TGA
The TGA initiated targeted compliance reviews of select listed medicines containing Magnesium to verify whether sponsors had appropriate evidence to support their medicine's exercise performance claims.
Out of 21 medicines reviewed, we found that:
- the evidence provided for five medicines (24%) was sufficient to support their exercise performance claims;
- insufficient evidence was provided for 16 medicines (76%);
- ten of those 16 medicines with insufficient evidence were cancelled from the Australian Register of Therapeutic Goods and withdrawn from further supply;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; and
- one sponsor was issued four infringement notices.
If you are a sponsor of a listed medicine containing magnesium that makes claims regarding exercise performance, you are encouraged to:
- review your supporting evidence using the evidence guidelines; and
- re-assess how your product is presented and ensure all claims-especially those related to exercise performance -are accurate, truthful, and not misleading.
For more details, please visit the Compliance and education for listed medicines page.
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