Six products remained in the market after the companies behind it took corrective action to remove the unsupported bone strength claims from their medicines and advertising.
One sponsor, Caruso’s Natural Health Pty Ltd, was also issued with an infringement notice for failing to hold evidence to support bone strength claim in its product Caruso’s Vitamin D3 1000IU.
This follows the Therapeutic Goods Administration’s (TGA) targeted compliance reviews of complementary medicines containing vitamin D and made claims related to bone strength.
Ten products containing vitamin D in the form of colecalciferol and have no calcium in their formulations, but made claims such as “helps enhance/promote bone strength” and “maintain/support bone strength” were selected randomly or based on regulatory intelligence for the review.
During which, the TGA asked sponsors of the products to submit evidence to support their product claims, and assessed their evidence based on its quality, relevance, and accuracy of the claims made.
“The limitations with the evidence provided included the study population, active ingredient, dosage and the results of some studies not being relevant to this medicine.
“Some of the evidence provided was also not of sufficient quality,” the TGA said in the compliance report.
What did the TGA focus on when assessing the evidence
- The relevance of the evidence to the specific medicine
- The quality of the evidence provided
- The evidence was reviewed in accordance with the Evidence Guidelines for listed medicines
- Re-evaluate the presentation of the medicine (including the name, label, web advertising, and its ARTG entry) to ensure that all claims made, especially in relation to bone strength are accurate, truthful and not misleading (Source: TGA)
The 10 products reviewed
The six products that remained in the market post-corrective actions:
- PHARMACY ACTION Vitamin D by Generic Health Pty Ltd
- Vita-D VITAMIN D SUPPLEMENT by Petrus Pharmaceuticals Pty Ltd
- Hivita Wellness VITAMIN D3 Plant Based Sunshine by Hivita Wellness Pty Ltd
- Nature’s Way High Strength K2 + D3 (previously Nature’s Way Vitamin K2 + D3) by Pharmacare Laboratories Pty Ltd
- Caruso’s Vitamin D3 1000IU by Caruso’s Natural Health Pty Ltd
- Sorenandin by McBoben Group
The four products that were cancelled and removed from the market by sponsors:
- Quality Health Australia Vitamin K2 + D3 by Pharmacare Laboratories Pty Ltd
- Bioglan Vitamin K2 + D3 by Natural Bio Pty Limited
- Vitamin D3 + K2 MK7 by Nature’s Care Manufacture Pty Limited
- Osteo-Restore by Interpath Pty Ltd
The review started in 2022, with the TGA announcing the findings and actions taken in August 2025.
In Australia, listed complementary medicines may be subject to a compliance review at any time so long as they are listed on the Australian Register of Therapeutic Goods (ARTG).
These products are only permitted to use therapeutic claims from a pre-approved list and sponsors of these products are required to certify that the products hold evidence to support the therapeutic claims made.
The purpose of the review is to verify whether sponsors had submitted appropriate evidence to support their vitamin D products’ bone strength related claims.
The TGA also published its review findings last month on products at risk of containing safrole - a naturally occurring substance that may pose health risks such as increasing cancer risk.
Another recent review completed was on whether products containing certain Artemisia species came with the required safety warnings, with findings published last December.
