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At Your Own Risk

In 2011, Americans spent some $30 billion on dietary supplements. Yet, except for the industry itself and a few politicians and “health freedom” advocates, you’d be hard pressed to find anyone (who’s given it some thought) of the opinion that dietary supplement regulation is adequate. Three recent reports, two from the government and one from a newspaper, demonstrate why this near-universal conclusion is warranted.

Another government report on lax supplement regulation

Here’s how an October, 2012, Department of Health and Human Services Office of Inspector General’s (OIG) report described the FDA’s regulatory authority:

DSHEA [Dietary Supplement Health and Education Act] does not require manufacturers to submit dietary supplements to FDA for safety or approval prior to sale. As a result, FDA has no comprehensive list of dietary supplements on the market. Dietary supplement manufacturers must ensure that their products are safe, they have evidence to substantiate structure/function claims, and that product labels are truthful and not misleading.

In other words, the fox guards the henhouse.


Because there is much confusion about structure/function claims, here is a somewhat lengthy explanation from the report about what they are and how they are different from disease claims, which dietary supplement manufacturers aren’t supposed to make. (Citations omitted.)

In general, structure/function claims describe the role of a dietary supplement in the structure and function of human bodies, but the claims may not explicitly or implicitly claim to prevent, treat, mitigate, cure, or diagnose a disease. A structure/function claim may also:

• claim a benefit related to a classical nutrient deficiency disease (e.g., scurvy) and disclose the prevalence of such disease in the United States,

• characterize the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function, or

• describe general well-being from consumption of a nutrient or dietary ingredient.

For example, a supplement may claim that it “curbs appetite to help with weight loss,” but it may not claim to “aid weight loss to treat obesity” because obesity is a disease. Similarly, a supplement may claim to “support immunity,” but may not claim to “boost the immune system against colds and flu” because the latter references specific diseases. Although FDA has issued regulations and published guidance describing the difference between structure/function claims and disease claims, it acknowledges the challenge of distinguishing between the two.

If the FDA has trouble interpreting DSHEA and its own regulations, imagine the problems everyone else has with “the challenge of distinguishing between the two.” The report continues:

DSHEA requires manufacturers to meet three requirements for placing a structure/function claim on a supplement label: (1) substantiation that the claim is truthful and not misleading, (2) notification to FDA within 30 days of marketing the supplement with the claim, and (3) a disclaimer on the supplement label.

“Substantiation of structure/function claims” means:

Manufacturers must have substantiation for the structure/function claims on their products’ labels to ensure that they are truthful and not misleading. . . .

However, this substantiation requirement is, shall we say, substantially limited by the fact that:

In any legal proceeding concerning structure/function claims, FDA must prove that the claim is false or misleading.

A further limitation is:

 DSHEA does not require manufacturers to submit the substantiation requirement to FDA to determine its adequacy and FDA may not compel manufacturers to produce substantial upon request.

So, let’s see. DSHEA requires substantiation of structure/ function claims but manufacturers are under no legal obligation share that information with the FDA even if the FDA asks for it. All the manufacturer has to do is notify the FDA of the structure/function claim and slap the Quack Miranda Warning on the label. Then it’s off to market. The burden is on the FDA to identify risky supplements, of which there are about 85,000, according to a recent New York Times story. And if the FDA takes a manufacturer to court it is up to the FDA to prove the lack of substantiation. In a classic case of bureaucratic understatement, this caused the OIG to conclude that the FDA “has limited authority to enforce the substantiation requirement.” Indeed.

And how is industry doing with that substantiation?

Even with these slack requirements, a sampling of 127 supplements marketed for weight loss and “immune system support” revealed manufacturers did not fully comply with FDA guidance on proper substantiation of claims. A wide variety of brands were selected from various locations across the country and the internet. A truly random sample was not possible because “no comprehensive list of dietary supplements or manufacturers exists.” The OIG would have looked at more supplements but only 61% of the manufacturers complied with its request for information. Here’s a sampling of structure/function claims from the report:

SBM post OIG study samples

Based on its review, the OIG concluded:

  • Most substantiation was not derived from human studies. 56% would be considered background information (e.g., in vitro and animal studies), which are not primary sources of evidence and therefore may not be sufficient to support claims.
  • None of the human studies met all of the FDA’s recommendations for competent and reliable evidence.
  • Human studies rarely showed a direct relationship to the claim. For example, evidence submitted to support a supplement claim that it burns fat because it contains a green tea extract was actually a study of drinking green tea.
  • Most human studies did not appear to represent the totality of the evidence. In this conclusion, the OIG relied on NCCAM staff, who told them that a large body of evidence contradicts structure/function claims. But a whopping 96% of human studies the OIG received were favorable to the supplement’s claim.
  • Most studies were not consistent with FDA guidance on quality. Another whopping figure here – 85% were not randomized, double-blind, parallel group, placebo-controlled trials.
  • About a third were not consistent with FDA guidance on the meaning of the claim made.
  • 10% did not qualify as substantiation at all.

As an example of this last deficiency, the OIG noted:

One company submitted a 30-year-old handwritten college term paper . . . while others included articles from trade newsletters; press releases; advertisements; and links to Web pages, such as Wikipedia or an online dictionary.

Only drugs can legally make disease claims, yet 20% of the supplements made such claims. Another chart from the study:

SBM post OIG study disease claims

The manufacturers couldn’t even get the bonehead requirements right. A majority of notification letters were missing required information. And 7% didn’t have the Quack Miranda Warning on the label.

In response to the report, the FDA said it would improve its notification system for structure/function claims, expand market surveillance to detect disease claims and enforce inclusion of the Quack Miranda Warning. However, as to the OIG’s recommendation that the FDA seek legislation requiring approval for all structure/function claims in labeling, the FDA would only commit to considering the possibility. Small wonder, given the fact that Congress has a conniption fit every time attempts are made to beef up regulation.

In addition to this report, the OIG issued another on dietary supplement regulation at the same time. Here, the title says it all:

Dietary Supplements: Companies May Be Difficult to Locate in an Emergency

True. When the government doesn’t know what products are out there or who makes them it would indeed be difficult to find the companies under the best of circumstances, much less in an emergency.

Putting a human face on the problem

Now to a feature story from Sunday’s New York Times, which recounts the heart-breaking tale of a body-building supplement and the death of a soldier.

