2026 Natural Health Products Regulation, Ministry of Health Consultation

Natural Health Products Regulation Consultation PSGRNZ PDF RESPONSE

Consultation on Natural Health Products. Consultation closed: November 2, 2026.
Consultation document: Purpose, principles and elements of a natural health products regulatory system, October 2026. Cabinet Paper, September 22, 2026.

1. Summary

Physicians and Scientists for Global Responsibility New Zealand (PSGRNZ) supports the development of a coherent, transparent and scientifically defensible regulatory framework for natural health products (NHPs). We welcome this initial consultation as an opportunity to establish the scientific and legal principles necessary for effective reform.

However, PSGRNZ considers that the Ministry of Health is not yet sufficiently prepared to proceed directly to drafting a regulatory impact statement or legislation. New Zealand's longstanding underinvestment in nutritional science has left significant gaps in institutional expertise and publicly disclosed methodologies for evaluating nutrients, supplements and other natural health products.

Officials strive to produce a proportionate response to a problem. Yet the problem definition has not been clearly articulated, and this is an essential starting point for regulatory reform. The problems arising from New Zealand's existing natural health products framework are interconnected, with consequences that differ across affected groups.

Two underlying problems require particular attention: (1) historical over-regulation of nutrients, subjecting them to medicine-like classifications and restrictions without sufficient consideration of their distinct nutritional functions, biological risk profiles and dose-dependent effects; and (2) chronic underinvestment in independent nutritional science and risk assessment, contributing to a regulatory culture in which restrictive classification can substitute for proportionate, evidence-based evaluation.

The consequences extend across different communities and professional groups. Restrictive nutrient classifications can constrain the clinical judgement of medical practitioners and other qualified health practitioners, particularly those with specialist expertise in nutritional interventions. Medical doctors with limited training in nutritional science may also be hesitant to prescribe medicine-classified nutrients, particularly where the classification creates an impression of pharmaceutical-level risk without a corresponding product-specific assessment.

The public may consequently face prescription requirements, additional consultation costs and barriers to access, disproportionately disadvantaging low-income communities where nutritional interventions are not publicly funded through Pharmac. Smaller domestic manufacturers and suppliers also face compliance costs that may render low-volume products commercially unviable, further restricting affordability, availability and consumer choice.

The limited evaluation preceding this consultation has been constrained by existing policy directions, an absence of systematic assessment of the costs of the current regime, and historical under-resourcing of its scientific foundations.

Consequently, the October 2026 consultation presents an outline of approaches for preliminary engagement without a clearly articulated central problem definition. Its options are remarkably rudimentary in their treatment of biological risk, scientific evidence, regulatory independence and the potential for improving existing legislation. (We are concerned that any future regulatory impact assessment might also fail to identify these broader challenges while stepping into the implementation of some already preferred model that might not sufficiently resolve them.)

The October options concentrate on administrative mechanisms, including ingredient lists, business licensing, product notification, manufacturing standards, health claims and regulatory oversight. Although these are legitimate matters for consultation, the document does not explain the scientific criteria that would underpin ingredient classification, risk-tiering, dose restrictions or the distinction between evidence of therapeutic benefit and biological safety. Nor does it identify how independent scientific assessment and periodic reassessment would be supported.

Importantly, reform of the existing legislative framework is not presented as a developed alternative. The consultation therefore risks directing public attention towards the design of a new regulatory structure before the necessity, scientific foundations and relative merits of that structure have been adequately established. It is not adequately equipped to address the underlying problems of historical over-regulation and inadequate scientific capacity, and risks reproducing these deficiencies within a new regulatory regime.

Against a backdrop of increasing chronic metabolic and mental illness, continued underinvestment by the Ministries responsible for Health and Science in nutritional monitoring, research and independent scientific assessment raises broader questions about public-health priorities. It is also important to recognise that in the four decades since the current regime was established, an extraordinary expansion of digital research tools has reduced many practical barriers to scientific investigation, creating greater opportunities for regulators, medical doctors, patients and natural health practitioners to access, critically evaluate and update nutritional evidence.

The Ministry of Health can harness these advances to strengthen its own scientific assessment capacity, develop more adaptable regulatory frameworks and respond flexibly to emerging evidence in a rapidly evolving informational landscape. Such a shift could transform and future-proof regulation, ensuring that classifications, safeguards and regulatory decisions reflect present and evolving nutritional knowledge and can evolve alongside scientific shifts, technological innovation and changing public-health needs.

Natural health products reform presents an opportunity to examine these systemic deficiencies within a wider public-interest framework, rather than treating regulation as an isolated administrative exercise.

