing criteria for when and how they will use their mandatory recall authority.”

  40. Zetetic says:

    Jeff sez: “Supplements have a strong record of safety, especially when compared to drugs or food.”

    You really must take into account the “True-Believer” mentality of those who are deep into “V&S” consumption. They are immune to the idea that that a side effect they’ve experienced could possibly have resulted from the mega doses of vitamins & supplement they’ve consumed. Then, or course, their chiropractor or naturopath certainly won’t warn them that there could be side effects – They need to keep the business! It’s always something else causing the problems – Bad Karma or something.

  41. Jann Bellamy says:

    Jeff is correct that the FDA now has mandatory recall authority. Next time I will read the ENTIRE statute. I am concerned, however, with the high bar set by the statute. To be recalled, the FDA must show that there is a reasonable probability that the supplement is adulterated or misbranded AND use will cause serious adverse health consequences or death. Thus, if the supplement is not adulterated or misbranded, but still could cause serious adverse consequences or death, the FDA would not have recall authority. Because of lack of pre-market and post-market safety and effectiveness research, we don’t know a lot about the effects of taking many supplements, even if they aren’t adulterated or misbranded.

  42. DavidRLogan says:

    Good post, Jann. Cosign 100%!

    My personal view is that taking supplemental vitamins is worthless at best, and possibly quite dangerous. The body has many redundant systems and there are many functional interactions for each nutrient. The metabolism of, say, Vitamin A is closely tied to that of Zinc and Vitamin D (which are tied to others). Taking any one or worse all three will cause extreme dysfunction as the body struggles to build metabolic complexes without many of the ancillary substances in whole foods (which we are still trying to understand!)

    Yes there are rare cases of deficiency (not so much in this country), but we are working on that by eg pro-vitamin A GMO’s, which are a better solution than vitamin supplements.

    Some of the herbs are another issue. But we are miles from understanding how they work, if they do (I think it was Skeptical H who put up the good read about curcumin and its potential problems despite the hype). For instance there has been some investigation at UNL into the chemistry of traditional Chinese medicines (not the metabolism, simply identifying potential agents and druggable targets). And part of the reason it is so hard is again because there are so many interactions/redundant pathways among the various plants. So even if there is an answer inside some of these organisms, that answer is not understood and that answer is certainly not to take store-bought herbal supplements in their present form.

    ***it is worth mentioning that in every pill I’ve tested (hundreds now…I’m pathetic), label claims were either not met or there was a contaminent issue. A family member took a popular sleep supplement and had a scary issue with their heart. Upon examination, the pill was found to contain some extremely toxic substances as well as a calcium filler which interfered with the asorption of the minerals it purported to provide!

    -David

  43. @DavidRLogan, supplement contamination is scary! There was a Chinese herbal (or from ants I think) supplement for male erectile dysfunction. I believe it was called Actra-RX, or Yilishen, and it worked wonders! … Because it was actually Viagra.

    I forget which supplement, I want to say glucosamine but I don’t see it in my notes so I’m probably wrong, seems to sometimes have significant amounts of manganese with it. People take massive doses because they expect pain relief, but don’t get any, and end up with manganese toxicity which is toxic at low doses and is very poisonous to the nervous system.

  44. Jeff says:

    @Zetetic: The only side-effect I have experienced from 40 years of supplement consumption is excellent health. Apparently you are the true believer — supplements must be harmful no matter what the data from FDA’s postmarketing surveillance shows. There’s also data from the American Association of Poison Control Centers

    I agree with Steven Novella that supplements should be studied for long-term risks. But many supplement critics argue for greatly restricted consumer access to supplements based solely on the perception of potentially harmful side-effects. As Jonathan Emord explains in Poison Politics, this thinking has taken hold in Europe, where most supplements can now be sold only in miniscule doses.

  45. mdstudent says:

    What’s the point of taking supplements when we can get all our essential nutrients from a varied and balanced diet? Assuming one doesn’t have access to such a diet or suffers from an underlying pathological condition (ex: pernicious anemia), supplements are, at best, completely useless and a big waste of money.

  46. lilady says:

    Here is an excellent “starting point” for information about vitamins and supplements…I especially like the “Fact Sheets”.

    http://ods.od.nih.gov/factsheets/list-all/

    O/T My husband who is not a reader of this blog wants to thank Dr. Hall for her review of the “Heart 411″ book:

    http://www.sciencebasedmedicine.org/index.php/an-owners-manual-for-the-heart/

    Thanks for wielding the ban hammer on the potty-mouthed, thread-derailing troll.

  47. CC says:

    Tangentially related question, here… does anybody know of a good resource for science based sports medicine? I don’t know enough about the subject to reliably pick one that’s truly science based from one that merely sounds plausible and aligns with the biases I’m sure I have. :-)

    I’m heartily sick of the superfood of the week and supplement pushing in running magazines, and likewise of the “doctor of naturopathy” sending out recommendations for vitamin megadoses and injections to the local running group. (There, that’s the link to the post’s actual topic – supplement pushers.) Their latest offering is customized electrolyte rehydration drinks based on an analysis of your sweat, because sweat contains electrolytes and clearly the only way to replace those is through a special electrolyte drink. The staffer sending the email said they were tested and their electrolyte levels were way higher than expected, so clearly they need to be buying this customized electrolyte drink! And we should all get tested too! Of *course* the results show they need to buy the special drinks.

    Thanks in advance for any links that may float my way…

  48. MerColOzcopy says:

    Wow, looks like it was a rough day. Perhaps a moment of silence for at least one casualty, or maybe not. As a newbie it was some what disheartening to see the rhetoric and condemnation. Perhaps some regretable language by some who should know better. Thanks Jeff for that link, I had no idea the amount of nutritional supplements taken exceeds 57 billion doses annually. I am usually never at a loss to make a comparison but I can not think of anything in every day life that is safer. The argument seems that if they actually do something for you then they must be dangerous and should be controlled, and in this case they are so safe they must be useless and what a big waste of money.

    Often the doctor-patient relationship leaves the patient feeling alienated. Perhaps people are compelled to take supplements as insurance. We all know how that works.

