Efficacy of medicines containing Vitamin D that use indications relating to bone

In 2022 we initiated targeted compliance reviews of selected listed medicines containing Vitamin D that made claims related to bone strength.

Why we conducted this review

Listed medicines may be subject to a compliance review at any time while they remain on the Australian Register of Therapeutic Goods (ARTG). Listed medicines are only permitted to use therapeutic claims from a pre-approved list. Sponsors of listed medicines are required to certify that they hold evidence to support their medicine’s therapeutic claims.

This review focused on verifying whether sponsors had appropriate evidence to support their bone strength related claims.

What we reviewed

We selected ten (10) listed medicines containing colecalciferol (Vitamin D) without calcium that made one or more of the following claims: 

• Helps enhance/promote bone strength
• Maintain/support bone strength

The medicines were selected randomly or based on regulatory intelligence.

What we did

We asked the sponsors of these medicines to provide evidence to support their claims. Our assessment focused on:

• the relevance of the evidence to the specific medicine; and
• the quality of the evidence provided.
• review your evidence in accordance with the Evidence Guidelines for listed medicines; and
• 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.

This process helped us determine whether the sponsors’ certifications were accurate and whether the claims made were compliant with regulatory requirements.

What we found

The sponsors of all (10) targeted medicines (100%) responded to our request for information. However, the evidence provided was not sufficient to support the bone strength claims made for any of the medicines. 

The sponsors of six medicines (60%) took corrective action to remove the unsupported bone strength claims from their medicines and advertising. These medicines remain on the ARTG.

Four medicines (40%) were cancelled from the ARTG and withdrawn from further supply.

One sponsor was issued with an infringement notice. 

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 compliance review for each medicine is published on the page Listed medicine compliance reports. Search for ‘Vitamin D’ in the search bar.

Information for sponsors

If you are the sponsor of a listed medicine containing Vitamin D that makes a claim in relation to bone strength you should:

Please be aware that your medicine may be selected for review at any time. We strongly encourage proactive sponsor engagement to ensure that your medicine complies with all relevant legal requirements at all times. Repeatedly failing to comply with legislative requirements could result in escalated enforcement actions, including infringement notices or other penalties.