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.
Issues related to efficacy
The efficacy of the medicine was not assessed as part of this review
Actions taken during the review
The TGA issued an infringement notice (https://www.tga.gov.au/media-release/shen-neng-herbal-medicines-group-pty-ltd-fined-53280-alleged-breaches-therapeutic-goods-legislation) to the sponsor for failing to provide information requested as part of the compliance review.
In addition, the TGA required the sponsor to correct the issues with the medicine. The sponsor responded with more information about the medicine and no further action was required.
This review was conducted as part of a targeted project
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.