Alert: Proposed Changes
To Dietary Supplement Regulations

A matter of concern for doctors and patients

On the 17^th December 2001 Medsafe, acting for the Ministry of Health, tabled a draft consultation paper on "Establishment, Governance and A Proposed Regulatory Framework for a Trans-Tasman Therapeutic Goods Agency" The proposal covers Medicines, Medical Devices and Dietary Supplements.

The regulation of medicines and medical devices, although being of concern to some medical practitioners are not the topics of this alert.

The prime concern of medical practitioners who may be formally qualified in and practise nutritional medicine, or who may encourage patients to use appropriate dietary supplement approaches, is that under the proposal, based on the Australian Therapeutic Goods Act, a significant number of products will become unavailable or more expensive to New Zealand patients.

The proposal will remove a patient’s access to many dietary supplements that may be important in helping improve or maintain wellness. History clearly shows that the TGA has established an absurdly restrictive regulatory environment in Australia.

Based on known history
the TGA-Medsafe based proposal will mean

• Many existing manufacturers and suppliers of dietary supplements will disappear along with their products from the health marketplace. ( In excess of 300 Australian manufacturers were unable to continue business in Australia when the TGA imposed regulatory control).
• Medical Practitioners will be unable to recommend or prescribe many products
• Many innovative dietary supplements will become unavailable to chronic disease sufferers.
• Trade barriers between New Zealand and other countries health products will limit choice
• Patients will have restricted access to health information on product labels that any citizen has a "right to know".
• Future submissions will show how this proposed move by Medsafe is flawed in most of its important aspects and that Medsafe are unable to adequately defend the Australianisation of our regulatory environment

In Conclusion