Three evaluations could reasonably have been provided even at this early stage:

An assessment of the existing regulatory framework, identifying demonstrated deficiencies and distinguishing biological safety concerns from administrative, classification and commercial barriers. This should examine who bears the costs of existing restrictions, including practitioners, consumers, low-income communities and smaller suppliers, and whether those restrictions are justified by evidence of biological risk.
A comparative evaluation of regulatory reform options, examining the potential benefits, costs and limitations of improving existing legislation against establishing a new regime. This should consider not only administrative efficiency and industry development, but also the distribution of compliance costs, effects on product affordability and availability, practitioner autonomy, consumer choice and equitable access to nutritional and therapeutic interventions.
An evaluation of the scientific foundations of regulation, establishing the principles and institutional capacity required for ingredient classification, risk-tiering, health claims and periodic reassessment. This should consider whether existing restrictions are supported by contemporary evidence of biological risk, including dose, exposure and individual susceptibility, and whether sufficient independent scientific expertise and funding exist to prevent precautionary restrictions becoming entrenched in the absence of systematic reassessment.

An important consideration throughout these evaluations is who bears the costs of regulatory decisions, and whether those costs are justified by demonstrated biological risks or arise from deficiencies in scientific evidence, classification processes and regulatory administration. Requirements that impose relatively modest costs on large manufacturers and financially secure consumers may create substantial barriers for smaller domestic suppliers, practitioners and people with limited financial resources.

Any assessment of reform must therefore consider not only product safety and administrative efficiency, but also the cumulative effects of regulation on affordability, professional practice, consumer choice and equitable access to nutritional and therapeutic interventions.

Unlike medicines, essential nutrients must be assessed in the context of their normal biological functions and the consequences of both inadequate and excessive intake. Assessments should consider dietary requirements, nutritional adequacy, relevant cofactors and interactions, tolerable upper intake levels, and differences associated with age, sex, life stage and physiological status.

New Zealand lacks a clearly established, continuously resourced public programme for reviewing these questions as scientific knowledge develops. Regulatory decisions may consequently depend on occasional commissioned reviews, without the benefit of consistent, enduring scientific assessment processes.

The Ministry's recent vitamin D classification review illustrates this problem. Although the report considered extensive scientific literature, it did not disclose a systematic search strategy, formal evidence-quality appraisal, structured nutrient risk assessment or explicit decision rule explaining the proposed classification threshold. Our concern is not necessarily the competence of the expert, but the institutional resources, methodological requirements and oversight governing such evaluations.

As the Hardys Daily Essential Nutrients (DEN) case illustrates, the cost of restricted access is itself a regulatory outcome, extending beyond legal requirements to influence clinical perceptions of risk and prescribing decisions. Suppliers have reported that some medical doctors declined to prescribe DEN because its classification as a medicine led them to anticipate a pharmaceutical-like adverse-effect profile, rather than considering its specific ingredients, doses and available safety evidence. These issues highlight the need for Government to evaluate not only the biological risks of allowing products onto the market, but also the public-health and financial consequences of making potentially beneficial nutritional interventions inaccessible or unaffordable, particularly for those least able to bear the costs. We examine these cases in Section 3.

Our concern is that regulatory powers may be established before the scientific framework necessary to exercise them consistently, proportionately and transparently has been developed.

This is all the more relevant as the proposed natural health products framework is being developed alongside reforms to medicines regulation. The October 2026 consultation excludes products intended to fall within the proposed Medical Products Bill. If the definition of a medicine or therapeutic purpose is settled separately, the NHP framework may inherit classification boundaries that have not been examined as part of the present consultation.

The result could be a nominally risk-proportionate NHP system that excludes certain nutrients because of claims or classifications established under another statute.

Invest in Nutrition for the Future

Rather than seeing scientific capacity as a regulatory cost, Government can recognise it as a long-term, public-good investment, delivering health, research, industry and export benefits.

New Zealand has an opportunity to transform natural health products regulation from a predominantly restrictive administrative exercise into a forward-looking investment in public health, scientific excellence and economic innovation.

International markets for personalised nutrition, functional foods, dietary supplements and healthy-ageing products are expanding rapidly, with forecast annual growth ranging from approximately 7% to 15%, while the broader biohacking sector is projected to grow even faster. These emerging markets reflect growing consumer interest in metabolic health, brain health, healthy ageing, personalised nutrition and interventions intended to prevent or reverse chronic illness.

A knowledgeable, scientifically adept Ministry and governance system could position New Zealand to participate in these developments, supporting domestic researchers, qualified health practitioners and innovative businesses to develop high-quality, evidence-based products for international markets. Investment in independent nutritional science, clinical research, biological risk assessment and transparent regulatory pathways could create competitive advantages through scientific credibility, product quality and demonstrable benefits.

