Now that’s what I’m talking about! Yesterday, the Justice Department announced criminal charges and lawsuits against the sellers of several supplements! This is the ort of thing that is long overdue—incredibly so, in fact. Before I get to this specific case, let’s discuss a little background.

One of the regular topics I write about, both on this blog and at my not-so-super-secret other group blog, is how supplement manufacturers take advantage of the lax regulation of dietary supplements in this country. It’s a problem in our laws that we’ve had since the supplement industry and its lapdogs in Congress (Senator Orrin Hatch from Utah, the home of the supplement industry, and Senator Tom Harkin, the man who is, more than anyone else, responsible for the creation of the National Center for Complementary and Integrative Health, formerly known as the National Center for Complementary and Alternative medicine, or NCCAM) managed to persuade Congress to pass the Dietary Supplement Health and Education Act (DSHEA) of 1994. It’s a law that basically regulates dietary supplements as food, rather than drugs, and does not require them to be tested for safety or efficacy before they can be marketed. On the surface, this would make sense if supplement manufacturers stuck to making only nutritional claims for their products, but they don’t.

In fact, the DSHEA, although forbidding supplement manufacturers from making drug claims for their supplements (e.g., the ability to treat or prevent specific diseases), the DSHEA does carve out a separate category of health claims that could be made for supplements, specifically so-called “structure-function” claims; that is, claims that the supplement somehow supports the structure or function of the body in some way—as long as no specific claims about diseases are made. That, of course, is how we got famous claims like, “boosts the immune system” (a meaningless phrase that should start your skeptical antennae twitching whenever you hear it) or “supports prostate health” (whatever that means). In the meantime, supplements can be almost anything the supplement industry wants them to be, from not unreasonable substances like vitamins, minerals, herbs or other botanicals, and amino acids, to other to substances that have little to do with diet. So loose are the rules over what can be a supplement that for a time an antivaccine chemist marketed an industrial chelator as a “dietary supplement.”

It took a case that blatant to motivate the FDA to act. It’s also not been at all uncommon for supplements to be contaminated with heavy metals or even with real pharmaceuticals. Yes, sometimes “herbal Viagra” sometimes contains actual Viagra, and DNA barcoding studies of such supplements find that many of these products don’t even contain the herbs that they are advertised to contain. This latter observation shows how poorly the law enforces the two aspects of the DSHEA that are reasonable: That supplement manufactures use good manufacturing processes and that they be able to certify that their supplements contain what they are advertised to contain. Indeed, the most ironic example of this occurred when über-quack Gary Null overdosed on vitamin D when the manufacturer of one of his supplements put ten times too much vitamin D in it. Meanwhile, a recent study linked dietary supplements to 20,000 visits to the emergency room every year.

Not surprisingly, in the 21 years since the passage of the DSHEA, the supplement industry has really taken off and is estimated to contribute $60 billion to the economy. So powerful is the industry that every effort to tighten up the DSHEA of 1994 has failed, most spectacularly when Senator John McCain, facing a major challenge from his right in the primary, gave up on an attempt to pass a law modifying the DSHEA to tighten regulations and in essence had to grovel to chief supplement industry lapdog Orrin Hatch.

Other good evidence of how much the supplement industry has taken advantage of the DSHEA comes from the press conference yesterday in which the FDA and the Justice Department announced:

The U.S. Food and Drug Administration, in partnership with other government agencies, today announced the results of a yearlong sweep of dietary supplements to identify potentially unsafe or tainted supplements. The sweep resulted in civil injunctions and criminal actions against 117 various manufacturers and/or distributors of dietary supplements and tainted products falsely marketed as dietary supplements. Among the cases announced today is a criminal case charging USPlabs LLC and several of its corporate officers. USPlabs was known for its widely popular workout and weight loss supplements, which it sold under names such as Jack3d and OxyElite Pro.

The investigation involved the FDA, the Department of Justice, the Internal Revenue Service’s Criminal Investigation Division, the Federal Trade Commission, the U.S. Postal Inspection Service, the Department of Defense and the U.S. Anti-Doping Agency and took over a year. Here’s the meat of the indictment:

The indictment alleges that USPlabs engaged in a conspiracy to import ingredients from China using false certificates of analysis and false labeling and then lied about the source and nature of those ingredients after it put them in its products. According to the indictment, USPlabs told some of its retailers and wholesalers that it used natural plant extracts in products called Jack3d and OxyElite Pro, when in fact it was using a synthetic stimulant manufactured in a Chinese chemical factory.

The indictment also alleges that the defendants sold some of their products without determining whether they would be safe to use. To the contrary, as the indictment notes, the defendants knew of studies that linked the products to liver toxicity.

We here this time and time again. Because most herbal remedies and supplements don’t do much of anything—and if they did they would be functioning as drugs—unscrupulous manufacturers sometimes decide to put actual drugs in the supplement. This might just be confirmation bias, but it seems to me that the most common kind of supplement I read about containing drugs are usually dietary supplements containing stimulants. Be that as it may, it gets worse than that.