  49. Jann Bellamy says:

    @ Jeff

    “But many supplement critics argue for greatly restricted consumer access to supplements based solely on the perception of potentially harmful side-effects.”

    “Greatly restricted consumer access?” It seems the supplement industry begins with a presumption that consumers must not be deprived of “access” to supplements without having to explain why consumers should have “access” to supplements at all. What I would like is some logical explanation from the supplement industry as to why anyone should be allowed to sell a product of no proven efficacy and uncertain safety. Why should anyone be allowed to sell a product with vague claims of effectiveness that few consumers fully understand? What is the logic behind selling a product on the basis of its beneficial effect on one’s health where no beneficial effect must be proven beforehand? Before one can argue that “access” to something must not be taken away, it seems it would be incumbent upon the proponent to explain why “access” is necessary or desirable in the first place.

  50. @CC, I wouldn’t say he caters exclusively to sports medicine, but Scott at Science-Based Pharmacy tackles many sports-related issues, and is very active in endurance sports as well: http://sciencebasedpharmacy.wordpress.com/

  51. WilliamLawrenceUtridge says:

    Jeff, how do you know your health is due to supplements? Do you exercise? Eat largely unprocessed, whole foods? Get adequate sleep? Have a job that is not particularly stressful? Such is the problem of correlation and causation – taking supplements may be (and probably is) associated with much greater attention paid, in general, to overall health. I would guess that greater disposable income and higher education are also carry-alongs. Dr. Gorski has pointed out this CAM glory-hogging in the past I believe – a patient gets surgical excision of a tumour, skips chemo and radiation, and takes some herbs. The cancer does not come back. What does the patient claim was responsible for their success? The herbs. Same thing here – people have a constellation of healthy behaviours, they add a vitamin, and suddenly all of their good health is due to the vitamin, not the diet, exercise, healthy weight and adequate sleep that all doctors recommend.

    Here at SBM, the point is to get people to think, rationally and with an empirical grounding, on what could be responsible for health, disease, alleviation of symptoms and promotion of health. Drugs are known to be risky, and vitamins aren’t miracles. Nobody is saying vitamins need to be pulled from shelves, that’s a “health freedom” talking point (where “freedom” is the freedom to pay too much money while being mislead by vitamin manufacturers – another situation where Big Pharma uses deception to shill their products). Some people need vitamins and minerals – either because of poor absorbability, poor digestion, lack of intrinsic factor, limited diet, heavy menstruation or some other reason. What should be recognized however, is that vitamins may carry risks, and that decisions to take vitamins (rather than get them through food) should be made on a rational basis. While a multivitamin once a day (or even better, once every two to three days) probably doesn’t do much harm, the real concern is high-doses taken over years by high risk groups under the belief that they’re taking a risk-free compound with guaranteed results (and often, with the thought that they can take this vitamin and maybe skip their vegetables for the next day/week/month/year).

    So no, I don’t want to take away your vitamins – I just want their risks and benefits to be appreciated. In particular, I want you to realize that there are risks, and unless you’ve an acute deficiency, there may not be any benefits. That’s hard to convince people of, when you have Big Pharma making vague claims on one side, and orthomolecular lunatics proclaiming vitamins a panacea on the other.

    Eat your vegetables, exercise, get enough sleep, and you probably don’t need the vitamins.

  52. CC says:

    SkepticalHealth: thanks! Looks like he covers supplement and vitamin nonsense as well. I recognize a few of those posts from here, actually, I guess more than one of the SBM authors have their own separate blogs as well.

  53. Scott says:

    Perhaps some regretable language by some who should know better.

    Is that meant to be an apology?

    The argument seems that if they actually do something for you then they must be dangerous and should be controlled, and in this case they are so safe they must be useless and what a big waste of money.

    The argument is that anything with physiological effects also has side effects, and supplements aren’t sufficiently studied to know what they are. Nor are they sufficiently studied to know that they have the claimed effects in the first place. So yes, they are either functionless, or must be presumed dangerous. There are no other possibilities without the science supplement sellers aren’t required to carry out. (And without that science, you also can’t tell which is which.)

    You’re also quite wrong to claim they’re safe – not known to be unsafe is a better description. And when nobody’s actually obliged to LOOK at whether they’re unsafe, that is no recommendation.

  54. stanmrak says:

    Arguing about nutritional studies is a waste of time. You’re never going to find even ONE legitimate study on nutritional supplements, for the simple reason that nutrients don’t work in isolation, and their effects can’t be measured that way. They’re not drugs!
    It’s impossible to remove all the variables in a nutritional study, as is necessary, to come up with valid scientific conclusions. The studies I see reported on in the mainstream press are completely bogus, typically designed by people who clearly have no idea what they’re doing. Any study on vitamin E, for example, is invalid if it doesn’t use a complete vitamin E complex, with all the tocopherols and tocotrienols included. Not to mention including the other nutrients that vitamin E works with synergystically – vitamin C, selenium, Co-Q10, etc. These studies never account for this; so how can they come up with any kind of reliable data?

  55. Scott says:

    If nutrients don’t work in isolation, and aren’t drugs, why exactly are nutritional supplements being sold in isolation and drug claims being made for them?

    If the studies are invalid, the supplements are invalid.

  56. Harriet Hall says:

    @stanmrak,

    “how can they come up with any kind of reliable data”

    How can you know your own ideas are correct?

  57. WilliamLawrenceUtridge says:

    stanmrak, are you arguing that vitamin supplements are unnecessary and we should get our vitamins from food? Because I think most people here would agree with you.

  58. stanmrak says:

    “If nutrients don’t work in isolation, and aren’t drugs, why exactly are nutritional supplements being sold in isolation and drug claims being made for them?”

    No drug claims can be made for supplements; that’s already illegal. We don’t need further legislation.

    It’s a free country, and some of us WANT to buy specific supplements to augment our already-healthy diets. Why do you care if that’s what I want to do? If you want to take statin drugs, be my guest… I think they’re worse than worthless, and there’s plenty of research that shows this. And do you have any idea what the markup on them is? I’ve heard that a bottle of statins that sells for as much as $250 costs less than $1 to manufacture. Where’s the outrage?

