Viti Organics (Organic Care Australia Pty Ltd)
Product Name
Viti Organics
Sponsor
ARTG
183337
Date of review outcome
Date of publication
Dec-21
Outcome
Medicine continues to be permitted for supply. Batches released from April 2022 must carry a corrected label with the updated medicine name of “Viti Organics”.
Is it safe to continue using this medicine?
Yes, if you follow the recommended actions below
What action should consumers take?
Seek advice from a suitably qualified health professional if you are or have been taking this medicine to support your skin health affected by vitiligo
Review scope
Targeted
Information reviewed
ARTG Record, Labels
Issues related to safety
The medicine name includes 'Vitiligo' which refers to a serious form of a skin disease that requires medical diagnosis and ongoing supervision.
Claims implying health benefits related to a serious form of a skin disease are not permitted for medicines that are available for self-selection without prior evaluation by the TGA. Use of the medicine, without involvement of a suitably qualified health professional, may lead to inappropriate use of this medicine by consumers and delay access to timely medical advice, which may result in adverse outcomes.
However, the medicine is unlikely to pose an immediate risk to consumers, as the medicine's label warns consumers to talk to a health professional if symptoms persist.
Claims implying health benefits related to a serious form of a skin disease are not permitted for medicines that are available for self-selection without prior evaluation by the TGA. Use of the medicine, without involvement of a suitably qualified health professional, may lead to inappropriate use of this medicine by consumers and delay access to timely medical advice, which may result in adverse outcomes.
However, the medicine is unlikely to pose an immediate risk to consumers, as the medicine's label warns consumers to talk to a health professional if symptoms persist.
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 medicine. The sponsor updated the label and ARTG record by changing the name of the medicine to “Viti Organics”.