Zen Fit Fruit Punch (Jeunesse Global Australia Pty Ltd)
Product Name
Zen Fit Fruit Punch
Date of review outcome
Date of publication
Mar-23
Outcome
Medicine continues to be permitted for supply
Is it safe to continue using this medicine?
Yes, based on the sponsor's certification. However, use of the medicine may pose a safety risk for some people. Follow the recommended actions below.
What action should consumers take?
This medicine contains sucralose. Consider whether the medicine is right for you if you have sensitivities to these substances. If you develop a reaction, discontinue use and consult a suitably qualified health practitioner.
Review scope
Random
Information reviewed
ARTG Record, Labels, Manufacturing Documentation, Website
Issues related to safety
The medicine contains sucralose which was not declared on the label. Sucralose is required to be declared on the labels of medicines as they may cause adverse reactions in individuals sensitive to such substances. However, current data indicates that use of the medicine is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
None
Actions taken during the review
The TGA required the sponsor to correct the issues with the medicine. The sponsor updated the labels to include the statement 'Contains sucralose'.