Watched Vitamania? Here’s how the TGA regulates vitamins in Australia

On the evening of 12 August 2018, the documentary “Vitamania” premiered in Australia. The documentary explores the role of vitamins and vitamin purchases around the world. To provide context for the film, we describe how the Therapeutic Goods Administration (TGA) regulates vitamins in Australia.

The TGA is responsible for regulating medicines and other therapeutic goods in Australia. We assess 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.

We assess lower risk medicines for safety and quality only. However, the commercial sponsor of the medicine is required to hold evidence that their product works, and they must provide this evidence to the TGA if we conduct a formal compliance review of the product.

The TGA’s 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 be passed on to consumers.

Depending on the vitamin and the dose, vitamins are regulated either as prescription medicines or as complementary, over the counter (OTC) medicines. Most vitamins fall into the category of low-risk complementary medicines, which means that the TGA assesses them for safety and quality only.

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

The TGA’s pre-market assessment of vitamins and other low-risk medicines for safety and quality 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 commercial sponsor of the product must choose from a pre-approved list of uses, and these uses can only relate to minor health problems. Products are prohibited from making claims about serious and life-threatening conditions.
• The product must be manufactured in a certified facility that meets quality standards.
• The sponsor of the product must hold evidence that their product does what they say it does.

Vitamins are subject to TGA market surveillance

For low-risk medicines, the TGA does not evaluate the commercial 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 as part of our targeted and random surveillance 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 approval to supply the product 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 or AUST L number

All medicines that are approved for supply by the TGA include either an AUST R number or an AUST L 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 low-risk listed medicines, such as most vitamin products, that the TGA has evaluated for safety and quality only.

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 and other complementary medicines may interact with other medicines or other supplements and may have side effects of their own. So when you are asked what medicines you are taking by your doctor or pharmacist (e.g. before surgery), remember to include vitamins and other complementary medicines on the list.

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 see a product or advertisement that appears to be making misleading claims, you should report it to the TGA.

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.

(Source: Therapeutic Goods Administration)