Debloat + Detox (Australian Health Vitality Pty Ltd)
Product Name
Debloat + Detox
Date of review outcome
Date of publication
Mar-23
Outcome
Medicine continues to be permitted for supply
Is it safe to continue using this medicine?
Yes, based on the sponsor's certification. However, use of the medicine may pose a safety risk for some people. Follow the recommended actions below.
What action should consumers take?
Use in children under 12 years is not recommended. Do not use this medicine if you are pregnant or likely to become pregnant. Do not use this medicine while breastfeeding. Always read the label and follow the directions for use.
Review scope
Targeted
Information reviewed
ARTG Record, Labels, Website
Issues related to safety
The website for the medicine was missing the mandatory warning statements as set out in 'What action should consumers take?'. The website also implied that taking the medicine during pregnancy and/or while breastfeeding is considered acceptable in some circumstances. However, the medicine should not be used by women who are pregnant and/or breastfeeding.
The warning statements were included on the label for the medicine. Therefore, this is unlikely to pose an immediate risk to consumer health and safety.
The warning statements were included on the label for the medicine. Therefore, this is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The efficacy of the medicine was not assessed as part of this review
Actions taken during the review
The TGA required the sponsor to correct the issues with the website. The sponsor updated the website to correct the issues.