The opportunity is not simply to regulate an expanding industry, but to build the scientific capability that enables it to flourish responsibly. A proportionate regulatory system should protect consumers from demonstrated harm while enabling innovation, supporting smaller domestic enterprises and ensuring that New Zealanders themselves benefit from advances in nutritional science.

PSGRNZ Recommends: Strategic Consultation on Six Major Themes

PSGRNZ therefore recommends that six major strategic themes are consulted upon, and that the outcomes of the reviews be published, together with proposed scientific and legal frameworks, to inform formal regulatory impact analysis prior to seeking Cabinet approval for legislative drafting.

Scientific Assessment and Institutional Capacity

Review and consult on the scientific principles, methodologies and institutional expertise required to evaluate natural health products and support proportionate regulatory decisions.

Include international assessment frameworks, particularly EFSA's nutrient risk-assessment principles, addressing biological hazards, dose–response, total exposure, susceptible populations and uncertainty.
Distinguish biological risk, nutritional adequacy, physiological benefit and therapeutic efficacy, with evidence requirements proportionate to potential harm.
Establish how New Zealand will maintain the independent scientific expertise and resources necessary to assess both product safety and the consequences of restricting access, particularly for consumers and qualified health practitioners.
Legal Definitions and Classification Boundaries

Review and consult on revised legal boundaries between foods, dietary supplements, natural health products and medicines, including the consequences of classification decisions for consumers, qualified health practitioners and suppliers.

The Medicines Act's therapeutic-purpose provisions are outdated and poorly aligned with contemporary nutritional science. Essential nutrients inherently exert physiological, metabolic and immunological effects as part of normal biological function. Such effects should not, in themselves, provide grounds for classification as medicines. The framework can:

Establish scientifically defensible boundaries based on the nature and magnitude of biological effects, dose, exposure, intended use and demonstrable risk, while distinguishing product safety from the substantiation of therapeutic claims. It should clarify when higher-dose products require professional supervision, which authority resolves classification disputes, and how decisions can be independently reviewed.
Ensure classification decisions account for their practical consequences, including prescription and consultation costs, barriers to practitioner-led care, access for low-income communities and the commercial viability of smaller domestic suppliers.
Proportionate Risk-Tiering and Safeguards

Review and consult on regulatory tiers reflecting the nature and severity of biological and product-related risks, while ensuring that regulatory burdens are proportionate to the risks being managed.

The framework can distinguish intrinsic toxicity from contamination, manufacturing defects, interactions, inappropriate use and individual susceptibility.
Establish when quality assurance, labelling, dose restrictions or professional supervision are justified, and when medicines-level controls are necessary.
Risk-tiering can recognise the importance of comparative risk assessment, including the relative risks and potential benefits of nutritional interventions and conventional medical treatments for comparable health conditions.
Regulatory decisions can consider the risks of both intervention and restricted access, including their wider public-health consequences. Compliance requirements can be assessed for their differential impacts on large and small suppliers, qualified health practitioners and consumers, particularly where additional costs may reduce product availability, affordability or equitable access without commensurate safety benefits.
International Scientific and Regulatory Evidence

Review and consult on criteria for evaluating the scientific quality of international guidelines, overseas assessments and regulatory decisions.

New Zealand agencies and industry applicants are likely to rely on international evidence and regulatory precedents, but decision-makers should have the skills and guidance to critically evaluate the quality of foreign regulatory approaches.

The framework can establish transparent criteria for evaluating the breadth, depth, scientific rigour and recency of overseas assessments, including their underlying methodologies, the independence and expertise of contributing specialists, and the disclosure and management of conflicts of interest.
New Zealand can keep pace with international scientific developments, giving appropriate weight to the most recent and comprehensive assessments while retaining responsibility for decisions appropriate to domestic circumstances.
Recognition of overseas evidence can assist to avoid unnecessary duplication of assessments and associated compliance costs, without compromising scientific scrutiny or consumer protection.
Scientific Reassessment and Regulatory Review

Review and consult on triggers for revising classifications, restrictions and permitted claims, including evidence that existing requirements impose disproportionate costs or barriers to access.

Triggers can include significant new evidence of benefit or harm, changes in exposure, emerging adverse events, international scientific developments and evidence that existing restrictions are disproportionate.
Reassessment can permit both stronger safeguards and reduced restrictions, supported by transparent decisions, independent review and ongoing scientific monitoring.
Reassessment can provide accessible pathways for qualified health practitioners, consumers and smaller suppliers to seek reconsideration of classifications where new evidence or demonstrated access barriers warrant review.
Public-Health Governance and Accountability

Review and consult on the statutory responsibilities, scientific independence and public accountability of the regulatory system, including its obligations to assess the distribution of regulatory costs and benefits.

