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

7 Options analysis

7.1 Option (a): amend the Medicines Act 1981

This option meets the objectives described in section 5. It also provides for the implementation of any applicable future health claims standards developed in the Code.

The principal issue with this option is that it would involve the amendment of a primary piece of legislation and would thus require passage through the New Zealand Parliament. This process is likely to take a considerable amount of time. It would be unlikely that an amendment would be in place by 13 August 2007 when the current exemption for the folate health claim expires.

7.2 Option (b): replace the current Medicines (Related Products (Exempted Food)) Regulations

Section 105 of the Medicines Act allows for the promulgation of regulations under the Act. A regulation can be drafted under this section and section 94(1)(b) of the Act exempting food products carrying health claims approved under the Health Claims Standard in the Code. This is the same kind of mechanism currently used to exempt the folate health claim from the provisions of the Act that prohibit therapeutic claims. Thus regulations can be made to exempt certain substances or articles from classification as Related Product. This, for example, may classify foods carrying “health claims that comply with the Code” as exempt from the provisions of the Act.

This option meets all of the objectives described in section 5 above and provides an effective regulatory solution to the implementation of Standard 1.2.7. It will require the approval of the Minister for Food Safety, the Minister of Health and Cabinet and can be gazetted before the expiry of the existing exemption on 13 August 2007.

7.3 Option (c): rely on the new Therapeutic Products and Medicines Bill

The new Therapeutic Products and Medicines Bill currently before Parliament does not include the category of Related Products and thus would not conflict with the health claims standards in the Code.

Although relying on the Bill to obviate the need for an exemption has the potential to be an effective solution and meet the objectives described in section 5, this would create a very tight timeframe between the current timeline for implementation of the Therapeutics Products and Medicines Bill and the expiry of the current exemption mechanism for the folate health claim. Such a tight timeframe would not allow for any unplanned delay of the implementation of the Therapeutics Products and Medicines Bill.