One of the supplements, OxyElite Pro, was recalled in 2013 after it was implicated in dozens of cases of acute liver failure due to nonviral hepatitis. Of these cases at least 3 received a liver transplant, and one death was reported. It turns out that OxyElite Pro contained a substance known as aegeline (which appeared as N-[2-hydroxy-2(4-methoxyphenyl) ethyl]-3-phenyl-2-propenamide on the label). Aegeline is extracted from Aegle marmelos (bael), a plant that has a long history of use in Ayurvedic medicine. Unfortunately, it wasn’t long before aegeline was identified as the likely culprit in this outbreak of liver injury. It turns out that the company never told the FDA that it was adding aegeline to its supplement.

But it’s even worse than that, still:

The indictment also alleges that USPlabs and its principals told the FDA in October 2013 that it would stop distribution of OxyElite Pro, once the product had been implicated in an outbreak of liver injuries. The indictment alleges that, despite this promise, USPLabs engaged in a surreptitious, all-hands-on-deck effort to sell as much OxyElite Pro as it could as quickly as possible. It was sold at dietary supplement stores across the nation.

If true, this is pure criminal behavior. Not only did USPlabs allegedly adulterate its supplement, but, when busted after that supplement caused a whole lot of people to have liver failure, the company did its damnedest to make as much money as it could selling its remaining stock. The sheer blatantness of the behavior is shocking and depressing.

Unfortunately, USPlabs and its OxyElite Pro product were not the only culprits. The DOJ filed a complaint in federal court on behalf of the FDA against Bethel Nutritional Consulting, Inc, including the company’s president and vice president. What did they do, allegedly? According to the complaint filed, Bethel distributed adulterated and misbranded supplements and unapproved new drugs, as well as demonstrated major deviations from current good manufacturing practices regulations. Truly, this was an example of scary substances manufactured under scary conditions.

Oh, and Bethel also made medical claims that some of their supplements were able to cure, mitigate, treat, or prevent diseases. It turns out that some of the products marketed as dietary supplements by Bethel contained—you guessed it!—real drugs. These included sibutramine, the active ingredient of Meridia, a drug approved in 1997 to treat obesity that was removed from the market in 2010 because of the risk of serious adverse events, including heart attack and stroke. There was also lorcarserin, the active pharmaceutical in Belviq, a drug approved by the FDA in 2012 for chronic weight management. This is a drug that can also cause significant side effects, including disturbances in attention or memory. It’s also can cause serotonin syndrome, particularly when taken with drugs that impact the serotonin system. The serotonin syndrome is a very serious, life-threatening condition due to elevated serotonin levels and produces a wide variety of symptoms, including: headache, agitation, hypomania, mental confusion, hallucinations, coma, shivering, sweating, hyperthermia, vasoconstriction, tachycardia, nausea, diarrhea, myoclonus (muscle twitching), and hyperreflexia (manifested by clonus), tremor.

Next, showing that it’s all about the money, the FDA’s announcement had a profound effect on stock prices of supplement companies:

Shares of dietary supplement retailers tumbled in heavy trading volume on Tuesday, spurring a surge in options hedging activity for those stocks even though fears they would be mentioned in a U.S. Department of Justice lawsuit did not materialize.

GNC Holdings’ shares tumbled as much as 27.1 percent to hit their lowest in four years, but closed 6.4 percent lower at $29.07. Daily volume was the largest ever according to Reuters data.

Unfortunately, USPlabs and Bethel, the two companies whose officers are facing criminal charges, are not publicly traded.

Finally, I took a brief look across the quackosphere for reactions to this news and was shocked by one of them. Believe it or not, this is Mike Adams:

Believe it or not, I agree that there is a fringe, criminal element in the dietary supplement industry, and this element is engaged in deceptive, dubious practices that put the public at risk.

While most of the dietary supplement industry operates ethically and honestly, a few bad apples are raking in millions of dollars each month in sales of dishonest, chemically-adulterated products that endanger the public.

The DOJ and FDA’s case must be pretty solid if even Mike Adams, master of the conspiracy theory, couldn’t come up with something other than the supplement companies to blame, as in a conspiracy by the government to discredit supplements. Either that, or he maybe he’s in the earliest stages of serotonin syndrome from taking OxyElite Pro. Whatever the reason, it’ll be interesting to see the reactions of quacks over the next few days. Will they emulate Adams and admit that there are criminal companies in the supplement industry and that supplement adulteration is a huge problem, or will they try to defend the indefensible?

The other question is this: When will Congress pass a law to tighten up the regulation of dietary supplements and rectify the deficiencies of the DSHEA? Sadly, given the current Congress and its extreme anti-regulatory bent, I don’t expect anything to happen sometimes soon.

Comments

  1. #1 Helianthus
    November 18, 2015

    The DOJ and FDA’s case must be pretty solid if even Mike Adams, master of the conspiracy theory, couldn’t come up with something other than the supplement companies to blame

    It seems indeed a bit OOC for the health Ranger, although I’m no so sure it’s really outside his usual M.O.
    I would posit myself two hypotheses:

    – it’s a case of “Caesar’s wife shouldn’t be suspected”: Mike’s customers want “natural” products, so any serious hint hitting mainstream media that these products could be laced with “chemicals” is reason enough to throw the suspected manufacturer under the bus, before customers are scared away. Note how he insists its a fringe which is dishonest. I predict a No True Scotsman follow-up.
    In short, classical damage control.