The Government can recognise its responsibility to protect and promote public health as distinct from its objectives of supporting industry growth and exports, and demonstrate that restrictions deliver public-health benefits proportionate to their scientific justification and social and economic consequences.
Scientific expertise in diet and nutrition can be supported by enduring institutional capacity and sufficient independent funding to enable officials to critically evaluate emerging evidence, including findings that challenge established scientific consensus or longstanding regulatory positions. This requires capacity beyond occasional, narrowly commissioned reviews.
The framework can require transparent expert appointments, disclosure and management of conflicts of interest, publication of scientific advice and decision criteria, and meaningful opportunities for independent scrutiny and review.
Regulatory accountability can extend to evaluating who bears the costs of regulatory decisions, including their effects on practitioner autonomy, consumer access, affordability for disadvantaged communities and the viability of smaller domestic suppliers.

The Economic Case for the Six Reviews:

A vibrant scientific environment that encourages independent inquiry, open debate and new ideas, while upholding rigorous standards of evidence, quality and best practice, provides fertile ground for creativity and innovation.

These synergies can nurture new products and approaches that improve domestic health while creating international export opportunities, strengthening New Zealand's reputation for natural products underpinned by scientific excellence.

Conversely, when regulatory and academic institutions are inadequately resourced, scientific conservatism can become entrenched. Smaller innovators and start-ups may face disproportionate barriers to developing and bringing products to market, particularly where emerging scientific concepts or approaches fall outside established regulatory assumptions or are not yet recognised as legitimate by the State.

PSGRNZ Recommends: Deepen the Purpose and Principles

Two purposes:

Public health, scientific integrity and informed choice

To protect and promote public health through scientifically justified, transparent, adaptable and proportionate regulation of the safety, quality and claimed benefits of natural health products; recognising established and emerging scientific knowledge, supporting informed consumer choice and appropriate professional judgement, and enabling affordable and timely access to products suitable for their intended use.

Responsible innovation and scientific excellence

To support a responsible, innovative and scientifically informed natural health products sector, including domestic research, product development and exports, through a regulatory framework that encourages independent scientific inquiry, accommodates advances in knowledge and technology, and maintains public confidence through transparent decision-making, independent scientific scrutiny and accountability.

Principles

PSGRNZ proposes that the current principles are too narrow.

Evidence of benefit and informed choice: Regulation recognises established histories of safe use and credible evidence of nutritional, physiological and therapeutic benefits, with evidential requirements proportionate to the nature and significance of claims. Consumers and health practitioners have access to clear, accurate information concerning benefits, harms and uncertainties.
Proportionality to biological risk: Regulation is proportionate to demonstrated or reasonably foreseeable biological risks from under-dosing as well as over-dosing at relevant exposures, considering dose, chemical form, duration, cumulative exposure, nutrient synergies, medical interactions and susceptible populations. Regulatory controls are no more restrictive than reasonably necessary to manage identified risks.
Distinction between scientific uncertainty and identified risk: Regulation can distinguish between uncertainty about therapeutic benefit, uncertainty about biological safety and scientifically identified risks of harm. That insufficient evidence of benefit may justify limitations on particular claims, but does not itself establish biological harm. Uncertainty about safety can prompt investigation proportionate to the plausibility and potential severity of adverse effects, the extent of relevant exposure and the significance of the evidence gaps. Where warranted, precautionary safeguards are targeted and proportionate, without an automatic presumption of harm. Decisions are transparent, independently reviewable and responsive to emerging scientific evidence.
Distinction between classification and risk: Product classifications distinguish established nutritional and physiological functions, evidence of therapeutic benefit and biological risk. Recognition of a physiological, immunological or metabolic effect, or therapeutic benefit, does not, by itself, trigger classification as a pharmaceutical medicine. Evidential requirements for claims are distinguished from controls necessary to manage biological risk.
Timely access and appropriate safeguards: Regulation supports affordable and timely access to natural health products, with appropriate safeguards, including dose restrictions, warnings, monitoring and clinician supervision where scientifically justified. The potential public-health consequences of unnecessarily restricting access are taken into account.
Scientific integrity, responsiveness and accountability: Regulatory decisions are grounded in the best available scientific evidence, using transparent and independently reviewable methods. Classifications, permitted claims and restrictions are subject to periodic and evidence-triggered reassessment, informed by relevant clinical and practitioner experience, independent scientific research and expert evaluation. Regulatory oversight is supported by accessible review mechanisms, feedback information from clinicians and practitioners, independent scientific scrutiny and public reporting.
Efficient administration and international alignment: Administrative and compliance requirements are efficient, proportionate and affordable, without unnecessarily disadvantaging consumers, qualified health practitioners, researchers or small businesses. International standards and practices are adopted only where scientifically justified and relevant to New Zealand's circumstances.
Distributed scientific expertise and practitioner autonomy: Regulators and regulation recognise that scientific knowledge and evidence-informed judgement develop across a continuum, from qualified clinicians and practitioners working directly with patients, through professional and independent scientific communities, to national regulatory authorities. The framework supports appropriate professional autonomy, access to emerging scientific evidence, systematic clinical observation and reporting, and mechanisms through which practitioner experience and independent research can inform regulatory review. Responsibilities for evaluating evidence, making binding regulatory decisions and maintaining public accountability are clearly defined, with safeguards proportionate to biological risk.

