They May not Be Coming for Your Guns, But They Are Definitely Coming for Your Minerals and Vitamins

Bonnie Kaplan, PhDJulia Rucklidge, PhD
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Something very concerning is developing in New Zealand. It is not unique to NZ – it has already happened in Australia, has been happening in Europe, and it will likely happen in the U.S. and Canada. Under the guise of regulating Natural Health Products (NHPs) to ensure their safety, the NHPs are actually being severely restricted.

In NZ, the government is passing legislation called the Natural Health and Supplementary Products Bill that will limit access to minerals and vitamins.

While safety and efficacy are important, this bill will ban for sale many NHPs that New Zealanders rely on for their health. In so doing, it will ban all of the formulas for which there is scientific evidence of benefit for mental health.

In fact, the bill will also eventually terminate Julia’s research.

Here is why: as part of the bill, the Ministry of Health has developed a “permitted ingredients” list of 5545 ingredients (like calcium, potassium and folic acid or less known ingredients like Bogbean leaf powder, Brassica juncea and pawpaw); however, all ingredients have a specified maximum daily dose for consumption. If you have been following our blog, you know that we both have studied the effect of micronutrients (i.e. ingredients contained in NHPs) on psychiatric symptoms. And you also know that we have emphasized the importance of consuming all the essential nutrients, in proper amounts and in balance. Unfortunately, the NZ Ministry of Health has taken a ‘single ingredient approach’ to the development of the list, because the list does not reflect the fact that when one consumes ingredients together, one can tolerate different doses safely compared to when an ingredient is consumed alone.

A perfect example of how guidelines based on single nutrients can be misleading is folate. Folate has an upper limit dose that is set based on the fact that excessive consumption can mask a B12 deficiency. However, if one consumes a multi-ingredient formula with both folate and B12, then folate levels can be much higher without adverse effects. This single ingredient approach the NZ government is following is outdated; we have discussed this single bullet fallacy at great length in previous blogs and why it is the wrong way to think about NHPs.

An additional disastrous implication of this single-nutrient framework for the Bill is this: if a product exceeds a specified dose, even for one ingredient, then the entire product cannot be sold in NZ. There are also blacklisted ingredients, ingredients that cannot be included in any NHP. Vanadium, a trace mineral contained in many vegetables and cereals, is one example; vanadium is useful in building strong bones and teeth, and also has a role in regulating blood sugar. Why would it be banned?

To make things even more complicated, the recommended definition of an NHP means that it cannot include a medicine. In NZ, vitamin D is a medicine if it is consumed above 25mcg. In other words, if an NHP has more than 25mcg (1000 IU) of Vitamin D, the entire product would be banned as the Medicines Act trumps the Natural Health and Supplement Products Bill. This is also the upper limit dose specified in the permitted ingredient list. Yet we know many people who choose to take more than 1000 IU of vitamin D, and the Dietary Reference Intakes of North America specify that it is safe to take 4000 IU/day (that’s the tolerable Upper Level), and the No Adverse Effect Level is 10,000 IU/day. Why would a nation restrict intake to 1000 IU if there is no apparent risk? Are there drug companies that will benefit financially when many nutrients are by prescription?

Another example is selenium. If a product has a daily dose greater than 150mcg of selenium, it cannot be included in an NHP. Let us point out that eating 5 brazil nuts would exceed this daily dose. Is that logical? And we could keep going about the absurdity of the list.

While Julia has been given assurances from the Minister of Health that her research on NHPs can continue (because research isn’t regulated by the new Bill), it is hard to imagine how this will actually operate. How can it be illegal to sell the products in NZ and yet be legal to import them into the country for research and/or personal use? In addition, there is a risk that after someone finishes participating in one of Julia’s trials, they will not then be able to purchase the nutrients from a New Zealand supplier. Why then would anyone be willing to volunteer for the research? And if they feel a formula benefited them, how will they feel when they are told they cannot buy it in NZ, but will have to import it for personal use? And whether a product can be imported is unclear, as medicines cannot be imported. Recall, vitamin D over 25mcg is a medicine.