    – I remember how Mike mounted his own analytical lab a few years back and suddenly found, CSI-like, that a few of his competitors’ products were full of heavy metals.
    Maybe it’s more on the same line. He may be quite happy that some big competitor is going to be put down a peg or two. More business going his way, or so he is hoping.

  2. #2 Chris Preston
    November 18, 2015

    Talking about Mikey’s lab, after spending all that money at the fire sale buying second hand gear, the output from Mikey’s lab has been nil since January.

    Didhis ICP break down?

  3. #3 capnkrunch
    November 18, 2015

    Wow, not even a “but Big Pharma kills x thousands every year” from Mikey. I bet we’ll get one of those over here.

    Also, while Mike was relatively sane in that post his commenters are picking up the slack:

    Please explain why twenty largest global. Pharmaceutical drug companies are. Self admitted CRIMINAL ORGANIZATIONS under voluntarily sign criminal consent decree orders with the US. Department. Of Justice?!

    Chris Preston@2

    Didhis ICP break down?

    I remember reading something about a reorganization and expansion that Mike was planning but I can’t find it again.

  4. #4 herr doktor bimler
    November 18, 2015

    a few bad apples

    Perhaps Mikey does not get the point that rot spreads, and there are never just a few bad apples.

  5. #5 JP
    November 18, 2015

    I remember how Mike mounted his own analytical lab a few years back and suddenly found, CSI-like, that a few of his competitors’ products were full of heavy metals.
    Maybe it’s more on the same line. He may be quite happy that some big competitor is going to be put down a peg or two. More business going his way, or so he is hoping.

    Yep. Exactly. If anything, this is totally in character for Mikey.

  6. #6 Todd W.
    http://www.harpocratesspeaks.com
    November 18, 2015

    Helianthus beat me to it. Adams’ response doesn’t surprise me at all. His competition is the one getting hit, so he’ll jump on the bandwagon to denigrate them while puffing himself up as one of the “trustworthy” sorts.

  7. #7 MikeMa
    November 18, 2015

    Anybody know if Mikey carried and sold these tainted products? He might be contrite to disple any guilt he might be feeling… Nah.

  8. #8 Helianthus
    November 18, 2015

    To go back at the OxyElite Pro compound, it’s both horrific and fascinating: they acted like the caricature of BigPharma often touted by alt-med.

    First piling in chemicalz in a pill, then denying it’s doing any harm, and then keeping selling it after evidence of harm is available.
    It will be interesting to hear the usual suspects explain why the FDA shouldn’t be looking into frauds like this.

    BTW, it may be in part the crossed skull-&-bones effect, but the bottles of OxyElite Pro in the picture have some ominous labeling.
    Firstly, it’s both “Pharmacist formulated”* and “Scientifically reviewed”**.
    But then there is the little warning “Physician clearance mandatory before use”.
    That is so blatantly hypocritical. You need a physician to tell you how much and how often to take it, but it’s no a drug, no sir.

    * Made inside a real pharmacist. Accept no substitute.
    ** the reviews’ conclusion is “bullsh!t”.

  9. #9 Dangerous Bacon
    November 18, 2015

    “The DOJ filed a complaint in federal court on behalf of the FDA against Bethel Nutritional Consulting, Inc, including the company’s president and vice president. What did they do, allegedly? According to the complaint filed, Bethel distributed adulterated and misbranded supplements and unapproved new drugs, as well as demonstrated major deviations from current good manufacturing practices regulations. Truly, this was an example of scary substances manufactured under scary conditions.”

    Gee, that’s not what Bethel says on its website (in an announcement of their shutdown effective 10/31).

    “Bethel Nutritional Consulting, Inc. was ordered by a Federal court to stop selling its products and recall all of our inventory. We cannot reopen until Bethel Nutritional comes into compliance with the U.S. Food and Drug Administration’s dietary supplement manufacturing regulations and requirements.”

    “This recall is not due to the supplements being harmful to the public, no refunds or exchanges will be given, You made return your product if you wish or dispose of it on your discretion to the address below.”

    They also “apologize to all of our loyal customers for this inconvenience.” 🙂

    https://www.bethel30.com/

    Truly loyal customers will overlook adulteration and bad manufacturing practices.

  10. #10 Denice Walter
    November 18, 2015

    A few things..

    You minions are correct:
    he did say something recently about adding additional analytic equipment to his lab
    and right, he can assure his marks that whatever HE sells is extremely fabuloso.: pure as nature intended and packed into capsules. He even TESTS it!

    There’s another angle – and Mike usually has more of them than a dodecahedron –
    the China Factor,
    Mikey hates China and often complains about its DIRE designs upon the West- our economies, our health – he’s even referred readers to Stansberry ((shudder)).

    Mike is married to a woman from Taiwan, set up his first businessy machinations there AND I believe his companies are still registered there as well.

    As far as I know, the other idiot has used facilities in Utah ( where his purely natural green products are created and in New Jersey where the vitamin D over-dosed mixture which harmed his customers and himself was made .**

    ** probably in small batches by teenaged vegan virgins who meticulously hand pick the ingredients in the rolling hills and blend them by hand in a pristine ceramic vat in a centuries old barn. Or in an industrial facility.

