Luxxe White Enhanced Glutathione (FR International Australia Pty Ltd)
Product Name
Luxxe White Enhanced Glutathione
ARTG
316145
Date of review outcome
Date of publication
Jun-2024
Outcome
Medicine is no longer permitted to be supplied
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 skin whitening, inhibiting oxidation, protecting cells, improving skin appearance, improving skin elasticity, and detoxing.
Be aware this medicine does not contain glutathione.
Be aware this medicine does not contain glutathione.
Review scope
Targeted
Information reviewed
ARTG Record, Labels, Website
Issues related to safety
The name, label, and website for this medicine contained claims regarding skin whitening. 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 medical advice or treatment when required and may result in adverse outcomes.
While advertising of this nature is unacceptable, the website for this medicine has been removed, and this medicine has not been marketed since November 2022. Therefore, this medicine is unlikely to pose an immediate risk to consumer health and safety.
While advertising of this nature is unacceptable, the website for this medicine has been removed, and this medicine has not been marketed since November 2022. Therefore, this medicine is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
This medicine does not contain glutathione as implied by its name. Therefore, this medicine may not work for claims related to glutathione.
The advertising for this medicine contained claims specified in 'What action should consumers take?' above. However, these claims were not covered by the sponsor's certification that they held evidence to substantiate them.
The advertising for this medicine contained claims specified in 'What action should consumers take?' above. 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 cancelled this medicine and withdrew it from further supply. Nevertheless, the TGA issued an educational letter to the sponsor outlining the issues with this medicine.