We have some evidence that the result could be tragic: over 10 years ago when Health Canada shut down Bonnie’s clinical research and, more importantly, closed the border so that Canadians could not buy this mineral and vitamin formula for several years, many law-abiding Canadians were enormously stressed at having to break the law and sneak it across the border from the U.S. (where it is manufactured). In addition, two adults committed suicide. In both cases (which were confirmed in court by the head of the Western Canadian Division of the Canadian Mental Health Association), the families said these people chose suicide rather than being forced to return to psychiatric medication when they could not access the nutrient formula that had brought them good mental health.

Here is why EVERYONE inside and outside of NZ should care about these developments: Julia, based in NZ, has been “quietly” conducting research that benefits people worldwide on the effectiveness and safety of micronutrients, and this research has been done outside of the radar of Big Pharma. Indeed, out of the 30 scientific publications on EMPowerplus (also sold variously as EMPoweplus Advanced, Q96, Daily Essential Nutrients) demonstrating the effectiveness of these formulas for the treatment of a variety of psychological/psychiatric symptoms ranging from ADHD to stress to PTSD to mood disorders, over half originate from Julia’s Mental Health and Nutrition Research Lab (1). There are three other publications under review and three current randomized controlled trials being conducted in the lab with more studies under development. Further, all of these studies have been approved by the national and local ethics committees indicating that these Ethics committees have determined, based on information provided on safety and toxicity of the doses being given, that the ingredients are safe for human consumption.

If this bill goes through, it will become increasingly difficult for Julia to conduct her research. Researchers from other parts of the world are currently unable, due to local government restrictions, to conduct this type of research. For example, there are strict regulations in Europe that mean no one could do this research there. Indeed, Julia has been approached by scientists from various European countries keen to replicate our work who then mention that they would have to use doses much lower than the ones we have studied. Please understand that we do not advocate for, nor do we study, ‘megadoses’ of any nutrient. All ingredients of all the formulas we have studied are at safe levels.

Once passed, the NZ bill will take at least 3 years to take effect, which gives us time to educate the government about the harm that will be caused by its passage. The Permitted List is currently up for consultation with the public. Submissions can be made to the Ministry of Health to ask for specific exemptions and reconsiderations. Public consultation ends on February 5th 2016.

Here is what we ask of our readers. Spread the word about what is going on. If you are currently benefiting from the research done in NZ and would like to share your story, or even if you just think it is unfortunate to limit access to products which have shown no harm, please make a comment, send an email to the NZ government  (and cc to [email protected]). Wouldn’t it be fantastic if the NZ government received emails from all over the world about the benefit of nutrients in treating mental illness based on research conducted in New Zealand? Please give us permission to use your stories. Stories of personal benefit are powerful at effecting change. Julia can collate these stories and send them to the Minister of Health. Julia has already been lobbying locally with Members of the NZ Parliament, writing to the Ministry of Health, applying for funding for the products as medicines and speaking in public forums and to the media.

And finally, this serious issue relates to our last blog on the need for funding for this research. Bonnie has put together a wish list of funds for scientists wanting to study broad-spectrum micronutrient treatment that amounts to several million dollars. Even meeting her first goal of $100,000 would go very far to contributing to more clinical trials. With more data, the stronger the position we have with our governments to ensure that citizens can treat their health symptoms with methods of their choosing.

MIA has done a fantastic job of educating the public on the downsides of psychiatric medications, the extensive list of problematic and dangerous side effects, and the very questionable data on which they have been approved. Given the poor track record of governments in permitting psychiatric drugs to be used that have since been shown to not only be ineffective but also very risky (e.g. paroxetine), can we even trust the governments to regulate NHPs such that efficacy and safety guide decisions rather than financial reasons? There must be a reasonable way to regulate NHPs without compromising access to formulas that have a proven track record. This research is necessary to ensure that can happen.

To read further about the undermining of this work, visit Mental Health Work Could Be Undermined.

Remember, neither of us benefits financially from the sale of any products.

