The legal risk is often created by the product claim, not just the product itself. A skincare, supplement, device or wellness product may look like ordinary ecommerce stock until the website says it treats, prevents, diagnoses or improves a health condition.
Main laws
Commonwealth Act
Therapeutic Goods Act 1989 (Cth)
The Therapeutic Goods Act affects supplements, health products, medical devices, therapeutic claims, ARTG and recalls.
In forceCommonwealthPlain-English guide5 practical checks
Plain-English explainers, not legal advice. Check the linked official source before you rely on a specific section, and get advice for your situation.
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Quick read
- This Act matters when a product crosses the line into therapeutic goods.
- For small businesses, the danger zone is making health, treatment, performance or medical claims without first checking ARTG, sponsor, manufacturing, advertising and recall...
Likely relevant if
- Supplement, wellness, skincare, cosmetic and health-product brands
- Importers, sponsors and distributors of therapeutic goods
- Medical device, pharmacy, telehealth and allied-health product businesses
Check first
- Check whether products are therapeutic goods, medical devices, biologicals or excluded goods.
- Confirm ARTG registration, listing, inclusion, exemption or approval pathways before supply.
- Keep evidence supporting permitted indications, claims and advertising statements.
Start here
Key points
- Classify the product before ordering stock or writing ads.
- Check whether ARTG registration, listing or inclusion is required.
- Confirm who is the Australian sponsor and who holds evidence for claims.
- Review ads, influencer scripts, labels and product pages together.
Launch risk
Risk points
- Do not copy overseas claims without checking Australian rules.
- Treat customer testimonials and before-and-after content as advertising risk.
- Keep supplier, manufacturing, evidence and adverse-event records.
- Plan recall and complaint steps before the first sale.
Plain-English glossary
- Therapeutic goods
- Goods that are used, represented or likely to be taken for therapeutic use, subject to definitions and exclusions.
- ARTG
- Australian Register of Therapeutic Goods, the register for many therapeutic goods supplied in Australia.
- Sponsor
- The person or entity responsible for importing, exporting or supplying therapeutic goods in Australia in the relevant capacity.
Common questions
Does this only apply to medicines?
No. It can also affect medical devices, biologicals, some supplements, some health products and goods that are represented as therapeutic goods.
Can marketing claims change the legal category?
Yes. Claims about treatment, prevention, diagnosis, health effects or therapeutic use can be central to whether the regime applies.
What should a startup check first?
Check whether the product is a therapeutic good, who the Australian sponsor is, whether ARTG entry is needed and what claims are allowed.