Caruso's Vitamin D3 1000IU (Caruso's Natural Health Pty Ltd)
Product Name
Caruso's Vitamin D3 1000IU
Sponsor
Date of review outcome
Date of publication
Dec-2024
Outcome
Medicine continues to be permitted for supply
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 this medicine is right for you given that the claim for helping promote bone strength was not substantiated by the sponsor.
Be aware that this medicine may not work as expected in relation to the maintenance of general health and wellbeing.
Be aware that this medicine may not work as expected in relation to the maintenance of general health and wellbeing.
Review scope
Targeted (see Additional Information below)
Information reviewed
ARTG Record, Evidence, Labels, Website
Issues related to safety
None
Issues related to efficacy
The sponsor did not hold sufficient evidence to support the claim related to helping promote bone strength. The limitations with the evidence included the study population, active ingredient, dosage and the results of some studies not being relevant to this medicine. The evidence provided was not of sufficient quality.
In addition, the website claimed that this medicine may help in the maintenance of general health and wellbeing. However, this claim was not covered by the sponsor's certification that they held evidence to substantiate it.
In addition, the website claimed that this medicine may help in the maintenance of general health and wellbeing. 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 updated the ARTG record, label and website to remove the unsupported claim about helping promote bone strength.
The TGA issued an infringement notice (https://www.tga.gov.au/news/media-releases/carusos-natural-health-pty-ltd-fined-alleged-offences-relating-regulatory-requirements) to the sponsor for failing to hold evidence to support this claim.
In addition, the TGA issued an educational letter to the sponsor outlining the remaining issue with this medicine. The sponsor was not required to respond but was expected to correct the issue.
The TGA issued an infringement notice (https://www.tga.gov.au/news/media-releases/carusos-natural-health-pty-ltd-fined-alleged-offences-relating-regulatory-requirements) to the sponsor for failing to hold evidence to support this claim.
In addition, the TGA issued an educational letter to the sponsor outlining the remaining issue with this medicine. The sponsor was not required to respond but was expected to correct the issue.
Additional information
This medicine was targeted to check its compliance in relation to claims about enhancing or promoting bone strength