Dear Dr Z,

Thank you for your recent letter to the Hon Annette King, Minister of Health, about proposals to introduce new controls on dietary supplements.

Unfortunately, some misinformation is circulating about the proposals and this is causing unnecessary concern. I would like to start by assuring you that there is no intention to place dietary supplements and natural medicines under the Medicines Act in June 2002. Reports that this is the case reflect a misunderstanding of the process that is under way, there is no intention to adopt the current Australian Therapeutic Goods Act in New Zealand.

The New Zealand and Australian Governments have agreed to investigate establishing a trans-Tasman agency to regulate medicines, medical devices and healthcare products for Australia and New Zealand. If the joint agency proceeds, new legislation will be required in both countries. This legislation would replace the Medicines Act in New Zealand and the Therapeutic Goods Act in Australia. It would not come into effect until 2004 at the earliest.

Work is in progress to identify an appropriate regulatory framework for complementary healthcare products that represents best regulatory practice and will adequately protect consumer health and safety. Details of how a joint agency might regulate these products is still being developed. A discussion paper is planned for release around

April this year to enable all interested parties to view the proposals and comment on them. I encourage you to take the opportunity to convey your views once you have seen the details of the proposal.

In New Zealand, dietary supplements are currently regulated as foods. Because it is not lawful for foods to carry therapeutic claims, manufacturers and distributors of dietary supplements are not permitted to provide consumers with the information they need in order to make informed choices.

In addition, the standards these products must meet are limited. This means that the Government and consumers have no guarantee that the ingredients of the products and the products themselves are safe and effective - adequate steps have been taken to ensure product quality for instance, that products contain only the stated ingredients in the quantities specified on the label, and that they are free from contamination with micro-organisms, heavy metals and so on.

Many New Zealanders choose to use dietary supplements and complementary medicines, and I fully support their right to do so. However, I believe that when purchasing products consumers have a right to expect those products to be safe and of high quality. I also believe that consumers have a right to receive adequate, truthful information to enable them to choose wisely and use products safely. Many of the dietary supplements on the market are safe and of good quality. However, even for these products it is currently not lawful for manufacturers and distributors to provide consumers with information about the therapeutic benefits of using the product.

It is intended that, under new legislation, all products used for a therapeutic purpose would be regulated according to the risk associated with their use. The regulatory controls applied to dietary supplements would be significantly less stringent than those applied to prescription medicines, in recognition of the different levels of risk. Manufacturers would need to have a quality system in their factory, and there would be a screening process for new ingredients to ensure they are safe for short and long-term use. It is proposed that an expert committee with members who are knowledgeable about herbal and complementary health products will provide advice on the safety of ingredients.

Companies will be able to make truthful claims about the health benefits of their products on labels and in advertisements. Dietary supplements and other complementary healthcare products would continue to be available from herbalists, supermarkets, health food stores and other retail outlets.

I can assure you that the proposal to regulate all products used for a therapeutic purpose under new legislation is being developed in the interests of the New Zealand public and is not being influenced by multinational pharmaceutical companies.

Thank you for sharing your concerns on this issue with the Minister.

Yours sincerely

Robin Boldarin