    “If the studies are invalid, the supplements are invalid”.

    Someone once, a long time ago, did a ‘invalid’ study that showed that the earth revolves around the sun; therefore, it does not.

  59. stanmrak says:

    “stanmrak, are you arguing that vitamin supplements are unnecessary and we should get our vitamins from food? Because I think most people here would agree with you.”

    No, I’m arguing for a free choice; I don’t care if anyone agrees with me or not.

  60. stanmrak says:

    “how can they come up with any kind of reliable data”

    How can you know your own ideas are correct?

    BINGO!!!! I don’t – and I’ll admit it. Anyone else willing to cop?
    In the end, you can’t ever be sure, no matter how educated you are, so why get all bent out of shape because someone else believes something else?

    The only study I truly believe in:

    Why Most Published Research Findings Are False
    http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.0020124

    which demonstrates that the conclusions of peer-reviewed studies, the holy grail of scientific truth, are only about 50% accurate, the same as a coin toss.

  61. Harriet Hall says:

    Stanmrak translated = “I don’t need no stinkin’ science.”

    “why get all bent out of shape because someone else believes something else?” I don’t get bent out of shape just because someone chooses to believe or chooses to take supplements without evidence. I do get bent out of shape when supplement salesmen misrepresent the current state of evidence and make claims not supported by any data.

  62. Purenoiz says:

    @stanmrak

    To quote concordance, if somebody throws this study at you, it’s likely they never read it.
    http://www.youtube.com/watch?v=hBNeuG10-ac&feature=g-user-c&context=G24633d9UCGXQYbcTJ33YLoo-rLsJ9Ist6ogoqkZwhVi7Ud3d-dZk

    Please take one statistics class, and look at the probability of something happening purely by chance alone. It’s actually quite fun and helps when you look at studies that support or nullify your previously held bias. I work for several supplement companies, and I can tell you this from my own experience, the majority of supplement manufacturers are lying to you or are honestly misinforming you ( I know man who sincerely belives magnesium stearate harms people, even though he bases it on a rat study where the rats were fed massive amounts equal to a human consuming Kg dosages). I don’t think he is a bad person nor a liar, but misinformed.

    Hoodia is a great example where there was more hoodia in capsules than there was a raw ingredient ever allowed by the African Government ( it is a protected plant species). So you could buy a supplement, and be not getting what you thought you were getting.

    Vitamins and food fortification have a proven track record of reducing certain diseases such as pellagra, goiter and spina bifida. But that doesn’t mean diddly about supplementing above and beyond what your body needs or can handle, no matter what some peddlers of the goods will tell you.

  63. Alia says:

    Well, I admit I supplement iron from time to time – my hemoglobin and hematocrit levels tend to be rather low and the alternative proposed by my doctor (eat more red meat) is simply not viable (I’m not vegetarian but I don’t like red meat, I prefer fish and poultry). And here’s a fun fact – the iron supplement I take is not a supplement, it’s a drug that’s passed all the necessary testing (not FDA, I’m not American).

  64. Jeff says:

    @stanmrak: Nutrition research is a flourishing field. There are a growing number of studies showing therapeutic benefit form the tocotrienol form of vitamin E. Of course the mainstream media tends to ignore such studies:

    1. Tocotrienols improved the condition of patients with end-stage liver disease

    2. Tocotrienols reduced the risk factors for metabolic syndrome

    The SELECT trial proved only that synthetic alpha-tocopherol slightly increased the risk for prostate cancer, possibly by displacing levels of gamma-tocopherol (associated with a reduced risk of cancer).

  65. @Jeff, wow, that is some funny reading.

    Among subjects supplemented with tocopherol alone, only 20 percent (one out of five) experienced reduced MELD score, while 50 percent (seven out of 14) of the tocotrienol supplemented subjects showed MELD score improvement.

    So 50% showed improvement, the other 50% worsened. Sounds like random chance.

    Get your news from respectable sources, not quack natural websites. Nothing is more sad that reading the completely inappropriate interpretation of a scientific study from a whacko natural news website.

  66. Jeff says:

    Jann Bellamy asks:

    What is the logic behind selling a product on the basis of its beneficial effect on one’s health where no beneficial effect must be proven beforehand?

    I thought the FDA had set the bar fairly high for claims made by supplement companies (including the much-maligned structure/function claim):
    http://www.khlaw.com/showpublication.aspx?Show=1218

    Consumers’ interests are not served by companies making false or exaggerated claims. Perhaps stronger enforcement measures are required — like those taken against makers of acai “weight-loss” products:
    http://www.naturalproductsinsider.com/news/2012/01/fda-halts-fake-acai-news-sites.aspx

    Jann Bellamy (and most SBM bloggers) seem to believe supplements must be presumed unsafe until such time expensive, long-term studies prove otherwise.

    To me it’s a clear freedom-of-choice issue: Dietary supplements have a long history of safe use. Until such time science proves specific harm, no government agency has the right to tell me which doses of what nutrients I may consume. Nutrients are not drugs and should not be regulated in the same way.

  67. Harriet Hall says:

    @ Jeff,
    “Jann Bellamy (and most SBM bloggers) seem to believe supplements must be presumed unsafe until such time expensive, long-term studies prove otherwise.”

    That’s not what I’m hearing. I’m hearing that most supplements are probably safe but that we can’t know for sure and can’t guarantee their safety without adequate monitoring or testing.

    “no government agency has the right to tell me which doses of what nutrients I may consume. Nutrients are not drugs and should not be regulated in the same way.”

    Is a government agency telling you how many strawberries or how much of a supplement you can ingest? If they are not drugs, why are you talking about doses? If they are food, why aren’t they eaten in the form of food rather than put into pills?

  68. 10000li says:

    Jeff made the point very well that Jann Bellamy revealed his/her paternalistic hand.

    The kind of America where everything is banned until it is proven safe is not the country I want to live in.

