Efficacy of Vitamin D for bone strength

We initiated targeted compliance reviews of selected listed medicines containing Vitamin D to verify whether sponsors had appropriate evidence to support their bone strength claims.

We found that the evidence provided by the sponsors was not sufficient to support the bone strength claims made for any of the medicines. Consequently, six sponsors removed the unsupported claims from their medicines and advertisements. In addition, four medicines were cancelled by the sponsor and withdrawn from further supply, and one sponsor was issued with an infringement notice. 

If you are a sponsor of a listed medicine containing Vitamin D that makes claims regarding bone strength, you are encouraged to:

• review your supporting evidence using the Evidence Guidelines; and
• re-assess how your product is presented and ensure all claims, especially those related to bone strength, are accurate, truthful, and not misleading.

For more details, please visit Compliance and education for listed medicines.