Greenshell Mussel 7500 (RBK Nutraceuticals Pty Ltd)
Product Name
Greenshell Mussel 7500
Sponsor
ARTG
282865
Date of review outcome
Date of publication
Mar-21
Outcome
Medicine is no longer permitted to be supplied
Is it safe to continue using this medicine?
Yes
What action should consumers take?
Consider whether the medicine is right for you given that claims for 'Helps enhance/promote joint health' and 'Maintain/support joint mobility/flexibility' were not substantiated by the sponsor
Review scope
Random
Information reviewed
ARTG Record, Evidence, Labels, Manufacturing Documentation, Website
Issues related to safety
None
Issues related to efficacy
The sponsor did not hold sufficient evidence to support the claims for 'Helps enhance/promote joint health' and 'Maintain/support joint mobility/flexibility'. The limitations with the evidence included that the daily doses, methods of preparation and study population were not relevant to the medicine. Additionally, the medicine was given with other medicines or ingredients which may have influenced the results.
Actions taken during the review
The TGA required the sponsor to correct the issues with the medicine. The sponsor cancelled the medicine and withdrew it from further supply.