In June of 2011, Michael Lee Sparling, a 22-year-old Army private stationed at Fort Bliss, Texas, collapsed after running in formation for about 10 minutes in 75 degree weather. He went into cardiac arrest and died later that day. Before the exercise, he had taken the recommended dose of Jack3d (pronounced “jacked”), a supplement sold by, among others, GNC, the retail dietary supplement chain, who advertised it as producing “ultra-intense muscle-gorging strength, energy, power and endurance.” Pvt. Sparling, who by all accounts was in excellent physical condition, purchased his Jack3d at an on-base GNC store.

Pvt. Sparling’s untimely death has once again ignited criticism of lax dietary supplement regulation in the United States, a subject we have addressed many times at SBM. Now joining the chorus of calls for reform are his parents, Leanne and Michael Sparling. Last month, the Sparlings filed a wrongful death lawsuit against GNC and Jack3d’s manufacturer, USPlabs. Ms. Sparling, who still wears her son’s dog tags, told the Times:

They just think they are too big and everybody’s afraid of them. They think I will just go away. Unfortunately for them, I won’t go away.

According to the Times, DMAA (dimethylamylamine), started out as an inhaled drug for nasal congestion. Because of potential side effects – tremors, headaches and nervousness – Eli Lilly withdrew it from the market voluntarily. In 2005, it reappeared as a dietary supplement based on the disputed claim that it can be found in a geranium grown in China. This doesn’t mean that any of the DMAA on the market actually comes from this plant, but such is the logic of the DSHEA.

Last April, the FDA sent warning letters to several supplement manufacturers saying it had no evidence DMAA is a legitimate dietary ingredient and citing its risks. (Health regulators in other countries, such as Sweden and Denmark, have actually banned DMAA-containing supplements.) Heart attacks, heart failure, kidney failure and liver failure were among the health problems reported to the FDA, as well as 5 deaths. GNC responded that it was “completely opposed to this unilateral, factually and legally unfounded action by the FDA.”

The Times story said that other organizations are also taking action. The World Anti-Doping Agency and Major League Baseball have banned methylhexaneamine, which is the same thing. The military removed supplements containing DMAA from base stores, including GNC. Col. Erin P. Edgar, a command surgeon with the U.S. Central Command, thinks the military, which sells “truckloads” of body-building supplements at its bases, should not be selling them at all.

And how did the industry respond?

Part of the problem is lack of any pre-market requirement of proof of safety and part of the problem is retailers like GNC, who aren’t regulated at all. As reported in the Times, both had predictable responses to the lawsuit and unfavorable publicity, as did the supplement industry.

The attorney for USPlabs said the company is “unaware” of any deaths from the proper use of Jack3d and that there is no evidence the reported deaths were caused by the product. Various spokespersons for GNC, which had about $4.2 billion in revenue last year, said the company had no reason to believe that DMAA is unsafe, that GNC sells legal products widely available from other retailers, and that it complies with all relevant regulatory guidelines. A spokesperson for the Council for Responsible Nutrition, an industry trade group, said that a majority of supplements are safe.

Unfortunately, all of these speakers are well within their rights. Manufacturers are under no obligation to test their supplements to see if they are fatal before they market them and they must report any deaths only if someone happens to complain. Even then, they are free to say there is no proven causal relationship. And if the FDA wants to challenge that, the FDA has the burden of proof. No doubt GNC does comply with all regulatory guidelines as there aren’t any regulations requiring retailers to inquire into safety or effectiveness. The Council spokesperson is probably right when he says that a majority of supplements are safe. We just don’t know which ones aren’t until we find out the hard way, when injury and death reaches a threshold that spurs further investigation. Or, as Dr. Amy Eichner, a special adviser to the anti-doping association for American Olympic athletes, told the Times:

No consumer can ever know what’s inside a bottle. We advise our athletes that all supplement use is at their own risk.

Great advice for all consumers, whether athletes or not. In fact, what we need instead of the Quack Miranda Warning on supplement labels is a more accurate disclaimer of FDA involvement in dietary supplement regulation:

FDA WARNING: Safety and effectiveness unknown. Use at your own risk.

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

Leave a Comment (56) ↓

56 thoughts on “At Your Own Risk

  1. BillyJoe says:

    This segment about complementary medicines aired on the ABC tonight:

    http://m.youtube.com/watch?v=nH8GwjLZ9IE

    Spot on, don’t you think

  2. Janet says:

    Unfortunately, no matter how often this information is reported, supporters/believers will only respond with sneers and snorts to the effect that the FDA is the suspect party in this “debate”. They will run on about Vioxx and …wait for it…thalidomide as evidence that the FDA is the culprit in the regulatory picture.

    Every article I read in the NY Times and every post Marion Nestle makes on her blog about supplements being loosely regulated, brings a flood of anti-FDA comments. The level of misinformation about supplements and the role of the FDA, to say nothing of the real role of “BigPharma” in all this (that is, the difference between the criticism of someone like Ben Goldacre and the criticism of a Mike Adams) is stunning.

    The bright spot is that last time I offered a rebuttal I got hundreds of votes while my legion of attackers got only a few each! Just an anecdote, alas, but it helps me to keep trying. :-)

  3. Sawyer says:

    @ Janet,

    Knowledge of thalidomide is my litmus test for whether or not someone really wants to understand the ins and outs of the FDA, as any honest critic would acknowledge both their successes and failures. Are there seriously people claiming it as a failure?

  4. Earthman says:

    I have looked at several sites selling supplements and I cannot see DMAA listed as an ingredient in Jack3d. Can you clarify this matter please. Is DMAA in Jack3d?

  5. Harriet Hall says:

    @Earthman,
    Here’s the Jack3d label. It definitely does contain DMAA. http://www.jack3d.org/ingredients

  6. Chris says:

    Sawyer:

    Are there seriously people claiming it as a failure?

    Yes. It is a very good indication of their knowledge of history. Recently comments at the blog of Dr. Gorski’s “friend” there have been claims that the MMR is dangerous because the government claimed thalidomide was safe, and someone was pushing a book where it was claimed that it was that it was only because of “bureaucratic delay” that the USA was saved from thalidomide.

