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Proposed Changes to the Regulation of Dietary Supplements

1 Introduction

In New Zealand, food-type and therapeutic-type dietary supplements are regulated by the Dietary Supplements Regulations 1985, (the Regulations) set under the Food Act 1981 (the Act). The Regulations provide a definition of dietary supplements; prescribe some maximum daily doses; permit the addition of specified food additives; specify some labelling requirements; and prohibit therapeutic claims unless permitted under the Medicines Act (1981)¹.

When the Regulations were drafted the products intended to be covered were not foods in use, appearance or presentation but nor were they medicines in the generally accepted sense. The range of products has expanded significantly in the last 20 years, and there are now many dietary supplements in tablet, capsule or powder form that are being used to achieve a therapeutic benefit. In this paper, these products are referred to as therapeutic-type dietary supplements or complementary medicines.

The range of products being sold as dietary supplements has also extended to include foods such as drinks and health bars with vitamins, minerals and other substances providing “health” benefits being added. These products are referred to in this paper as food-type dietary supplements or complementary foods.

In 2003, New Zealand and Australia signed the Agreement between the Government of Australia and the Government of New Zealand for the Establishment of a Joint Scheme for the Regulation of Therapeutic Products. New Zealand and Australia will both require new legislation to implement the scheme and to establish a new joint agency to regulate medicines (including complementary medicines), medical devices and blood and blood components for both countries.

The New Zealand Food Safety Authority (NZFSA) released a discussion document in 2004, proposing changes to the Regulations². There was general support for the proposed changes but these were delayed pending the establishment of the Australia New Zealand Therapeutic Products Authority (ANZTPA). These proposed changes are included in this proposal. The paper also foreshadows the prospect that complementary foods will eventually be regulated under the Australia New Zealand Food Standards Code (the Code).

¹ See Appendix 1, The New Zealand Dietary Supplements Regulations (1985)

² Proposed Changes to the Dietary Supplements Regulations 1985: Discussion Paper. Found at: http://www.nzfsa.govt.nz/policy-law/consultation/archive/01-04/index.htm