    There are many options regarding testing the safety and effectiveness of vitamins and supplements. Below is a not exhaustive list of the top choices:

    1. Make the producers prove s&e before they can sell products. This would likely remove a very large number of products from the market since there is no clear, objective definition of “effective.” Only the biggest v&s companies would be able to comply, since s&e testing is so expensive. v&s would ultimately cost the same and be as unavailable to the consumer as are pharmaceuticals.

    2. Make the government prove un-safeness and ineffectiveness before products could be banned. This is basically the same as doing nothing, since the government agency that would do the testing and could do the banning would need something the government is in short supply of: Taxpayer’s hard-earned money. And I’m not that keen on even more government intervention in my daily life.

    3. Create 3rd party testing of v&s for s&e and let those companies publish their results for free. This is always problematic because if they provide positive evidence for a vitamin or supplement, they would be called a shill for that v&s manufacturer; if they provide negative evidence against a v or s, they would be called a shill for Big Pharma or the competition or government – no matter how rigorous were their methods.

    4. Caveat emptor. While this is my preferred philosophical method of solving problems in the marketplace, I recognize that is is not very popular and not widely effective. Ultimately, however, it is the only way to ensure that you are spending your money on something you want, at a price you want to pay, to do what you want it to do, because no government agency, no private company, no consumer watchdog agency really knows what’s best for you, and each is full of normal human beings who may have even the purest motives, but suffer from the same imperfections as the rest of us. And we should always ask, “Quis custodiet ipsos custodes?”

    Someone presented a false dichotomy about the FDA (and government agencies in general): The FDA can be both toothless and draconian at the same time – It all depends on how they direct their attention. The FDA can be toothless with respect to Big Pharma because Big Pharma has Big Money to lobby against strict rules on themselves and the FDA can be draconian towards v&s because Big Pharma has Big Money to lobby for strict rules on v&s.* The FDA could easily be patsies of Big Pharma by creating barriers to entry into the market that companies with large pocketbooks can surmount, but smaller start-ups could never get over. I hope no one here believes that the regulation of food, drugs and cosmetics (or anything else, for that matter) ensures that only the best make it to market. It only means that only the worst get blocked or removed from the market, eventually.

    While some people may feel better when they hand over their lives to those promising to save them from all the evils of the world, and while there are certainly lots and lots of people promising to do just that very thing – Paladins who really believe their job is to protect us from baddies, and from our own ignorance – I prefer to make my own judgments, even if they are bad ones, so long as I have the freedom to do so. And when that freedom is taken away from me, I have to wonder about the motives of those taking it away. Do you really believe I am so short-sighted as to not research the food, drugs and vitamins I take? and the people who are recommending them? I know I spend more time ensuring my own protection than do most other people, but spending or not spending that time is the consumer’s free choice. Isn’t it ironic to advocate that we spend the time ensuring that we are eating balanced diets of high-quality foods that we prepare for ourselves, but then tell us we’ll never have the time or intelligence to figure out what v&s are good for us and what are not?

    Here’s how it works for me: I know that most v&s are total garbage. I have looked into the various producers and found one that I like for the v&s I want to buy. I use v&s because I have seen positive results from supplementing my diet – with no other changes in lifestyle. My anecdotal evidence is sufficient proof for me of the s&e of the v&s I use. I don’t advocate that anyone else do what I do, but I really do expect them to figure it out for themselves. If, however, they don’t want to, that’s not my problem. I don’t see the need for government to be charged with coming in and saving them from themselves.

    *Note: I’m not saying that Big Pharma is necessarily the villain and that v&s companies are excessively put upon, so don’t waste time pretending I’m defending v&s.

  69. DavidRLogan says:

    @Jeff I’ve always had sympathy toward lefty sorts of libertarianisn and even classical libertarianism. And so, I guess I do think we have some robust freedom from government interference except with regards to taxation (a species of left libertarianism)…but of course you see that is not enough…if dangerous supplements are ingested (either acute or chronic danger) you might not be the only one to bear the cost…negative externalities may go toward healthcare, public litigation,(customers/patients at your work!), etc.

    Either way, I didn’t get the feeling from this thread that government was actually trying to take supplements away from you. I got the feeling we were discussing what claims supplement manufacturers ought to make upon an impressionable public, and whether vitamin supplements were generally safe (or not). From the evidence you gave it wasn’t clear to me that supplements were in danger (in fact they seem more popular than ever…and the bills mention by Jann lend themselves to more supplement usage)…care to elaborate?

    Also, I think the bar you set for unsafety (*proven* unsafe) is a bit high. We have proven (for all purposes) some things, like soot, unsafe. But there’s little in nutrition that is completely uncontroversial. And so, we rely heavily on the absence of positive proof (as many have mentioned), reasonable arguments that jive with our understanding of biology (eg nutrients are best absorbed when present with the thousands of ancillary nutrients in whole foods), and our personal studentship (in my case), medical practice, professorship, whatever (as I mentioned I’ve yet to find supplements that meet label claims, are not contaminated, do not contain fillers that inhibit metabolism of the supplement, etc.)

    You mention that millions take supplements as evidence for their safety. But how healthy would those people be if they ate whole foods? We’ll never know, but it’s not clear the bar for safety should be based on the consumption habits of millions of Americans. “Safe” is not a rigid designator, and in my view the safety (health) of Americans is compromised by the practice of using vitamin, etc. supplements.

    Best,
    -David

  70. Alia says:

    BTW, I’ve just read a very informative and sensible article about OTC drugs, supplements and advertising on one of our most popular portals (not in English, so I won’t post a link). Hopefully some people will take it to their hearts.

    And you know what, I’ve just realised a very scary fact. My mother-in-law, who falls for all woo, all kinds of supplements, herbal remedies and homeopathy, holds an MSc in pharmacology. Granded, she’s retired and before her retirement she had an office job at a drug wholesaler for at least 15 years – but still, she really should have known better. And yet she falls for all this (especially if it’s advertised by her best friend who is even worse), which is really depressing.

