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 This single ingredient approach the NZ government is following is outdated; we have discussed this single bullet fallacy at great length in previous blogs and why it is the wrong way to think about NHPs.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 julia.ruckl[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:
- http://www.ncbi.nlm.nih.gov/pubmed/?term=rucklidge+JJ
