The consultation document released this month outlined four approaches to allowing and defining health claims, including automatically recognizing health claims from specified countries, allowing industry to self-substantiate claims based on certain types of scientific evidence and/or evidence of traditional use, and providing a list of pre-approved health claims associated with specific products or ingredients.
The government noted that automatically recognizing health claims from specified countries could help support informed consumer choice and access to a wide range of natural health products.
Allowing industry to self-substantiate product claims based on scientific evidence, on the other hand, could support industry development and exports, while maintaining confidence in New Zealand’s reputation as a manufacturer of quality products that are safe and suitable for their intended use.
The push for therapeutic claims
The ability to make therapeutic claims on dietary supplements has long been a key priority for New Zealand’s natural health products industry, which argues that current restrictions have limited export opportunities.
Hopes of gaining permission to make therapeutic claims were raised last month when Food Safety Minister Andrew Hoggard announced a series of updates that would allow exporters to make such claims in accordance with the requirements of importing countries.
Natural Health Products NZ (NHPNZ) Government Affairs Director Samantha Gray presented the ongoing consultation as a significant opportunity for industry to shape natural health products regulations.
“This targeted consultation is the mechanism that will ensure New Zealand value-add innovators can scale into high-growth global consumer wellness categories,” she said in a LinkedIn post.
The government indicated that standalone, comprehensive natural health products could be considered, alongside amendments to existing legislation.
“While regulations made under existing legislation can address some issues, many natural health products do not fit neatly within the current food, medicines or cosmetics frameworks,” the Ministry of Health communicated. “Targeted changes may only provide a partial solution. Nonetheless, in considering feedback on approaches to regulating NHPs, the government will consider whether a standalone, comprehensive NHP Bill is required, or if issues can be appropriately addressed through amendments to existing laws (eg, the Medicines Act 1981, Food Act 2014).”
Further considerations
The consultation also seeks to define natural health products, which could include oral ingested products such as dietary supplements and some herbal remedies and topical products, such as herbal remedies and cosmetics that make health claims.
“One of the areas we are engaging on is how natural health products should be defined and how clear boundaries should be established between natural health products, foods and medicines,” the ministry stated.
It has proposed a broad definition of natural health products through either a list of recognized or prohibited ingredients or via automatic recognition of ingredients from specified countries.
Pre-market requirements are also under consideration, with options ranging from notification of “higher-risk” products only to notification of all products or no product notification at all.
For general manufacturing requirements, the ministry has proposed a tiered, risk-proportionate approach. “Higher-risk” products requiring export certification would need to comply with appropriate Good Manufacturing Practice (GMP), while “mid- and lower-risk” products would face less stringent requirements, potentially based on the regulatory approach for food businesses.
An alternative would be for all commercially sold products to meet the same manufacturing standards, with exemptions for export products and small-scale producers.
The consultation is open through Nov. 2.
