Hivita Wellness VITAMIN D3 Plant Based Sunshine (Hivita Wellness Pty Ltd)
Product Name
Hivita Wellness VITAMIN D3 Plant Based Sunshine
Sponsor
ARTG
375479
Date of review outcome
Date of publication
Mar-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?
Do not exceed a maximum dose of one capsule per day. Consider whether this medicine is right for you based on it potentially not working as expected in relation to helping enhance or promote bone strength.
Review scope
Targeted (see Additional Information below)
Information reviewed
ARTG Record, Evidence, Labels, Website
Issues related to safety
The website for this medicine stated a maximum daily dose of four capsules, which exceeded the 25 microgram daily limit for colecalciferol (vitamin D) permitted for listed medicines. Ingredient limits for listed medicines are in place to ensure their safety. While this is unacceptable, this information has been removed from the website, and the label for this medicine included a dosage within permissible limits (one capsule daily). As such, this medicine is unlikely to pose an immediate safety risk to consumers.
Issues related to efficacy
The sponsor did not hold sufficient evidence to support claims in relation to helping enhance or promote bone strength. Limitations with the evidence included the results of studies not being relevant to the claims for this medicine, and some sources not being of sufficient quality.
Actions taken during the review
The TGA required the sponsor to correct the issues with this medicine. The sponsor updated the ARTG record and website to correct the issues.
Additional information
This medicine was targeted to check its compliance in relation to claims about enhancing or promoting bone strength