    I think knowing about thalidomide is a good litmus test. I read about it
    in Protecting America’s Health: The FDA, Business, and One Hundred Years of Regulation.

  7. mousethatroared says:

    HeHe – “bureaucratic delay” is essentially true. The problem is people’s inability to see a “bureaucratic delay” as a good thing.

  8. Jeff says:

    One anecdote doesn’t prove DMAA caused anyone’s death. No connection has been established. If I told about my positive experiences with supplements my comments would be dismissed as unscientific and irrelevant. There is some disagreement about whether DMAA is a legitimate dietary ingredient:

    http://www.nutraingredients-usa.com/Research/DMAA-not-in-geranium-says-yet-another-study

    Instead of simply issuing warning letters the FDA could immediately remove DMAA from the marketplace for any of three reasons:

    1. It was determined DMAA is actually causing serious adverse reactions.

    2. The agency decided DMAA is not a legitimate dietary ingredient and therefore not a legal supplement.

    3. The agency determines no New Dietary Ingredient application has been filed, with safety data included. This would make any product containing DMAA adulterated and therefore illegal.

    The FDA cites reasons 2 and 3 in its warning letters about DMAA. This makes the issue one of enforcement, not regulation. Why is the agency taking so long to act?

    Chris gave his recommendation for a book about the FDA. Here’s mine:
    http://www.amazon.com/Fight-Your-Health-Exposing-Betrayal/dp/1933927178/ref=la_B001K8VWX0_1_3?ie=UTF8&qid=1363887465&sr=1-3

  9. Chris says:

    MTR, that “bureaucratic delay” was Dr. Kelsey insisting on seeing some specific animal tests, especially after “she developed an interest in teratogens and earned her Ph.D. and M.D”> in Chicago. The actual “delay” was Richardson-Merrell not providing the requested information and wasting everyone’s time by badgering her.

  10. WilliamLawrenceUtridge says:

    Jeff, you should read the NYT article linked in Jann Bellamy’s post. It’s quite interesting. This is not a matter of a single anecdote.

    The publisher of your linked-to book (Truth in Wellness) sounds awesome. Any publisher with “truth” in its name must really, really want the truth, and I bet it’s not at all a marketing gimmick.

    Have you contacted your congressperson to support a more stringent separation between government and industry, for the FDA to have more resources and authority to exercise their oversight mandate? Also, the book seems to be about criticizing the oversight of the FDA regarding drug companies. Bar the fact that drug companies manufacture supplements, what does it have to do with the regulation of supplements? Unless you are advocating for supplements to have the same degree of oversight and proof-claims required of drugs, which I would heartily endorse.

    Noting that the FDA is less than perfect certainly justifies a stronger, more independent agency with less influence from industry. Certainly it does nothing to indicate supplements are harmless or effective.

  11. lilady says:

    @ Jeff: And…here’s my link to the author of your book, who is the owner of a MLM supplements company and a “Board Certified Nutritionist”.

    http://www.wellnessresources.com/supplements.php

    He’s not a Registered Dietician is he?

    Comparing a “Board Certified Nurtritionist” to a Registered Dietician is similar to comparing a “toothologist” to a dentist.

    http://www.youtube.com/watch?v=uRqB5-egs1s

  12. Jeff says:

    Lilady: Wellness Resources sells supplements, but is not an MLM company. My understanding was that nutritionists and dieticians are in somewhat different professions, with one not necessarily inferior to the other:

    http://www.anh-usa.org/campaigns/monopoly-over-nutritional-therapy/

  13. lilady says:

    @ Jeff: Check out Wellness Resources “Affiliate Program”:

    http://www.wellnessresources.com/affiliate.php

    Check out the Wikipedia entry for “Dietician” which is a “protected professional title” in the United States.

    http://en.wikipedia.org/wiki/Dietitian

    Dieticians graduate with a minimum B.Sc. degree from a university and have undergone rotations with a preceptors in clinical areas, before they sit for licensing boards to obtain their professional license.

    “Nutritionists” have a variety of educational backgrounds; some attended colleges, some take “college courses” online and some are self-styled “nutritionists” without any “college” credits…similar to a “toothiologist’s” credentials.

  14. Jann Bellamy says:

    @ Jeff:

    “One anecdote doesn’t prove DMAA caused anyone’s death. No connection has been established.”

    As WLU pointed out, it’s not just one incident. No one is saying a connection has “been established” but few would disagree that there is sufficient circumstantial evidence of a connection to warrant concern, which is why objective third parties like the military are taking action.

    “The FDA cites reasons 2 and 3 in its warning letters about DMAA. This makes the issue one of enforcement, not regulation. Why is the agency taking so long to act?”

    I don’t know but I imagine it has something to do with lack of resources. Citing reasons 2 and 3 doesn’t mean there is no evidence of 1. It makes sense that the FDA would try to get DMAA off the market by citing the reasons for which it has the strongest case. In fact, according to the Times story, many of the companies who received warning letters have already removed DMAA from their products. USPlabs and the FDA are apparently in negotiations, although still disagreeing, about whether DMAA must be removed. If the FDA can get products off the market in this manner it is a whole lot cheaper than confiscating them and fighting the issue in court.

  15. WilliamLawrenceUtridge says:

    Lilady: Wellness Resources sells supplements, but is not an MLM company.

    So..the conflict of interest between Big Pharma, the FDA and the advice and regulation of drugs (which, let’s remember, must be proven safe and effective in clinical trials for initial use, and to make any claims for off-label use, there must be further clinical trials) – that’s a horror story. But the owner of a company that sells supplements, who gives advice on supplements, who is a world-renowned researcher on leptin, who sells leptin-related products (products which are not proven safe or effective, have no clinical trials, and who are free to make essentially any claim as long as it’s with a nod and a wink) – that’s fine. That’s perfectly acceptable. You can trust him.

    Can you explain the distinction to me?

    “It’s not a MLM company” is a little like arguing “sure, Pol Pot killed millions of his own citizens – but he wasn’t Hitler“. Talk about damned with faint praise.

    My understanding was that nutritionists and dieticians are in somewhat different professions, with one not necessarily inferior to the other:
    http://www.anh-usa.org/campaigns/monopoly-over-nutritional-therapy/

    The ANH appears to be a health freedom advocacy organization (i.e. the freedom to be bilked out of money for ineffective drug-pretenders) that seems offended at the idea of science-based standards.