  71. William B'Livion says:

    @Jann Bellamy
    “”"It seems the supplement industry begins with a presumption that consumers must not be deprived of “access” to supplements without having to explain why consumers should have “access” to supplements at all. “”"

    I realize that this is an outdated notion, but in general this country (Well, the United States, I’m not in it right now, and I miss it horribly) was founded, in part, on the notion that what was not explicitly forbidden was allowed, and that banning things–ranging from actions to items to ideas–was not something that was to be done arbitrarily and without good reason.

    I shouldn’t have to prove my innocence, nor prove why I should have access to something. The onus is put on the person BRINGING the charges to prove them. This was (more or less (handwaving)) the enlightenment that Cervantes is bemoaning the death of.

    If one takes vitamin E in excessive doses one might (maybe even “probably will”) have a higher risk of prostate cancer. This is the individuals responsibility, and with things like this *the individual* bears (or should bear) the brunt of the costs (this is one reason among many that I don’t like socialized…I mean single payer health care financing solutions). We make antibiotics ‘prescription only’ because the abuse of antibiotics harms the whole community by evolving resistant microbes. We put certain types of pain killers either off limits or by prescription only because the nature of those drugs mean much greater negative externalities when they are abused (not always by the person purchasing them, but resale “down-stream”).

    Some of us still mostly believe in the old fashioned and outdated notions of individual autonomy and personal responsibility.

    I’d like to see something like the Underwriters Laboratory for nutrition and supplement information. A neutral, audit-able third party that certifies the purity and whether the claims made actually hold up under scrutiny.

    I realize this is a worldview that most of you can’t get behind, but there’s a lot of us out here who don’t really have all that much trust in our goverment. Some of use because we’ve *worked* for that government in some capacity or other for a long time and know from experience just how f*ked it is.

    I also know that the “Nutraceutical” industry is filled with folks who were too corrupt and dirty to get jobs in government.

    Can’t win on either side here.

  72. William B'Livion says:

    @Alia:

    My mother was a Orthopedic Clinical Specialist for something like 30 years, an employee health nurse for a few years before that and a other jobs before I was born.

    She falls for a lot of that carp.

    One big problem is that even if you’re like me and go *looking* for the research too much of the information is behind really expensive paywalls, so I all I can get are abstracts and popular press articles. I have a couple friends I can ask if I need a specific article, but that only works AFTER I’ve narrowed it down to an article or 6.

  73. Jeff says:

    Either way, I didn’t get the feeling from this thread that government was actually trying to take supplements away from you.

    Have you read about the FDA’s Draft Guidance concerning New Dietary Ingredients for Dietary Supplements, released in 2011? Jann Bellamy’s post refers to it. SBM’s David Kroll blogged about it
    Here.

    If enforced by the FDA, these rules would have a devastating effect on the supplement industry. Thousands of products could be ruled illegal and removed from the market. Academics like Pieter Cohen and politicians like Illinois Senator Dick Durbin have been trying for years to restrict consumers’ access to supplements.

  74. PernilleN says:

    “more than 100 million Americans consume dietary supplements, spending more than $28 billion annually”

    Does anyone know how much is spent on pharmaceutical medicines pr year?

  75. Purenoiz says:

    @PernilleN
    “Does anyone know how much is spent on pharmaceutical medicines pr year?”

    Why not ask how much we spend on cars, on movies or plaid golf pants? The amount of money a nation spends on goods or services proves what exactly? Isn’t that just a trolling question?

    @10000li
    I agree that in essence to consumers free choice. I wonder how free that choice is when people are actively lied to about the products they may choose to consume. Europharma’s Tri-iodide is a perfect example.
    http://www.europharmausa.com/products/tri-iodine/
    I am not sure where Terry Lemeron of Europharma gets his information that “… it has been estimated that the entire population is deficient in iodine”. Oh wait, it’s not from actual studies, but from this book “Iodine, Why You Need It and Why You Can’t Live Without It,”
    “Iodine is the most misunderstood nutrient. After 12 years of practicing medicine, I can say that it is impossible to achieve your optimal health if you do not have adequate iodine levels. I have yet to see any item that is more important to promoting health or optimizing the function of the immune system than iodine.”
    –David Brownstein, M.D.

    No studies, just a book. And that is in essence what I dealt with everyday while I’ve worked in health food stores and watched people come rushing in with newsletters, magazine articles or advertisements using fear of a possible illness to sell a product. In essence the freedom to choose comes from being informed. There are strong elements in the supplement industry would like to be able to say whatever they wish without having to back it up with evidence to support the myriad of health claims they make. In essence they want to make drug claims, with out doing the work other companies do. I.E they want special treatment to to compete where they have no business competing. http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm143534.htm But hey, I guess that is just crushing their “freedom” to do what ever, free from consequences.

  76. Jann Bellamy says:

    @ Jeff

    “I thought the FDA had set the bar fairly high for claims made by supplement companies (including the much-maligned structure/function claim):
    http://www.khlaw.com/showpublication.aspx?Show=1218”

    It’s hard to argue that FDA has set a high bar when the document referenced is merely unenforceable guidance, as the FDA itself points out:

    “FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.”
    http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/DietarySupplements/ucm073200.htm

    “Consumers’ interests are not served by companies making false or exaggerated claims. Perhaps stronger enforcement measures are required — like those taken against makers of acai ‘weight-loss’ products:
    http://www.naturalproductsinsider.com/news/2012/01/fda-halts-fake-acai-news-sites.aspx.”

    Doesn’t seem to be doing much good. Acai weight loss claims are alive and well on the internet.

    http://www.acaiberry.abilityhub.com/

    http://www.acaiberrycoloncleansediet.com/

    https://cdn.syndtk.net/aa/support/terms/slm/t_14303957995.html

    http://www.aprovenproduct.com/acailand.php?t=gae%2Bacai&gclid=CJKTmJ2i364CFQll7AodQxXwXA

    “Jann Bellamy (and most SBM bloggers) seem to believe supplements must be presumed unsafe until such time expensive, long-term studies prove otherwise.”

