Breast PMS Relief capsules (previously 'Breast Health capsules') (Health Direction Pty Ltd)
Product Name
Breast PMS Relief capsules (previously 'Breast Health capsules')
Sponsor
Date of review outcome
Date of publication
Jun-2024
Outcome
Medicine continues to be permitted for supply. Batches released after 8 December 2023 must have corrected labels.
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?
Consider whether this medicine is right for you based on it potentially not working as expected in relation to maintaining and supporting general breast health
Review scope
Targeted
Information reviewed
ARTG Record, Evidence, Labels, Website
Issues related to safety
The name of this medicine contained claims regarding maintaining and supporting general breast health. These claims are 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 suitability qualified health professional when required, which may result in adverse outcomes.
While advertising of this nature is unacceptable, the label and website for this medicine advised consumers to talk to their healthcare professional if symptoms persist. As such, this medicine is unlikely to pose an immediate risk to consumer health and safety.
While advertising of this nature is unacceptable, the label and website for this medicine advised consumers to talk to their healthcare professional if symptoms persist. As such, this medicine is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The name of this medicine contained claims regarding maintaining and supporting general breast health. 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 the issues.