Nature's Sunshine Vari-Gone (Nature's Sunshine Products of Australia Pty Ltd)
Product Name
Nature's Sunshine Vari-Gone
Date of review outcome
Date of publication
Mar-2025
Outcome
Medicine continues to be permitted for supply. Batches released after July 2023 must carry a corrected label with the warning statement ‘If symptoms persist, talk to your health professional’.
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?
If symptoms persist, talk to your health professional
Review scope
Targeted
Information reviewed
ARTG Record, Labels
Issues related to safety
The label for this medicine was missing the mandatory warning statement specified in 'What actions should consumers take?’ above. This warning statement is necessary to ensure the safe use of this medicine.
While this omission is unacceptable, supply of this medicine without the warning statement stopped in July 2023. As such, this medicine is unlikely to pose an immediate risk to consumer health and safety.
While this omission is unacceptable, supply of this medicine without the warning statement stopped in July 2023. As such, this medicine is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The efficacy of this medicine was not assessed as part of this review
Actions taken during the review
The TGA required the sponsor to correct the issue with this medicine. The sponsor updated the label to correct the issue.