    Speaking for myself only, I believe that safety is unknown for most supplements. You can’t argue a history of safe use when safety data is, until recently (and only for serious adverse events) not collected or studied. So the issue, for me, is whether a product of unknown safety should be sold to the public, especially where a health benefit is claimed. If allowed at all, I think each supplement label should (where applicable) carry a warning to the effect: “No safety data exists on the use of this product and its use could be hazardous to your health. Take at your own risk.” As for “expensive, long-term studies” those aren’t going to come along very often because the dietary supplement industry doesn’t want to pay for them. So the industry can keep us in a perpetual state of “safe until proven otherwise.”

    “To me it’s a clear freedom-of-choice issue: Dietary supplements have a long history of safe use. Until such time science proves specific harm, no government agency has the right to tell me which doses of what nutrients I may consume. Nutrients are not drugs and should not be regulated in the same way.”

    You can take as much of anything you want. A “nutrient” is a constituent of food necessary for normal physiologic function. It is only through the magic of DSHEA that dietary supplements are the equivalents of nutrients in food.

    I argue that if a company wants to make money off the public selling a product, it must truthfully disclose to the public exactly what is being sold and not be cute about it with “structure/function” claims, or employ the Quack Miranda Warning. The government does have the authority to prevent companies from making misleading or false claims and selling unsafe products and that is what I think the FDA and the FTC are trying to do within the limitations of their statutory authority. Of course, that statutory authority — in the main, DSHEA — is a huge problem.

  77. Harriet Hall says:

    Re “health freedom” – If the government stayed out of regulating foods, pharmaceuticals, and diet supplements, people would know they had to do their own research, and private companies would step into the gap to provide information. The problem is that the government is expected to provide some regulation and most people are under the false impression that everything offered for sale has been evaluated and approved by the government. We have the illusion of consumer protection without the reality.

  78. @ Dr. Hall

    The problem is that the government is expected to provide some regulation and most people are under the false impression that everything offered for sale has been evaluated and approved by the government. We have the illusion of consumer protection without the reality.

    That’s probably the best way I’ve seen the whole problem of alternative medicine all of this other crap worded.

  79. Jeff says:

    Jann Bellamy:

    My understanding was that a finalized draft guidance lets industry know FDA’s interpretation of a particular law and how the agency intends to enforce it. Apparently FDA believes it has authority to take enforcement action agianst companies making unsubstantiated structure/function claims:
    http://www.infomercialwatch.org/fda/cortislim.shtml

    This email from the Council For Responsible Nutrition shows how seriously the supplement industry is taking the NDI Draft Guidance:

    As FDA has reminded us, this draft guidance document describes the agency’s interpretation of the requirements for NDIs—it is not a new regulation and does not create new rights or responsibilities for the industry. Nevertheless, this draft guidance does represent an important step for the dietary supplement industry—and for the Agency—as it demonstrates further implementation of the requirements of the Dietary Supplement Health and Education Act (DSHEA) and will give companies clearer understanding of FDA’s expectations under the law….This guidance has potential for short- and long-term implications for our industry and for our consumers’ ability to have access to in-demand products and we want to be sure the guidance is appropriate, reasonable and practical for industry and the more than 150 million consumers who use dietary supplements year after year (CRN, e-mail, July 1, 2011).

    The FDA has been collecting supplement adverse event data for many years, even before mandatory reporting by industry. The agency only starting posting the figures recently. Studies show supplements cause few adverse events (see pubmed/18570167). Since the passage of DSHEA in 1994 only one supplement has caused any meaningful number of AERs: Ephedra, which is now banned.

    PernilleN asks:

    Does anyone know how much is spent on pharmaceutical medicines pr year?

    According to this article annual U.S. sales run about $320 Billion.

  80. LMA says:

    The worst thing about all of this IMO is the disservice it does for people like myself who have legitimate, science-based, doctor prescribed needs to take particular vitamins and supplements (for example, since I began taking Melatonin, I have greatly reduced my reliance on Ambien, and since I take Methotrexate, it is necessary for me to take Folic acid). Because there is no FDA oversight and regulation, there is no way for us to know whether a particular brand (or as tests by Consumer Reports have revealed, even by batch) of such supplements is reliable, contains the correct dosage, etc. Fortunately for me, but not most Americans, I am affluent enough/have good enough health insurance, that I can afford to have my Rheumatologist draw and test my blood every six weeks or so, and to then can afford to buy Vitamin D when he says my numbers are low, for example. But again, that doesn’t give me any immediate assurance that I’m actually paying for what I think I’m getting when I head to the pharmacy.

  81. JPZ says:

    Well Jann,

    You have done a so much more worthy job than Scott. Pardon me if I am the voice of dissent:

    In 1938, Congress found it hard to throw out all the drugs people had been using for so long (e.g morphine, heparin, etc.). So, they grandfathered all of those drugs but placed a number of restrictions on them to ensure that they were safe and effective.

    In 1994, Congress found it hard to throw out the dietary supplements people had used for so long (go back and check the 1938 laws before you get your tail all out of wank). So they (like in 1938) grandfathered in all supplements on the market before the grandfather clause. So, all of them are ex post facto safe. But they aren’t. You can throw a hissy fit that pre-1994 ingredients aren’t tested. But find me any amount of guanifenesin pre-1938 data that is superior.

    Yeah, some folks are dismissing me as a troll, but this is evidence and data.

  82. Scott says:

    No drug claims can be made for supplements; that’s already illegal. We don’t need further legislation.

    And yet, they’re made routinely. Supplements are regularly sold for weight loss, preventing colds/flu, and treating arthritis. And that’s just what I saw on commercials last night. All structured as “wink, wink, nudge, nudge” combinations of structure/function claims, testimonials, and implication – but nonetheless quite clear.

    Quibble about whether it’s a question of new legislation vs. enforcing existing if you like, but it’s incontestable that the status quo is one where supplements routinely make clear drug claims. And the reasons people TAKE the supplements are generally due to the drug claims. Relatively little supplement use is actually to provide nutrients missing from the diet, AFAICT.

    If the function is to provide nutrition, then improved diet should be the tool. Supplementation doesn’t make sense in that case unless there’s something preventing the user from obtaining the proper nutrition from their diet. Any other use of supplementation is as a drug.