  11. #11 Denice Walter
    November 18, 2015

    I went back and re-read the beginning of Mike’s article:
    he names several US governmental agencies.
    Wait, isn’t he the guy who calls the government fascism?

  12. #12 Helianthus
    November 18, 2015

    @ Denice

    by teenaged vegan virgins who meticulously hand pick the ingredients […] Or in an industrial facility.

    Eh, you know how difficult it is nowadays to find a true teenaged vegan?

  13. #13 Chris Hickie
    November 18, 2015

    Is there a list of all 117 distributors and manufacturers against whom action were taken? I would love to see action against “Quincy Bioscience”, the scamsters behind prevagen, the brain supplement that claims to improve your memory but is a protein than cannot possibly make it past the GI tract and through the blood brain barrier (and the company has never shown this for humans (they have a vague claim for dogs) even though the company jumped from in vitro spritzing of prevagen on rat hippocampal slices to saying it works in people).

    Amazing what you can do when you have no qualms about ripping people off.

  14. #14 jane
    November 18, 2015

    A few truths:

    1. There are detailed, expensive, drug-like Good Manufacturing Practices established for supplements, and active enforcement campaigns in progress. Of course some crooks cheat, as do some crooks in every industry. We do not ban the practice of allopathy because of the Mark Mideis.

    2. Products labeled “dietary supplements” that contain undeclared drugs or untested drug analogues are ILLEGAL DRUGS. Banning safe herbs and vitamins because such products can be dangerously adulterated is no more rational than banning infant formula because it can be dangerously adulterated.

    3. DSHEA does not require premarket safety testing for supplements that were in use before it was passed. The FDA has the power to remove existing products from the market if they are shown to be unsafe, and those who wish to market new dietary ingredients must submit elaborate dossiers that, in the FDA’s opinion, demonstrate safety as foods. There are not and never can be hundreds of billions of dollars available to do elaborate clinical trials and non-clinical studies for each of the many botanicals that have been used for centuries or millennia and cannot be patented; hence a demand for exhaustive testing is really a demand for permanent criminalization.

    4. An increasing number of botanicals, including most of the top sellers in the U.S., have been shown effective in multiple placebo-controlled human trials. Should sellers be able to reference results of these trials on their websites or packaging? If not, is it not outrageous to suggest that they should before selling the product acquire the riches to prove its efficacy?

  15. #15 Orac
    November 18, 2015

    An increasing number of botanicals, including most of the top sellers in the U.S., have been shown effective in multiple placebo-controlled human trials.

    Which botanicals? Safe and effective for what specific indications? Do tell, and include Pubmed links to studies. Most botanicals and supplements I’ve seen tested in RCTs have failed miserably.

  16. #16 Helianthus
    November 18, 2015

    @ jane

    First riddle me this:

    What is a drug, and what is a food?

    And why should anyone be able to sell one as the other?

  17. #17 Denice Walter
    November 18, 2015

    @ Helianthus:

    Ha.

    At any rate, being true to my sublime quest, I listened to all 4 of Mikey’s audios ( 50 minutes) to understand his MO.
    Bear with me.

    -In the first, he re-iterates how this investigation doesn’t involve superfoods ( his products) but those for
    – weight loss
    – body builders
    -“doping”/performance enhancing
    Sleazy companies aim at kids who want to lose weight, build muscle or improve their athletic performance without work!
    Not normal people!

    As an example, he says ma huang was banned because scammy operators extracted ephedra and then, kids took overdoses. In Chinese medicine, an herb with many substances in it is taken holistically.

    HE does LAB work- his new lab will have HPLC to detect pesticides and hidden drugs; his present lab detects metals.
    He’s seen “shady stuff” in the industry.

    – 2. Shady companies add caffeine ( USP Lab, Texas). Every industry has a “criminal element” . He doesn’t trust most sources for supplements until he TESTS. He uses quality control and “Good Manufacturing Practice”.

    -3. There’s always a “fringe element” E.g. Sunrise sells a product for opiate addicts. This cheap product includes additives, artificial ingredients and GMO corn!
    He would NEVER sell that!

    Mike has to approve of companies that advertise on his site-
    one of these scammers offered him 20,000 USD a month.
    He said NO. He is ethical. He sells purity itself.

    He didn’t think much of GNC when he visited them once. Big retailers don’t TEST like he does.

    -4 Con artists sell crazy products like Oxy Elite Pro. Others add real meds like Prozac. They falsify labels and call it herbal. ( 4-6 minutes in) Especially form CHINA! ( I told you so!)
    There is a CRIMINAL NETWORK. afoot.

    His advice is:
    buy from sources you trust ( WE test everything)
    beware of unrealistic claims
    buy from companies who monitor products ( like him)

    Also:
    beware of de-tox products.
    Next year, he’ll reveal how raw food companies scam customers with extragavant ad copy.

    Eat real food ( which he sells) you can grow your own ( he sells the kit you need).

  18. #18 Denice Walter
    November 18, 2015

    FROM CHINA!

  19. #19 Anthony
    November 18, 2015

    Given how often athletes busted for doping claim to have been using herbal supplements, it should be no shock that herbal sports supplements often contain drugs.

