Is Shilajit Legal in New Zealand? What Medsafe and the Regulations Actually Say
This is not legal advice, and New Zealand's regulatory system for products like this is genuinely mid-overhaul. What follows is what we could verify directly from Medsafe, Food Standards Australia New Zealand and general biosecurity guidance, stated plainly where the picture is clear and flagged honestly where it is not.
In this article
Key takeaways
- We found no mention of shilajit by name in any New Zealand law, schedule, or Medsafe alert. That absence is a genuine data point, not the same thing as an official clearance.
- New Zealand's supplement law is mid-overhaul: a proposed Natural Health Products Bill was withdrawn in 2017, a successor Therapeutic Products Act 2023 was itself repealed in December 2024, and a replacement has been promised but not yet enacted at the time of writing.
- Classification depends heavily on the claims made about a product, the same principle that applies in Australia, so a general wellness product without therapeutic claims sits differently to one making specific health promises.
Medsafe: medicines vs dietary supplements vs food
Medsafe, part of New Zealand's Ministry of Health, administers the Dietary Supplements Regulations 1985, made under what is now the Food Act 2014. A dietary supplement is defined as a substance for oral use, in a controlled dosage form, intended to supplement the diet. Under Regulation 11, a dietary supplement cannot contain a controlled drug under the Misuse of Drugs Act 1975, cannot contain a prescription, restricted or pharmacy-only medicine, and cannot carry therapeutic claims.
There is no pre-market approval process or product register for dietary supplements in New Zealand. A seller self-certifies compliance rather than seeking approval for a specific product before sale. If a product works through what the law calls a pharmacological, immunological or metabolic mode of action, it can instead be classified as a medicine under the Medicines Act 1981, which does require approval. In practice, this means classification depends heavily on how a product is presented and what claims are made about it, not on a fixed list of approved and banned substances.
A regulatory system currently being rebuilt
It is worth knowing that New Zealand's supplement law has been in flux for over a decade. A Natural Health and Supplementary Products Bill was introduced in 2011, reached a second reading in 2013, and was formally withdrawn in November 2017 without being enacted. A successor, the Therapeutic Products Act 2023, was passed but was then repealed via the Therapeutic Products Act Repeal Bill in December 2024. As of the time of writing, the government has stated an intention to develop a new Medical Products Bill and a separate, lighter-handed bill specifically for natural health products, but neither had been enacted. In the meantime, dietary supplements continue to sit under the older 1985 regulations. Anyone relying on this for a current legal position should check directly with Medsafe or the Ministry of Health for the latest status.
FSANZ: a genuine joint Australia and New Zealand regulator
Food Standards Australia New Zealand (FSANZ) is a real, bi-national statutory authority operating under a 1995 treaty, with a joint food standards system formally in force from 1 July 1996. This is a genuine shared regulator, not an Australian-only body that happens to be referenced in New Zealand. FSANZ's Food Standards Code, covering composition, labelling and contaminant limits, applies in New Zealand directly. We could not find a record of shilajit specifically being assessed under FSANZ's novel food provisions, one way or the other.
Biosecurity and import requirements
New Zealand's biosecurity system is genuinely strict, and importing goods can involve up to three separate agencies: Medsafe (classification), the New Zealand Customs Service (border processing), and Biosecurity New Zealand, part of the Ministry for Primary Industries, which issues Import Health Standards for categories of risk goods under the Biosecurity Act 1993. Most unprocessed goods cannot be imported without an applicable Import Health Standard. We searched specifically for an Import Health Standard naming shilajit, mineral pitch, or a comparable mineral resin exudate, and found none. This is a genuine gap in what is publicly documented, not something we can responsibly resolve on your behalf. Commercial importers should confirm current requirements directly with Biosecurity New Zealand rather than assume either way.
Is shilajit named anywhere in New Zealand law?
We searched New Zealand legislation and Medsafe's alert and compliance pages specifically for the term shilajit and found no mention at all: no scheduling under the Misuse of Drugs Act 1975, no listing in any medicines or poisons schedule, and no recorded Medsafe consumer alert or compliance action. This absence is the honest finding, and it is worth being precise about what it does and does not mean. It means shilajit is not a specifically named, regulated substance in New Zealand law. It does not mean the product has been officially reviewed and cleared, because no such review process exists for it to have gone through.
Lab-tested, see batch #1093
Not a regulatory approval, but a checkable fact
No review process exists that could clear a product like this, so a batch report is not an approval. It does show what was measured. Batch #1093 was independently tested by Eurofins Food Australia, including heavy metals and fulvic and humic acid content, and the full report is public.
Read the batch #1093 reportA lab report describes one batch. It is not a regulatory approval or clearance, and it does not show that a product treats or prevents any condition.
FAQ
Is shilajit banned in New Zealand?
We found no evidence of it being banned, scheduled, or subject to any recorded Medsafe alert. This is not the same as a formal clearance, since no product-specific approval process applies to a substance in this category.
Can shilajit be sold in New Zealand as a dietary supplement?
A dietary supplement sold under the 1985 regulations cannot carry therapeutic claims and cannot contain a scheduled medicine. Whether a specific product qualifies depends on how it is presented and what claims are made about it.
Does Australia's regulatory position apply in New Zealand?
No. Australia and New Zealand have separate medicines regulators, Australia's TGA and New Zealand's Medsafe, even though food standards are jointly regulated through FSANZ. Do not assume one country's position applies in the other.
References
- Medsafe, New Zealand Ministry of Health. Dietary Supplements Regulation guidance.
- Medsafe, New Zealand Ministry of Health. Product Categorisation guidance.
- New Zealand Ministry of Health. Regulating medicines, medical devices and natural health products, policy documents.
- Food Standards Australia New Zealand. About FSANZ and the joint food standards system.
- New Zealand Biosecurity Act 1993, Import Health Standards framework.
Some figures above were accessed via secondary reporting rather than primary government text where direct access was limited; noted transparently in our internal research record. This article is general information, not legal advice.