2. The Current Natural Health Products Regime: Limited Official Assessment

The Food-Medicines Regulatory Landscape

New Zealand's existing natural health products framework operates across the Food Act 2014, the Dietary Supplements Regulations 1985, the Medicines Act 1981 and the Medicines Regulations 1984. These instruments perform different regulatory functions, with responsibilities divided principally between the Ministry for Primary Industries and the Ministry of Health/Medsafe.

Figure 1 Ministry of Health. Accessed November 1, 2026.

This division creates tensions and scientific contradictions that should reasonably be addressed with any revision of natural health products regulation. Dietary supplements are subject to ingredient, composition and dose requirements under food legislation, while products intended for therapeutic purposes may fall within medicines legislation. Consequently, a nutritional formulation can become subject to substantially different regulatory controls because of its composition, dose or intended use, without the classification decision necessarily establishing that the formulation presents an unacceptable biological risk.

PSGRNZ's examination (below) of the Hardys Daily Essential Nutrients case illustrates this difficulty. The regulatory treatment of a multinutrient formulation involved statutory limits for particular nutrients, medicines classifications and the therapeutic purposes for which the product was intended. However, the key public-health questions concern the biological safety of the formulation at relevant exposures, the evidence of biological benefit, appropriate conditions of use and the consequences of restricting access were not addressed by the Ministry.

The problem is not necessarily that the Food Act and Medicines Act are legally inconsistent. Rather, their intersection may leave important scientific and public-health questions insufficiently examined. Food-safety regulation does not necessarily address therapeutic nutritional requirements, while medicines classification does not, by itself, establish whether a particular nutrient dose is harmful or beneficial.

This raises a spectrum of challenges across any proposed reform: should New Zealand first modernise the definitions, dose restrictions, therapeutic-claims provisions and classification procedures within existing legislation, or is a standalone statute necessary to resolve these difficulties?

PSGRNZ recommends that the Ministry undertake a comparative assessment of these legislative options, informed by the six essential reviews proposed in this submission. These reviews would establish the scientific, legal and governance foundations for proportionate regulation, including transparent criteria for nutritional adequacy, therapeutic benefit, biological risk, dose–response, susceptible populations and periodic reassessment. They would also clarify institutional responsibilities for maintaining the scientific evidence base and reviewing restrictions as knowledge develops.

Without these foundations, new legislation risks reproducing the same classification tensions within a different administrative structure.

Officials have identified targeted amendments to the existing framework but it is difficult to identify a comprehensive evaluation of the existing regime against the costs, benefits and feasibility of any alternative reforms.

Officials have not produced a report evaluating the challenges of operating within the current regime, such as overly restrictive guideline limits, health and safety complaints, and impediments to New Zealand industries and consumer access. Nor have they evaluated the barriers that arise when a nutrient is classified as a medicine because of a claimed physiological, immunological or metabolic effect (often a recognised biological pathway of that nutrient), or the resulting challenges for public access.[1]

February 2024 – Sapere Regulatory Scan: International approaches to Natural Health Product regulations
February 2025 -H2025061418: Targeted improvements for regulating natural health products
April 2025 - H2025065159: Update on the impacts of changes to the regulation of dietary supplements
May 2025 - H2025066272: Evaluating regulatory pathways to enable dietary supplement exports
September 2026 - Cabinet paper: Natural health products regulation – approval to engage

PSGRNZ observes that any assessment of alternatives has been limited by the existing policy direction and the limited content in these related policy papers. The February 2025 Ministry of Health briefing rejected targeted amendments partly because they might divert resources from developing standalone legislation. Consequently, the potential for improving the existing framework was not assessed through a comprehensive, comparative evaluation of regulatory outcomes.

The costs and benefits of reform remain insufficiently quantified. Although officials identified legislative fragmentation, export barriers and classification difficulties, the documents do not establish the extent of existing consumer safety failures or the anticipated improvements from a new regime. Nor do they adequately evaluate the potential consequences of additional regulation for affordability, consumer access, small suppliers and practitioner autonomy, alongside the benefits of stronger safeguards.