    Note their comparison:

    In general, nutritionists are health practitioners with comprehensive knowledge of how nutrition impacts the whole body focusing on medical nutrition therapy, metabolism and biochemistry, and work primarily in private practice settings conducting one-on-one nutrition counseling. Nutritionists practice an integrative approach to medicine and concentrate on prevention and treatment of chronic disease. Dietitians, in general, are experts in nutrition science with training focusing on institutional diets and food service management–developing diets for hospital patients, school food service programs, and nursing homes. Dietitians can provide individualized counseling on diet and disease and there can be an overlap in the type of work each profession practices.

    It sure sounds sciencey (“medical nutrition therapy”, a rather meaningless term since food isn’t medicine) but the “integrative” part suggests they are unscientific practitioners dedicated to overselling supplements. Dietitians meanwhile, appear to practice with a scientific basis and focus on food rather than vitamins. The claim also references doctors, nurses and acupuncturists in the same breath, which is absurd. There’s appeals to “monopoly” (more health freedom rhetoric) but essentially no reference to science. Their recommended reading is quite interesting. I see numerous books that appear to be polemics against GMO, “health freedom”, a pile of books about corruption within medicine, a book by Gary Null (GARY NULL!!!), a nonsense book about how anxiety are caused by toxins and cranialsacral alignment, a book about the failure of the FDA published by “Life Extension Magazine”, and some other wonderful choices.

    They oppose vaccination, lie about GMO foods, lie about the FDA’s role, have a lovely dichotomy regarding health sustainability (because our choices really are as simple as trees versus stumps), invokes M-theory (quantum woo!) to draw a distinction between “natural” molecules and “unnatural” molecules, support chelation and according to their “accomplishments“, were leaders in the effort to create the NCCAM.

    I was going to suggest we go easy, that there might be a distinction between UK and US definitions of dietitian and nutritionist, but in this case Dara O’Briain seems to be quite correct – these guys are toothiologists. Jeff, you are not supporting your case by invoking this group.

  16. pharmavixen says:

    Actually, there hasn’t been just “the one single incident” with Jack3d. There was also the death of Claire Squires, the British marathon runner, in 2012:

    http://www.guardian.co.uk/uk/2013/jan/30/claire-squires-runner-dmaa-fatal

    The unexplained death of Claire Squires, a fit and healthy 30-year-old, one mile from the end of the London marathon last year, caught the country’s imagination….On Wednesday a coroner ruled that the most likely cause off her death was a single dose of Jack3d, a performance-enhancing supplement that at the time was legal to buy, possess and use.

    The article at Guardian.UK also cites the death of a man in Australia.

    Drugs may have benefits that are substantial and life-saving, like antibiotics, for instance, and the risks balance against these. Supplements, however, are taken for vague and frivolous reasons, like enhancing athletic performance or increasing muscle mass. So the burden of proof for safety must be ironclad. If you’re taking a product basically for bragging rights at the pub, or to look better at the beach, there really shouldn’t be any risk at all.

    What are the “benefits” of supplements, really? I mean, other than for the bottom line of the people who sell them.

  17. Quill says:

    “FDA WARNING: Safety and effectiveness unknown. Use at your own risk.”

    Oh, that would be so good! And given what I just read about in this article, it seems not only necessary but properly truthful.

  18. Iris Carden says:

    We’ve got the same (or very similar) issues in Australia, with very few effective Therapeutic Drugs Administration restrictions on supplements or alternative therapies.

  19. BillyJoe says:

    Iris,

    Did you watch the first segment of the first episode of “The Checkout” on the ABC on Thursday night:

    http://m.youtube.com/watch?v=nH8GwjLZ9IE

  20. elburto says:

    pharmavixen – You beat me to it.

    Sorry Jeff, but a coroner’s inquest trumps “Nuh-uh, prove it!” every time. Recommending, as a rebuttal, anything that includes buzzwords such as “integrative” or “health freedom” merely serves to strengthen Jann’s original point.

    @Chris – I see you’ve had another sex change. Can’t say I blame you, the queues are always smaller in the men’s loos!

  21. Jeff says:

    WilliamLawrenceUtridge:

    Wow! Your comments are interesting to read, even if I don’t always agree. The articles about nutrition on the Wellness Resources website are some of the best written and most informative you’ll find anywhere. Take for example, This well-referenced summary of research on the tocotrienol form of vitamin E (I take my tocotrienols every day):

    http://www.wellnessresources.com/health/articles/tocotrienols_twenty_years_of_dazzling_cardiovascular_and_cancer_research

    I donate money to the Alliance for Natural Health and support most of their positions.

  22. Scott says:

    “Well-referenced?” I suppose if your only standard is “has references at all.” I actually took a look through their supposed evidence. There isn’t any. Lots of in vitro theorizing, some animal studies, one teensy (25) human study which only got statistically significant results by excluding subjects. And what was the explanation given for excluding those subjects? They were poor responders! Well, duh, if you selectively throw away the bad results you can make what’s left look good.

    What that ACTUALLY shows is that there are some interesting effects in vitro, while what human evidence there is fails to show any benefit. THIS is what’s being claimed as sufficient reason to buy the stuff?

  23. Scott says:

    Oh yes, and that one study only looked at one of the claimed benefits.

    In all seriousness, if that’s what you consider good enough to hold it up as exemplary, it really shows more than anything that the claims being made are completely unfounded.

  24. WilliamLawrenceUtridge says:

    Wow! Your comments are interesting to read, even if I don’t always agree. The articles about nutrition on the Wellness Resources website are some of the best written and most informative you’ll find anywhere. Take for example, This well-referenced summary of research on the tocotrienol form of vitamin E (I take my tocotrienols every day):

    Your comments are filled with fallacies you don’t appear to recognize. I get my vitamin E from food, since supplements may kill you. Certainly the NIH’s page on vitamin E, far more science-based and realiable than these nutters, is cautious. That seems far, far more like the “best written and most informative you’ll find anywhere”. Primarily because it doesn’t assume a priori that supplements are harmless and beneficial. Why on earth do people object so strongly to getting their vitamins from food?

    I donate money to the Alliance for Natural Health and support most of their positions.

