The medicine contains the herbal ingredient Cinnamomum cassia which may contain coumarin, a potentially harmful substance. There are quantity restrictions in place for coumarin to ensure the safe use of listed medicines. The sponsor did not have documentation to support their certification that the medicine complied with safety limits for coumarin. However, subsequent testing indicated that the quantity of coumarin in the medicine is within permissible limits and 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 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.