YOU GUI WAN (Shen Neng Herbal Medicines Group Pty Ltd)
Product Name
YOU GUI WAN
ARTG
Date of review outcome
Date of publication
Sep-22
Outcome
Medicine continues to be permitted for supply
Is it safe to continue using this medicine?
Yes
What action should consumers take?
None
Review scope
Targeted (see Additional Information below)
Information reviewed
ARTG Record, Labels, Manufacturing Documentation
Issues related to safety
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 about the medicine and updated the label to correct a minor issue. No further action was required.
In addition, the TGA required the sponsor to correct the issues with the medicine. The sponsor responded with more information about the medicine and updated the label to correct a minor issue. No further action was required.
Additional information
This review was conducted as part of a targeted project