What are the labelling rules for natural health products in Australia?
CompliGUARD reviews this compliance area against TGA · AHPRA · FSANZ · ACCC frameworks for Australian health brands — here's what the regulations say.
CompliGUARD reviews natural health product labelling against the Therapeutic Goods Act and FSANZ Food Standards Code. Labelling rules for natural health products in Australia depend on classification — Listed Medicines (AUST L) are governed by TGA labelling requirements including Therapeutic Goods Order No. 92; food products are governed by FSANZ Standard 1.2.1; and all products must not carry misleading claims under the Australian Consumer Law.
The rule: Therapeutic Goods Act 1989 / Australia New Zealand Food Standards Code, TGA Act s.9; TGO No. 92; FSANZ Standard 1.2.1; ACL s.18
The labelling requirements for a natural health product are determined by its regulatory classification. Products listed on the ARTG as Listed Medicines (AUST L) are subject to Therapeutic Goods Order No. 92 and the Therapeutic Goods Act 1989 labelling requirements. Products classified as foods are subject to FSANZ Standard 1.2.1, which sets out mandatory labelling information including ingredient lists, allergen declarations, nutrition information panels, and country of origin statements. Products that sit on the food-medicine boundary require a classification determination before the correct labelling standard can be applied. Applying the wrong labelling standard — even inadvertently — constitutes non-compliance under whichever framework actually governs the product.
What this means in practice
- Determine product classification before designing labels — the labelling requirements differ significantly between TGA-regulated Listed Medicines and FSANZ-regulated food products.
- For Listed Medicines: ensure AUST L number, sponsor details, ingredient list, directions for use, and required advisory statements are all present.
- For food products: ensure the nutrition information panel, ingredient list, allergen declarations, and country of origin statement meet FSANZ Standard 1.2.1 requirements.
- For borderline products: use the TGA Food-Medicine Interface Guidance Tool to confirm classification before selecting which labelling standard to apply.
- Review all label claims — including imagery and taglines — against the ACL misleading conduct standard regardless of which primary framework applies.
Common mistakes
Applying food labelling standards to a product that should be classified as a Listed Medicine
A natural health product that meets the definition of a therapeutic good requires ARTG listing and TGA-compliant labelling — applying FSANZ food labelling standards to a therapeutic good does not satisfy TGA requirements and may constitute supply of an unregistered therapeutic good.
Confirm classification using the TGA Food-Medicine Interface Guidance Tool before finalising labels. If classification is unclear, seek regulatory advice before going to print.
Omitting allergen declarations on natural health food products
FSANZ Standard 1.2.3 requires mandatory allergen declarations for foods containing any of the prescribed allergens — including gluten, dairy, soy, nuts, eggs, and shellfish. Natural health food products frequently contain these ingredients and are subject to the same allergen declaration requirements as conventional foods.
Review the ingredient list for all prescribed allergens under Standard 1.2.3 and include required declarations in the correct format on the label.
Not updating labels when the product is exported to New Zealand
The Australia New Zealand Food Standards Code applies in both countries but TGA product registration does not extend to New Zealand. Products exported to New Zealand may be subject to Medsafe requirements in addition to or instead of TGA requirements, depending on classification.
Confirm regulatory requirements for each market separately before exporting natural health products across the Tasman.
Compliant vs non-compliant example
❌ NON-COMPLIANT
Applying food labelling standards to a product that should be classified as a Listed Medicine
✅ COMPLIANT
Confirm classification using the TGA Food-Medicine Interface Guidance Tool before finalising labels. If classification is unclear, seek regulatory advice before going to print.
The enforcement context
State and territory food authorities and the TGA both have powers to audit natural health product labels and take enforcement action. Products found to be incorrectly classified — and therefore carrying the wrong labelling — may be subject to recall, market withdrawal, or enforcement action under the applicable framework.
Before you publish, check it.
CompliGUARD reviews natural health product label content against TGA and FSANZ labelling requirements based on product classification.
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Regulatory references
- Therapeutic Goods Act 1989 (Cth), s.9
- Therapeutic Goods Order No. 92
- Australia New Zealand Food Standards Code, Standard 1.2.1 (Requirements for labelling and other information)
- Australia New Zealand Food Standards Code, Standard 1.2.3 (Mandatory warning and advisory statements and declarations)
- Australian Consumer Law (Competition and Consumer Act 2010, Schedule 2), s.18