Efficacy of listed medicines for exercise performance

What we did

We required sponsors to provide evidence to support their medicine’s claims. Our assessment focused on:

• the relevance of the evidence to the specific medicine; and
• the quality of the evidence provided.

This process helped us determine whether the sponsors’ certifications were accurate and whether the claims made were compliant with regulatory requirements.

What we found

The sponsors of all (21) targeted medicines (100%) responded to our request for information. 

The evidence provided for five medicines (24%) was sufficient to support their exercise performance claims. 

However, insufficient evidence was provided for 16 medicines (76%). 

• Ten of those 16 medicines with insufficient evidence were cancelled from the ARTG and withdrawn from further supply. 
• Six of those 16 medicines with insufficient evidence remained available for supply after the unsupported exercise performance claims were removed. 
• Additionally, one sponsor was issued four infringement notices.

The limitations with the evidence provided included the study population, active ingredient, dosage and the results of some studies not being relevant to the medicine. Some of the evidence provided was also not of sufficient quality.

Search the Listed medicine compliance reports to view the published results for each compliance review. Search for ‘exercise, muscle or physical performance’ in the search bar.

Information for sponsors

If you are the sponsor of a listed medicine containing magnesium that makes claims relating to exercise performance, you should:

• review your evidence in accordance with the evidence guidelines for listed medicines, and
• review the presentation of your medicine (including the name, label, advertising and ARTG entry) to ensure that all claims made, especially in relation to exercise performance are accurate, truthful and not misleading.

Please be aware that your medicine may be selected for review at any time. We strongly encourage proactive sponsor engagement to ensure that your medicine complies with all relevant legal requirements at all times. Repeated failure to comply with legislative requirements could result in escalated enforcement actions, including infringement notices or other penalties.