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Alpha Brain – What’s Wrong with the Supplement Industry

There is an endless stream of supplement products on the market that are of questionable value. They tend to follow a similar pattern: put an essentially random assortment of vitamins, minerals, perhaps herbs and nutritional elements into a pill and then make whatever pseudo-health claims you want. Usually the claim is implied in the name of the product itself – sleepwell, or brainboost. The popular product Airborne fits this mold. It is essentially a multivitamin with the unfounded claim that it will prevent infection by boosting the immune system.

In the US, regulations (under DSHEA) specifically allow “structure/function” claims without any requirement for evidence to back up the claims. In other words, as long as you don’t mention a disease by name, you can make pretty much whatever claim you want. This was supposed to be good for the consumer, when in fact it is springtime for industry at the expense of the consumer. If your claims are outrageous enough the FTC can still go after you, but they are playing a game of whack-a-mole and losing.

Another pattern that is common is for a supplement product to contain specific components that are claimed to have specific benefits. Often these claims are based upon evidence – just the wrong kind of evidence. Basic science evidence is used inappropriately to support clinical claims. This strategy is more insidious, as it gives the public the sense that the product is science-based when it isn’t.

Recently a product came to my attention which fits this mold perfectly – Alpha Brain. This is a supplement that claims to “enhance” mental function, sleep, creativity, and athletic performance. Their website includes a section called “The science behind alpha-brain.” I always find it amusing to following the links for promised evidence on such sites. What they never seem to contain is links or references to primary sources that actually demonstrate the claims they are making.

The site reviews all of the ingredients in Alpha-Brain explaining the science behind the claims – let’s look in detail at just one example, GPC choline, which is an essential nutrient and a precursor for the neurotransmitter acetylcholine. The site claims:

There is scientific evidence that proves that increased levels of acetylcholine in the body can dramatically increase memory and cognitive ability of men and women of all ages[1]

The reference given is not to a peer-reviewed study, but to another promotional site that simply makes more claims about the benefits of choline. The concept here is not implausible, but also cannot be assumed, and is very common in the supplement industry. The idea is that a precursor of an important molecule in the body will increase the availability and therefore function of that molecule. That could be true, if availability of the precursor is the rate-limiting-step in the production and function of the molecule. Specifically in this case, is the nutritional availability of choline limiting the production and function of acetylcholine?

Choline is an essential nutrient, so (as is true with all nutrients) in someone who is undernourished or with specific deficits in their diet, supplementing will help. But in someone with an adequate diet, there is no reason to assume that more will be better. Supplements treat deficiencies – but there is no reason to think that taking additional nutrients beyond the minimum necessary will have functional benefits.

They then report:

A study performed by Sangiorgi Barbagallo at the University of Palermo studied 2044 candidates who suffered from recent stroke or transient ischemic attack. The study concluded that administration of GPC choline confirmed its therapeutic role in improving cognitive ability in this group of study subjects.

They don’t give the reference, but I tracked in down. This is an excellent example of how a company can cite studies to make is seem as if their claims are evidence-based when they are not. The question is – how relevant is this study to Alpha-Brain? There are two major problems: The first is that the study (which was not blinded, but even if we take its results at face value) used 1000mg IM (intramuscular) for 28 days, followed by 400mg orally daily. Alpha-Brain contains 100mg of GPC choline. IM administration likely has a completely different bioavailability than an oral dose. And of course the dosing for 28 days was 10 times that in the supplement.

A bigger problem, however, is the study population – those recovering from a stroke or TIA. When the body is under physiological stress demand for nutrients are likely to become a limiting factor in the rate of recovery, even when those same nutrients are not a limiting factor in a healthy individual. You therefore cannot extrapolate from a disease population to a healthy population – just because a nutrient helps recovery does not mean it will enhance normal function.

The same is true for Alzheimer’s disease. There is evidence that choline supplements may improve the symptoms of dementia. But this does not mean they will enhance mental function in a healthy individual.

Conclusion

I am presenting just one illustrative example of the types of deceptive marketing practice by the supplement industry, specifically with their use of scientific evidence. They use the evidence as a marketing tool, not as a way to determine the net clinical effects of a product. Several types of deceptive use of evidence are common: using basic science studies to support clinical claims, using studies in ill subjects to make claims about enhancing normal function, referencing secondary sources or sources that do not support the claims being made, and making inappropriate comparisons to different doses and routes of administration.

The goal is to create the impression that the supplement being marketed has health benefits that are backed by science – but the devil is always in the details. What they never seem to provide is rigorous studies of their actual product published in the peer-reviewed literature showing the specific benefits they are claiming when used as directed.

Posted in: Herbs & Supplements, Science and Medicine

Leave a Comment (59) ↓

59 thoughts on “Alpha Brain – What’s Wrong with the Supplement Industry

  1. cervantes says:

    Let’s call it like it is. This is fraud. It is thievery. It is evil.

    What I do not understand is why, the powers of the FDA aside, the state Attorneys General cannot simply prosecute these people for fraud under ordinary statutes. Taking people’s money under false pretenses is illegal under the laws of all 50 states, the District of Columbia, and Puerto Rico. What’s the problem here?

  2. IANAL, but…

    Fraud is often difficult to prove. You have to prove willful and knowing intent to deceive. In the case of supplements, you’d have to be able to legally prove that the defendant knew their claims were false. It’s not enough to show they cherry picked weak support for their claims.

    In a court of law, it would likely be difficult enough to prove the claims are false, let alone that the defendant knew they were false, baring any smoking gun memos or emails. A jury might well conclude that a reasonable person would find the claims to be reasonable. Even if a jury concluded the claims were false and unsupported, they might still conclude the defendant was simply naive and misinformed and acted in good faith.

  3. Anthro says:

    @cervantes

    The problem in many cases might be that the authorities in question are also “believers” in supplements.

    ——

    Having sent many articles similar to this to my woo-ish friends I am sad to tell that the only response I get is an hysterical, “don’t take away my CHOICE”. I counter with something about INFORMED choice and all I get is, “this is AMERICA and we have FREEDOM OF RELIGION (belief)”.

