Greens against proposed regulation of Dietary Supplements

It is difficult to fathom why the Government is so determined to regulate dietary supplements as medicines instead of allowing them to continue to be regulated as foods. Regulating them as medicines could well place excessive restrictions on them which may result in many dietary supplements becoming unavailable or restricted, costing more, and falling under the control of trans-national pharmaceutical companies.

The government's fixation with dietary supplements is inexplicable, given that supplements such as herbs, vitamins, minerals and nutrients are a valuable tool in maintaining health and wellness, and in counteracting the fact that many processed foods are severely deficient in essential nutrients. Furthermore, even the Government acknowledges that dietary supplements pose very little risk to the public.

A far more urgent priority for the Government to focus on, in my view, would be the inappropriate prescribing of pharmaceutical drugs, and the adverse side effects of drugs and their interactions which is a serious cause of illness and even death.

The Green Party agrees that consumers need to be reassured that all dietary supplements sold in New Zealand are safe and effective. However there's no need to effectively shift control of dietary supplements to Australia to achieve this. All we need to do is update New Zealand legislation along the lines of a bill which was drawn up four years ago, which would regulate dietary supplements in New Zealand without any of the negative effects of 'harmonisation'.

What is more astonishing is that the Australian states are not even fully harmonised with each other. So the proposal is to harmonise with a system which is not even harmonised itself!

Australia has been seen internationally as being out of step in its regulation of dietary supplements ever since it introduced its Therapeutic Goods Administration (TGA) in 1989. According to the International Committee of the American National Nutritional Foods Association, Australia is viewed as having the most draconian regulatory regime for dietary supplements in the world. Why would we want to join forces with such an over-regulated regime?

The joint Trans-Tasman agency proposed under the government's plan would be called the Australian Therapeutic Goods Administration. It would have complete control over the importation, manufacture and supply of all dietary supplements. It would also issue marketing approvals; set out the requirements for advertising and making claims; deal with labelling, packaging, distribution, and storage requirements; provide product approval and product licensing; and administer sanctions for any breach of regulatory requirements.

The Australian system is very different from New Zealand's current system and that of most other western countries. Instead of having a negative list of substances which have known adverse effects and therefore cannot be used, the new system would involve a positive list of ingredients that are allowed to be used in dietary supplements.

Any natural substance on the list would have to be approved by the new agency. If the current Australian system is adopted here it could cost as much as $10,000 for every new substance to be added to the list. Any dietary supplements or products, whether imported into New Zealand or manufactured here, would also have to be licensed.

The new product approval and licensing provisions will require a complicated and expensive bureaucracy to administer – that is entirely unnecessary due to the low risk that dietary supplements pose.

Small to medium sized New Zealand businesses which manufacture and/or import dietary supplements will also be hit hard, and many expect to be forced out of business by the excessive costs of registering and licensing of substances and products under the new system. If the Australian system is adopted there will also be an annual charge of $15,000 to inspect the premises of every business where products are manufactured. The importer would have to pay these charges, making it extremely expensive importers who bring in products from several different manufacturers.

Representatives of Medsafe (the Ministry of Health department heading the project) say there is industry support for the move to harmonise. While a few large and mainly Australian businesses favour the new system because of the monopoly that will inevitably be created as smaller businesses are forced out of the market, most small to medium businesses who manufacture or supply dietary supplements tell us they are strongly opposed.

Consumers too will be adversely effected by the proposed new legislation. They will very likely face a marked reduction in their choice and access to many dietary supplements. It is currently estimated that more than 200 substances used in dietary supplements in New Zealand are not allowed in Australia. Furthermore, many products imported from overseas may be disallowed under the new system. Supplements from countries like the US and Canada, for example, may be hard to get hold of despite the fact that those countries have internationally respected regulatory systems which ensure the safety and quality of their therapeutic products.

It's not just New Zealand consumers and business owners that will suffer. There are also cultural implications which have not been properly addressed. Medsafe say that they have adequately dealt with the Treaty of Waitangi by allowing Maori to pick and use medicinal herbs for their personal use. They have clearly not, however, considered the obvious financial barriers that the new system will impose which will prevent Maori from commercialising their herbs.

There is also a large Asian population in New Zealand, many of whom rely on Chinese herbal remedies imported from Asia. Many of these remedies may become illegal in this country if anything like the current Australian system is adopted.

Unfortunately, the bad news doesn't stop there. The proposed new Trans-Tasman joint agency will effectively remove our sovereignty in this area. Like ANZFA, it will be essentially an Australian agency, set up under Australian law, located in Australia, no doubt staffed predominantly by Australians and dominated by Australia. There is to be three Australians on the governing board of the agency, and two 'others', who may or may not be New Zealanders. So Australians will effectively decide how our dietary supplements are regulated.

The moves to introduce greater controls over dietary supplements are part of an international plan to 'harmonise' all dietary supplements which is being driven by Codex, an international agency set up under the United Nations through the Food and Agriculture Organisation and the World Health Organisation. Codex is heavily weighted by pharmaceutical representatives and is widely believed to be behind moves to limit access to natural health information, and to high potency vitamins and other natural substances without a prescription.

Pharmaceutical companies have already taken over most of the natural health industry in Norway and Germany, where Codex standards have been most closely adopted. What is most concerning about the proposed joint system between New Zealand and Australia is that restrictive upper limits may be set on vitamins, minerals, and other natural substances, effectively putting higher dose supplements under the prescription only category – a similar process and outcome to what happens under the Codex standards.

The Government could achieve all its objectives by introducing more appropriate and updated New Zealand legislation. This legislation could include accepting the already high standards required for US and Canadian manufacturers, using a 'negative' list instead of the positive one which creates an enormous amount of cost and bureaucracy, implementing a high standard of Good Manufacturing Practice for New Zealand manufacturers, continuing to allow non-country specific labelling, and introducing appropriate regulations which ensure the protection of consumers (US legislation could serve as a good model). Of course whatever system is developed to ensure the safety and quality of our dietary supplements should be equally applied to all foods, so that consumers can be assured that their food is safe also.

The papers published by Medsafe about the harmonisation leave many unanswered questions. What upper limits will be set for vitamins, minerals and other natural substances? What and how many products will be taken off the market? What and how many products will be transferred into the prescription only category? What claims will be disallowed? None of these questions have been answered yet. It appears that the Ministry of Health wants to pass this legislation and work out these details afterwards – when it will be too late to stop it.

In April the Government will be releasing a discussion document about its plans and there will be a six week consultation period. It is crucial that we stop the present proposal at that stage because otherwise it may be too late to stop the juggernaut. The Government's intention after consulting with the public is to sign a joint treaty with Australia to set up the new system.

Only after the treaty has been signed would the Government introduce retrospective legislation implementing the system in New Zealand law. At that stage the public would be able make submissions at Select Committee stage – but it would be too late to significantly change things because the treaty will have already been signed.