The scientific foundations of regulation remain underexamined. The documents discuss ingredient permissions, composition limits, medicine classification and health claims without demonstrating a systematic evaluation of the scientific criteria and processes underpinning these decisions. New legislation will not, by itself, provide the scientific expertise, research capacity, exposure data, dose–response assessments or independent reassessment mechanisms necessary for proportionate, evidence-based regulation.

The current six-page Appendix One presents a preliminary range of approaches to defining natural health products, permitted ingredients, pre-market requirements, health claims, manufacturing, labelling, exemptions and regulatory oversight. As an initial engagement document, it is understandably broad. However, the options are largely administrative, concentrating on ingredient lists, licensing, notification, compliance and enforcement, without adequately articulating the scientific and public-interest criteria that would govern these mechanisms.

In particular, the proposed approaches do not explain how biological risk would be assessed, how higher- and lower-risk products would be distinguished, or how decisions concerning ingredient restrictions, dose limits and therapeutic claims would be independently reviewed as evidence develops. Nor is systematic improvement of the existing legislative framework presented as a developed alternative, notwithstanding the Ministry's earlier identification of opportunities for targeted reform.

The concern is therefore not that the consultation lacks detailed legislative proposals, but that it invites public preferences on regulatory structures before establishing the scientific foundations, demonstrated deficiencies and comparative costs and benefits necessary to inform those preferences. An initial consultation should establish the scope of the problem and the principles governing its resolution, rather than risk narrowing public consideration to a selection of administrative mechanisms.

Without this foundation, consultation responses may identify preferences for particular regulatory arrangements without providing a reliable basis for determining whether those arrangements are necessary, proportionate or capable of improving public-health outcomes.

3. Regulatory Classification in Practice: Two Case Studies

3.1 Case Study of the 2025 Vitamin D Evaluation

The Ministry commissioned an independent expert report, Classification of Vitamin D: Review of Classifications for Dietary Supplements (October 2025), which surveys an extensive body of literature on vitamin D requirements, physiological functions, clinical benefits and potential adverse effects. The report considered randomised controlled trials, observational studies, systematic reviews and Mendelian randomisation research.[2]

A systematic scientific assessment would integrate hazard, dose-response, total dietary and supplemental exposure, susceptible populations and uncertainty. However, a reproducible methodology for identifying, selecting, appraising or integrating the evidence in the paper was not disclosed and no systematic literature-search strategy, database selection, search dates, eligibility criteria, study-exclusion records or formal risk-of-bias assessment are presented.

The report did not identify an established methodological framework, such as PRISMA for systematic-review reporting, GRADE for assessing certainty in intervention effects, or the European Food Safety Authority’s (EFSA) structured approach to assessing tolerable upper intake levels for nutrients. These frameworks serve different purposes and need not all be applied to a classification review. However, their absence highlights the lack of an explicit, fit-for-purpose assessment methodology.

Unresolved dose-response and safety questions

The report stated that supplementation with 2,000 IU daily can achieve serum 25-hydroxyvitamin D concentrations above 75 nmol/L in more than 90% of adults. However, the cited reference, Cui et al. (2023)[3], is a pooled analysis of worldwide vitamin D deficiency prevalence, rather than a dose-response study establishing this population-wide estimate. Although the estimate also appears in Pludowski et al. (2024)[4], the report did not identify the underlying trials, model response distributions or assumptions necessary to independently verify it.

The review acknowledged substantial individual variation in vitamin D requirements, including differences associated with baseline status, age, body weight, skin pigmentation and geographical location. Nevertheless, it did not present a population-specific analysis demonstrating the proportion of New Zealand adults expected to achieve particular serum concentrations at 1,000, 2,000 or 3,000 IU daily, and it did not establish an independently reproducible decision rule explaining why 2,000 IU daily is acceptable for general sale while 3,000 IU is not.

The report discussed relevant hazards, including hypercalcaemia, hypercalciuria, kidney stones and possible adverse effects associated with higher or prolonged supplementation. This is particularly relevant as a tolerable upper intake level, a recommended intake and a legal general-sale limit are scientifically and legally distinct concepts. A tolerable upper intake level is not automatically the appropriate threshold for restricting access to a nutrient.

