SHEN NENG MU XIANG SHUN QI WAN (Shen Neng Herbal Medicines Group Pty Ltd)

The medicine contains a herbal ingredient (Saussurea costus) which could be confused for Aristolochia species of herbs. Aristolochia herbs contain aristolochic acids, which are not permitted to be present in listed medicines. The sponsor was required to provide testing results to the TGA prior to supply, to demonstrate that their medicine did not contain aristolochic acids, but failed to do so. Subsequent testing indicated that the medicine did not contain aristolochic acids and was therefore unlikely to pose a safety risk to consumers.
Manufacturing documents provided by the sponsor contained information regarding the composition of the medicine that was inconsistent with the ARTG record. These inconsistencies could affect the quality and therefore the safety of the medicine. However, the ingredients in the medicine are not at risk of exceeding quantity limits put in place for safety, and it is therefore unlikely to pose an immediate risk to consumers.
The labels for the medicine contained a claim about tinnitus (ringing in the ears), which can be a serious condition that requires diagnosis, treatment or supervision by a suitably qualified health professional. This is not permitted for medicines that are available for self-selection without prior evaluation by the TGA. The reference to tinnitus has the potential to lead consumers with the condition to delay access to timely medical advice or treatment when required, resulting in adverse outcomes. However, supply of the medicine stopped in October 2021, and available data indicate that use of the medicine is unlikely to pose an immediate risk to consumer health and safety.