What mandatory information must appear on supplement labels 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 supplement labels for the mandatory information required under the Therapeutic Goods Act and Advertising Code. Listed Medicine supplement labels in Australia must include the AUST L number, sponsor name and address, product name, directions for use, warnings, ingredient list, and the statement 'Always read the label and follow the directions for use' — these are mandatory requirements under the Therapeutic Goods Act 1989 and the Therapeutic Goods Advertising Code 2021.
The rule: Therapeutic Goods Act 1989 / Therapeutic Goods Advertising Code 2021, TGA Act s.9; TGAC 2021 s.14–16; Therapeutic Goods Order No. 92
Listed Medicine labels in Australia are governed by the Therapeutic Goods Act 1989, Therapeutic Goods Order No. 92 (Standard for labels of non-prescription medicines), and the Therapeutic Goods Advertising Code 2021. Mandatory label elements include: the AUST L or AUST R number in a prominent position, the sponsor's name and Australian address, the product name, a full ingredient list, directions for use, required advisory statements, and where the label also constitutes advertising, the 'always read the label' statement. Missing any mandatory element constitutes a breach of both the Act and the Code.
What this means in practice
- Display the AUST L or AUST R number prominently on the label — it must be clearly legible and not obscured by design elements.
- Include the sponsor's name and full Australian address — a PO box is not an adequate address for TGA labelling purposes.
- List all active and excipient ingredients in descending order of quantity — the ingredient list must be complete and accurate as currently formulated.
- Include all required advisory statements from Therapeutic Goods Order No. 92 for the product's ingredient and indication profile.
- Where the label includes advertising content (health claims, promotional language), the 'always read the label and follow the directions for use' statement is mandatory.
Common mistakes
Omitting the AUST number from front-of-pack label elements
The AUST number must appear on the label in a way that is clearly associated with the product — placing it only on the base of a bottle in a font too small to read does not satisfy the prominence requirement.
Display the AUST number on the primary display panel or immediately adjacent to the product name in a legible font size.
Using a registered business address that is not an Australian address
The TGA requires an Australian address for the sponsor — an international address, a registered agent address outside Australia, or a PO box does not satisfy the requirement.
Ensure the sponsor address on the label is a full Australian street address where correspondence can be received.
Failing to update labels after ARTG listing amendments
Where a product's ARTG listing is amended — for example, after a formulation change or indication update — the label must be updated to reflect the current listing. Selling product with labels that do not match the current ARTG entry is a breach of the Act.
Trigger a label review whenever the ARTG listing is amended. Establish a process linking formulation change management to label compliance review.
Compliant vs non-compliant example
❌ NON-COMPLIANT
Omitting the AUST number from front-of-pack label elements
✅ COMPLIANT
Display the AUST number on the primary display panel or immediately adjacent to the product name in a legible font size.
The enforcement context
TGA label audits are conducted as part of post-market surveillance. Non-compliant labels can result in TGA-directed product recalls, removal from the ARTG, and infringement notices. Label compliance is one of the most commonly cited issues in TGA compliance education materials and enforcement actions.
Before you publish, check it.
CompliGUARD reviews supplement label content against TGA labelling requirements and the Therapeutic Goods Advertising Code.
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Regulatory references
- Therapeutic Goods Act 1989 (Cth), s.9
- Therapeutic Goods Order No. 92 — Standard for labels of non-prescription medicines
- Therapeutic Goods Advertising Code 2021 (Cth), s.14–16