    Nevertheless, I have forwarded this piece to a number of people–hope springs eternal.

  4. …for a criminal fraud case, you need to prove fraud beyond a reasonable doubt.

    Considering the basis of many false or unsupported supplement claims is a basic or theoretical plausibility of the claim, as with choline in this example, reasonable doubt might be hard to get past.

  5. cervantes says:

    I’m not a lawyer either but I will say . . .

    Some cases might be difficult to prove, but I’ll bet they could find some that aren’t so hard — where you could prove that the claims are completely bogus. I agree it would take a lot of prosecutorial resources and it would be a big deal, but still.

  6. CarolM says:

    I was just thinking today that there has been a supplement du jour every since I can remember. Now it’s vitamin D. Nobody gets enough D, even in the tropics!! this the reason for EVERYTHING that’s ailing you!!

    So while I have dropped many of the other supps I took off and on, never quite convinced, now I reluctantly take a Walmart D3 supp. And still don’t know if this is just hype again, or not.

  7. Chris says:

    One of the retired doctored revered by those who demonize vaccines is Russell Blaylock. He also sells a Brain Repair supplement. Clicking through the website, it also has some similar sciencey words without real meaning as “alpha-brain.”

  8. Scott says:

    I think it’s pretty clearly ETHICALLY fraudulent, even if it doesn’t rise to the legal standard and/or can’t be proven adequately. Despite the attempts of Big Supplement to portray requirements for clinical testing as meaningless hoops solely meant to keep them off the market, without that testing they can’t know whether the claims they’re making are accurate.

    The evidence needed to demonstrate safety and efficacy, and the evidence needed to obtain FDA approval as a drug, are not materially different…

  9. Scott says:

    Sorry for the double post, had a bit of an editing snafu. That last sentence should read

    The evidence needed to demonstrate safety and efficacy for a supplement, and the evidence needed to obtain FDA approval as a drug, are not materially different…

  10. I’d really like to put together a list of the most common functional/ structural claims used for supplements, and slap them all on a bottle of municipal tap water and market it, just to demonstrate how easy it is to make those claims.

    Now available in stores: VitaTap
    Naturally derived.
    Absolutely essential for a healthy life
    Promotes longevity.
    Boosts the immune system.
    Promotes healthy digestion and nutrient absorption.
    Vital for proper organ function.
    Supports healthy joints.
    Key to proper liver function.
    Improves cognitive mental function, concentration, creativity, and memory.
    Male and female enhancement.
    Increases energy, athletic performance, balance, and vitality w/ no crash.
    Contains no caffeine or sugar.
    Helps support quality, restful sleep.
    Promotes regularity.
    As safe as water!

    etc

  11. Jann Bellamy says:

    @cervantes
    “What I do not understand is why . . . the state Attorneys General cannot simply prosecute these people for fraud under ordinary statutes”

    The supplement makers will most certainly raise the defense of preemption — that is, that in enacting the DSHEA Congress intended that federal law preempt any state law which might interfere with its regulatory scheme. They might not win, but it would be a hurdle to overcome in any action by a state Attorney General. It is also a question of resources. State Attorneys General have a lot on their plates now — financial fraud, crime, health care fraud on a massive scale — and budgets are tight.

    The plaintiffs’ personal injury attorneys may be catching on though. There are a couple of class actions suits in California against Boiron, a homeopathic “remedy” manufacturer, that seem to be getting some buzz in the legal field. Similar actions could be brought against supplement manufacturers (although, again, they will raise the preemption defense). I am hoping this will become a trend — like the tobacco cases.

  12. Jan, do you think civil suits would be more likely to be fruitful vs criminal fraud prosecution? I only work for lawyers, but it seems to me the burden would be harder in a criminal case vs a civil suit.

  13. JPZ says:

    @Steven Novella

    I can understand your frustration with the proportionately low enforcement of the dietary supplement regulations by the FDA and FTC. I too would like to see more deceptive supplements taken off the market. But, just as you and I expect there to be evidence supporting dietary supplement claims, I think the readership can expect evidence to support your claims. For example:

    “…then make whatever pseudo-health claims you want.”

    The FDA specifies what health-related claims can legally be put on a dietary supplement label (http://www.fda [dot] gov/Food/DietarySupplements/DietarySupplementLabeling/default.htm). The FTC specifies what health-related claims can legally be used in advertising (http://business.ftc [dot] gov/documents/bus09-dietary-supplements-advertising-guide-industry). If you put a “pseudo-health claim” on your label or in your advertising that violates these rules, you are breaking the law.

    “Usually the claim is implied in the name of the product itself – sleepwell, or brainboost.”

    Use of product names that are implied disease claims is specifically prohibited by the FDA (http://www.fda [dot] gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/DietarySupplements/ucm103340.htm) in Criterion 4.

    “The popular product Airborne fits this mold. It is essentially a multivitamin with the unfounded claim that it will prevent infection by boosting the immune system.”

    Airborne was prosecuted by the FTC with a settlement of $30 million USD (http://www.ftc [dot] gov/opa/2008/08/airborne.shtm).

    “In the US, regulations (under DSHEA) specifically allow “structure/function” claims without any requirement for evidence to back up the claims.”

    The FDA has provided guidance for industry on how much scientific evidence is needed to back a structure-function claim as well as standards of scientific quality (http://www.fda [dot] gov/food/guidancecomplianceregulatoryinformation/guidancedocuments/dietarysupplements/ucm073200.htm). If they initiate an office action against a company, they will reference this guidance.

    “Supplements treat deficiencies…”

    The FDA says, “A dietary supplement is a product taken by mouth that contains a “dietary ingredient” intended to supplement the diet.” (http://www.fda [dot] gov/Food/DietarySupplements/ConsumerInformation/ucm110417.htm). Many commentators here make the same statement about treating deficiencies, but it simply isn’t true. Supplements can’t legally even use the word “treat.”

    “Several types of deceptive use of evidence are common: using basic science studies to support clinical claims, using studies in ill subjects to make claims about enhancing normal function, referencing secondary sources or sources that do not support the claims being made, and making inappropriate comparisons to different doses and routes of administration.”

