Natural Medicine Regulation: FAQ

Twenty questions about natural medicine regulation in Australia , answered plainly

Forty-three. That's how many browser tabs I had open the afternoon I tried to map the full Australian regulatory picture for complementary medicines, cannabinoids, peptides and psychedelics in one sitting. A colleague walked past my desk at the Queensland University of Technology library annex on Musk Avenue and asked if I was doing a research project or having a breakdown. Possibly both.

The point is: this is genuinely complicated territory, and I reckon the confusion causes real harm , people make decisions based on half-understood rules. So below are the questions we get asked most often, answered as carefully as I can without the fifty browser tabs.

The regulatory framework

1. What body regulates natural medicines in Australia?

The Therapeutic Goods Administration (TGA), a division of the Australian Department of Health and Aged Care, is the primary regulator. It administers the Therapeutic Goods Act 1989 (Cth) and the associated Poisons Standard (formally the Standard for the Uniform Scheduling of Medicines and Poisons, or SUSMP). State and territory health departments administer their own controlled-substances legislation, which mirrors the Poisons Standard but can add local conditions.

2. What is the ARTG and why does it matter?

The Australian Register of Therapeutic Goods (ARTG) is the official list of products that may be lawfully supplied in Australia. A product not on the ARTG , or not exempt from registration; cannot legally be sold here as a therapeutic good. It matters because "natural" or "herbal" does not automatically mean listed or approved.

3. What's the difference between a Listed and a Registered medicine?

Listed medicines (AUST L or AUST L(A)) go through a lower-evidence pathway: the TGA assesses ingredients for safety and quality, but the sponsor self-certifies the efficacy evidence. Registered medicines (AUST R) undergo full pre-market TGA evaluation of safety, quality and efficacy. Most herbal, vitamin and mineral supplements are Listed. Most prescription pharmaceuticals, including approved cannabis medicines, are Registered.

4. What is Good Manufacturing Practice and does it apply to natural medicines?

Yes. Good Manufacturing Practice (GMP) applies across the board. Manufacturers must hold or use facilities that meet TGA GMP standards, including for herbal extracts and standardised extracts. Overseas manufacturers supplying Australia must also satisfy TGA's overseas GMP clearance process.

Cannabinoids and cannabis medicines

5. Are cannabinoid medicines legal in Australia?

Regulated, not simply "legal" or "illegal", the distinction matters. Cannabis medicines are controlled under both the Poisons Standard and the Narcotic Drugs Act 1967 (Cth). Cannabidiol (CBD) at low doses (up to 150 mg/day) was down-scheduled to Schedule 3 (pharmacist-only) in 2021 for specific approved products. Higher-dose CBD and all THC-containing products remain Schedule 8 (controlled drugs), requiring a prescription and, in most states, a permit.

6. What schedule are most cannabis medicines under?

Schedule 8. That means they are prescription-only at minimum, with additional state-level controlled-drug requirements layered on top. Prescribers generally need to obtain state/territory approval before prescribing Schedule 8 cannabis medicines, though some states have streamlined this for TGA-approved products.

7. How does a patient legally access a cannabis medicine?

There are three main pathways. First, if a product is on the ARTG, a doctor prescribes it under normal prescription rules. Second, unapproved products can be accessed via the TGA's Special Access Scheme (SAS); Category B notification or Category A for terminal illness. Third, patients can access unapproved products through an Authorised Prescriber, a doctor approved by the TGA to prescribe a specific unapproved product to a class of patients without case-by-case SAS approval. I'd point anyone navigating this toward the TGA's own guidance rather than a social-media thread.

8. What about minor cannabinoids like CBG, CBN, or delta-8-THC?

Most are caught by the Poisons Standard regardless of how they are labelled or sourced. CBG and CBN are listed as Schedule 4 when in preparations for human therapeutic use. Delta-8-THC is a Schedule 9 prohibited substance in Australia, it does not occupy some legal grey zone here the way it briefly did in parts of the United States. Similarly, HHC and THCP are captured under Schedule 9 as THC analogues. The short version is: if it's a psychoactive cannabinoid, assume Schedule 9 unless you can specifically confirm otherwise in the current Poisons Standard.

9. What is the endocannabinoid system, briefly?

It's a cell-signalling system found throughout the body, involving CB1 receptors, CB2 receptors, and endogenous ligands like anandamide. A fuller explanation lives in our endocannabinoid system glossary entry. Regulatory classification of exogenous cannabinoids does not depend on their endocannabinoid system activity, it depends on chemical structure and scheduling decisions made by the TGA and state authorities.

10. Do terpenes have any scheduling status?

Generally, no; isolated terpenes such as myrcene, limonene, beta-caryophyllene or linalool are not scheduled under the Poisons Standard and are widely used in food, fragrance and cosmetics. Their presence in a cannabis product does not change that product's scheduling; the scheduling follows the cannabinoid content. Research into entourage effect hypotheses involving terpenes is ongoing but does not affect current regulatory classification.

