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Proposed Changes to the Regulation of Dietary Supplements

4 Background

The Regulations have been under review for some time. In 2004 NZFSA released a discussion paper³ to canvas views on proposed changes to the Regulations. The discussion paper was in two parts. The first part canvassed the future of the Regulations generally and proposed a separation of the regulation of products currently within the scope of the Regulations:

• food-type dietary supplements would remain under the Food Act 1981, regulated by a form of the Regulations pending provisions being made in the Code, and

• therapeutic-type dietary supplements (to be known as complementary medicines under new therapeutic products legislation) would move to coverage under the proposed joint regulatory scheme⁴.

The second part of the discussion paper proposed specific technical amendments be made to the Regulations as a transitional measure pending further change.

NZFSA received 33 submissions on this paper but the review was deferred pending the establishment of ANZTPA and the regulatory scheme. It was generally accepted that the Regulations were outdated and in need of reform. Submissions were supportive of the following proposed changes:

• food-type dietary supplements should be regulated as food under the Code

• permissions for artificial sweeteners should be the same as those available under the Code

• the specified maximum daily dose for vitamin B12 should be removed

• mandatory allergen labelling and labelling in English should be required.

The Government has decided that therapeutic-type dietary supplements will in future be regulated as therapeutic products. It was intended that they would be regulated as complementary medicines under the proposed joint regulatory scheme for therapeutic products to be administered by ANZTPA. Since the discussion paper was released in 2004, the establishment of ANZTPA, the commencement of the joint regulatory scheme for therapeutic products then planned for July 2005, has been delayed a further two years.

³ 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

⁴ For details of the proposed joint regulatory scheme and the consultation programme currently in progress see www.anztpa.org