Please find following a brief summary and extended discussion on the consequences of the pending natural health bill currently in parliament.
Summary
Third reading planned for Natural Health and Supplementary Products Bill banning most Natural Health Product (NHP) ingredients without just cause.
Many Natural Health Products will disappear if they contain even one ingredient that is not on their ‘Permitted list’. Many suppliers will also disappear as a result.
Therapeutic NHP ingredients can be reclassified as medicines and then banned for use in NHP’s, even when there are no safety issues. OR
Any NHP ingredient that has a therapeutic benefit can be re-classified as a medicine. Once it is classed as a medicine, it will be black-listed for use in Natural Health
Products.
All claims must be selected from a pre – approved list which is based on pharmaceutical principals, rendering them inappropriate for NHP’s.
No accountability for harm or death as a result of consumers losing their healthcare products. I still prefer this version
The Bill does not recognise that denying access to banned products could result in harm or death. There are no provisions in the Bill to make allowances for this if it does happen.
You can provide feedback to the Government on the bill, sign a petition on www.Change.org and sign up for updates on this important matter.
Discussion
The passing of the Natural Health and Supplementary Products Bill would result in many Natural Health Products (NHPs) becoming either severely restricted (via low dosage limits), or being made outright illegal in NZ.
This includes products containing nutrients which are essential to human health. In some cases this will directly lead to harm, as consumers will no longer be able to purchase products used to keep themselves well.
Many Naturopaths, Herbalists, Homeopaths, etc. will be unable to properly practice as they will no longer be able to prescribe to their patients needs.
The proposed financing model of the new system presents significant risk to the majority of NZ small business supplement manufactures, an outcome likely to result in only a small handful of large manufacturers remaining viable. This will result in significant loss of variety of product in the natural supplements market in NZ.
The Bill would allow Medsafe (the business unit of the Ministry of Health) to increase its control over NHPs by the following means:
It will reverse the basic historic principle confirming our rights to consume any natural health ingredient that is absent from a short defined ‘Black-list’ of substances which have rightly been proven dangerous.
The number of ingredients we can currently access is too high to quantify, yet no deaths have been attributed to these ingredients or products (see “No Deaths from Supplements. No Deaths from Minerals. No Deaths from Amino Acids. No Deaths from Herbs” http://orthomolecular.org/resources/omns/v12n02.shtml)
Our present system will be replaced by a ‘White-list’ of permitted ingredients and only ingredients on this list will be sold in NZ. Furthermore, many ingredients have severe dosage and application restrictions placed upon them. There is no scientific reasoning or justification for such limitations, and no history of risk to human health.
This proposed White-list currently comprises 5,545 ingredients. This may sound extensive, but to indicate what this means in terms of lost ingredients we need only look to a small subset of naturally occurring ingredients called ‘Polyphenols’*, of which there are over 8,000 identified at this time. Add to that the numerous subsets of vitamins, minerals, herbs, amino acids, enzymes, etc. it becomes apparent the number of ingredients we stand to lose greatly dwarfs the number available to remain.
See below for instructions on interpreting the attached proposed ‘White-list of Permitted Ingredients’.
* Polyphenols are abundant micronutrients in our diet, and evidence for their role in the prevention of degenerative diseases such as cancer and cardiovascular diseases is emerging.
<This Bill will class any ingredient that has a therapeutic benefit as a medicine> OR This Bill enables the MOH to class any ingredient that has a therapeutic benefit as a medicine. If they consider an ingredient to be therapeutic they can do this, regardless of whether the manufacturer makes claims or not. If it is classed as a medicine, it will be black-listed and made illegal to use as a natural health ingredient. This will have a destructive effect on the NHPs market, as any product of significant benefit to human health can be banned.
The Bill will control all claims made by manufacturers on NHPs by means of a pre–approved list of claims, structured on a per ingredient basis. The authors of this legislation are again demonstrating their lack of understanding of how NHPs work. Their pharmaceutical mind-set can only deal with a one-active-ingredient/one-result approach. NHPs can contain hundreds of compounds that work in concert.
The Bill does not recognise that denying access to products can result in harm or death to patients who rely on these products, as has happened in Canada and other countries around the world. There are no provisions in the Bill to make allowances if this occurs.
The regulatory system will be funded by industry on a Full Cost Recovery Basis. This means that costs for industry will rise as products disappear due to the ‘White-list’ restrictions. Short run products will not justify registration into the system, thus will be discontinued, which will force products off the market, and smaller operators to close. Every time a manufacturer reduces its product range or closes its doors, the remaining products and manufacturers will have to shoulder more of the financial burden of funding the agency. The biggest players will benefit from this approach, as they can afford the fees - and this approach will increase their market share. This is one reason why large manufacturers support this bill.
The ‘single ingredient approach’, which is the framework of the Bill, is outdated and misleading for two reasons:
1. It does not reflect the fact that when ingredients are consumed together, higher doses can be safely tolerated above the consumption of a single ingredient.
2. If any one ingredient in a product exceeds a specified dose, then the entire product will be outlawed in NZ. Most supplements have multiple ingredients, affecting a huge number of supplements that New Zealanders are already relying on for their health and well-being.
What Can You Do?
This Bill will soon have its third and final reading to become law, and is expected to take effect around June 2016. The Regulations are expected to come into force shortly afterwards.
The Government is asking for public feedback on the Bill: http://www.health.govt.nz/publication/regulation-natural-health-products-consultation
1. Submissions on the Consultation Document close at 5pm on Friday 5 Feb 2016
2. Submissions on the draft List of Conditions about which a claim can be made & the draft Permitted List will open on 6 Feb 2016 and close on 31 May 2016.
Sign the petition started by Professor Julia Rucklidge on http://www.Change.org. Simply add your first name, last name, email, city (and reason if you like) to the text box on the right of the page, then click Sign. Please also share this petition. https://www.change.org/p/naturalhealthproducts-moh-govt-nz-keep-access-to-nutrients-in-nz-that-have-a-proven-safety-record-and-therapeutic-benefit
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Permitted Ingredients 'White-list' File
We have attached the proposed ‘White-list’ of permitted ingredients. It is important for you to see if any ingredients that you presently use in your supplements are not on the list. Note that this list also includes in red those ingredients which they propose to ban.
To view the Permitted Ingredients White-list
If you don't have Microsoft Excel, you can download a viewer at this link (for Microsoft PCs). Save the file (total 75mb) then double click to run it, and accept the installation defaults. Once installed, you can open the viewer and view the Excel file.
https://www.microsoft.com/en-nz/download/details.aspx?id=10
To Search the Permitted Ingredients White-list
Either from Microsoft Excel, or the viewer installed above, you can search the file by pressing CTRL-F and entering the ingredient name. Also check max permitted daily dose, and internal / external application. You can select various options and click Find Next to jump to the next text entry.
What the Columns mean
Click on the Explanatory Notes tab at the bottom. They state that if it’s written in red the ingredient has been determined to be unacceptable. Lines 79 -81 explain what Y, N & U mean in the Outcome Column. If you go back to the listing there is a ‘Reason’ column, which states ‘rejected by IJEACCM on safety grounds’. IJEACCM stands for The Interim Joint Expert Advisory Committee on Complementary Medicines, a NZ/Australian initiative