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Reference:

  1. http://www.ncbi.nlm.nih.gov/pubmed/?term=rucklidge+JJ
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Bonnie Kaplan, PhD
Nutrition and Mental Health: Bonnie has published on the biological basis of mental health – in particular, the contribution of nutrition to brain development and function, micronutrient treatments for mental disorders, and the effect of intrauterine nutrition on brain development and maternal mental health.
Julia Rucklidge, PhD
Nutrition and Mental Health: Julia's interest in nutrition and mental illness grew out of her own research showing poor outcomes for children with psychiatric illness despite conventional treatments. She has been investigating the role of micronutrients in mental illness.

15 COMMENTS

  1. Great article title!

    I wonder how these regulations work in the USA? Don’t know if such research is allowed here. I would guess that it is.

    I’m waiting for the article title that says, “They May Not Be Coming For Your Guns, But They Are Definitely Coming For Your Neuroleptics.” That will be the day. And of course, that is what should be happening given the danger of psych drugs.

    One criticism of this, “the benefit of nutrients in treating mental illness based on research conducted in New Zealand?”

    No… There are no valid, reliable separable mental illness categories. We have no evidence that any supposed mental illness diagnosis represents a discrete brain disease. So, let’s stop assuming that conclusion! Just because ignorant government bureaucrats assume believe in mental illness categories is not a good reason to pander to them. So why keep using this illusory term?

    There are alternatives. How about, “Nutrients help people with life problems feel and function better?”

    Would you tell someone looking for help, “These nutrients will help treat your mental illness” or “These nutrients can help you feel and function better?”

    Which of these is more accurate optimistic? Authors, feel free to answer.

    • “There are no valid, reliable separable mental illness categories… So why keep using this illusory term?”

      Excellent observation. Why is it that in the realm of ‘alternative’ treatments it’s always suddenly OK to use the medical language of illness and disease again?

      I’ve looked at this legislation and find nothing whatsoever to object to. The aim is to ensure that consumers get what is on the label and to protect them against shonky claims. To that end there is a regime of registration/licensing fees and a requirement that all therapeutic claims be substantiated. I fully support this.

      • It was meant to be a rhetorical question. But if it’s asked seriously, it’s probably not hard to identify one of the answers why the authors continue to use the term mental illness. A reason is likely that they work for an academic or state institution where there is pressure to work under the establishment framework of considering behavioral and psychological problems “mental illnesses”. The authors probably have been taught to write in this way, and may unconsciously feel that to have their writing accepted for publication by their peers and by journals, they have to use the term mental illness as if it actually meant something valid or reliable. This is far from unique to these particular authors but is a pressure that industry and the public’s reluctance to face the real causes of psychological-behavioral problems pushes onto them.

        It is ironic that in an article on alternative approaches, the language of mental illness is being used; I didn’t notice that before.

        • Thanks for your comments BPD transformation. It is indeed ironic, and we are aware of the issues you raise. We are stuck between a rock and a hard place as in order to get this line of research accepted and become a part of mainstream medicine, or even have it funded, and not viewed as quackery, then it can be necessary to use a common language to a certain extent. One battle at a time.

      • Thanks for the comment, the problem isn’t with the Bill per Se (although defining an NHP as something that doesn’t contain a medicine is in my view problematic as discussed in the article). I agree, it is important that there is evidence to back claims. The problem is with the permitted ingredient list where the government has taken a one ingredient approach to regulating products, specifying upper doses that may be reasonable if consumed alone, but are not reasonable when consumed in combination with other ingredients.

  2. Thanks for the post. I am a parent who uses teas, vitamins, herbs, elements, spices, essential oils, Manuka honey, amino acids, tinctures, etcetera, and indeed whole foods in the way that other parents use pharmaceuticals. Not just for my ‘difficult’ child’s mental/emotional health but for a broad range of health issues. (I use conventional medicine where necessary; but it is very rarely necessary.) I’ve been adversely affected by Health Canada rules, and I recognize that Big Pharma, in collusion with governments, wants us all on its chemical cocktails. I’ll try and write an email with a cc.

