Australia · Supplements

Supplement Labelling in Australia

A practical guide to Supplement Labelling for supplements sold in Australia: who it applies to, what to prepare, and the mistakes that cause rejection.

Who needs it

Labels must show the ingredient list, dosage, warnings, and local importer details; Online sellers listing supplements for buyers in Australia

Authority

Therapeutic Goods Administration

Legal basis

Therapeutic Goods Act 1989

Local representative

A local notifying entity is required

Timeline

Before sale; notification review takes weeks

Cost

Dossier and testing costs vary by ingredient

If you do not comply

Seizure, fines, and listing removal

Who needs this

Labels must show the ingredient list, dosage, warnings, and local importer details
Online sellers listing supplements for buyers in Australia

Documents you need

Supplement label artwork
Ingredient and dosage review
Product information file
GMP certificate

Compliance checklist

Tick each item as you collect it. Saved in this browser only.

Supplement label artwork
Ingredient and dosage review
Product information file
GMP certificate

How to comply

Apply dosage and warning information
Check whether ingredients are permitted locally
Prepare the product information file
Register or notify where required

Brief for your lab or agent

Copy this into an email, then edit the product and channel.

Request: Supplement Labelling — Australia
Product category: Supplements
Authority: Therapeutic Goods Administration
Legal basis: Therapeutic Goods Act 1989

Documents we already have:
  1. Supplement label artwork
  2. Ingredient and dosage review
  3. Product information file
  4. GMP certificate

Questions:
  1. Does our product fall under Supplement Labelling in Australia?
  2. Which test standards or evidence do you accept?
  3. What is the current fee and lead time?
  4. Is a local representative required, and can you act as one?

Cost and timeline

Before sale; notification review takes weeks.

Dossier and testing costs vary by ingredient.

Common rejection reasons

Dosage instructions missing
Ingredient not permitted
Claims too strong for the category
Label missing required warnings

Registration, notification, or certification is not the same as approval. Keep the technical file current and make sure the label, listing, and submitted data match.