    That’s horrifying. Why would you support an entity that supports pseudoscience and opposes vaccination? Do you like babies dying of preventable but untreatable diseases like pertussis? Vaccinations shouldn’t be a choice, they should be a medical necessity. Happily I would endorse rooftop vaccination through snipers if it brought rates up to herd immunity levels.

    Why would you oppose genetic modification, aside from ignorance?

    Why do you think “health freedom” is a good thing, when really it is the “freedom” for companies to lie to their customers, distort results and resist any form of meaningful oversight? Why apply such a double-standard? The startling hypocrisy of CAM supporters on this fact alone never ceases to amaze me – drug companies invest billions of dollars in testing and must demonstrate efficacy resulting in conflicts of interest; supplement manufacturers invest almost no money in safety or efficacy but have no conflict of interest. What an immense double-standard.

    I have to agree with Scott, the articles seem less “well referenced” than “cherry-picked” and “confirmation biased”. Are you a genetically high-cholesterol pig? No? Then why would you care about results found in genetically high-cholesterol pigs? People aren’t pigs! Or test tubes! You’re assuming that information generated in a lab, under highly artificial conditions, with highly modified subjects, automatically apply to people. Further, you are assuming that people don’t have compensating mechanisms, biology or biochemical pathways that could render the pathological processes in other animals completely moot. There’s a reason you don’t apply the results for bladder cancer in rats automatically to humans – their urine formation is fundamentally different from ours. There’s a reason animal and bench studies are insufficient for anything but further study – people aren’t high cholesterol pigs, or heavily-inbred mice, or isolated cells floating in a test tube.

  25. KPmedic says:

    I’m an army medic assigned to an infantry unit in Afghanistan. Even out here, there is a panoply of supplements that soldiers either order or have sent to them in bulk. As a result of being the resident medical expert (yikes), I frequently get asked which supplements are most effective. I do my best to warn them that not only am I not qualified to confidently appraise their safety and efficacy, but that the research within the medical community is limited and likely biased, depending on the source of research.

    Its strange to me that a command surgeon would oppose their use, but the troops themselves have no training on their harm. Such is how business seems to be conducted here. At least in the infantry, if you aren’t using supplements, the perception is that you aren’t trying to be fit.

    Anyway, its an uphill battle. Maybe I should make this article required reading.

  26. Jeff says:

    “Happily I would endorse rooftop vaccination through snipers if it brought rates up to herd immunity levels.”

    Someone forgot to take his meds today.

  27. WilliamLawrenceUtridge says:

    Someone forgot to take his meds today.

    Nope, I just think that people dying from preventable diseases due to spurious, ill-informed, illogical reasoning is stupid. I’m not sure why CAM supporters are so willing to support parents watching helplessly while their infants slowly strangle to death because of pertussis. Why do you think this is superior to getting vaccinated?

    Plus, think of how exciting it would make things. There would be people whose job title was “vaccination sniper”. That’s Dr. McNinja territory!

    I’m perfectly fine with people who have genuine objections to getting vaccinated not getting vaccinated (i.e. egg allergies, impaired immunity). I am not fine with ignorant middle-class humanities graduates treating the scientific literature as if it were a garden to be picked over based on taste. I am not fine with people who are unable to take or benefit from vaccines dying because of this. Most objections to vaccination are spurious. Believing vitamins and supplements are a substitute is simply wrong.

    But please, focus on the obvious joke in my comment and completely ignore the substantive points because you can’t address them and are unwilling to admit your beliefs have zero scientific foundation. Please. It confirms by beliefs about CAM supporters, and there’s nothing us jumped-up chimps like more than confirmation bias.

  28. lilady says:

    @ Jeff: WLU provided you with the “patient” page on Vitamin E available at the NIH ODS (Office of Dietary Supplements). Here’s the “professionals” page on Vitamin E from the NIH-ODS, I support the NIH ODS through my tax dollars and I refuse to support the “nutritionist” who hawks his supplements on the internet.

    http://ods.od.nih.gov/factsheets/VitaminE-HealthProfessional/

    I’m so underwhelmed with the old pig and mouse studies of short duration that you find as the “be all and end all” of dietetic research.

    Now see the extended longitudinal RCT/double blinded studies conducted on tens of thousands of humans that are heavily referenced on the NIH-ODS website.

    See also, the inability to accurately detect severe Vitamin E deficiencies, which are exceeding rare deficiencies, as long as people eat a balance healthy diet.

    (Watch for the anecdote) I participated in an early double blinded placebo controlled trial of Lipitor, chosen because I have familiar hypercholesterolemia and my total cholesterol blood level always approached 400 mg/dL.

    When the study was unblinded, my total cholesterol blood level was measured at 180 mg/dL…and has remained at that level for the past 20 years…so obviously I received Lipitor during the trial and the generic Atorvastin that I take every day has kept my total blood cholesterol WNL.

  29. Chris says:

    elburto:

    @Chris – I see you’ve had another sex change. Can’t say I blame you, the queues are always smaller in the men’s loos

    ;-)

    I do it on purpose. It was fun to get calls from other engineers who had not met me, and hearing the gasp of surprise on the other end of the phone. Also Dr. Novella gave Dr. Kelsey a sex-change in a discussion about thalidomide on the SGU. That was quickly corrected!

    By the way, my book recommendation was more on topic. Another would be Natural Causes: Death, Lies and Politics in America’s Vitamin and Herbal Supplement Industry.

  30. Chris says:

    Blockquote fail! Well, what I have to say starts with the winking smiley!

  31. elburto says:

    Jeff -

    Someone forgot to take his meds today.

    Aaand there we have it folks! The ableism cherry on top of the sCAM fail-cake.

    sCAM enthusiasts always trip themselves up eventually, and the veneer of ~mah health freedumbs~ cracks wide open, and reveals a fetid, stinking core of anti-science, vaccine-denial, and blockheaded senselessness of the sort that insists that children are better dead from VPDs than “contaminated” by vaccines.

  32. Jann Bellamy says:

    I just read a quote attributed to Neil deGrasse Tyson in this morning’s newspaper — in an obituary, of all things. It was a favorite of the deceased:

    “The good thing about science is that it’s true whether or not you believe in it.”

    Appropriate for the current discussion, I thought.

  33. Jeff says:

    “The good thing about science is that it’s true whether or not you believe in it.”

