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Luxxe White Enhanced Glutathione (FR International Australia Pty Ltd)
Product Name
Luxxe White Enhanced Glutathione
ARTG
394853
Date of review outcome
Date cancellation takes effect
Date of publication
Sep-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.
Be aware this medicine does not contain glutathione.
Be aware this medicine does not contain glutathione.
Review scope
Targeted
Information reviewed
ARTG Record, Labels, Manufacturing Documentation, Website
Issues related to safety
The name of this medicine implied it could be used for skin whitening. 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 medical advice or treatment when required, which may result in adverse outcomes.
While claims of this nature are unacceptable, current data indicates this medicine is unlikely to pose an immediate risk to consumer health and safety.
While claims of this nature are unacceptable, current data indicates 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, it may not work for claims related to glutathione.
The name of this medicine implied it could be used for skin whitening. However, this claim was not covered by the sponsor's certification that they held evidence to substantiate it.
The name of this medicine implied it could be used for skin whitening. However, this claim was not covered by the sponsor's certification that they held evidence to substantiate it.
Actions taken during the review
The TGA required the sponsor to correct the issues with this medicine. The sponsor did not sufficiently address the issues. The TGA cancelled this medicine and withdrew permission for further supply.
Grounds for cancellation
It appears to the Secretary that the presentation of the goods in the case of listed goods is unacceptable (paragraph 30(2)(aa) of the Act)