  20. #20 Dangerous Bacon
    November 18, 2015

    jane appears to be confused with her claim that “elaborate dossiers” have to be submitted to the FDA for approval of dietary supplements and that “premarket safety testing” is required for new supplements. She may be referring to specific _food_additives or colorings. Dietary supplements have no such requirements before going on sale, except that if you want to sell something with a “new dietary ingredient” you have to notify the FDA, provide some safety justification and wait 75 days before springing your product on consumers. There would only be a holdup if the FDA had upfront safety concerns.

    “We do not ban the practice of allopathy because of the Mark Mideis.”

    While it is inane to refer to “the practice of allopathy” in this manner (since use of dietary supplements as suggested by their promoters _is_ allopathy), it is even dumber to suggest that proposed requirements for proper testing and disclosure amount to a “ban”.

    “There are not and never can be hundreds of billions of dollars available to do elaborate clinical trials and non-clinical studies for each of the many botanicals that have been used for centuries or millennia and cannot be patented”

    This is also a ludicrous statement, seeing that supplement dealers resist doing even minimal clinical evaluations of their products, and spent a tiny percentage of revenues on research compared to the percentage spent by pharmaceutical companies (maybe 1-2% at best, compared to the 15-20% or more routinely spent by pharma). And obviously, botanical-derived drugs can and are patented all the time.

    jane needs to stop getting her information solely from the supplement industry and its apologists.

  21. #21 Mephistopheles O'Brien
    November 18, 2015

    1. There are detailed, expensive, drug-like Good Manufacturing Practices established for supplements, and active enforcement campaigns in progress. Of course some crooks cheat, as do some crooks in every industry. We do not ban the practice of allopathy because of the Mark Mideis.

    What is the process to ensure those processes are complied with? Are they similar to enforcement for pharmaceutical companies?

    2. Products labeled “dietary supplements” that contain undeclared drugs or untested drug analogues are ILLEGAL DRUGS. Banning safe herbs and vitamins because such products can be dangerously adulterated is no more rational than banning infant formula because it can be dangerously adulterated.

    Nobody I’m aware of is calling for banning such substances, merely enforcing the manufacturing processes you say exist and making sure that the bottle contains what the label says.

  22. #22 RobRN
    November 18, 2015

    A while ago, there was an article at Mike Adams’ Natural News site which was a commentary that promoted a product that Mike sells. I posted a question asking if Mike’s supplements were USP… It was removed!

  23. #23 JP
    November 18, 2015

    There’s always a “fringe element” E.g. Sunrise sells a product for opiate addicts. This cheap product includes additives, artificial ingredients and GMO corn!

    Because people struggling with an opiate addiction really need to be worried about… GMO corn.

    The mind, it boggles.

  24. #24 Sarah A
    November 18, 2015

    @ Jane #14
    No one’s talking about banning supplements – we’re talking about subjecting them to the same regulation and scrutiny as other pharmaceutical products – because that’s exactly what they are. Supplements are not food – they are substances that are consumed in small amounts specifically for their (alleged) bioactive properties. Everything else is just advertising.

    And no one is stopping supplement manufacturer’s or retailers from providing references to any clinical studies, double-blind placebo-controlled or not. I see references to “scientific studies” in supplement marketing materials all the time, though in my experience they generally turn out to be either in vitro or animal studies, or small, poorly-designed human studies.

    And don’t give me that crap about how supplement manufacturer’s can’t afford to test their products – supplements are an $18 billion industry, an appreciable fraction of the <a href="http://www.ibisworld.com/industry/default.aspx?indid=487"$131 billion pharmaceutical industry. If some small pharmaceutical start-up with limited capital wanted to sell a new product, would you consider it “outrageous” to expect them to test it first?

  25. #25 herr doktor bimler
    November 18, 2015

    * Made inside a real pharmacist. Accept no substitute.

    I am reminded of the Red Lion Scotch whisky I encountered in Laos, where the promotional copy on the label proudly proclaimed that it was “Blended and Bottled by Expert from AUSTRALIA”.
    That’s how I knew it was a prestige product, not like the True Manhood whisky and the other cheap imitations.
    It is also apparently “smooth and mellon”.

  26. #26 JDK
    Canada
    November 18, 2015

    The CBC up here has been giving Health Canada a bad time on it’s regulation of natural products and supplements. They had a big show planned for Friday last but was pre-empted by the Paris attacks. A previous show revealed how the journalist invented a supplement and got it approved in ten days. Just a product name and some marketing hype.
    some interesting factoids here: http://www.cbc.ca/news/health/fifth-estate-vitamins-herbal-health-canada-1.3316208

  27. #27 Rich Bly
    Ocean Shores
    November 18, 2015

    Below is a link to DOJ concerning the actions against some supplement suppliers. I don’t know if it is complete or not.

    http://www.justice.gov/opa/pr/justice-department-and-federal-partners-announce-enforcement-actions-dietary-supplement-cases

  28. #28 Krebiozen
    November 18, 2015

    Sarah A,

    If some small pharmaceutical start-up with limited capital wanted to sell a new product, would you consider it “outrageous” to expect them to test it first?