    I agree. The science says DMAA is probably not a legitimate dietary ingredient and doesn’t belong in any dietary supplement. The provisions in DSHEA are quite sufficient to remove this substance from the marketplace. This is the first product since Ephedra to warrant this kind of action from the FDA. The science also shows the vast majority of supplements are quite safe – much safer than drugs, vaccines, or even food. Figures from the FDA, CDC, and the American Association of Poison Control Centers show this quite clearly.

  34. BillyJoe says:

    “The science also shows the vast majority of supplements are quite safe”
    The science shows that the vast majority of supplements are useless in the vast majority of circumstances.

    “The good thing about science is that it’s true whether or not you believe in it.”
    Provided what is “true” is what the evidence tells us is true, otherwise the same can be said for objects of faith.

  35. WilliamLawrenceUtridge says:

    I agree. The science says DMAA is probably not a legitimate dietary ingredient and doesn’t belong in any dietary supplement.

    While I agree, I will ask – how do you know? Supplements aren’t tested or monitored in anything close to a meaningful way. You should write your congressperson to advocate for better controls over and monitoring of supplements instead of wasting your time here.

    The provisions in DSHEA are quite sufficient to remove this substance from the marketplace.

    Not really, the burden of proof is on the FDA to indicate harms. How does it do this when there is no systematic monitoring? Well, as in this case, people die. Actually, this case isn’t enough – more people have to die. Because supplements are assumed to be safe and effective, not tested, an absurd double-standard you don’t seem to see. If supplements are as effective as you assert, testing should show this easily (as well as any adverse health effects or impact on secondary markers). But you want to maintain your double-standard, wasting money or wasting lives. The FDA doesn’t have resources or the mandate to actively monitor the vast, nigh-endless number of combined and permuted supplements and compounds released every year.

    This is the first product since Ephedra to warrant this kind of action from the FDA.

    How do you know? Do you monitor the adverse effects of supplements in your spare time? If there were a small, base-rate increase in deaths due to supplements (such as apparently occurs for vitamin E), it would require extensive monitoring.

    The science also shows the vast majority of supplements are quite safe – much safer than drugs, vaccines, or even food.

    Well, if “science” does so, since “science” is a public exercise, you should be able to provide references to support your assertions. Please, provide the sources that show that DMAA is both safe and effective. And has been stated here many times – drugs must be proven safe and effective. Drugs are accompanied by a list of side effects, but also a list of main effects that demonstrate you’re getting something for those risks. There’s even risk:benefit calculations made showing nigh-exactly what your chances of dying are versus your chances of living longer.

    Safer than vaccines my ass. Vaccines prevent deadly diseases, and the risks are incredibly minimal. Vaccines are so safe it can be difficult to tell if serious side effects are real or illusory. Not to mention safety and effectiveness testing informs you of the substantive risks and what to look for. How do you know what to look for in supplements with no safety testing? You don’t.

    If supplements have a biological effect beyond just food, they act as drugs and should be monitored and controlled as such. Why you insist a double-standard, I don’t understand. Actually I do – your personal biases and logical fallacies prevent you from seeing you have a double-standard, and like so many humans you are resistant to admitting you’re wrong.

    Figures from the FDA, CDC, and the American Association of Poison Control Centers show this quite clearly.

    Please link to the section of their websites where they show the specific monitoring of DMAA.

  36. Jeff says:

    “Not really, the burden of proof is on the FDA to indicate harms. How does it do this when there is no systematic monitoring?”

    Did you read my earlier posts? The FDA can remove DMAA from the marketplace for any of three reasons:

    1. It was determined DMAA actually caused serious adverse reactions.

    2. The agency decided DMAA is not a legitimate dietary ingredient and therefore not a legal supplement.

    3. The agency determines no New Dietary Ingredient application has been filed, with safety data included. This would make any product containing DMAA adulterated (and illegal).

    DMAA is a fairly new supplement ingredient. It was not grandfathered in when DSHEA passed in 1994. By law an application for a New Dietary Ingredient application must be filed with the FDA; this must include data showing DMAA can be taken safely under normal use. Since no NDI application has been filed, DMAA is considered adulterated and therefore illegal.

    The FDA has sent several warning letters citing reasons 2 and 3. Firms ignoring the warning letters are subject to criminal prosecution with possible fines and jail time. The agency does not have to prove DMAA has caused harm to get it off the market.

    There certainly is systematic monitoring of supplement adverse events. Since 2007 the supplement industry has been subject to mandatory reporting of serious AERs. The FDA posts these figures online. 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 prescription drugs:

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

    Naturally-occurring molecules (supplements) have a far superior safety profile compared to synthetic lab-created molecules (drugs). This is one reason supplements and drugs should not be regulated in the same way.

    “If supplements have a biological effect beyond just food, they act as drugs and should be monitored and controlled as such.”

    Supplements are safer than food. Data for foodborn illness is 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.”

  37. pharmavixen says:

    Supplements are safer than food. Data for foodborn illness is 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.”

    What if there was the same exposure to supplements as there is to food? We don’t know how many people take supplements precisely, other than extrapolating indirectly from sales. I know I have bought supplements and they have sat in my cupboard until they passed their “best before” date.

    But we know everybody eats.

    The risk versus benefit still isn’t established here. If we don’t eat, we die. But we don’t need supplements. The whole “wellness” industry is there to convince healthy people that mere health isn’t good enough – we also need “wellness,” and for that we must take supplements.

    FWIW, I subscribe to a Health Canada service that sends me advisories, warnings, and recalls. Since 2000, when their website started tracking these, there have been over a thousand recalls of natural products, including supplements, for various reasons, such as contamination with bacteria or heavy metal, finding undeclared DMAA (banned in Canada), and finding all sorts of undeclared prescription medications, including antibiotics, sildenafil (Viagra), diuretics, sibutramine (a weight-loss drug), antihypertensives, etc.

  38. WilliamLawrenceUtridge says:

    Did you read my earlier posts? The FDA can remove DMAA from the marketplace for any of three reasons:

    But with tens of thousands of untested supplements on the marketplace, how can the FDA possibly monitor them all? This is one ingredient, removing it leaves thousands more for consumers to waste their money and risk their health on.

