New Zealand’s Troublesome Quest to Regulate Natural Health Products
New Zealand has been grappling for decades with the question of how to properly regulate natural health products, a broad category encompassing everything from vitamins and probiotics to herbal remedies. While not classified as medicines, their potential impact on health has generated calls for stricter oversight.
"The regulations for dietary supplements, which form a large part of this sector, are now approaching 40 years old. Reform is long overdue," says a leading health law expert. "But exactly how and when these changes will happen remains unclear."
One stumbling block has been defining these products. New Zealand distinguishes them from medicines, which are substances intended to treat or prevent disease and must undergo rigorous testing by Medsafe, the country’s medicine regulator.
But unlike foods, which have their own distinct regulatory framework, natural health products fall into a blurry territory.
“Whether a product is considered to be a food, a supplemented food, a formulated food, a medicine, a dietary supplement, or something else entirely, can be difficult to assess in borderline cases, to the extent that higher courts have been involved in classifying certain products," notes a legal team from Bell Gully, a leading law firm.
The current regulatory framework, based primarily on the Dietary Supplements Regulations from 1985, imposes limits on vitamin and mineral concentrations but lacks pre-market approval. This allows for quick product entry but has raised concerns about safety risks, especially concerning improper use, ingredients, and manufacturing practices.
There was hope for change with the introduction of the Therapeutic Products Act (TPA) in 2021. The TPA proposed a new system for regulating both medicines and natural health products, including market authorization for certain products and stricter rules on health benefit claims, similar to regulations in Australia.
This legislation aimed to bring clarity and ensure consumer safety while allowing legitimate businesses to thrive.
“The TPA would have classified any product which was intended for maintaining or promoting human health and which contained a natural health product ingredient… below a certain concentration as a natural health product. Such natural health products would have required market authorization before they were sold,” explained a legal expert.
But the TPA faced significant opposition, with some arguing it would excessively burden the natural health product industry. Ultimately, the coalition government repealed the TPA, returning New Zealand to its previous convoluted system.
Now, New Zealand faces a moment of decision. The Dietary Supplements Regulations are scheduled to expire in March 2026.
"We need to find a different approach," stated government officials. “We’ll be consulting with consumers and industry over the next year and aim to have a new set of regulations in place.”
The path forward is uncertain. Balancing consumer safety with the free flow of innovation within the health product sector remains a complex challenge for New Zealand lawmakers.