    First, I would ask you to quantify “common” (I “commonly” see the moderators and commentators on SBM ask others to quantify similar vague quantity statements). Second, I have seen all of these as well. I agree that there are some irresponsible companies within the dietary supplement industry. As for using ill subjects in clinical trials, the FDA has restricted structure-function claims to “maintains healthy XYZ” and then both the FDA and FTC expect treatment paradigms to substantiate these claims. I would characterize this as an industry reaction to regulation, not necessarily an attempt to deceive (although in some cases it may very well be). But, I do agree that more studies should be done on healthy subjects.

    “What they never seem to provide is rigorous studies of their actual product published in the peer-reviewed literature showing the specific benefits they are claiming when used as directed.”

    I think this is formally called an association fallacy, but I have always called it tarring with the same brush. Since you used the term “never,” how many studies do I need to provide to counter the association fallacy? One (http://www.ncbi.nlm.nih [at] gov/pubmed/20434961)? Two (http://www.ncbi.nlm.nih [dot] gov/pubmed/19922649)? Three (http://www.ncbi.nlm.nih [dot] gov/pubmed/21677076)? More?

    The government could devote more resources to enforcement of the dietary supplement regulations, I agree. Congress needs to loosen its purse strings to make that happen. Until then, you are doing the right thing by bringing deceptive supplements to the attention of a wider audience.

  14. JPZ says:

    @everyone

    Oops, I guess I broke the length limit on posts this time, and I tried to get around the limit on links (but it didn’t work). Suffice it to say that I have a lengthy comment (with lots of references) awaiting moderation.

  15. Zetetic says:

    AIRBORNE – DHSEA at it’s worst – The public has been scammed for way too long with this one! Airborne doesn’t really come from the “natural” realm at all, it’s promoted by a very slick marketing gambit.

    I often confront commercial pharmacists with pointed questions about the ethics of the ever incresing offerings like this and other products like homeopathic preparations. Their usual response is “the public demands it” or some other such nonsense.

    A couple of years ago I called a collegue (healthcare professional with about 30 years experience) on Airborne. She mentioned going on a flight soon and intending to pre-dose with loads of Airborne. When I pointed out to her the herbal elements had no scientific evidence of efficacy and she could substitute all the common vitamins in the product for a few cents with bulk vitamins purchased from Costco, she was incredulous and more than a little miffed!

  16. tmac57 says:

    Karl-You forgot:
    It’s ingredients have been used by ancient cultures for thousands of years.

  17. JPZ says:

    @moderators

    How long do posts “awaiting moderation” usually take to get through the moderator queue? I apologize if I sound over-eager, but my post addresses some of the issues already coming up in the discussion thread (e.g. what happened to Airborne), and I would like to stimulate some discussion from my perspective as a dietary supplement industry insider.

  18. JPZ says:

    @moderators

    Thank you!

  19. Ali771 says:

    “But in someone with an adequate diet, there is no reason to assume that more will be better. Supplements treat deficiencies – but there is no reason to think that taking additional nutrients beyond the minimum necessary will have functional benefits.”
    This point has been emphasized recently in the media: (http://well.blogs.nytimes.com/2011/10/11/more-evidence-against-vitamin-use/). It’s possible that many will hear this evidence and think twice about downing supplements that might be dangerous (and aren’t cheap).
    Also, I have to hand it to the Berkeley Wellness Letter, who made the case against Airborne back in 2005…
    http://www.wellnessletter.com/html/ds/dsZicam.php

  20. Ali771 says:

    @ Karl Withakay
    Love it. Don’t forget “gluten free!”

  21. Jeff says:

    Dr. Novella’a post deals mainly with Alpha Brain’s claims on behalf of Glyceryl Phosphoryl Choline(GPC). He makes two good points:

    1. Most GPC trials invloved subjects suffering from dementia; much less research has been done using healthy young adults.

    2. The product’s recommended dose of 100 mg. GPC is probably too small to do much of anything. Most trials used oral doses of 400-1200 mg.

    One meta-analysis evaluated 13 GPC trials, some of which were placebo-controlled (pubmed/11589921). The reviewers found GPC to be effective for various kinds of dementia.

    This article gives a much more complete summary of research involving GPC:
    http://www.dockidd.com/pdf/GPC,3_04.pdf.pdf

  22. majkinetor says:

    Disappointing …

    First , its not GPC alone. Don’t be ridiculous. Its in combination with nootropics.

    Its well known fact that Piracetam + GPC makes all kinds of improvements in memory, AD, muscle jerks etc…. and its postulated that it does that by improving AH levels.

    There are like zillions of studies on that.

    I am surprised Novela is so slopy to not take things in adequate context. I do think that this nootropic drink could be much better formulated.

    There are other well known benefits of Choline like increased fat oxidation. Choline deficient diet is one way to induce obesity in lab.

  23. joroncho says:

    @majkinetor references please…

    It is customary to include references when you make claims such as this, thanks.

  24. Scott says:

    Its well known fact that Piracetam + GPC makes all kinds of improvements in memory, AD, muscle jerks etc…. and its postulated that it does that by improving AH levels.
    There are like zillions of studies on that.

    Then you should have no trouble providing the relevant PubMed references.

    Choline deficient diet is one way to induce obesity in lab.

    All sorts of things work in the lab but not the real world. Got any meaningful evidence (i.e. appropriately-sized double-blind randomized placebo-controlled human trials)?

  25. majkinetor says:

    Sure, if you are so lazy…

    http://www.ncbi.nlm.nih.gov/pubmed/7301036

    it was shown that twice the dose of piracetam (200 mg/kg) or choline (200 mg/kg) alone, still did not enhance retention nearly as well as when piracetam and choline (100 mg/kg of each) were administered together

    http://www.ncbi.nlm.nih.gov/pubmed/2392950

    Citicholine in a dose of 100 mg/kg, as well as the combination of 50 mg/kg CCh and 500 mg/kg PC, not only completely prevented the scopolamine-induced amnesia, but they also significantly increased the retention of the memory traces in the scopolamine-treated mice compared with the retention observed in the control animals

    http://www.sciencedirect.com/science/article/pii/0091305784902168

    The effects of various piracetam + choline combinations on an experimental model of memory were investigated. Mice were given two sessions in a simple photo-cell activity cage and the decrease in activity at the second session (habituation) served as an index of retention. Retention was facilitated by post-session administration of 2000 mg/kg piracetam IP and 50 mg/kg piracetam + 50 mg/kg choline IP. Similar injections of choline alone (10 to 200 mg/kg IP), piracetam alone (10 to 1000 mg/kg IP) or other combinations of piracetam and choline were without effect. These results, consistent with those reported elsewhere, suggest that piracetam can interact with choline to facilitate memory processes in mice.