    But at least for this ingredient, I hope you are advocating your congressperson to pressure the FDA to remove DMAA from the market – without more input and voter pressure, how does the FDA know which ingredient out of thousands to take action on? And if you want to actually address the problem rather than one symptom, you should also advocate for better regulation of supplements and more resources for the FDA. But you won’t, because of your double-standard, drugs are bad, supplements good (even when they kill people through sudden cardiac arrest).

    DMAA is a fairly new supplement ingredient. It was not grandfathered in when DSHEA passed in 1994. By law an application for a New Dietary Ingredient application must be filed with the FDA; this must include data showing DMAA can be taken safely under normal use. Since no NDI application has been filed, DMAA is considered adulterated and therefore illegal.

    As opposed to all the other thousands of ingredients released unmonitored, unregulated, untested, with no verification of purity, potency and certainly no safety or efficacy. Again, you are focusing on the symptom, not the problem.

    The supplement figures can be compared to those for prescription drugs:

    The supplement figures can absolutely not be compared to prescription drugs, for a variety of reasons – monitoring is far less systematic, there is no expert role or monitoring from doctors like there are with drugs, there is no process to recognize standard adverse effects that allows easier record keeping, there is essentially no incentive to monitor, there is no biochemical testing or evaluation to guess at what the adverse effects might be, there are no proxy measures that can be monitored, and I’m sure more reasons can be thought of rather easily. Supplements have nothing close to the monitoring of drugs, and also have absolutely nothing comparable in either safety or efficacy. If supplements don’t work, they are a waste of money. If they have a significant biological effect, they act like drugs and are likely to have side effects. Either way, you are taking a risk – hopefully one solely to your wallet.

    Naturally-occurring molecules (supplements) have a far superior safety profile compared to synthetic lab-created molecules (drugs). This is one reason supplements and drugs should not be regulated in the same way.

    Bitter almond is natural. How does its safety profile compare to a vaccine? How does mandrake root? Do you consider that natural? How about safe? What about the venom of an Inland Taipan snake? Perfectly natural – how safe is it compared to AZT? What about a fava bean? Is that natural? If someone with G6PD deficiency eats enough of them, they die.

    Your assertion that “natural” is safer than “laboratory” is nonsense, it is a product of indoctrination and fallacy, not fact. All substances should be evaluated on a case-by-case basis for both safety and efficacy. Why are you so fond of putting money into Big Supplement’s bottles?

    Supplements are safer than food. Data for foodborn illness is 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.”

    How many people take supplements? Of those, how many are poisoned by them each year? All humans consume food, the same can not be said of supplements, and again, there is nothing comparable in terms of monitoring. You should contact your congressperson to get a fraction of the supplement industries billions of dollars per year to go into safety and effectiveness testing so citizens are no longer putting their health at risk or their throwing their money away on worthless pills that are redundant to food.

  39. Jeff says:

    pharmavixen:

    In his recent SBM post, Who Takes Supplements and Why, Scott Gavura used figures from The National Health and Nutrition Examination Survey (NHANES): just over half the US population (about 157 million people) uses dietary supplements.

    The drug-based model of American healthcare doesn’t admit to a therapeutic benefit from any dietary supplement. All supplements are supposedly worthless. But what if certain nutrient deficiencies are more prevalent than many doctors think? Consider the essential mineral zinc, as just one example:

    1. http://www.sciencedaily.com/releases/2012/10/121001141003.htm
    2. http://knowledgeofhealth.com/modern-day-zinc-deficiency-epidemic/

  40. Narad says:

    Consider the essential mineral zinc, as just one example

    And the references you offer are a press release for a paper on elderly mice (which is actually here) and a Gish gallop from vitamin salesman Bill Sardi?

  41. Marc Stephens Is Insane says:

    Here are some rational thoughts from a real doctor on supplements in general and Bill Sardi in specific. His agenda is solely to sell his brand of supplements. Notice in the comments at the botoom Sardi refuses to answer if he has any science credentials or degrees and lashes out with hostility when confronted.

    “Can You Trust Bill Sardi?”

    http://mdprevent.blogspot.ca/2012/10/can-bill-sardi-be-trusted.html

    He’s just another Mercola or Mike Adams with lots of products to sell.

    Update as of March 21, 2013

    Bill Sardi or someone working on his behalf sent me two copies of his book, The New Turth About Vitamins & Minerals. On the cover of the book, he displays Purity’s Perfect Multi, the multivitamin he sells. The entire book is dedicated to persuading the reader that if you want a quality multivitamin, only he sells it. In fact, in the back of the book, Sardi includes a survey of multivitamins where he grades the major brands out of 100 points. Not surprisingly, his product gets a 96, with the next closest product is graded 68 out of 100, with the numbers dropping fast from there.

    Out of curiosity, I started reading the book, but had to stop when I realized that although he occasionally quoted some reasonable studies, many were studies done in animals, which hold little relevance to humans. The book was the most self-serving book I have ever tried to read. After a few pages of copious notes, I had enough.

    Again I caution, beware of people telling you how great are the supplements they are trying to sell you.

  42. pharmavixen says:

    In his recent SBM post, Who Takes Supplements and Why, Scott Gavura used figures from The National Health and Nutrition Examination Survey (NHANES): just over half the US population (about 157 million people) uses dietary supplements.

    Fair enough. Still, it’s an estimate at best in comparison with the absolutely certain knowledge that everybody eats. (Other than the tiny handful who subsist on total parenteral nutrition who I mention in case you do in your next post :)

    The drug-based model of American healthcare doesn’t admit to a therapeutic benefit from any dietary supplement. All supplements are supposedly worthless.

    Straw man, and not even true. For decades we’ve been promoting calcium supplements for people at risk of osteoporosis, iron supplements for people with iron deficiency anemia, B12 for pernicious anemia, and folate for pregnant women and those trying to conceive, thiamine to prevent Wernicke’s encephalopathy in the treatment of alcohol withdrawal. Promoters of hyervitamin therapy cite the well-documented effects of niacin on lowering cholesterol levels, but we tend to give statins instead not because we hate vitamins, but because statins are safer and have fewer side effects.

