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Beyond Alpha EstroControl (TW Health Pty Ltd)
Product Name
Beyond Alpha EstroControl
Sponsor
ARTG details
- 464665
Date of review outcome
Date of publication
Dec-2025
Outcome
Medicine is no longer permitted to be supplied and has been recalled by the sponsor
Is it safe to continue using this medicine?
Yes, based on the sponsor's certification. However, use of this medicine may pose a safety risk for some people. Follow the recommended actions below.
What action should consumers take?
This medicine is not recommended for use by pregnant and lactating women. If you are pregnant, lactating or planning to be pregnant, cease use and consult with your doctor before taking this medicine.
Consider whether this medicine is right for you based on it potentially not working as expected in relation to supporting and maintaining oestrogen metabolism, promoting healthy oestrogen metabolism in the liver and controlling oestrogen levels in the body.
Consider whether this medicine is right for you based on it potentially not working as expected in relation to supporting and maintaining oestrogen metabolism, promoting healthy oestrogen metabolism in the liver and controlling oestrogen levels in the body.
Review scope
Targeted
Information reviewed
ARTG Record, Labels
Issues related to safety
The labels for this medicine were missing the mandatory warning statement for the ingredients glutathione and resveratrol, as set out under 'what action should consumers take?'. This warning statement is necessary to ensure the safe use of this medicine and to alert consumers to safety risks prior to taking this medicine.
The labels for this medicine also contained claims relating to supporting and maintaining oestrogen metabolism, promoting healthy oestrogen metabolism in the liver and controlling oestrogen levels in the body. 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, resulting in adverse outcomes.
However, this medicine was recalled and is unlikely to pose a further risk to consumer health and safety.
The labels for this medicine also contained claims relating to supporting and maintaining oestrogen metabolism, promoting healthy oestrogen metabolism in the liver and controlling oestrogen levels in the body. 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, resulting in adverse outcomes.
However, this medicine was recalled and is unlikely to pose a further risk to consumer health and safety.
Issues related to efficacy
The labels claimed that this medicine may support and maintain oestrogen metabolism, promote healthy oestrogen metabolism in the liver and control oestrogen levels in the body. However, these claims were not covered by the sponsor's certification that they held evidence to substantiate them.
Actions taken during the review
The sponsor recalled this medicine from the market, cancelled and withdrew it from further supply. Nevertheless, the TGA issued an educational letter to the sponsor outlining the issues with this medicine.