    All in all, the principle is known that nootropics work multiple times better as synergy.

  26. JPZ says:

    I am a little surprised that I posted a counter-point to Steven Novella’s lambasting of the dietary supplement industry a full day ago with no reply (to me, it seems a long period of time given the cycle of posts on SBM – one could almost wait a few days to make a comment go away). Normally, SBM has no tolerance for poorly constituted or unscientific arguments – neither do I. For example, commentators were all over majkinetors last post in 2-3 hours.

    I welcome science-based discussion.

  27. JPZ says:

    Two blog posts afterwards now. Although, you know, the initial post was delayed in moderation for some time, so we should all keep that in mind as a delaying factor in responding. We all need more time to consider a comment we just encountered. My apologies for my impatience. I look forward to your reply, Steven.

  28. ConspicuousCarl says:

    JPZ on 26 Oct 2011 at 1:36 pm
    Use of product names that are implied disease claims is specifically prohibited by the FDA [...] in Criterion 4.

    That section specifies that the name can’t imply a DISEASE claim. That same section also states:

    “For example, ‘Soothing Sleep’ could be considered a claim to treat insomnia, a disease, unless other context in the labeling makes clear that the claim relates to a non-disease condition, such as occasional sleeplessness.”

    So yes, they CAN get away with it if the label also includes a not-intended-to-treat-any-disease explanation.

    Here are some product names currently for sale on Amazon:

    Fat Metabolizer
    Healthy Liver
    Natural Calm
    Immune C
    AgeLoc
    Super Colon Cleanse
    Nu Skin (brand)

    Airborne was prosecuted by the FTC with a settlement of $30 million USD (http://www.ftc [dot] gov/opa/2008/08/airborne.shtm).

    And yet Airborne still exists on store shelves, and has the claim that it “Helps support your immune system” even though it is a worthless product.

    The settlement was for their disease references, such as “colds”, which are no longer mentioned. I also notice, though I don’t know for sure if it was referenced in the case, that their boxes no longer have the pictures of cartoonish germs flying over the airline passenger’s head. Now he is just staring nervously upward at nothing in particular.

    “Supplements treat deficiencies…”

    The FDA says, “A dietary supplement is a product taken by mouth that contains a “dietary ingredient” intended to supplement the diet.” (http://www.fda [dot] gov/Food/DietarySupplements/ConsumerInformation/ucm110417.htm). Many commentators here make the same statement about treating deficiencies, but it simply isn’t true. Supplements can’t legally even use the word “treat.”

    Novella can defend his own desired meaning here, but I am confused by yours.

    The literal meaning of your statement above is that you think supplements do not treat deficiencies. Maybe my medical knowledge is inferior to yours, but supplements seem like a way to treat deficiencies. Does a vitamin C supplement not help if a person is not getting enough vitamin C in their diet? Should I simply not be using the specific word “treat” as a general word for responding to a situation?

  29. majkinetor says:

    I already posted more detailed references, but since it didn’t show up (probably because I called people lazy), here are some of them again:

    http://www.sciencedirect.com/science/article/pii/0091305784902168
    http://www.ncbi.nlm.nih.gov/pubmed/7301036

    Its well known that nootropics are more effective in synergy. Thats why Novela’s conclusions are not appropriate.

  30. Scott says:

    @ majkinetor:

    Requiring that YOU provide the references which YOU consider to be adequate to support YOUR claim isn’t “lazy.” It is, rather, intellectually dishonest of you to demand that others attempt to prove your claims for you, and to somehow divine what specific evidence you’re using as the foundation of your argument.

    Of your citations, one was in rats and two in mice. In other words, preclinical results which could reasonably be used as part of a foundation for human trials. They provide no meaningful support whatsoever for specific claims of benefit for specific products in humans.

    Accordingly, you have successfully demonstrated that there is no justification for offering such products for sale at this time, and that the specific claims being made are lies. So what exactly are you objecting to again?

  31. JPZ says:

    @ConspicuousCarl

    Thank you for your reply!

    “So yes, they CAN get away with it if the label also includes a not-intended-to-treat-any-disease explanation.”

    You are on the right tack, but it is a little more nuanced than that. If you label a product “Stops a Heart Attack,” you are likely to be in violation of the law no matter how you qualify it. If you label something “Soothing Sleep,” then it is still ambiguous as to what you actually mean. If you don’t qualify it with a statement like “helps promote restful sleep,” then the FDA will say that a reasonable person could think “Soothing Sleep” implies “treats insomnia” – which could be a violation of the regulation. The FDA mandated disclaimer, “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease” – doesn’t get you off the hook for any label claim. It just has to be on the label by law.

    “And yet Airborne still exists on store shelves, and has the claim that it “Helps support your immune system” even though it is a worthless product.”

    Good point, so let me clarify. I am not sure of the legal details, but Airborne settled with the FTC – the FTC didn’t shut them down (http://www.ftc.gov/os/caselist/0723183/080814airborneorder.pdf). Airborne got to stay on the market, but they had to pay $30 million and stop making all real and implied disease claims (including cartoon germs on packages). Now they are making the “helps support the immune system” claims – which is what Kelloggs got in trouble with Rice Krispies labeling. If Airborne gets busted as a second-time offender, I would bet the FTC throws the book at them.

    “The literal meaning of your statement above is that you think supplements do not treat deficiencies.”

