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Health, Nutrition and Related Claims: Enabling Provisions in New Zealand Law

4 The problem

In order for products carrying the folate health claim to remain on the market in New Zealand after 13 August 2007, it is necessary that the exemption from their classification as Related Products enabled by the Medicines (Related Products (Exempted Foods)) Regulations 2003 be extended. Transitional Standard 1.1A.2 does not have a specific expiry date but will expire two years after the introduction of the Health Claims Standard. It is expected that the Health Claims Standard will be gazetted in November or December 2007.

In order for New Zealand to meet its obligations under the Food Treaty with Australia and our statutory requirements under section 11B(b) of the Food Act 1981, the Transitional Standard 1.1A.2 and the Health Claims Standard need to be given legal effect in New Zealand Law.

While New Zealand may “opt-out” or vary from a standard (covered by Annex C of the Food Treaty), this action is constrained to situations where exceptional health, safety, third country, environmental or cultural factors exist. The Food Treaty also stipulates that any New Zealand variation shall not create a barrier to trade unless exceptional health, safety and environmental concerns exist. In the cases of the folate health claim and the Health Claims Standard, “opting out” or variance from these standards is not an option as exceptional circumstances do not exist.

The Medicines Act 1981 prohibits the application of therapeutic claims to any Related Product including foods. The high level claims and some general-level claims in the proposal for the Health Claims Standard are considered therapeutic claims under the Medicines Act. It is therefore necessary to take legislative steps to exempt foods that carry such health claims approved under the Code from prohibition.

There is currently a Bill before Parliament proposing the repeal of the Medicines Act 1981 with provisions to enable the establishment of a trans-Tasman agency to regulate therapeutic products under a joint regulatory scheme. The Therapeutic Products and Medicines Bill, in its draft form, does not require an exemption for health claims of the form proposed for the Health Claims Standard because the category of Related Product does not exist in the Bill. It is unlikely however, that the new regulatory scheme will be in place before the current exemption mechanism expires on 13 August 2007.