    If there really were benefits to supplementation as purported by altmed practitioners, Big Pharma wouldn’t suppress that knowledge. Big Pharma would write it across the sky, and make billions. We’ve already seen it already – when there was that hoopla five or six years ago about the Vitamin D deficiency from which we all supposedly suffer, resulting in mental illness, multiple sclerosis, and cancer, we couldn’t keep vitamin D on the shelves. In the city where I live, people were obsessively hysterically phoning every pharmacy looking for elusive stock.

    Just a few examples off the top of my head.

  43. Narad says:

    thiamine to prevent Wernicke’s encephalopathy in the treatment of alcohol withdrawal

    Minor correction: Wernicke’s is not part of AWS but rather results from chronic substitution of EtOH calories for solid food.

  44. Jeff says:

    Marc Stephens Is Insane: I readily concede that an actual doctor’s opinion would carry more weight than mine. But you don’t deal with the substance of Sardi’s article – you only attack him personally.

  45. Marc Stephens Is Insane says:

    I merely supplied a link to a website. I paraphrased what the MD who owns the blog said, and stated Sardi is in business to sell his stuff, like Mercola and Adams. How is that “attacking him personally”?

  46. Narad says:

    But you don’t deal with the substance of Sardi’s article

    Oddly, neither do you.

  47. Marc Stephens Is Insane says:

    THe point is, Sardi, Mercola, Adams et. al. blog about all these supplements and vitamins “we all need” that they just so happen to sell. In my world that means there’s no objectivity; it’s merely advertising. Do you believe Big Macs look as good in real life as on TV commercials? People and companies never lie or bend the truth their products, do they?

    Here’s a parallel: if the CEO or Merck or Pfizer had a blog touting his/her company’s medications, you’d scream it’s all conflict of interest, it’s merely marketing, they’re shills, they only want to sell their products, etc. But when a vitamin peddler does the same thing, it’s fair and objective reporting. I see.

  48. Marc Stephens Is Insane says:

    Should have written “People and companies never lie or bend the truth to sell their products, do they?”

  49. DugganSC says:

    Probably worth mentioning that, outside of people potentially suffering from osteoporosis, calcium supplements may be doing more harm than good.

  50. WilliamLawrenceUtridge says:

    The drug-based model of American healthcare doesn’t admit to a therapeutic benefit from any dietary supplement.

    That’s nonsense. Evidence-based health care admits there is therepeutic benefit in cases of deficiency, though last I heard there was no such thing as a “DMAA deficiency”. For other claims, evidence-based healthcare requires evidence – precisely what supplement manufacturers are reluctant to provide or pursue because it would add to their overhead and possibly detract from their ever-so-lucrative sales of evidence-free supplements. Also, the health care provided Americans, such as it is, is strongly preventive – vaccines prevent infectious diseases, nutritional fortification prevents deficiency of those rare vitamins not readily available or of special note, dietary recommendations are aimed to support healthy weight and healthy lives. Supplement promoters and CAM supporters like to pretend that health care is not preventive, when really what they want is to sell (or in your case, buy) supplements without restriction. I could claim that supplement manufacturers want to kill helpless babies, but I don’t, because that’s not what they want. Supplement manufacturers just want to make as high a profit as they possibly can without restriction or oversight by the government, or any bad press for the deaths or disability their supplements may cause. Gosh, it’s almost like they’re a company, not some sort of magical firehose of sunshine and rainbows. Certainly Sardi seems quite willing to spin doctor to keep selling his products.

    Further, merely because patients don’t follow their doctor’s recommendations to maintain a healthy weight, eat unprocessed foods for most meals and exercise doesn’t mean American health care is drug-based. It means a lot of patients’ corpulence is hamburger-based.

    All supplements are supposedly worthless. But what if certain nutrient deficiencies are more prevalent than many doctors think? Consider the essential mineral zinc, as just one example:

    1. http://www.sciencedaily.com/releases/2012/10/121001141003.htm
    2. http://knowledgeofhealth.com/modern-day-zinc-deficiency-epidemic/

    Two points:
    1) As MSII notes, you’re linking to the website of someone who sells supplements. Do you think perhaps he might not be the best place to go for neutral information on dietary supplements? Would you ask the president of Pfizer how great his or her latest pharmaceutical creation was and expect an honest answer? Why the double-standard? Why is Bill Sardi, who sells supplements, a neutral source of unbiased information, but the NIH, FDA, CDC and other agencies that don’t sell supplements are somehow villains?
    2) Why are you advocating for supplements in this regard? Wouldn’t it be better for people to increase their intakes of lean beef, beans, whole grains, cereals, lean cheeses, chick peas and the like rather than risk losing their sense of smell due to high-dose zinc supplements? It’s bizarre to me that CAM supporters like yourself are so averse to drugs and the like, but also seem averse to getting your nutrients from food. Isn’t that more natural?

    As a final point, MSII doesn’t attack Sardi personally – he points out that Sardi has a financial conflict of interest regarding health advice. He also pointed out that humans are not elderly mice, thus illustrating that we perhaps should not treat research on mice as if it applied immediately and universally to humans. Again, there is a double-standard: Big Pharma can’t be trusted because they make billions from selling drugs, but Little Supplement can, because…they make millions selling vitamins? And you would be kicking and screaming of AstraZeneca released a new drug on the basis of rat results, but lab studies on rodents are adequate to recommend zinc supplements (despite the risk of “nausea, vomiting, loss of appetite, abdominal cramps, diarrhea, and headaches…low copper status, altered iron function, reduced immune function, and reduced levels of high-density lipoproteins…significant increase in hospitalizations for genitourinary causes, raising the possibility that chronically high intakes of zinc adversely affect some aspects of urinary physiology” and loss of smell). That seems like base hypocrisy.

    Jeff, why do you hold such a stringent double-standard? Do you sell supplements for a living?

    Yeah, conflict of interest accusations suck.

  51. Ian.Bradley says:

    The bright side of knowing all this news about badly manufactured supplements is that it’s out in the open, and we know the FDA is doing its job of hunting down dietary supplement manufacturers who do not comply with cGMPs. Warning letters have been issued and if these manufacturers still do not comply, they will be forced to close down. This hopefully sends a sharp message to other dietary supplement manufacturers that they better buck up if they want to remain in business. Supplement business owners, like me, have turned to dietary supplement manufacturers who have a proven track record for producing reliable supplements and are regularly audited by reputable third-parties, like the NSF, to ensure they’re properly adhering to GMP guidelines.

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