    I may not have been very clear. The FDA defines dietary supplements as, “…a product taken by mouth that contains a “dietary ingredient” intended to supplement the diet.” I felt that Steven’s statement, “Supplements treat deficiencies…” implied that supplements should ONLY be used to treat deficiencies. Other commentators on SBM have explicitly said dietary supplements should only be used to treat nutrient deficiencies, but I may have extrapolated beyond Steven’s intent with his statement (I’ll have to see what he says). In my opinion, supplements can be used to treat nutrient deficiencies and they can also be used for other purposes as allowed by the FDA.

  32. Scott says:

    Once you’re using for some reason other than addressing a nutritional deficiency, logically speaking it has become a drug as opposed to a supplement. (It’s not ‘supplementing’ the diet, but to produce some specific health effect different than nutritional requirements.) The unfortunate conflation of these concepts is really only useful for quacks who want to wink-wink-nudge-nudge classify their miracle treatments for all ills as “food.”

  33. Scott “Once you’re using for some reason other than addressing a nutritional deficiency, logically speaking it has become a drug as opposed to a supplement.”

    Are folic acid supplements to prevent birth defects and calcium to prevent osteoporosis treating a deficiency or a drug? I’ve never really thought of them that way.

  34. JPZ says:

    @Scott

    You are certainly welcome to create your own personal definitions for “drug” and “dietary supplement.” Please don’t be upset with others when they disagree. They may have created their own definitions as well, or they may be following the definitions supplied in the Code of Federal Regulations (http://en.wikipedia.org/wiki/Federal_Food,_Drug,_and_Cosmetic_Act). I tend to stick with the statutory definitions (although I do not agree with them in every case, and this is why I advocate for scientifically sound testing of nutritional product safety and efficacy). If you feel the statutory definitions are illogical or unjust, you might want to write to your congressional representatives (if you are in the USA). I don’t think an “Occupy The FDA” would be well-received. ;)

  35. Scott says:

    @ JPZ:

    My point is that the FDA definition is nonsensical, and the only purpose it serves (and for which it was expressly designed) is to legitimize quackery. So long as that is understood, and the definitions being used by different parties to the discussion are clear, I agree that it’s not terribly practically relevant.

    Are folic acid supplements to prevent birth defects and calcium to prevent osteoporosis treating a deficiency or a drug? I’ve never really thought of them that way.

    That’s pretty close to the fuzzy line, but I’d tend to fall on the side of categorizing them as a drug and a supplement (respectively) in those contexts. Basically the way I think of it is to consider what the first-line approach is. If the first recommendation is “eat more of these types of foods to get more of this nutrient,” and “take this pill” is used as a fallback if dietary adjustment is not an option for some reason, I would call it a supplement. If the first recommendation is “take this pill” I call it a drug. My impression is that in the case of folic acid, nobody really recommends trying to get it from diet. But those at risk for osteoporosis are recommended to drink more milk and otherwise consume a calcium-rich diet, and supplement if that does not suffice. (Layperson’s understanding from observing recommendations given to family members; if the accepted standard of care is otherwise then my position would change.)

  36. JPZ says:

    @Scott

    “My point is that the FDA definition is nonsensical, and the only purpose it serves (and for which it was expressly designed) is to legitimize quackery.”

    I have yet to see a personalized definition of “drug” or “dietary supplement” that was not seriously flawed and/or filled with gray areas. I would actually be very interested in better definitions. For now, there are statutory definitions to follow.

    To say this is legitimized quackery ignores the fact that the efficacy of some nutritional products is supported by clinical trials. I listed three in my reply to Steven’s original post that used otherwise healthy subjects, and I can provide more using healthy or sick subjects (subject to the three link limit imposed by the blog and the amount of time I want to devote to this). So, now all you need to do is prove that all dietary supplements are quackery.

    A significant source of frustration with dietary supplements is that most of them on the shelves today were automatically approved by the 1994 grandfather clause in DSHEA. The grandfathered supplements did not have to undergo safety or efficacy testing to be sold. This is exactly the same thing that happened in 1938 when the FDA grandfathered in all drugs on the market at that time (e.g. morphine, digitoxin, colchicine and colloidal silver) without requiring safety or efficacy testing. Imagine how much legitimized quackery was around in 1938! The way the FDA got around this grandfather clause was to require safety and efficacy testing of these drugs if they were ever reformulated from the original pre-1938 formula. Today, the FDA has a proposed rulemaking (Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues) to do the exact same thing – require safety testing if you reformulate a pre-1994 nutritional ingredient. Requirements for efficacy testing are claim-specific, and this is an area that needs more enforcement to get rid of irresponsible companies with irresponsible claims.

  37. Purenoiz says:

    @Scott
    “My point is that the FDA definition is nonsensical, and the only purpose it serves (and for which it was expressly designed) is to legitimize quackery.”

    I would argue that the main goal of DSHEA 1994 wasn’t to legitimize quackery, but to protect the interests of businesses over the welfare of the consumer. The ultimate in quackery was protected back in 1938 with the Federal Food, Drug, and Cosmetic Act. Congress caved in to consumer pressure, to pass DSHEA. I work in the industry, and the industry is proud of it’s ability mobilize the voting public into contacting their representatives en masse to get this protection. It is the ultimate in deregulation and supply side economics. That being said, the quacks use it as a shield to hide behind. This may come across as possibly pedantic, but I think this distinction is important.

    To begin with go and check out and support Ginger Campbell, MD, listen to the podcast on Cognitive Dissonance at www. I will sum it up for you, people who invest time and energy into something dig in and defend themselves with more vigor to justify the choices they have made. Given that
    1) DSHEA opened a can of worms by deregulating or more aptly mis-regulating supplements.
    2) These consumers have a strong belief and investment in supplements; I am not addressing woo or medical quacks here.
    3) The more they evidence showing they are wrong, their brain will react to the conflicting information, and cause great stress in the individual feeling cognitive dissonance at that time.

    So just showing people who are not trained in statistics nor the scientific process the “facts that prove I am right and your beliefs are wrong” will not only go no where, it will create a backlash that is counter productive. The consumer, and let’s be frank that without consumers the industry would be weak or dead. I am arguing that instead of attacking companies that are really no different from any other consumer good i.e purchase this and your life gets better, it would be better to focus on those who practice medicine illegally or sell drugs as supplements. As much as we would like to regulate away stupidity and poor rationalizations from a fear induced desire to prevent the ravages of old age, it just won’t happen. I think a good marketing campaign, such as the british sketches “That Mitchell and Webb look”, to inform would be consumers just how silly their purchases really are.

