Swisse Ultiboost Cho-Less (Swisse Wellness Pty Ltd)
Product Name
Swisse Ultiboost Cho-Less
Sponsor
ARTG
382799
Date of review outcome
Date of publication
Mar-23
Outcome
Medicine is no longer permitted to be supplied
Is it safe to continue using this medicine?
Yes, based on the sponsor's certification. However, follow the recommended actions below.
What action should consumers take?
Consider whether the medicine is right for you based on it potentially not working as expected in relation to reducing cholesterol
Review scope
Targeted
Information reviewed
ARTG Record
Issues related to safety
The name of the medicine implied it can reduce cholesterol. This is not permitted for medicines that are available for self-selection without prior evaluation by the TGA. Abnormal cholesterol levels require supervision by a suitably qualified health professional. References to reducing cholesterol have the potential to lead consumers to delay access to timely medical advice or treatment when required, resulting in adverse outcomes.
However, given the medicine was never marketed in Australia, it is unlikely to pose an immediate risk to consumer health and safety.
However, given the medicine was never marketed in Australia, it is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The medicine name implied it can reduce cholesterol. However, this claim was not covered by the sponsor's certification that they held evidence to substantiate it.
Actions taken during the review
The sponsor cancelled the medicine and withdrew it from further supply. Nevertheless, the TGA issued an educational letter to the sponsor outlining the issues with the medicine.