Facia Premium (Contract Manufacturing & Packaging Services Pty Ltd)
Product Name
Facia Premium
ARTG
295927
Date of review outcome
Date of publication
Sep-22
Outcome
Medicine continues to be permitted for supply. From March 2022, the sponsor is prohibited from advertising the medicine for skin lightening claims.
Is it safe to continue using this medicine?
Yes, based on the sponsor’s certification
What action should consumers take?
Consider whether the medicine is right for you based on it potentially not working as expected in relation to skin lightening
Review scope
Targeted
Information reviewed
ARTG Record, Labels, Manufacturing Documentation
Issues related to safety
The safety of the medicine was not assessed as part of this review
Issues related to efficacy
The label claimed that the medicine may help with skin lightening. This claim is not permitted for medicines that are available for self-selection without prior evaluation by the TGA. Further, this claim was not covered by the sponsor’s certification that they held evidence to substantiate them.
Actions taken during the review
The TGA issued a prevention notice (https://www.tga.gov.au/prevention-notice-contract-manufacturing-packaging-services-pty-ltd) to the sponsor for advertising the medicine for a therapeutic use that was not permitted