    It’s a free country, and some of us WANT to buy specific supplements to augment our already-healthy diets. Why do you care if that’s what I want to do?

    I don’t care what you want to do. I care about supplement manufacturers lying to the public.

    “If the studies are invalid, the supplements are invalid”.
    Someone once, a long time ago, did a ‘invalid’ study that showed that the earth revolves around the sun; therefore, it does not.

    Your statement has not the faintest connection to what I said. The supplement manufacturers do not have data demonstrating that the claims they make (of efficacy OR safety) are correct. They are therefore invalid claims. Some of those claims might be borne out were the actual science to be done, but that’s irrelevant. Until the science is done, there’s no way to tell WHICH claims are accurate, and it’s grossly unethical (and should be illegal) to make the claims at all.

  83. Harriet Hall says:

    @JPZ,

    In 1938 the FDA grandfathered prescription drugs “but placed a number of restrictions on them to ensure that they were safe and effective.”

    In 1994 Congress grandfathered diet supplements but did not place adequate restrictions on them to ensure that they were safe and effective.

  84. Quill says:

    LMA wrote:

    Because there is no FDA oversight and regulation, there is no way for us to know whether a particular brand (or as tests by Consumer Reports have revealed, even by batch) of such supplements is reliable, contains the correct dosage, etc.

    In fact there is a way to get some decent data on supplement brands. There is a private firm, Consumerlab, that does test many supplements and provides access to all their reports for about $20/year. They seem to be a reputable firm and have been cited here as well as on Quackwatch and other science-based sites.

    http://en.wikipedia.org/wiki/ConsumerLab.com

  85. LMA says:

    Well that’s good to know, Quill, but again, that presupposes that someone is wealthy enough to subscribe to that service, or informed enough to know they might need to. OTOH, if the average person has a headache, they don’t have to go on the internet, subscribe to a testing service, and research the various brands of aspirin and ibuprofen — they can just go to CVS, pick up a bottle of Advil, consult the label for dosing, and they’re done. And, if perchance they instead had a bottle of funky-smelling Motrin in the cabinet, they’ll probably be alerted by the local news, network news, newspaper or online news that there’s been a big recall of Johnson & Johnson products and that they should replace that Motrin!

  86. Quill says:

    I hear you, LMA. I agree completely with Dr. Hall above where she wrote “In 1994 Congress grandfathered diet supplements but did not place adequate restrictions on them to ensure that they were safe and effective.” At the very least supplements should be tested for accuracy in labeling and for any adulteration. The public would be well served by simply knowing what the heck was in the bottles, nevermind if they actually do anything.

    I also have several medical issues that require supplements. It bothers me no end that I can’t, as you say, just go to CVS and get something. I’ve had to do some research to ensure I’m actually getting what I’m paying for.

  87. Jeff says:

    JPZ states that supplements are unsafe. Can he provide any “evidence and data” for this?

    The FDA has been increasing GMP inspections since full compliance became mandatory in June, 2010. The agency estimates that eventually 25% of supplement companies will be forced out of business due to the high cost of GMP compliance. Those firms using sloppy or unsafe production methods will be unable to continue — this is as it should be.

    The FDA would need to expend considerable time and effort enforcing rules in the NDI Guidance. FDA bureaucrats claim this is necessary to enhance supplement safety. Since these burdensome regulations would not make supplements safer (they already are), I wish they would use more of their valuable resources enforcing laws against those companies making false or exaggerated claims for their products.

  88. LMA says:

    Are you actually trying to make us “feel bad” for those “supplement companies will be forced out of business due to the high cost,” Jeff? Right now the cost — both monetarily and physically (in those cases, for example, where people have bought supplements that later turned out to be adulterated with toxins, viagra, etc) — is on consumers. And that’s just plain wrong.

  89. Scott says:

    JPZ states that supplements are unsafe. Can he provide any “evidence and data” for this?

    In any sane regulatory system, the burden would be on the supplement manufacturers to prove that they are safe, NOT on others to prove them unsafe.

  90. Calli Arcale says:

    JPZ:

    Others have already addressed that the supplement rules in 1994 are not really comparable to the much stricter rules for grandfathering in 1938, but I’d like to add something else…..

    ….so you’re arguing, then, that if the FDA screwed up in 1938 they should be allowed to repeat the mistake? Have we learned nothing in over half a century? The truth is, of course, that in 1938 they did not simply say “if it has an old ingredient, it’s good, we don’t need any data”. In fact, many drugs were removed from the market at that point. One notable example is a liquid formulation of sulfanilamide in use in the 1930s. Under existing legislation, it was illegal because it was improperly labeled — it was marked as an elixir, which would indicate alcohol as the solvent, but actually it used diethylene glycol. It had been widely used, but had undergone no safety testing in this formulation. It killed over a hundred people, and was precisely why the new legislation creating the FDA in 1938 required safety testing of all new drugs and cosmetics before coming to market.

    Under the 1994 DSHEA legislation, however, a supplement introduced as recently as 1990 would not have required safety testing and would have been grandfathered in as long as it was labeled correctly. And even after the legislation, as long as all of the *ingredients* have been tested or are already generally recognized as safe, it wouldn’t matter. You can bring a new supplement to market as long as the ingredients are all GRAS and you label it correctly. That’s not the case with a pharmaceutical; the entire drug has to be tested. Even if what you’re introducing is just a new formulation of ibuprofen, you’ll need to test it in that new formulation. (As I understand it. I hope I will be corrected if I am wrong.)

    I’m an engineer, working in aerospace and defense. We’d lose a lot of business if we didn’t do safety testing of all of our products in *exactly* the delivered configuration, because we’d risk killing people if our systems failed. Heck, one of my projects is with NASA, and is for an unmanned spacecraft — a mistake will kill nobody. They’re still ferocious about testing at all levels, because a tiny error or unexpected interaction between two components could spell the end of the mission. I’ve never quite understood why we’re so much more blase about things we swallow in order to modify our own bodies, which are much more complex than a mere spacecraft.