    Mercuric chloride was used “for centuries or millennia” to treat various ills so perhaps they could grandfather it in (that’s sarcasm, obviously). Since we still keep discovering that various botanicals (e.g. Aristolochia and bael) and supplements (e.g. calcium and perhaps multivitamins) have adverse effects, maybe we should be testing everything to be sure. As I have pointed out many times before, if any herb or supplement was associated with the same cardiovascular events that Vioxx does, we wouldn’t know (and it seems likely that calcium supplements are even worse, but without the benefits of Vioxx).

  29. #29 Krebiozen
    November 18, 2015

    “that Vioxx is

  30. #30 JustaTech
    November 18, 2015

    jane @14: With regard to your point about the FDA being allowed to remove products from the market if they are shown to be unsafe: what about all the people who got sick, needed liver transplants or died to show that Jack3d was unsafe?

    I want to be able to buy my calcium supplements, confident that they have been shown to be safe (not effective, just safe), that they contain the amount of calcium the bottle says, and that all the filler ingredients are on the label. Processed foods have to do that (at least as far as labeling), so why don’t supplement.

    All this post-hoc action on dangerous supplements feels very ‘invisible hand of the market’ libertarian to me, and it does absolutely nothing for the people who were harmed.

  31. #31 JustaTech
    November 18, 2015

    And I just read Krebiozen’s link (@28) on calcium supplementation. Well, I’m not in those demographics yet, and I’m hoping to need extra calcium here soon, but I think I’ll stop before I’m old.

    Here’s a tale of the dangers of too much calcium from a food source. When I was a kid I would give my guinea pig broccoli stems as a treat. Now, these stems were as long as he was (narrower in diameter) and he loved them. he’d get maybe 2 a week in the winter. Then one day he started screaming and peeing blood so we rushed him off to the vet, who discovered a bladder stone. (The vet removed it surgically and the guinea pig lived many more years.) The vet was very clear that the stone was caused by all the broccoli we were feeding the guinea pig.

    Lesson of the story: don’t eat your own buy weight in broccoli twice a week.

  32. #32 LIz Ditz
    Great State of California
    November 18, 2015

    Refresh my memory: is Mikey the one who claims all US vaccines are made in China and therefore unsafe, or is that somebody else?

    Tim Bolen makes that claim but I think Mikey or maybe Alex Jones made the claim too. I can’t keep the bozos straight.

    The Vaccine Standards Clause – Whereas, we are aware that vaccines, for our children, are NOT MANUFACTURED IN THE US, but in Third World countries, like China, India, and Bengladesh, each batch, of each vaccine, mandated in the program, must be:

    From the long screed here, about only I, Tim Bolen, could have rescued the SB277 Opposition Campaign but You Didn’t Listen to MEEEEEEE!

    http://www.bolenreport.com/autism/antivaccine%20yes15.htm

  33. #33 LIz Ditz
    Great State of California
    November 18, 2015

    Boogered the block quotes again. Sorry. RETURN THE EDIT FEATURE!!!!!

  34. #34 Denice Walter
    November 18, 2015

    @ Liz:

    Mikey has disparaged many products from China but I don’t recall him saying “all” vaccines but certainly he has aroused suspicion about contaminated vaccines and meds.

    I can’t for the life of me fathom how people can read his swill and then reward him with purchases from his ‘store’. But people admire his writing and think him a fountain overflowing with life enhancing wisdom.

    At least, Bolen is earning little to nada.

  35. #35 wijo
    November 18, 2015

    Serious question, where/from whom do I buy the supplements my physicians recommend?

  36. #36 Lighthorse
    November 19, 2015

    As much as I don’t like to say it, from skeptics to consumers and purveyors of dietary supplements, there are no end of misconceptions about the rules and regulations for their production and marketing and the research and lack thereof behind the same products.

    @JDK #26: Like you, I look forward to seeing the CBC Markeplace investigation, which was postponed due to the terrorists attacks in France. My guess is they couldn’t afford the bandwidth, thanks to the right-wing, anti-science Conservative Party government who cut the CBC to the proverbial bone, to say nothing of physically removing Canadian scientists from flights before they could make presentations at conferences. I wonder how many American are aware of the Canadian scientific community has gone through. But I digress.

    The product that the CBC managed to so quickly get passed was a homeopathic preparation, which is not the same thing as a supplement. Even so, the regulations are designed to allow them to pass in short order, provided they meet certain criteria or the claims are in conformation with Health Canada Monographs, many of which are built upon the flimsiest of evidence, or fall under traditional use claims (e.g., Chinese and ayurvedic).

    @Denise Walter #17:

    “There’s always a “fringe element” E.g. Sunrise sells a product for opiate addicts. This cheap product includes additives, artificial ingredients and GMO corn!
    He would NEVER sell that!”

    For what it’s worth, any product marketed to opiate addicts for the treatment of addiction is classified by the FDA as a drug. Maybe that’s the real reason why he wouldn’t sell it.

    @ Jane #14: Having participated in the patenting process for botanicals, including food plants, I can tell you that they can and are patented, and with great regularity. In fact, there are literally 100s of patents on plants, including herbals medicines sold as dietary supplements. Some of the patents are for combinations of botanicals for the treatment of one condition and another; others concern extraction methods; and still others are for constituents of botanicals. The patents are issued to dietary supplement manufacturers, corporations, research institutions, and individuals.

