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Nature’s Way High Strength K2 + D3 (previously Nature’s Way Vitamin K2 + D3) (Pharmacare Laboratories Pty Ltd)
Product Name
Nature’s Way High Strength K2 + D3 (previously Nature’s Way Vitamin K2 + D3)
Sponsor
ARTG details
Date of review outcome
Date of publication
Jun-2025
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?
Seek advice from a suitably qualified health practitioner if you have been taking this medicine to inhibit calcium build-up in the blood vessels.
Consider whether this medicine is right for you given that the claim for helping to enhance or promote bone strength in individuals over 50 years was not substantiated by the sponsor.
Be aware that this medicine may also not work as expected in relation to promoting the absorption of calcium into bones.
Consider whether this medicine is right for you given that the claim for helping to enhance or promote bone strength in individuals over 50 years was not substantiated by the sponsor.
Be aware that this medicine may also not work as expected in relation to promoting the absorption of calcium into bones.
Review scope
Targeted (see Additional Information below)
Information reviewed
ARTG Record, Evidence, Labels, Website
Issues related to safety
The label and website for this medicine contained claims related to inhibiting calcium build-up in blood vessels. This claim is not permitted for listed medicines without prior evaluation or approval from the TGA. References to non-permitted claims have the potential to lead consumers to delay access to timely advice or treatment from a suitably qualified health professional when required, which may result in adverse outcomes.
While advertising of this nature is unacceptable, this claim has been removed. In addition, current data indicates that use of this medicine is unlikely to pose an immediate risk to consumer health and safety.
While advertising of this nature is unacceptable, this claim has been removed. In addition, current data indicates that use of this medicine is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The sponsor did not hold sufficient evidence to support the claim related to helping enhance or promote bone strength in individuals over 50 years. The limitations with the evidence 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 not of sufficient quality.
The label and website for this medicine contained claims related to absorbing calcium into the bones and inhibiting calcium build-up in blood vessels. However, these claims were not covered by the sponsor's certification that they held evidence to substantiate them.
The label and website for this medicine contained claims related to absorbing calcium into the bones and inhibiting calcium build-up in blood vessels. However, these claims were not covered by the sponsor's certification that they held evidence to substantiate them.
Actions taken during the review
The TGA required the sponsor to correct the issues with this medicine. The sponsor updated the ARTG record, label and website to correct these issues.
Additional information
This medicine was targeted to check its compliance in relation to claims about enhancing or promoting bone strength