Ensure access to nutrients in NZ that have a proven safety record and therapeutic benefit

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Ensure access to nutrients in NZ that have a proven safety record and therapeutic benefit

This petition had 6,820 supporters
Julia Rucklidge started this petition to Ministers of Parliament (NZ Government) and

Something very concerning is developing in New Zealand. It is not unique to NZ – it has already happened in Australia and Canada, has been happening in Europe, and it will likely happen in the U.S. 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 nutrients like minerals and vitamins. Please see http://www.health.govt.nz/publication/regulation-natural-health-products-consultation for more information on the Bill.

While safety and efficacy are important, this Bill will essentially ban for sale many NHPs that New Zealanders rely on for their health, including ones that have been shown to have therapeutic benefit, like the products that have been researched for the last decade by Professor Julia Rucklidge at the University of Canterbury. This research has demonstrated the effectiveness of micronutrients for the treatment of a variety of psychological/psychiatric symptoms ranging from ADHD to stress to PTSD to mood disorders. The research has also documented a superb safety record of the micronutrients. These products are currently under threat.

Why would these nutrients be essentially banned when the Ministry of Health currently states that no banning is intended? Because the Ministry has developed a "Permitted Ingredient List", a list of the 5545 ingredients that are currently allowed in an NHP but all with specified doses. If a product contains an ingredient above the specified dose, it is required to be registered as a Medicine or cannot be sold. However, as acknowledged in the Regulatory Impact Statements “obtaining an approval for a natural health product under the Medicines Act is not seen as a viable option as, unlike medicines, producers cannot generally patent natural products and recoup the costs associated with product approval through a period of exclusive marketing”. By forcing registration through the Medicines Act, these products will be effectively banned as the Medicines Act is designed to deal with drugs with one ingredient, not complex products with many non-patenable ingredients. What company would invest in registration of a product where they would gain no commercial advantage for doing so?

Another problem with the legislation is that it does not cover research. What type of research will be permitted as evidence that a therapeutic claim can be made? And will research that is conducted for therapeutic benefit be reviewed by the Standing Committee for Therapeutic Trials (SCOTT/medsafe)? Evidence to date indicates this is exactly what medsafe would require. But SCOTT is very costly and only appropriate for large pharmaceutical companies and their single ingredient drugs. Small trials, pilot trials, student theses would be unable to be conducted as the application fee ($6,500) alone would overwhelm the budgets of researchers who plan to carry out investigations independent of the companies that manufacture the products. Opportunities for generation of new knowledge would be lost. One would think that the Ministry would welcome any research into NHPs; however, the process in place suggests otherwise.

Unfortunately, the NZ Ministry of Health has also taken a ‘single ingredient approach’ to the development of the "Permitted Ingredient List" (PIL), a list of the 5545 ingredients that are currently allowed in an NHP but all with specified doses. As such, it is extremely limiting and not reflective of how nutrients are consumed to be of greatest benefit to health. The ‘single ingredient approach’ that is behind the development of 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.

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. Some nutrients are not even on the PIL. 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 not be on the list?

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 could not be sold as an NHP as the Medicines Act trumps the Natural Health and Supplement Products Bill. Yet based on research, many people would 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?

Another example is selenium. If a product has a daily dose greater than 150mcg of selenium, it cannot be included in an NHP. Eating 5 brazil nuts would exceed this daily dose. Is that logical? For a country that is selenium deficient, why limit the amount of selenium in NHPs such that it does not even address this deficiency? The UK, which also has selenium deficiency, allows at least 200mcg. Potassium is limited at 100mg. You would get that amount out of eating a quarter of a banana. And the list goes on.

There is some evidence that the result could be tragic: over 10 years ago when Health Canada shut down clinical research in this area and, more importantly, closed the border so that Canadians could not buy a 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.

The legislation and the Permitted Ingredient List needs to be reviewed in light of this research and unforeseen outcomes. This Bill will directly lead to harm given that consumers will no longer be able to purchase nutrients to keep themselves well. This Bill is not proportional with the low level of risk associated with NHPs. The government has not produced any evidence that these products have been harmful. The only truly necessarily regulation that is required is ensuring that supplements have exactly what they say they have in them.

To learn more about the research on micronutrients, please watch a TEDx talk delivered on November 1st 2014 in Christchurch (only 18 minutes): https://www.youtube.com/watch?v=3dqXHHCc5lA

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