    Below are the legal definitions of food and drugs. How is that nonsensical? It only gets nonsensical when companies violate the law, and then mount inane arguments that their products shouldn’t be regulated as a drug, because they don’t have side effects. It’s not useful for society to have 250 million different views on what is or isn’t a dietary supplement or a drug. If somebody markets a supplement as a drug, they should get punished severely for it.
    From fda.gov
    Dietary Supplements: Questions and Answers
    What is a dietary supplement?

    A dietary supplement is a product taken by mouth that contains a “dietary ingredient” intended to supplement or enhance the diet. The “dietary ingredients” in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, soft gels, gel caps, liquids, or powders. Whatever their form may be, the Dietary Supplement Health and Education Act of 1994 places dietary supplements in a special category under the general umbrella of “foods,” not drugs, and requires that every supplement be labeled a dietary supplement.

    How does the law define a drug?
    The FD&C Act defines drugs, in part, by their intended use, as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals” [FD&C Act, sec. 201(g)(1)].

  38. JPZ says:

    @Purenoiz

    Well, you do have an informed and nuanced view of our industry. But I do have some comments:

    “…but to protect the interests of businesses over the welfare of the consumer.”

    OK, I agree that shifting burden of proof for lack of safety of a dietary supplement to the FDA rather than the producer temporarily puts the interests of business over that of the consumer – especially when Congress underfunds the FDA for that responsibility. But, this is exactly what they did in 1938 with drugs. I am not sure exactly why regulatory agencies go the “grandfathering” route, but I imagine it keeps everything from grinding to a halt with red tape due to approval backlog. I personally am happy that one part of the new NDI proposal may put a lot of grandfathered nutritional ingredients through the safety test.

    “I work in the industry, and the industry is proud of it’s ability mobilize the voting public into contacting their representatives en masse to get this protection. It is the ultimate in deregulation and supply side economics”

    Yes, certain segments of the dietary supplement consuming public can be passionate true believers. I tend to think that the mobilization of these true believers (maybe 5-75,000 per company?) would have had little effect without Senators Hatch and Harkin supporting DSHEA. Right now, there is a subset of the supplement manufacturers fighting any regulation of dietary supplements and using their influence on their true believers for lobbying. So far, without the support of more respectable industry groups and larger suppliers, they aren’t getting much traction (as far as I know).

    “The consumer, and let’s be frank that without consumers the industry would be weak or dead”

    As the history of the various laws brought into effect to support the FDA has shown us, without regulation, the dietary supplement consumers might end up weak or dead due to irresponsible companies.

    “…then mount inane arguments that their products shouldn’t be regulated as a drug, because they don’t have side effects.”

    Amen, brother/sister. If you don’t test for side-effects, how do you know they don’t exist?

  39. JPZ says:

    Well, given that I have used science-based evidence (IMHO) to dispute nearly everything in Steven’s post except the potentially questionable nature of Alpha Brain (I haven’t reviewed the evidence yet) and the agreement that some dietary supplement company practices are irresponsible, I am rather curious why we have not heard a response from the author.

  40. Jeff says:

    The more they evidence showing they are wrong, their brain will react to the conflicting information, and cause great stress in the individual feeling cognitive dissonance at that time.

    I suppose the “evidence” Purenoiz is referring to includes the “Vitamins Will Kill You” studies getting so much recent media coverage. Many scientists and doctors have posted rebuttals to these studies. Here is just one example:

    http://www.orthomolecular.org/resources/omns/v07n10.shtml

    I would take issue with Purenoiz’ rather patronizing view of the 150 million Americans who take supplements, i.e., that they are simply too dumb and ignorant to know any better.

    JPZ states:

    Right now, there is a subset of the supplement manufacturers fighting any regulation of dietary supplements and using their influence on their true believers for lobbying. So far, without the support of more respectable industry groups and larger suppliers, they aren’t getting much traction (as far as I know).

    I think this is rather misleading. All the big supplement trade groups (Council For Responsible Nutrition, Natural Products Asssociation, etc.) favor reasonable regulation. They all support Good Manufacturing Practices and mandatory adverse event reporting. All the major trade groups also have serious objections to many parts of the NDI Guidance. (See article, NutraIngredients: Mister on NDI guidance: ‘We are terribly disappointed.’)

  41. Scott
    My point is that the FDA definition is nonsensical, and the only purpose it serves (and for which it was expressly designed) is to legitimize quackery. So long as that is understood, and the definitions being used by different parties to the discussion are clear, I agree that it’s not terribly practically relevant.

    Scott, if I was reading a newspaper article or editorial and the writer claimed that the FDA definition of supplement was expressly designed to legitimize quackery, I would expect the writer to either back that statement up with solid information and sources or would discount the writer for only catering to their party line and those readers who will believe them regardless evidence.

    Or maybe the B in SBM actually stands for barbershop, always the appropriate place for throwing around conspiracy theories. :)

  42. Jeff says:

    Research has shown that supplements can do much more than treat nutrient deficiencies (as JPZ has pointed out). Studies going back to the 1980s have shown that Pantethine, a fat-soluble form of vitamin B5, can lower total cholesterol and LDL cholesterol. One recent controlled trial reinforces this finding. The doses used, 600-900 mg., were much higher than what would be needed to treat a B5 deficiency. In other words, Pantethine can do what statins claim to do, without statins’ harmful side-effects.

    This was the purpose of DSHEA’s definition of a dietary supplement: to make sure consumers have access to safe, natural substances (like Pantethine) in therapeutic doses.

  43. weing says:

    “In other words, Pantethine can do what statins claim to do, without statins’ harmful side-effects.” 3% decrease in cholesterol. Wow! Statins don’t just claim to lower cholesterol. They actually do, the weaker ones about 20% lowering, the more potent give over 50% lowering. No comparison. I don’t have anything against it, I’ll take even 3% if the patient can’t tolerate the statin.