Peptides

11. What are peptides, in a regulatory sense?

Peptides are short chains of amino acids linked by peptide bonds. In a regulatory sense, many synthetic peptides intended for human use are therapeutic goods and require ARTG inclusion or a valid access pathway. The TGA has been actively enforcing against the supply of unapproved peptides, particularly those marketed for performance enhancement or body composition.

12. Are performance-enhancement peptides legal to buy in Australia?

Plainly: most are not. Synthetic peptides marketed for performance or anti-ageing purposes, including various research-labelled peptides circulating online, are frequently unapproved therapeutic goods. Supplying an unapproved therapeutic good in Australia is illegal under the Therapeutic Goods Act 1989. The TGA has issued multiple warnings and taken enforcement action in this space. "Research chemical" or "not for human use" labelling does not change the legal position if the substance meets the definition of a therapeutic good.

13. What about GLP-1 receptor agonist peptides?

GLP-1 receptor agonists that are approved therapeutic goods in Australia are Schedule 4 prescription-only medicines. Compounded versions are a more complex area; the TGA has issued specific guidance on compounding of these substances, including restrictions on active pharmaceutical ingredient sourcing. If a prescriber or compounder is involved, their obligations under the Therapeutic Goods Act and relevant pharmacy legislation still apply. Unapproved raw peptide material supplied outside those frameworks raises the same enforcement issues as other unapproved peptides.

Psychedelics

14. What is the legal status of psilocybin in Australia?

Psilocybin is a Schedule 9 prohibited substance under the Poisons Standard. Possession, supply and manufacture outside of authorised frameworks is a criminal offence under Commonwealth and state law. From 1 July 2023, the TGA created a limited exception: Authorised Prescribers, specialist psychiatrists approved by the TGA, may prescribe Schedule 8 psilocybin (rescheduled for this purpose only) for a specific class of patients under defined conditions. This is a narrow, supervised clinical pathway. It is not a general legalisation. Outside of that authorised pathway, psilocybin remains Schedule 9.

15. Can a GP prescribe psilocybin?

No. Only TGA-approved Authorised Prescribers who are specialist psychiatrists may prescribe psilocybin under the current framework. There is no SAS pathway for psilocybin for most conditions; the Authorised Prescriber route is the only legal clinical access point, and it comes with strict oversight requirements.

16. What about MDMA?

Similarly narrow. MDMA was rescheduled from Schedule 9 to Schedule 8 for the specific purpose of Authorised Prescriber use in post-traumatic stress disorder from 1 July 2023. Outside that clinical framework, MDMA remains a Schedule 9 prohibited substance. No home use, no self-directed protocols. If you see content online presenting MDMA use as a straightforward therapeutic option, it is not describing the Australian legal position accurately.

Phytomedicine and herbal medicines

17. What is phytomedicine and how is it regulated?

Phytomedicine refers to plant-derived preparations used for their presumed physiological effects. In Australia, these sit under the Listed medicines pathway if sold as therapeutic goods, requiring ARTG listing and GMP-compliant manufacture. Permitted ingredients and permitted indications are governed by the TGA's Permitted Indications list; a product cannot make claims beyond those permitted without going through the full Registered pathway.

18. Are herbal medicines allowed to make health claims?

Only within the TGA's Permitted Indications framework for Listed medicines, and only at the "low-level" claim standard. Claims implying treatment or cure of serious diseases require full Registration evidence. The TGA's Advertising Code also applies; misleading therapeutic claims in advertising are an offence regardless of whether the product itself is correctly listed.

Bioavailability and formulation

19. Does the form of a natural medicine affect its regulatory status?

Form affects bioavailability and pharmacokinetics, including first-pass metabolism considerations, but not scheduling. A cannabinoid is still scheduled at the same level whether it's an oil, a capsule, or a subcutaneous injection. That said, formulation can affect which product approvals apply; an ARTG-listed product is only approved in the specific form and dose listed.

20. What's the difference between full-spectrum, broad-spectrum and isolate in a regulatory context?

These terms describe the cannabinoid profile of a preparation. Full-spectrum preparations contain multiple cannabinoids including THC; broad-spectrum preparations aim to remove THC while retaining other cannabinoids; isolate is a single purified cannabinoid. From a regulatory standpoint, the scheduling of a preparation follows its highest-scheduled component. A full-spectrum product containing any THC is a Schedule 8 product regardless of THC concentration (above the 1% w/w threshold for unscheduled hemp food products). The marketing language does not change the scheduling classification.

Honestly, I find the gap between public understanding and the actual regulatory framework one of the more frustrating things about this field. The rules exist for good reasons; they're just not well explained in plain language anywhere that's easy to find. I hope this goes some way toward filling that gap; and if something here has shifted since publication (the Poisons Standard is updated regularly), the TGA website is always the authoritative source.

Sources

• Poisons Standard (SUSMP), Therapeutic Goods Administration (TGA)
• Medicinal cannabis guidance documents, Therapeutic Goods Administration (TGA)
• Authorised Prescribers for psilocybin and MDMA; Therapeutic Goods Administration (TGA)
• Cannabis: drug facts, Alcohol and Drug Foundation (ADF)

, Tom Whitfield, Health librarian, references & fact-checking