    @Orac #15:

    “Which botanicals? Safe and effective for what specific indications? Do tell, and include Pubmed links to studies. Most botanicals and supplements I’ve seen tested in RCTs have failed miserably.”

    Correct me if I’m wrong, but I suspect that you are referring to the more popular botanicals sold in the U.S. after they were subjected to independent clinical trials by the NIH. Among them were saw palmetto, black cohosh, and ginkgo, which are hardly representative of botanicals in general, the majority of which have never been the subject of a RCT. As for botanicals that have been shown effective in RCT, there are any number of examples, as indicated by the handful of examples in the following, for which I was careful not to include combination products containing more than one ingredient:

    Nigella sativa in the treatment of dyslidemia:
    http://www.ncbi.nlm.nih.gov/pubmed/24685020
    http://www.ncbi.nlm.nih.gov/pubmed/26029855

    Ginkgo in the treatment of PMS:
    http://www.ncbi.nlm.nih.gov/pubmed/19678774
    http://www.ncbi.nlm.nih.gov/pubmed/8235261

    Saffron in the treatment of depression:
    http://www.ncbi.nlm.nih.gov/pubmed/24299602

    Black elderberries in the treatment influenza:
    http://www.ncbi.nlm.nih.gov/pubmed/15080016
    http://www.ncbi.nlm.nih.gov/pubmed/9395631

    Boswellia serrata (Indian frankincense) and osteoarthritis:
    http://www.ncbi.nlm.nih.gov/pubmed/18667054
    http://www.ncbi.nlm.nih.gov/pubmed/12622457

    Vitex agnus castus in the treatment of PMS:
    http://www.ncbi.nlm.nih.gov/pubmed/11159568
    http://www.ncbi.nlm.nih.gov/pubmed/23022391
    http://www.ncbi.nlm.nih.gov/pubmed/22359078
    http://www.ncbi.nlm.nih.gov/pubmed/20334585
    http://www.ncbi.nlm.nih.gov/pubmed/19269753

    Hibiscus sabdariffa for adolescent dyslipidemia:
    http://www.ncbi.nlm.nih.gov/pubmed/24082826

    Hibiscus sabdariffa for hypertension:
    A review of 5 RCTs:
    http://www.ncbi.nlm.nih.gov/pubmed/25875025

  37. #37 Helianthus
    France
    November 19, 2015

    @ wijo

    Depends.
    In my country, vitamins and minerals cocktails on prescription would be purchased at the local pharmacy. It may be an overpriced product*, but chances are it is partially reimbursed by our social welfare system, if it is on prescription.

    If your physician has some of these products conveniently on a display in the waiting room, or you find out his wife/brother/nephew is manning the drugstore he sent you to, you may want to go to a different physician.

    Either way, the point Orac and a few others have been making here is that buying supplements is like buying a fruit basket. Until you remove the pineapple from the top, you don’t know that’s inside. Caveat emptor.

    * OK, even more overpriced than the usual.

  38. #38 herr doktor bimler
    November 19, 2015

    “This recall is not due to the supplements being harmful to the public, no refunds or exchanges will be given

    Nothing says “integrity” like pre-emptively trying to persuade the customers that they’re not entitled to their money back, even if the advertised contents of the pills they bought bore little relationship to the actual contents.

  39. #39 Lighthorse
    November 19, 2015

    @Helianthus #37: “Either way, the point Orac and a few others have been making here is that buying supplements is like buying a fruit basket. Until you remove the pineapple from the top, you don’t know that’s inside. Caveat emptor.”

    One of a number of problems in the U.S., at least, is that the FDA has placed too much trust in the dietary supplements industry. Regardless of current Good Manufacturing Practices (cGMPs) enacted at the insistence of the Industry, the FDA has failed to adequately monitor products for compliance with identity, purity, and strength.

    On the issue of so-called structure/function claims, as incredible as it may seem, the FDA has not agreed with the Inspector General of the U.S. Department of Health and Human Services to obtain authority to “review substantiation” for the claims “to determine whether they are truthful or misleading.” Leaving the more obvious illegal claims for the treatment or prevention of disease, I can assure you that many products are marketed with unsubstantiated claims. For instance, in the case of a product in which one or more of the ingredients are backed with well controlled clinical trials, in the absence of clinical trials to demonstrate the efficacy of the combination, it would not stand the test of scientific evaluation for substantiation. Simply put, one or more of the ingredients may interfere with the others. In some cases, the ingredients could be detrimental, as demonstrated for the combination of grape seed extract (500 mg/day) and vitamin C (1000 mg/day) on blood pressure:

    http://www.ncbi.nlm.nih.gov/pubmed/25234339
    http://www.ncbi.nlm.nih.gov/pubmed/15662232

  40. #40 Big Willie
    November 19, 2015

    Wow!! I was sponsored by this company for 3 years and had ads of myself in Powerlifting USA Magazine!!!

  41. #41 Adam
    November 19, 2015

    The correct response is to do what the EU does and crack down on dietary supplements. They have a whitelist of permitted ingredients at permitted doses and everything else is defacto banned. It could go even further and ban chinese medicine (for example) but at least it controls the supplement market. Of course some people order their stuff over the internet from a abroad and every now and again someone ends up dead as a result.