  91. trrll says:

    “The FDA would need to expend considerable time and effort enforcing rules in the NDI Guidance. FDA bureaucrats claim this is necessary to enhance supplement safety. Since these burdensome regulations would not make supplements safer (they already are), I wish they would use more of their valuable resources enforcing laws against those companies making false or exaggerated claims for their products.”

    Burdensome? All the regulations seem to require is an accurate account of the ingredients or method of preparation of a supplement, along with appropriate safety information regarding any chemicals added. Surely, any responsible manufacturer would have this rather basic information already immediately available, wouldn’t you think? The food supplement industry is hugely profitable, selling cheaply made products at enormous markups. The information the FDA is asking for is minimal, particularly compared to the kind of detailed clinical studies, frequently costing hundreds of thousands of dollars to conduct, that are required for pharmaceuticals.

  92. Jeff says:

    Calli Arcale: So you’re suggesting there is an eqivalence of risk from spacecraft components, drugs, and supplements? DSHEA states that dietary supplements are composed of dietary ingredients:

    A dietary ingredient is a vitamin; a mineral; an herb or other botanical; an amino acid; a dietary substance for use by man to supplement the diet by increasing total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of any of the above dietary ingredients.

    Would you require manufacturers of food products to conduct expensive safety testing? Do we need toxicology studies or human clinical trials every time Kraft comes out with a new mac & cheese offering? Most supplements are purified components of food which have been in the human diet for centuries. One glance at the FDA’s post-marketing surveillance data shows there is a vast difference between the safety profiles of supplements vs. food or drugs.

    I have nothing against research — the more science the better. But making expensive safety testing mandatory for supplements seems unnecessary. There is also the question of cost. Drug companies can afford phase 3 clinical trials only because of patent protection. As natural substances most supplements cannot be patented.

    The FDA’s Draft Guidance for NDIs requires expensive toxicology studies, not only for each new dietary ingredient, but for each new supplement containing those NDIs. This would result in supplement prices approaching those of prescription drugs. This would put supplements out of financial reach for most consumers. Undoubtedly this was intended by the FDA; agency bureaucrats have the same kind of hostility towards supplements as most SBM bloggers.

  93. Scott says:

    @ Jeff:

    Your own quote demonstrates that supplements are not in fact defined as what would be normally understood as “dietary ingredients” – the common understanding of which would be “something normally consumed as food.” Minerals, herbs, etc. do not fit that at all. And that’s not even considering the incredible weasel wording of “supplement the diet by increasing total dietary intake,” which could be twisted to cover anything at all. Shall we “supplement the diet by increasing total dietary intake [of statins]” for example? (See red yeast rice.)

    Would you require manufacturers of food products to conduct expensive safety testing? Do we need toxicology studies or human clinical trials every time Kraft comes out with a new mac & cheese offering?

    If they’re going to sell it with a recommendation that people eat 100x as much cheese powder as anyone ever had in the past, so that it would prevent the common cold, cure cancer, or produce weight loss, YES they bloody well better carry out safety and efficacy testing.

    The bottom line is that most supplements, as created and marketed, ARE DRUGS by any functional definition. They are sold with clear claims to treat disease, without any relationship to or consideration of what people do or have eaten, not with the purpose of filling in some nutrient lacking in the diet. And if they can do what they claim, it’s because they are pharmacologically active and therefore have side effects as well.

    DHSEA was created, by legislators well-paid by supplement manufacturers, to allow the manufacture and sale of unregulated drugs by disingenuous labelling. That’s the long and short of it.

  94. Jeff says:

    DSHEA’s definition of dietary ingredients makes sense to me. Vitamins, minerals, amino acids, herbs, etc., certainly are components of food consumed as part of a normal diet.

    Any supplement company making a health claim without scientific proof and FDA approval is doing so illegally. The FDA has been surprisingly lax enforcing this law:
    http://www.nutraingredients-usa.com/Regulation/FDA-fails-to-deter-H1N1-fraud-claims-New-York-legal-expert

    Instead of enforcing laws against false health claims, the FDA proposes instead to use up considerable resources enforcing the complex set of rules in the Draft Guidance for NDIs. The agency claims this will make supplements even safer than they already are.

    The vast majority of supplements are marketed legally, without making any claims of curing diseases. The FDA has banned RYR products containing more than trace amounts of Monacolin K (identical to Lovestatin):
    http://www.medicinenet.com/red_yeast_rice_and_cholesterol/article.htm

  95. Jeff says:

    @Scott: you say that supplements are “pharmacologically active” and should therefore be regulated like drugs. But what if food itself is pharmacologically active?

    What if my own diet is not high in omega-3s, but I want its potentially beneficial effects on my cognitive abilities as I grow older? And what if I discover there’s scientific evidence that supplemental DHA will give me similar benefits? As a responsible, reasonably well-informed consumer, DSHEA ensures I have access to safe, affordable DHA supplements. There is an omega-3 preparation obtainable by prescription only, but it’s about nine times as expensive as the supplemental form.

    This is why I think some bureaucrats and health professionals have such an intense dislike for DSHEA — They are philosophically opposed to consumers having any degree of control over decisions concerning their own health.

  96. JPZ says:

    @HH

    Did you read the law?

    Check out the new NDI proposal from the FDA, nearly mirrors the revisions of the 1938 law.

    Really, you missed that?

  97. JPZ says:

    @Calli

    Rules from REVISIONS (1962?) to the 1938 law placed the same restrictions on existing drugs that the new NDI guidance places on dietary supplements.

    So, show me the pre-1938 safety testing of heparin… No? Then, protest that as you watch people die (sorry, overly dramatic?).

    Both the drug and dietary supplement rules exempted safety testing in favor of legislative expediency…

    The DHSEA laws required a definition against which new ingredients should be measured. The FDA only recently published them. Tell me how those are different from the post-1938 expectations. Come on, it will be fun to hear this.

  98. Jeff says:

    HOUSE ENERGY & COMMERCE COMMITTEE MEMBERS CALL ON FDA TO “RE-EXAMINE” NDI GUIDANCE

    Dan Burton isn’t the only Congressman who understands the NDI Guidance is an unworkable document. This is a very hopeful sign.

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