Sports supplements declared to be medicines

How sports supplements are regulated in Australia

In Australia, a sports supplement can be classified as either a food or a medicine in law (see Food and medicine regulation). How it is classified depends on factors including the product's ingredients, marketing claims and how it is presented (including the dosage form - pill, food bar, powder etc.).

Many sports supplements are appropriately marketed as foods in Australia. However, some contain ingredients that have stimulant or other drug-like effects, such as changes to hormone levels, or are in a medicinal dosage form (e.g. tablets, pills and capsules). These products can present a higher risk to the consumer and it is therefore inappropriate to have them available for purchase as foods.

Because of safety concerns related to the use of certain sports supplements, a declaration has been made providing legal clarification on which sports supplements are considered therapeutic goods in Australia. Determining whether a product is a food or a medicine is important because there are different requirements for medicines and foods that depend on factors including product ingredients, and how they are manufactured, labelled and advertised.

Sports supplements now declared to be therapeutic goods

The legal clarification provided by the declaration means that sports supplements will be regulated by the TGA as therapeutic goods if:

• they are presented in the medicinal dosage form of a pill, tablet or capsule, or
• their ingredients are higher-risk to consumers

A sports supplement contains a higher-risk ingredient if there are:

• substances present in the product, regardless of how they got there, that are 'scheduled' in the Australian Poisons Standard (e.g. prescription medicine ingredients)
• ingredients that are intentionally added to the product that are classified as a substance banned for use in sport by the World Anti-Doping Agency
• ingredients that are intentionally added to the product that are substances included in a list of 'Relevant Substances' specified in the declaration

Sports supplements that will not be affected

Sports supplements that contain ingredients appropriate for food and that are presented as food will be regulated as food e.g. protein powders, nutrition bars, energy drinks.

Other products that do not make any therapeutic claims, including in relation to sports or exercise performance, will also be unaffected by the declaration e.g. artificial sweeteners.

Impacts on consumer choice

Consumers will continue to be able to buy sports supplement products.

Those that contain only appropriate ingredients and are in a presentation appropriate for foods (e.g. protein powders) will continue to be marketed as foods. There will also continue to be sports supplements supplied in Australia as medicines (these products have an AUST L or AUST R number on the front label to identify that these products are entered on the Australian Register of Therapeutic Goods - ARTG).

Consumers may see changes to some sports supplements on the market in relation to their formulation, claims, labelling and advertising, as manufacturers of those affected products choose to change certain aspects of their products to be regulated as a food or a medicine.

Availability of listed medicine sports supplements

Sports supplements presented as a pill, tablet or capsule and only containing lower risk ingredients may start to be regulated as a 'listed medicine' (the same as many vitamin and dietary supplements). Listed medicines carry an 'AUST L' number and are readily available from general retail stores (such as supermarkets and supplement stores) and do not require a prescription to purchase them. It is anticipated that most sports supplements declared to be therapeutic goods would fall into the 'listed medicine' category.

Availability of sports supplement products containing higher risk ingredients

Sports supplements presented as a pill, tablet or capsule or containing higher risk ingredients may change to be regulated as a 'registered medicine' and carry an 'AUST R' number on their labels. Depending on their ingredients and health claims (indications), registered medicines can be available at general retail stores (e.g. paracetamol products), or at pharmacies with the advice of a pharmacist (e.g. certain anti-inflammatory medicines) or a doctor's prescription (e.g. hormone preparations).

Implementation of changes

The declaration will come into effect on 30 November 2020. Sports supplements that are covered by the declaration and contain higher-risk ingredients will from that time be regulated as medicines and be required to comply with all applicable therapeutic goods legislation.

Sports supplements that are presented as tablets, capsules or pills and do not contain ingredients covered by the declaration will have 3 years (by 30 November 2023) to comply with the legislation (e.g. change their dosage form to remain regulated as food or become a therapeutic good).

More information

• Submissions received and the Government response: Proposed clarification that certain sports supplements are therapeutic goods
• Regulatory Impact Statement