    Liz Sydney
    ourviolentchild.wordpress.com

  3. Hi Julia and Bonnie,
    Being from NZ myself I find this very disturbing and I want you both to know you will have my full support.
    I’m also annoyed (but not surprised) that this hasn’t come to my attention before now. I would like to talk to you more about how we can campaign around this issue and will email you directly Julia. I have shared your blog on my networks and as Health Action where I work also has health promotion contracts as well as peer support (which I work in) I hope to get a submission in from our organisation.
    Using supplements has allowed me to be mostly medication free and your research has helped me make decisions around stopping all prophylactic medications. Unfortunately the cost of micro nutrients has stopped me trailing these which is a problem in it’s self, but to have further restrictions to access what we need is diabolical. interesting how they sold the introduction to this bill around supplements not having in them what they say they have in them. I am so over Big Pharma’s influence.

  4. “Are there drug companies that will benefit financially when many nutrients are by prescription?”

    Considering that New Zealand, together with the U.S., bears the dubious distinction of being 1 of only 2 countries that allow direct consumer advertising by Big Pharma, it would seem that the industry has a great deal of power and influence in N.Z. So, one need not to be a conspiracy theorist to suspect Big Pharma of playing some role in this nefarious development.

    Thank you, Bonnie and Julia, for your research on how nutrition (diet, nutrient supplementation and probiotics) affect mental health and help alleviate psychiatric symptoms/mental illness. I will definitely contact the Government of NZ and voice my strong opposition to the proposed scheme.

  5. It IS logical to limit the amount of selenium in products because that mineral can be toxic in high doses. Here is a case of an Australian man who died from selenium poisoning:
    https://www.mja.com.au/journal/2006/185/7/accidental-death-acute-selenium-poisoning

    Many other supplements can make people ill and there has been no repeatable scientific study that shows benefit for any supplement. In fact it is looking like supplements may be doing more harm than good. High dose vitamin E may even shorten lifespans.
    http://www.webmd.com/food-recipes/20041110/high-dose-vitamin-e-may-shorten-life-span

    The supplement industry is guilty of selling people snake oil. Recently it was discovered that GNC, Walmart, Waldgreens and Target were selling adulterated herbs and it not contain the herbs they claimed to have. A 2012 paper published in the Journal of the American Medical Association warned that lack of regulation of the supplement industry could lead to “adverse events.” In the past five years, tainted supplements have been associated with kidney failure, hepatitis and other problems. http://archinte.jamanetwork.com/article.aspx?articleid=1213825

    • Thank you radames for bringing to attention the problems of megadoses as well as taking an ingredient on its own, which we identified as practices we don’t typically endorse. The man who overdoses on selenium, took 10g on its own. That would be a level that is above the upper limit for that ingredient. Indeed it is 100 times the current stipulated level. We are asking the NZ government to allow ingredients to be purchased at levels that are higher than currently listed, but of course not in toxic levels! We have issues with the doses listed, as they do not reflect the science and our knowledge of how nutrients work together. Most things are toxic if consumed at a high enough level.

      Regarding your comment about “no repeatable scientific study that shows benefit of any supplement”, we respectfully ask that you read our blogs where we have documented the evidence to date and have pointed out the published scientific literature supporting broad spectrum micronutrients as efficacious in the treatment of health issues. We have also addressed the studies that suggest that taking supplements shorten our lifespan. I encourage you to read them!

      We certainly agree that supplements should contain what they say they contain, that is not the issue we have raised regarding the legislation.

  6. Broad spectrum micronutrients from FOOD are beneficial. There are so many different micronutrients in foods like broccoli that we cannot know which ones are causing the benefit. So it’s best to eat a diet with lots of fruit and vegetables and skip the pills.

  7. As usual smart people who do their research and know how to use these nutrients will loose freedoms to protect dumb people from being ripped off by the supplement industry. Its all about safety !!

    Isn’t great having a governments watch over us like we are little children ?

    Way to go nanny state ! Protect us all from our stupid selves because being treated like an adult capable of making life decisions is over rated anyway.