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Research-supported guide

What AUST L means on a supplement label

Supplements sold as medicines in Australia carry a short code starting with AUST. It is easy to read as a stamp of approval, but it means something more specific. Here is what an AUST L number tells you, what it does not, and how it differs from AUST L(A) and AUST R.

  • An AUST L number means a product is a listed medicine on the Australian Register of Therapeutic Goods.
  • Listed medicines can only use pre-approved low-risk ingredients and pre-approved claims for minor health conditions, and must be made in a certified facility.
  • For AUST L products, the TGA has not assessed the evidence for their claims before sale. The sponsor is expected to hold that evidence.
  • AUST L(A) and AUST R medicines have had their evidence assessed by the TGA, and only they can carry a TGA assessed claim.
  • The TGA can review listed products after sale and cancel them from the register.

The short version

An AUST L number on a supplement label means the product is a listed medicine on the Australian Register of Therapeutic Goods. It can only contain ingredients from a pre-approved low-risk list, can only make claims from a pre-approved list, and must be made in a facility that meets manufacturing quality standards.

It does not mean the TGA has checked the evidence that the product does what it says. For most listed medicines, that evidence is not assessed before the product goes on sale.

What an AUST number is

In Australia, vitamins, minerals and other supplements sold as medicines are regulated by the Therapeutic Goods Administration, the TGA. Medicines approved for supply are entered on the Australian Register of Therapeutic Goods, usually called the ARTG.

According to the TGA, all medicines approved for supply carry one of three numbers on their label: an AUST R, an AUST L or an AUST L(A) number. The letters tell you which pathway the product went through, and that tells you what the TGA did, and did not, check before it went on sale.

The three kinds of AUST number

Number What it is Evidence for its claims assessed by the TGA before sale?
AUST L Listed medicine. Pre-approved low-risk ingredients and pre-approved claims for minor health conditions only. No
AUST L(A) Assessed listed medicine. The same kind of low-risk product, with its efficacy assessed by the TGA before sale. Yes
AUST R Registered medicine. Evaluated by the TGA before sale. Yes

What an AUST L number tells you

The product is on the register. It has been entered on the ARTG and can be legally supplied in Australia as a medicine.

Its ingredients come from an approved list. Listed medicines can only contain ingredients from a list of low-risk ingredients the TGA has already approved.

Its claims come from an approved list. The company responsible for the product, known as the sponsor, must choose its uses from a pre-approved list of indications, and those uses can only relate to minor health conditions. A listed medicine cannot make claims about serious conditions.

It is made to a quality standard. Listed medicines must be manufactured in a certified facility that meets manufacturing quality standards.

It can be checked after sale. The TGA may review any product on the ARTG as part of its compliance reviews, and says it can and does cancel medicines from the register when problems are found.

What an AUST L number does not tell you

That the TGA has checked whether it works. The TGA states plainly that if there is an AUST L number on the label, it has not assessed the scientific evidence for the medicine's claims before the product entered the market. The sponsor is expected to hold that evidence, but it is not reviewed up front.

That the TGA endorses it. Being on the register means a product is allowed to be supplied. It is not a recommendation.

That it suits you. A low-risk ingredient can still interact with medicines or be unsuitable for some people. Magnesium is a good example: it interacts with several common medicines and is a particular concern for people with reduced kidney function. Our guide to magnesium side effects and interactions covers this.

What "TGA assessed" means

Some labels carry a "TGA assessed" statement or symbol. According to the TGA, this shows that the TGA has assessed the medicine's indications and found them supported by scientific evidence.

Only two kinds of medicine can use that claim: registered complementary medicines with an AUST R number, and assessed listed medicines with an AUST L(A) number. A product with a plain AUST L number cannot.

Other things on the label worth reading

The AUST number is one line on the label. A few others are just as useful.

The equivalent amount of a mineral. Where a medicine contains a mineral for supplementation, Australian labels must declare how much of the mineral element it contains, not just the compound. That is the "equivalent to" figure, and it is the one to compare between products. Our guide to elemental magnesium explains why the two numbers differ so much.

Every active ingredient. Many supplements contain more than one active ingredient. The TGA advises checking the label of every vitamin or supplement you take for vitamin B6, for example, because it appears in many products, including magnesium supplements, and too much can damage nerves.

Warnings and directions. These are specific to the product. Read them each time you buy, because formulations can change.

How to check a product

The TGA publishes a searchable version of the ARTG on its website, with guidance on how to use it. You can use it to check whether a product is on the register and which kind of AUST number it holds.

A product without an AUST number is not necessarily unlawful, but it is not a medicine on the ARTG. Some products that look like supplements are sold as foods, which are regulated differently. Products bought from overseas websites may not be on the ARTG at all.

If you are unsure about a product, a pharmacist can help you read the label and check it against your other medicines. Nothing on this page is a substitute for individual medical advice.

Questions, clearly answered.

01What does AUST L mean?

It means the product is a listed medicine on the Australian Register of Therapeutic Goods. It can only use pre-approved low-risk ingredients and pre-approved claims, and must be made in a certified facility. The TGA has not assessed the evidence for its claims before sale.

02Does an AUST L number mean the TGA has approved the product's claims?

No. For a product with an AUST L number, the TGA has not assessed the scientific evidence for its claims before it went on sale. The sponsor is expected to hold that evidence.

03What is the difference between AUST L, AUST L(A) and AUST R?

AUST L products are listed without pre-market assessment of their claims. AUST L(A) products are listed after the TGA has assessed their efficacy. AUST R products are registered medicines evaluated by the TGA before sale.

04What does TGA assessed mean on a label?

It shows the TGA has assessed the medicine's indications and found them supported by scientific evidence. Only AUST R and AUST L(A) medicines can use it.

05How do I check whether a supplement is on the ARTG?

The TGA publishes a searchable version of the Australian Register of Therapeutic Goods on its website. A pharmacist can also help you check a product.

Read the evidence yourself.

Sources are provided so readers can examine the research and official guidance directly.

01 How are vitamins regulated in Australia?Therapeutic Goods Administration

AUST L listed medicines are not pre-market evaluated but can only use pre-approved low-risk ingredients and pre-approved indications for minor health conditions. Sponsors should hold evidence of efficacy. Must be made in a certified facility. AUST L(A) medicines have efficacy assessed before sale. The TGA may review products and can cancel them from the ARTG.

02 AUST numbers on medicine labelsTherapeutic Goods Administration

All medicines included in the ARTG must show the relevant AUST number on the label. Medicines with AUST R and AUST L(A) numbers are assessed for efficacy. Those with AUST L numbers are not.

03 Medicine labels: Guidance on TGO 91 and TGO 92Therapeutic Goods Administration

TGA guidance on the labelling standard for non-prescription medicines. Where a medicine contains a mineral for supplementation, the name and quantity of the mineral element must be declared on the label, for example calcium carbonate with the statement equivalent to calcium 500 mg. This applies to all mineral supplements.

04 Are you unknowingly taking too much vitamin B6?Therapeutic Goods Administration

Vitamin B6 is found in a range of products including multivitamins and magnesium, zinc and iron supplements. Advises checking the label of every supplement for vitamin B6.

05 Searching the Australian Register of Therapeutic Goods (ARTG)Therapeutic Goods Administration

TGA guidance on searching the public Australian Register of Therapeutic Goods.