3.2 Case Study: Hardys DEN Nutrients

Hardy’s Daily Essential Nutrients (DEN), a broad-spectrum formulation of nutrients with long histories of safe use and well-characterised risk profiles, was recently classified as a medicine. The trigger for medicines classification was technical and based on the legislative trigger. Despite a substantial body of research on DEN, officials did not evaluate its safety nor compare the adverse-effect profile with those of psychiatric medicines conventionally prescribed for related conditions (and the potential benefits that the public may have from changing to DEN).[5] [6] [7] [8] [9]

In an October 2024 Official Information Act response (H2024052860), Medsafe confirmed that it held no information on DEN's risk profile, no published literature on its safety or efficacy, and no records of consultation or advice sought to reclassify the product.[10] Instead, the classification arose from statutory ingredient, dose and therapeutic-purpose provisions. A subsequent Ministry briefing confirmed that even revising the relevant nutrient dose limits would not remove the medicines classification arising from the product's therapeutic purpose.[11]

Medsafe's classification captured lithium orotate (a naturally present component of another ingredient in one of the Hardy’s products) within prescription-medicine controls, despite the substantial difference between trace or low-dose lithium exposure and the pharmacological doses used in psychiatric treatment. Professor Julia Rucklidge's subsequent application to reclassify lithium at environmentally relevant levels was declined in 2025.[12] The case highlighted the need for regulatory assessments that distinguish chemical form, dose, exposure and demonstrated biological risk. Such assessments must recognise the substantial differences between low-dose exposure and pharmacological treatment.

The Hardys case suggests that officials were reluctant to challenge the Medicines Act 1981 by considering the proportionality of the risks that could be experienced by people diagnosed with related psychiatric conditions, and consider not just the potential benefits, but the relative safety compared with conventional treatment options.

The Hardy's case demonstrates the need to distinguish nutritional interventions from pharmaceutical treatments and to assess their relative risks, potential benefits and available treatment alternatives. Recognising this distinction is central to ensuring that regulatory restrictions are proportionate to scientifically established risks.

The challenge for a new regime is to ensure that restrictions on nutritional interventions are justified by transparent, product-specific assessments of biological risk at relevant exposures.

3.3 Scientific Rigour Requires Biological Context and Classification Must Follow Risk

The vitamin D and Hardys DEN cases illustrate how medicines classification can be driven by therapeutic purpose, ingredient restrictions or uncertainty about clinical benefit, without a sufficiently transparent assessment of biological risk at relevant exposures.

In the vitamin D case, the review placed considerable emphasis on therapeutic uses and the circumstances requiring professional supervision. However, whether a nutrient has sufficient evidence to support a particular disease-treatment claim is a separate question from whether it presents an unacceptable biological risk at a specified dose.

Similarly, Hardys DEN was captured by medicines classification provisions despite Medsafe acknowledging that it held no product-specific risk assessment or published safety and efficacy literature. The presence of lithium orotate also highlighted uncertainty about whether regulatory decisions could adequately distinguish low-dose exposure from the substantially higher doses used in psychiatric treatment, and the disproportionate impact on low-socioeconomic groups.

These cases demonstrate the need to separate biological risk assessment, evidence of benefit, claims substantiation and legal classification. Where nutritional interventions are proposed for conditions conventionally treated with medicines, their potential benefits and adverse effects should also be considered in the context of available treatment alternatives.

Nutritional risk assessment presents particular methodological challenges because essential nutrients have physiological functions, and both inadequate and excessive intakes may produce adverse health consequences. Biological effects depend on dose, chemical form, duration, total exposure, nutrient interactions and individual susceptibility.

For vitamin D, baseline serum 25-hydroxyvitamin D concentrations, adiposity, age, sunlight exposure, gastrointestinal absorption, relevant medical conditions and concurrent medications may influence supplementation responses. For Hardys DEN, the presence of multiple interacting micronutrients, including low-dose lithium in the original formulation, similarly requires assessment of the actual formulation, exposure levels and potential adverse effects rather than reliance on classification by ingredient or therapeutic purpose alone.

The European Food Safety Authority's (EFSA) 2024 Guidance for establishing and applying tolerable upper intake levels for vitamins and essential minerals provides an established approach to nutrient safety assessment.[13] It incorporates hazard identification, hazard characterisation, intake assessment and risk characterisation, including dose-response relationships, total exposure, susceptible populations and scientific uncertainty.

Where particular risks are identified, screening, product labelling, dose restrictions or healthcare supervision may provide more proportionate safeguards than restrictions applied indiscriminately to the general population.

A tolerable upper intake level is a health-based reference value for assessing risk from total chronic exposure; it is neither a recommended intake nor automatically an appropriate legal general-sale limit. Equally, the presence of a nutrient in a medicine-classified formulation does not establish that every dose or exposure presents equivalent risk.

Any future Natural Health Products regime must be supported by the capacity to conduct scientifically reproducible assessments of the nature, probability and severity of biological harm at relevant exposures, alongside consideration of nutritional benefits, available alternatives and proportionate safeguards.