  44. JPZ says:

    @Jeff

    “I think this is rather misleading. All the big supplement trade groups (Council For Responsible Nutrition, Natural Products Asssociation, etc.) favor reasonable regulation.”

    Which is why I mentioned the “more respectable industry groups” to cover those associations you listed. When I spoke of “subset” I was thinking about the recent move by Jarrow (http://www.nutraingredients-usa.com/Regulation/Jarrow-Rogovin-proposes-new-supplement-trade-association-There-s-no-need-say-existing-associations) and one other small group that I can’t seem to locate their name again. Nevertheless, these are fringe groups, not the bulk of the industry.

  45. JPZ says:

    @Jeff

    Pantethine is two molecules of pantothenic acid (B5) joined together, and it isn’t a great source of B5 because a good portion of it is absorbed intact. It is thought to function by being a precursor for CoA metabolism. Pantethine isn’t a good example of more of a vitamin being better. It is actually a distinct compound with distinct functions.

    @weing

    Anecdotally, I have heard that some physicians like to use pantethine for lipid lowering in kidney dialysis patients because of low toxicity.

  46. Purenoiz says:

    @Jeff,

    Your assumptions on what I mean by confronted by evidence, and my opinion that the majority of the 150m Americans are “that they are simply too dumb and ignorant to know any better.” are both wrong.

    I’m not sure what role you have in the supplement industry, me, my initial experience is in the retail environment and in now I work as a liaison between the retailer and manufacturers. Are there some dumb consumers, sure, are they all dumb, nope, not even close. The evidence I refer to may be as simple as EPA is EPA, whether it comes from cod, krill or salmon, and that it is EPA’s unique shape that allows COX-2 to convert it into a anti inflammatory prostaglandin; the shape is what plays a crucial role how the liver uses EPA to lower triglycerides (think lovaza). I’ve had retailers tell me that it is crucial for a nutrient to be fermented in order for it to be because the “fill in the ancient ethnic group” used to ferment it. The evidence I speak of is the pre conceived notions that people have, all people, and the challenge of overcoming the cognitive dissonance when the evidence competes with their beliefs. Some people think that just because a company did a “study” on the product, it is some how has a much higher guarantee of efficacy, even if the study is a cell culture study in a petri dish.

    That some rationalizations are based in stupidity may be a bit harsh, then again visit a health food store after Dr Oz mentions a product that will cause weight loss or help with X and ask how sales are on the product. Neti Pots were out of stock for six months due to his appearance on Oprah, same with astazanthin albeit for not as long. I don’t expect consumers to be experts in supplements and biochemistry, however their reaction to information that doesn’t sit with their beliefs will cause dissonance, even if the information is simple like ” cod liver oil is fish oil, fish oil is a source of omega-3′s, so cod liver oil is a source of Omega-3′s.” I try not to make customers feel dumb for their beliefs that are wrong, it just may not come through in my writing.

  47. Jeff says:

    @weing:

    I should have stated my argument differently: While statins are more effective at lowering cholesterol than pantethine, they have a potential for some rather serious side-effects.

    I would like to redeem my original position, namely that safe, natural substances can be useful in doses higher than those required to correct a deficiency. Here’s one cardiologist who uses niacin to improve his patients’ cholesterol profile:

    Using Niacin to Improve Cardiovascular Health

    Because of DSHEA, niacin is classified as a dietary supplement; therefore it can’t be patented and consumers can obtain it easily and inexpensively.

  48. JPZ says:

    @Jeff

    I don’t think this redeemed your last post. Physicians have been using high dose niacin for cholesterol reduction since the mid-1950′s (http://www.ncbi.nlm.nih.gov/pubmed/13511314) I think. Low dose niacin in food fortification and multivitamins was never an issue before DSHEA to the best of my knowledge. Many forms of niacin are patented based on the slow-release technology, et al. I am not sure it is a great idea to manage your own cholesterol with dietary supplement niacin (with unknown rate of release characteristics) anyways. I am not sure how this example supports the importance of DSHEA.

  49. weing says:

    @Jeff,

    I don’t think Niacin is that safe either. At the doses required, it can be hepatotoxic, diabetic control can worsen, gout can be precipitated, GI bleeding can occur, and there were increased strokes in the recent AIM-HIGH trial. That doesn’t mean I don’t use it. I do, but selectively.

  50. Jeff says:

    Weing: Not being a doctor myself I can only go by what Dr. William Davis states about the non-patented, fast-dissolving form of niacin:

    Niacin is very safe and easy to use, if used properly. In my experience, over 95% of people who follow these guidelines are able to take niacin with only minimal hot flushes. Potentially serious side effects are almost never seen.

    He does say the slow-release form should be avoided; also that people with certain medical conditions or those using doses over 4000 mg. should do so only under a doctor’s supervision. Of course I defer to your knowledge and experience, but based on the evidence available niacin would still seem to have a much safer profile than statins.

    JPZ: We continue to disagree over the value and meaning of DSHEA. Dr. Davis makes it clear the vast majority of people wishing to use the fast-dissolving form of niacin can do so safely. Your comment on pantethine reminded me of a well-referenced article which explains what makes it such a unique compound:

    http://www.wellnessresources.com/tips/articles/pantethine_boost_your_brain_cardio_health_metabolism_and_detoxification/

  51. JPZ says:

    @Jeff

    No, this isn’t about DSHEA. It is about your using clumsy and poorly thought out examples to defend DSHEA to an audience that isn’t going to take your word for it. Pantethine and niacin are both efficacious, but they have nothing at all to do with whether DSHEA is a good or bad thing. In fact, by using them as examples to defend DSHEA, you only betray your ignorance of the science behind their use and efficacy. You are not doing the dietary supplement industry any favor by defending it badly. I am starting to understand why nybgrus considered you an eight year old trying to show off what little you know in an adult conversation – but I forebear in favor of patience and open-mindedness.

    Although, I will admit, my belief in the science-based nature of this forum has been tested by Steven and Scott ignoring citation-backed data contrary to their beliefs (I thought only CAMers did that), but I suppose it IS worthwhile to discuss the scientific merits of various viewpoints with the many science-focused commentators and staff in the discussions here. Plus, the topics raised here, regardless of the author, are quite informative!

