Supplements
Listed isn’t substantiated. The TGA grants the AUST L. You still have to defend the claim.
Talk to us about your evidence strategy.
Contact usSupplements in Australia are regulated as therapeutic goods. Most sit on the ARTG as AUST L listed medicines, where the sponsor self-certifies that the product holds evidence for every indication on the label. The TGA can audit. The Australian Competition and Consumer Commission (ACCC) layers on top, enforcing the Australian Consumer Law (ACL) against misleading efficacy claims. Parallaxis helps supplement brands and ingredient houses build the substantiation file before the product is listed, and closes evidence gaps on products already in market.
New Zealand handles supplements differently again. Traditional dietary supplements fall under the Dietary Supplements Regulations 1985, administered by Medsafe, while food-type supplements sit under the Food Act 2014 and the Supplemented Food Standard, administered by MPI. A new natural health products regime has been signalled but is not yet in force. The Commerce Commission enforces the Fair Trading Act on misleading claims, the same way the ACCC does in Australia. Selling across both markets means satisfying both regimes.
Who This Is For
B2C. Supplement brands.
Nutraceuticals, gym and sports nutrition, functional foods, beauty from within, condition-led blends. You are selling to consumers who read the label and want proof.
B2B. Ingredient manufacturers and contract formulators.
Your customers are asking for substantiation packs and clinical data, not just COAs.
The Regulatory Landscape
Most supplements list via this pathway. Sponsors choose from the Permissible Indications. Listing is fast and low cost. The trade-off: the sponsor must hold evidence for every indication, to a standard and specific format that the TGA requires and can audit.
AUST L(A) sits between AUST L and AUST R. Listings can reference more serious conditions, once individually assessed by TGA. It is a middle path: more rigorous and higher-trust than AUST L, without the full pre-market burden of an AUST R registration.
Higher risk or condition-specific products that refer to indications outside of the permissible indications list. Full pre-market efficacy and safety review.
Orally ingested products with cosmetic claims, such as skin, hair and nails, are declared therapeutic goods. The beauty-from-within category lives here. Any therapeutic-level claim that sits outside of the permissible indication list will require an AUST R submission.
Functional and fortified foods sit under FSANZ, a joint Australian and New Zealand regulatory body. The FSANZ Food Standards Code governs what nutritive substances can be added to food, what health claims are permitted, and how they must be substantiated. Permitted health claims are a defined list, and the evidence standard is stringent.
‘TGA listed’ is not a shield. The ACCC can act on misleading marketing claims regardless of listing status.
Where Brands Get Stuck
Indications chosen without confirming evidence exists to substantiate them.
Marketing claims that overshoot what is actually listed on the ARTG.
Ingredient evidence at one dose used to substantiate a different dose or form.
The Proof We Build
- Permissible indication match.
- Systematic evidence search and synthesis to TGA standard.
- Evidence matrix: every claim, every source, every quality rating.
- Audit-ready substantiation file.
- Claims architecture across pack, website, paid media and regulated channels.
When to Talk to Us
You are listing a new product and need an evidence dossier as part of the AUST L requirements.
You have an AUST L portfolio and no consolidated evidence substantiation file.
You have an AUST L portfolio with evidence dossiers that haven’t been reviewed in the last 24 months.
The TGA, a distributor, retailer or investor has asked for an evidence pack.
Common Questions
AUST L is the listed pathway. The sponsor self-certifies safety, quality and evidence for permitted indications. AUST R is the registered pathway requiring TGA pre-market review.
The assessed listed pathway. The sponsor uses permissible indications as with AUST L, but the TGA assesses the efficacy evidence before listing. It sits between AUST L self-certification and full AUST R registration.
The list of indications a sponsor can choose from when listing a medicine. Anything outside the list requires the additional supported indication process and a higher evidence bar.
No. A listing means the product is on the ARTG. It does not immunise the brand from Australian Consumer Law action on misleading or unsubstantiated marketing claims.