This is an extract of our larger submission. To access our full submission including the Appendix which details our response to the individual consultation questions CLICK HERE.

REFERENCES

[1] See for example a 2026 Ministry of Health Consultation on proposed changes to the classification of Vitamin D. https://consult.health.govt.nz/medsafe/vitamin-d-classification/supporting_documents/vitamin-d-consultation-2026-information-questionspdf

[2] Ministry of Health (October 2025). Expert Report. Classification of Vitamin D. Review of Classifications for Dietary Supplements. https://consult.health.govt.nz/medsafe/vitamin-d-classification/supporting_documents/vitamin-d-consultation-2026-expert-reportpdf

[3] Cui A, Zhang T, Xiao P, Fan Z, Wang H, Zhuang Y. Global and regional prevalence of vitamin D deficiency in population

based studies from 2000 to 2022: A pooled analysis of 7.9 million participants. Front Nutr. 2023 Mar 17;10:1070808.

[4] Pludowski P, Grant WB, Karras SN, Zittermann A, Pilz S. Vitamin D Supplementation: A Review of the Evidence Arguing for a Daily Dose of 2000 International Units (50 µg) of Vitamin D for Adults in the General Population. Nutrients. 2024 Jan 29;16(3):391.

[5] Rucklidge JJ, Johnstone JM, Villagomez A, Ranjbar N, Kaplan BJ (2023) Broad Spectrum Micronutrients and Mental

Health. Chapter 9. In Nutritional psychiatry: A primer for clinicians, pages 152-171. Edited by Ted Dinan. Cambridge

University Press. DOI: 10.1017/978100929986

[6] Chand, A., Darling, K. & Rucklidge, J.J. Duration effects of micronutrients in children with ADHD: Randomised

controlled trial vs. Open-Label extension. Eur Child Adolesc Psychiatry 35, 463–475 (2026).

https://doi.org/10.1007/s00787-025-02841-3

[7] Mitchell, M., Bradley, H., Blampied, N.M., Mulder, R.T., Rucklidge, J.J. (2025). Protective effect of micronutrients used

to treat antenatal depression on rates of postnatal depression at six months: A secondary analysis of NUTRIMUM.

Journal of Affective Disorders 388 (2025) 119560. DOI: 10.1016/j.jad.2025.119560

[8] Rucklidge JJ, Usman Azfali M, Kaplan BJ et al (2021). Massacre, Earthquake, Flood: Translational science evidence

that the use of micronutrients post-disaster reduces the risk of post-traumatic stress in survivors of disasters.

International Perspectives in Psychology 10(1):39–54. DOI: 10.1027/2157-3891/a000003.

[9] Blampied M, Tylianakis JM, Bell C, et al. Efficacy and safety of a vitamin-mineral intervention for symptoms of anxiety and depression in adults: A randomised placebo-controlled trial "NoMAD". J Affect Disord 2023; 339: 954-964. DOI: 10.1016/j.jad.2023.05.077.

[10] Ministry of Health (October 30, 2024). Official Information Act request: Hardys Daily Essential Nutrients. H2024052860 https://fyi.org.nz/request/28602/response/111282/attach/7/H2024052860%20Response.pdf

[11] Ministry of Health (April 9, 2025) Aide-Mémoire Meeting with Minister Hoggard and Professor Julia Rucklidge to discuss ‘Daily Essential Nutrients’. H2025064312. https://www.health.govt.nz/system/files/2025-11/H2025064312-Aide-Memoire-Meeting-with-Minister-Hoggard-and-Julia-Rucklidge-to%20discuss-Daily-Essential-Nutrients.pdf

[12] Medsafe. Minutes for the 74th meeting of the Medicines Classification Committee held at 133 Molesworth Street, Wellington on 23 July 2025. 5.4 Lithium (Prof Julia Rucklidge). https://www.medsafe.govt.nz/profs/class/Minutes/2021-2025/74mccMin23July2025.htm

[13] EFSA NDA Panel (EFSA Panel on Nutrition, Novel Foods and Food Allergens), Turck, D., Bohn, T., Cámara, M., Castenmiller, J., de Henauw, S., Hirsch-Ernst, K.-I., Jos, A., Maciuk, A., Mangelsdorf, I., McNulty, B., Pentieva, K., Siani, A., Thies, F., Aggett, P., Crous-Bou, M., Cubadda, F., Dopter, A., Fairweather-Tait, S.,… Naska, A. (2024). Guidance for establishing and applying tolerable upper intake levels for vitamins and essential minerals. EFSA Journal, 22(11), e9052. https://doi.org/10.2903/j.efsa.2024.9052