How are vitamins regulated in Australia?

For some people, vitamins play an important part in their health.  For example, folic acid taken during pregnancy can reduce the risk of birth defects, while vitamin D can promote bone health in someone with a vitamin D deficiency.

In Australia, the Therapeutic Goods Administration (TGA) regulates all vitamins for safety and quality.

Like any medicine, vitamins can have side effects or interact in unwanted ways with other medicines. Vitamins should only be used as directed on the label, and you should consult a health professional if you experience any health issues while taking a vitamin.

In this article, we will explain how we regulate vitamins, and how the AUST number (the Australian Register of Therapeutic Goods (ARTG) identification number) on the product label tells you what kind of TGA scrutiny a vitamin has received.

How the TGA regulates vitamins

The TGA is responsible for regulating medicines and other therapeutic goods in Australia. We evaluate higher risk medicines for safety, quality and efficacy before they can be legally supplied in Australia. Efficacy refers to whether a product does what it says it is going to do. Medicines that have been premarket evaluated for quality, safety and efficacy by the TGA are called registered medicines and have an AUST R number on their medicine label.

We do not premarket evaluate lower risk medicines, but we regulate the safety and quality of these medicines by limiting them to use only pre-approved low-risk ingredients, make only pre-approved low-risk indications (health claims), and requiring they be made under quality manufacturing principles. These medicines are called listed medicines and have an AUST L number on their medicine label.

The sponsor (‘product owner’) of a listed medicine is also required to hold evidence that their product works, and they must provide this evidence to the TGA if we ask them to.

While AUST L medicines have not been pre-market evaluated by the TGA, there is another type of listed medicine, called listed assessed medicines, which are evaluated by the TGA for efficacy pre-market. These have an AUST L(A) number on the medicine label. Like other listed medicines they can only use pre-approved low risk ingredients.

The TGA's regulatory approach reduces the cost of approving low-risk medicines. If we reviewed all low-risk products for efficacy before they were permitted on the market, the additional costs would likely be passed on to consumers and it would take significantly more time for new products to become available.

Depending on the vitamin type and the dose, vitamins are regulated either as registered medicines (prescription medicines or registered complementary medicines), or as listed medicines (listed or assessed listed medicines). Most vitamins fall into the category of listed medicines, which means that these are not evaluated by the TGA pre-market.

Vitamins must meet specific criteria before they can be legally supplied in Australia

The TGA's regulation of vitamins and other low-risk medicines as listed medicines involves products meeting specific criteria:

• The product must only contain ingredients from a pre-approved list that the TGA has already assessed for safety and quality.
• The sponsor of the product must choose from a pre-approved list of indications and these uses can only relate to minor health conditions. Listed medicines are prohibited from making claims about serious and life-threatening conditions.
• The product must be manufactured in a certified facility that meets manufacturing quality standards.
• The sponsor of the product should hold evidence that their product does what they say it does (efficacy).

Vitamins are subject to TGA market surveillance

For low-risk medicines, the TGA does not evaluate the sponsor's evidence of product efficacy before the product goes on the market, nor do we examine the final product and its label. However, we may review any product on the ARTG as part of compliance reviews of products on the market. Every year we review several hundred products in this manner.

If a TGA review finds that a sponsor does not hold sufficient evidence of their product's efficacy, we can, and do, cancel their medicine from the ARTG which means it can no longer be supplied in Australia. Other forms of non-compliance, such as inappropriate or inaccurate labels, can also lead to cancellation. We regularly publish lists of cancelled products on the TGA website.

Check the label for an AUST R, AUST L or AUST L(A) number

All medicines that are approved for supply by the TGA include either an AUST R, an AUST L or an AUST L(A) number on their label.

AUST R numbers are for registered medicines that the TGA has evaluated for safety, quality and efficacy.

AUST L numbers are for listed medicines, that have not been pre-market evaluated by the TGA but can only use pre-approved low risk ingredients and pre-approved low risk indications.

AUST L(A) numbers are for listed assessed medicines that have undergone a TGA pre-market assessment of the efficacy of the medicine’s indications. Like other listed medicines, these medicines can only contain low risk ingredients from a TGA pre-approved list.

Medicines that do not display these numbers may not be approved for sale in Australia. This is especially a concern for products sold online, which may contain unlisted, potentially dangerous ingredients. As such, the TGA recommends consumers only purchase products that include AUST numbers on their medicine label.

Seek professional advice

Taking vitamins comes with many of the same considerations as other medicines. Always read the label of a vitamin product and follow the instructions for use.

Some vitamins may have side effects or may interact with other medicines . So when you are asked what medicines you are taking by your doctor or pharmacist (e.g. before surgery), remember to include vitamins on the list, along with any other medicines.

Report significant problems and unexpected side effects

Everyone can play an important role in monitoring the advertising and safety of medicines in Australia.

If you experience an unexpected side effect when taking a medicine, you should seek advice from a health professional as soon as possible and also report the event to the TGA.

If you see a product or advertisement that appears to be making claims that don’t seem truthful, you should report it to the TGA.