Selling gummy supplements in Australia means working through a clear regulatory framework. Two things matter most: Good Manufacturing Practice (GMP) and the Therapeutic Goods Administration (TGA) requirements.
Key Regulatory Bodies and Frameworks
The TGA regulates therapeutic goods in Australia, including most supplements. Most gummy supplements are complementary medicines, and the usual pathway is listing as a "listed medicine" with an AUST L number on the ARTG.
Essential Certifications and Standards
To sell them legally, you need these:
- TGA Listing (AUST L Number): Listing on the ARTG requires an Australian sponsor (an Australian company that carries on business there). Overseas brands set up an Australian entity or appoint a local sponsor. Listing is by self-certification, not pre-market approval.
- GMP Certification: Every manufacturing step must take place at a GMP-compliant site. An Australian site needs a TGA manufacturing licence; an overseas site, such as a US contract manufacturer, needs GMP clearance or certification, applied for by the sponsor.
- Quality Testing: The sponsor must hold evidence that each batch meets standards for identity, purity, strength, and composition, tested in-house or by an independent laboratory. The TGA can request that evidence at any time.
Important Considerations for Compliance
Core certifications aren't everything. You also need to get these right:
- Accurate Labeling: Labels must show the AUST L number, active ingredient names and quantities, batch number, and expiry date. Listed medicines may only use low-level indications, and no claim may suggest the product can diagnose, treat, cure, or prevent disease.
- Ingredient Approval: Check that every ingredient, active and inactive, appears in the Therapeutic Goods (Permissible Ingredients) Determination for listed and assessed listed medicines.
- Supply Chain Verification: If you use a contract manufacturer, confirm the site holds a current TGA manufacturing licence (Australia) or GMP clearance or certification (overseas), and that each manufacturing step is covered.
Medicine or Food: Classification Depends on Claims
A gummy supplement is regulated as a therapeutic good or a food depending on its claims. A gummy with therapeutic claims is a medicine under the TGA, so the listing, sponsor, and GMP requirements above apply. A gummy presented purely as a food is regulated by Food Standards Australia New Zealand and the state and territory food agencies instead. That route has no ARTG listing or TGA GMP requirement; the product must instead meet the Australia New Zealand Food Standards Code.
The requirements look dense, but each is manageable in turn. The cleanest route is a manufacturer that already holds GMP clearance or certification and knows the Australian listing process.