  52. Jeff says:

    I will continiue to express my views even though many readers of this blog will disagree with me. Thankfully SBM allows me to do this. I was responding to Purenoiz’ rambling attack on DSHEA. I gave two valid examples of safe, natural compounds which have therapeutic value. Because of DSHEA pantethine and niacin are regulated (properly) as dietary supplements, not as drugs or food additives. This makes them easily obtainable by consumers who wish to take control of their own health.

    There are other studies like this one showing the value of pantethine. It’s a small study (29 patients), but it was placebo-controlled and got better results than the first one I linked to.

    Of course more research is needed to prove conclusively the cholesterol-lowering ability of pantethine. But there is enough evidence to make pantethine a rational choice for someone with elevated LDL-C who wants to avoid using statins.

  53. JPZ says:

    @Jeff

    You can comment all you want, but people are going to challenge what you say if you don’t have your facts straight. DSHEA and related regulations are all about maintaining or bolstering good health. “Lowers cholesterol” is a disease claim that can’t be put on dietary supplements legally.

    Also, people generally go to their PCP to get blood lipids run anyways. If your PCP says you need to lower your LDL-cholesterol by 40%, it is not a smart idea to exercise your health freedom and choose to control it yourself with pantethine, niacin or Benecol. If your LDL-cholesterol is only slightly elevated, then I suppose you could opt to use dietary supplements to get it back in the normal range, but you also have the option to take control of your health and make your lifestyle a little more healthy and opt to eat more oatmeal, soy protein, etc. Your PCP is going to have you come back anyway to monitor your progress, i.e. you will be managing a disease under the supervision of a physician. So, you aren’t taking control of your health. You are taking a condition, mildly elevated LDL, where (I don’t think) statins aren’t the first choice for treatment and choosing to use dietary supplements in place of better studied lifestyle changes. I know some people make the lifestyle changes and take dietary supplements, but how do they know they needed both?

    Also, the pantethine and niacin you get in a dietary supplement are derived from total chemical synthesis (i.e. how drugs are made). There is nothing “natural” about it.

  54. Greg Nozick says:

    Has anyone here actually tried the product?
    Looks like all the ingredients are good for you.

  55. Harriet Hall says:

    @Greg Nozick,

    “Has anyone here actually tried the product?
    Looks like all the ingredients are good for you.”

    Probably no one here has tried the product, for these reasons:
    (1) Lack of evidence for benefit (i.e. no reason to try it)
    (2) Lack of evidence of harmlessness
    (3) Trying something yourself is not a way to find out if it works. If you feel better, it might not be due to the product, and if you feel no change it might be that you are actually improved in some way that you are not aware of.

    The ingredients are nutrients, but that doesn’t mean that taking more of those nutrients is good for you.

  56. Jeff says:

    @JPZ:
    I agree that most people take supplements for wellness and prevention. Despite the FDA’s prohibition against disease claims many consumers will also research supplements for possible therapeutic uses. Many American doctors hand out statins like candy, regardless of potential side-effects. Some of these same doctors have a strong bias against the use of dietary supplements.

    Besides pantethine and niacin, other supplements have demonstrated potential for lowering cholesterol, e.g., tocotrienols, phytosterols, and the ubiquinol form of CoQ10. In moderate doses, none of these substances have a documented history of serious side-effects, including fast-dissolving niacin. For someone with mildly elevated LDL cholesterol, a perfectly logical choice would be a combination of these supplements plus dietary/lifestyle changes. DSHEA allows consumers more control when making these choices.

    Of course many supplements are made synthetically, but they are molecule-identical to the natural compound (unlike drugs).

  57. Harriet Hall says:

    @ Jeff,

    “Many American doctors hand out statins like candy, regardless of potential side-effects.”

    Do you have any evidence that any doctor is handing out statins like candy, regardless of potential side effects?”
    I don’t know of anyone who fits that description; and if someone does, it’s malpractice and he should be disciplined.

    You cited an alarmist article. What about the JUPITER study? 18,000 patients showed no difference in side effects between the statin and placebo groups. http://www.sciencebasedmedicine.org/index.php/statins-are-better-on-jupiter/

    Statins have been unfairly demonized by denialists like the International Network of Cholesterol Skeptics. http://www.sciencebasedmedicine.org/index.php/the-international-network-of-cholesterol-skeptics/ Statins have been proven effective in reducing all-cause mortality for patients at risk. They not only lower LDL cholesterol, but also have an effect against inflammation. Good doctors prescribe them selectively. Other treatments can’t compare: diet/lifestyle changes help, but generally don’t lower LDL sufficiently; other drug/supplement treatments have not been shown to reduce mortality. Red yeast rice is touted as a natural alternative, but in fact it is a statin mixed with other plant components and more uncertain in dosage.

  58. WilliamLawrenceUtridge says:

    Of course many supplements are made synthetically, but they are molecule-identical to the natural compound (unlike drugs).

    Jeff, your comment implies that drugs, being molecularly non-identical to natural compounds, are somehow the worse for it. Why would being molecularly identical to a natural compound be an advantage? Snake venom would be considered a natural compound, as would arsenic; both are deadly. The extract derived from willow bark relieves pain, but damages the stomach. In contrast, the modifications made in a lab to produce aspirin result in a compound that is not identical to a natural one, but is much easier on the stomach lining and thus is superior for human use. Death due to aortic anyeurism is natural while surgery to correct it (and various congenital defects such as a hole between the chambers of the heart) is quite unnatural.

    Natural is not necessarily better, and believing natural compounds to be inherently more healthy is the naturalistic fallacy.

    Also, most if not all doctors will prescribe vitamin supplements in cases of frank deficiency. The fact that they don’t try to use them as if they were drugs or as a general panacea is a mark of an evidence-based practice, not a flaw. Vitamins can cause harm, both acutely and chronically, and the only valid use I am aware of (high-dose niacin to treat high cholesterol) comes with significant risks (significant vasodilation and liver failure) and a relatively narrow band between effective and toxic doses.

    If it has an effect, it will almost certainly have risks, natural or no.

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