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Proposed Changes to the Regulation of Dietary Supplements

5 The Problem

Both the food and medicine regulatory systems in Australia and New Zealand are aligning but the regulation of food-type dietary supplements in New Zealand remains anomalous in this process. Reformation of dietary supplements regulation would facilitate better trans-Tasman alignment and clarify the relationship between the regulation of food-type dietary supplements and requirements in the Code.

The Regulations were originally intended to cover dietary supplements such as vitamins, minerals, herbs and synthetic nutrients in pharmaceutical dosage form (eg, tablets and capsules) used to supplement the diet. Over the past 21 years the types of products being sold under the Regulations has extended well beyond the intended coverage. Products controlled under the Regulations now include highly fortified foods (presented in a food rather than a pharmaceutical form) as well as tablets and capsules containing substances that have an apparent therapeutic purpose. The Regulations do not provide adequate control for either of these product groups and therapeutic-type dietary supplements are no longer appropriately regulated as foods under the Food Act.

The Food Act relates to the sale of food and it is administered by NZFSA, which has responsibility for all food-related legislation. The core business of NZFSA is promoting and achieving food safety and food export market access. When the Regulations were promulgated in 1985, they were administered by the Ministry of Health.

Unlike foods regulated under the Code, food-type dietary supplements are entering the food supply with little or no safety assessment (including no impact analysis on dietary exposure). This can lead to problems such as the lack of warning labels or appropriate advice on the safe use of products where there may be reasons against certain population groups using products (those on some medications, for example).

Additionally, some substances that have intoxicating effects⁵ may be sold as dietary supplements with little or no safety assessment. For example, in April 2005 an attempt was made to market a drink containing Benzylpiperazine (BZP), claiming that it was a dietary supplement. NZFSA was able to reject this claim under the Food Act because BZP is not a naturally derived food ingredient. However, other substances with intoxicating effects (that may be equally or more harmful⁶) may still be freely sold as dietary supplements to the general population without restriction if they are naturally derived from foods. Society has a general expectation that risks associated with the use of intoxicating substances require regulation, for example the control of alcohol under the Sale of Liquor Act and the standards under the Code relating to alcoholic drinks.

⁵ Intoxicating substance has the Concise Oxford Dictionary 10th Edition meaning of intoxicate: 1 (of an alcoholic drink or a drug) cause (someone) to lose control of their faculties. 2 poison. 3 excite or exhilarate.; and substance: an intoxicating or narcotic drug.

⁶ See: Gee, P. et al., (2005) Toxic effects of BZP-based herbal party pills in humans: a prospective study in Christchurch, New Zealand. The New Zealand Medical Journal 118 (1227). The study implicated BZP as a cause of a variety of adverse effects, including life threatening seizures in neurologically normal subjects. Patients experienced symptoms such as insomnia, anxiety, nausea, vomiting, palpitations, dystonia (a neurological movement disorder involving involuntary, sustained muscle contractions), and urinary retention. Some adverse reactions persisted up to 24 hours after ingestion and fifteen toxic seizures were recorded with two patients suffered life-threatening toxicity with status epilepticus and severe respiratory and metabolic acidosis.