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Selling dietary supplements in New Zealand

In New Zealand, dietary supplements fall under the Dietary Supplements Regulations 1985, made under the Food Act 2014. Medsafe administers the regulations and MPI the Food Act. There is no pre-approval: the sponsor answers for quality, safety and compliance. A supplement may not contain scheduled medicines or controlled drugs, or claim a therapeutic purpose.

Updated · Each section links to the official source it comes from

Main instrument
Dietary Supplements Regulations 1985
Who administers it
Medsafe; MPI administers the Food Act 2014
Before sale
No pre-approval; the sponsor answers for the product
Claims
No stated or implied therapeutic purpose
Folic acid
300 µg a day, or 500 µg with a Medsafe-verified declaration
Importing
Through an importer registered with MPI

Before a product goes on sale

The questions to answer, in the order they usually come up.

  1. 1Is it a dietary supplement, a supplemented food, a sports food or a medicine? Read more
  2. 2Does any ingredient appear in the medicines schedules or as a controlled drug? Read more
  3. 3Does it stay within the regulations' labelling rules and maximum daily doses? Read more
  4. 4Do the label, website and social media avoid therapeutic claims? Read more
  5. 5Does it contain more than 300 µg of folic acid a day? Read more
  6. 6Who imports, makes and packs it, and are they registered? Read more

The rules, by area

What each area covers, the texts that set it, and what the official pages say.

Which category the product falls in

Ingredients, purpose and presentation decide whether a product is a supplement, a food or a therapeutic product.

  • Medsafe describes dietary supplements as substances for oral use, packed in a controlled dosage form, intended to supplement the intake of substances normally derived from food.
  • Dietary supplements cannot contain controlled drugs under the Misuse of Drugs Act 1975, or substances scheduled as prescription, restricted or pharmacy-only medicines under the Medicines Act 1981.
  • Categorisation is determined by a product's ingredients, its purpose for use and the way it is presented in the market.
  • A supplemented food is a food with a substance added, or modified, to perform a physiological role beyond providing nutrition; it is regulated under the Food Act 2014 and its own New Zealand standard.
  • Medsafe can be asked for a categorisation decision, with the product's ingredients, label, promotional material and any approvals from other regulators.

How we help: Compliant Always reads your formula against the medicines schedules and keeps the categorisation reasoning with the product. Ask about this

The Dietary Supplements Regulations 1985

The minimal requirements for supplements supplied in New Zealand.

  • Regulation 5 lists the label: the common name, net quantity, the name and address of the manufacturer, seller or packer or their agent, a consumer information panel, the words 'dietary supplement', a batch number, a date mark no more than 5 years after manufacture, and the recommended daily dose.
  • Since 18 December 2024, regulation 2B says the joint food standards (the Food Standards Code) do not apply to dietary supplements.
  • Regulation 11 bars labelling or advertising about treating or preventing disease, changing body shape, size or weight, or altering normal physiological function, except as the Medicines Act 1981 permits.
  • The regulations set requirements including labelling and maximum permitted daily doses for several vitamins and minerals.
  • There is no pre-approval process; the sponsor, the person legally responsible for placing the product on the market, answers for its quality, safety and compliance.
  • Medsafe's checklist for supplements includes that the label carries the words 'Dietary Supplement' and that daily doses stay within regulation 3.
  • Dietary supplements are not assessed by a government agency, and Medsafe does not verify sponsors' declarations of compliance.

How we help: Compliant Always sets your label and daily doses beside the regulations, and keeps the sponsor's evidence with each product. Ask about this

Therapeutic claims

What a supplement may not say, wherever it says it.

  • Therapeutic claims are not permitted for dietary supplements, supplemented foods or cosmetics; regulation 11 of the Dietary Supplements Regulations covers labelling and marketing.
  • A therapeutic purpose includes preventing, diagnosing, alleviating or treating a disease, and influencing or modifying a physiological process.
  • The purpose can be stated or implied in label claims, websites, advertising images, testimonials, references to traditional use, social media and influencer material.
  • A product with a therapeutic purpose is categorised as a medicine, a medical device or a related product.
  • Under the Fair Trading Act, a business needs reasonable grounds for a claim when it makes it.

How we help: Compliant Always reads your label and marketing copy against the therapeutic-purpose definition and flags wording that crosses it. Ask about this

Folic acid

A specific dose limit, with a route to a higher one.

  • The maximum daily dose of folic acid in a dietary supplement is 300 micrograms.
  • It may rise to 500 micrograms a day if the sponsor shows Medsafe that the product is made in a facility with good manufacturing practice (GMP) certification, using a sponsor declaration and GMP evidence less than three years old.
  • A product over 300 micrograms cannot be supplied until Medsafe returns the verified declaration, which the sponsor keeps for at least one year after the last batch supplied expires.
  • A change of sponsor, product name, maximum daily dose, manufacturing site or packing site needs a new declaration before supply.

How we help: Compliant Always keeps the verified declaration and GMP evidence with the product, and shows when the evidence passes three years. Ask about this

Import, manufacture and packing

The Food Act and biosecurity rules that apply to the businesses behind a supplement.