    But I doubt the US has the balls to do anything as radical as the EU. There is too much money in this racket for politicians at any level to try and stop it.

  42. #42 Calli Arcale
    http://fractalwonder.wordpress.com
    November 19, 2015

    Regarding death due to calcium supplementation and the relative risks of various drugs, I remember reading a story once about an experimental trial of treating erosive esophagitis (basically, the result of long-term untreated GERD) with astoundingly massive doses of calcium carbonate to try and suppress digestive acids long enough for the esophagus to heal. Given that erosive esophagitis leads to Barret’s esophagus, which is a precancerous condition, and that esophageal cancers are one of the nastier cancers to get, this was a pretty big deal. This was long before anybody had invented an H2 or proton pump inhibitor, so there really was no other treatment.

    Well, they gave these massive doses to the men in the study group, and it did work. For most of them. There was at least one death due to complications of calcium overdose, and they recommended this treatment only be done in the hospital for that reason.

    And this is why I love my Prilosec. It has its own side effects, but they’re not as severe, and it can keep my esophagus from getting that bad in the first place. I know a lot of people, alties in particular, think that acid reflux is either an invented disease to sell drugs, or a sign of a poor lifestyle, but they only think this because they don’t have it themselves. It’s a much more serious disease than people think, and it can kill you if left alone long enough.

  43. #43 Denice Walter
    November 19, 2015

    @ Callie Arcale:

    So you have one less thing about which to worry.

    My late father had several bouts with ulcers after age 70. Later on ( after age 85), they found (early) Barrett’s and controlled it with ranitidine. After a few years they even stopped endoscopy because didn’t progress.

    I think that he had the silent type of GERD/ GORD because he had no symptoms of reflux/ ulcers at all until he had severe bleeding-
    having our familial slow clotting didn’t help.
    His life was often an adventure.

    Therefore, if I have the slightest symptoms of reflux, I head to the store for OTC acid blockers.

  44. #44 Derek Freyberg
    November 20, 2015

    @Helianthus (#12):
    Shades of “Hair”

  45. #45 Derek Freyberg
    November 20, 2015

    @CalliArcale (#42):
    If you have GERD, and it’s due to incompetent lower esophageal sphincter (the valve at the top of the stomach not closing properly so stomach acid leaks back up), funduplication to “tighten” that valve may be the cure.
    I am definitely not a doctor, so talk to yours, but I had GERD 15 years ago, went temporarily on a PPI, then had a laparoscopic funduplication (overnight stay surgery) and have not had a problem since. I was told, back then, that the surgery cure rate was around 85-90%; I’d be surprised if it wasn’t better now.
    Oh, and you lose weight, or at least I did, from the smaller stomach (YMMV).

  46. #46 Derek Freyberg
    November 20, 2015

    @LizDitz (#32,33):
    Did you really have to expose us to that? – if I’d had anything liquid near my keyboard, it would have been drowned!
    Thanks!

  47. #47 Ernie Gordon
    November 20, 2015

    While not to the point of causing physical harm, I had chronic, debilitating acid reflux for years. Can’t describe the physical trauma in words that would convey the suffering, starting with lack of sleep due to the discomfort all the way to irregularity that was life-limiting. 2 years ago my provider suggested I try cutting white flour from my diet. Cured. Until I started watching what I ate I had no idea the volumes of white flour I was ingesting, but pizza and junk foods are a thing of the past for me. A break in routine involving desserts like cookies or cake or pie and it recurs. Lesson learned.

  48. #48 Dangerous Bacon
    November 21, 2015

    GERD seems to be second only to migraines in the number of proposed triggers and factors providing relief.

    I had GERD bad enough some years ago to have a brief PPI trial. Then it went away with only brief relatively trivial recurrences since then. If I’d been on a severe dietary restriction at the time it improved that would probably have gotten the credit.

  49. #49 Mephistopheles O'Brien
    November 21, 2015

    From the long screed here, about only I, Tim Bolen, could have rescued the SB277 Opposition Campaign but You Didn’t Listen to MEEEEEEE!

    I find it impossible to read PaTim Bolen without hearing it in the voice of the late Stephen Stucker.

  50. #50 Dr. Acula
    November 22, 2015

    It’s also can cause serotonin syndrome, particularly when taken with drugs that impact the serotonin system. The serotonin syndrome is a very serious, life-threatening condition due to elevated serotonin levels and produces a wide variety of symptoms, including: headache, agitation, hypomania, mental confusion, hallucinations, coma, shivering, sweating, hyperthermia, vasoconstriction, tachycardia, nausea, diarrhea, myoclonus (muscle twitching), and hyperreflexia (manifested by clonus), tremor.

    ^^ Thats how I know the 5-HTP is working. For a good time, call Ken stack this by consuming a big block of tasty, crunchy Dubliner cheeze.

  51. #51 prn
    December 17, 2015

    I for one am glad for the DSHEA. It often allows life enhancing or even life saving products and dosages to be marketed at affordable prices.

    Despite the DSHEA, the FDA has still managed to corruptly abduct even vitamins from the marketplace (e.g. read up on the disappearance of pyridoxamine, a B6 vitamin) .

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