  • The Food Act 2014 requires food imported for sale, including dietary supplements, to come in through an importer registered with MPI.
  • Supplements should be made, packed and sold in line with the Food Act 2014 and the Food Regulations 2015; most businesses that make, pack or sell them register under a national programme or a food control plan.
  • Supplements with ingredients from animals also need to meet the Animal Products Act 1999 or the Food Act 2014, and the Biosecurity Act 1993.
  • MPI sets import health standards relevant to some dietary supplements.
  • Medsafe can issue export certificates for supplements made in New Zealand; they state that supplements are not assessed by a government agency.

How we help: Compliant Always keeps the importer registration, food control plan or programme details and biosecurity documents with each product. Ask about this

Sports foods and formulated supplementary foods

Foods with their own standards in the joint Food Standards Code.

  • Formulated supplementary sports foods follow Standard 2.9.4, which applies in New Zealand.
  • Their labels state that the food is not a sole source of nutrition and should be used with a nutritious diet and appropriate training or exercise, with directions and the recommended amount in one day.
  • Unless Division 3 permits it, the label must not link the food to enhanced athletic performance or beneficial physiological effects.
  • Formulated meal replacements and formulated supplementary foods follow Standard 2.9.3, with minimum protein, energy and vitamin and mineral levels per serving.

How we help: Compliant Always reads sports and meal replacement labels against the standard that applies, line by line. Ask about this

Who answers for what

WhoWhat they answer forHow we help
SponsorPlacing the supplement on the market: its quality, safety and compliance with the regulations.The product file, declarations and evidence kept together and dated.
BrandThe label, website and social media claims made for the product.Copy read against the therapeutic-purpose line before it goes out.
Manufacturer or packerMaking and packing under the Food Act 2014, and GMP evidence where folic acid needs it.GMP certificates and batch records kept by product and lot.
Registered food importerBringing supplements in for sale.Suppliers' documents read and dated before the goods arrive.

Questions businesses ask

Do dietary supplements need approval before sale in New Zealand?
No. There is no pre-approval process. The sponsor, the person legally responsible for placing the product on the market, answers for its quality and safety and for meeting the Dietary Supplements Regulations 1985.
Who regulates dietary supplements in New Zealand?
Medsafe administers the Dietary Supplements Regulations 1985, and the Ministry for Primary Industries administers the Food Act 2014, under which those regulations fall.
Can a supplement make health claims in New Zealand?
It cannot claim a therapeutic purpose, such as treating or preventing a disease or modifying a physiological process. Medsafe looks at labels, websites, advertising, testimonials and social media to judge the purpose.
What ingredients are not allowed in New Zealand supplements?
Controlled drugs under the Misuse of Drugs Act 1975, and substances scheduled as prescription, restricted or pharmacy-only medicines under the Medicines Act 1981. Medsafe's classification database shows which substances are scheduled.
What is the folic acid limit for supplements in New Zealand?
300 micrograms a day, or up to 500 micrograms if Medsafe has verified the sponsor's declaration that the product is made in a GMP-certified facility.
Do I need to register to import supplements into New Zealand?
Yes. Dietary supplements fall under the Food Act 2014, which requires food imported for sale to come in through an importer registered with MPI.
What is the difference between a dietary supplement and a supplemented food?
A dietary supplement is taken orally in a controlled dosage form to supplement the diet. A supplemented food is a food with substances added for a physiological role beyond nutrition, and it follows its own New Zealand standard under the Food Act 2014.
Do sports supplements have their own rules in New Zealand?
Formulated supplementary sports foods follow Standard 2.9.4 of the Food Standards Code, which applies in New Zealand, with set label statements and limits on performance claims.
Can Medsafe tell me how my product is categorised?
Yes. You can ask Medsafe for a categorisation, with the ingredients and strengths, the purpose and mode of action, the label, promotional material and any approvals from other regulators.
Does a supplement label need the words 'Dietary Supplement'?
Medsafe's checklist for compliance with the regulations includes that the labelling carries the words 'Dietary Supplement'.
Does the Food Standards Code apply to dietary supplements in New Zealand?
No. Since 18 December 2024, regulation 2B of the Dietary Supplements Regulations 1985 says the joint food standards do not apply to dietary supplements; the regulations set their label and dose rules.
Can a supplement in New Zealand claim to help with weight loss?
Regulation 11 of the Dietary Supplements Regulations 1985 bars labelling or advertising about changing body shape, size or weight, or treating or preventing disease, except as the Medicines Act 1981 permits.
How does Compliant Always help with selling in New Zealand?
Our team reads the rules for the markets you sell in, including the Food Standards Code New Zealand shares with Australia. Compliant Always shows which apply to your product, keeps the documents behind each one ready, and watches the sources for changes. It shows what the requirements say and what your documents show; you decide.

Sources

Compliant Always is a product of Lettuce Labs LLC. It shows what requirements say and what your documents show. It is not legal advice, and you decide.

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