Cortitrol (Nu Skin Enterprises Australia Inc)
Product Name
Cortitrol
ARTG
383413
Date of review outcome
Date of publication
Mar-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, use of this medicine may pose a safety risk for some people. Follow the recommended actions below.
What action should consumers take?
Seek advice from a suitably qualified health practitioner if you have been taking this medicine to manage or control cortisol levels.
Consider whether this medicine is right for you based on it potentially not working as expected in relation to helping the body adapt to stress; reducing restlessness, tiredness, lack of sleep or feeling run-down; and improving mental focus and function.
Consider whether this medicine is right for you based on it potentially not working as expected in relation to helping the body adapt to stress; reducing restlessness, tiredness, lack of sleep or feeling run-down; and improving mental focus and function.
Review scope
Targeted
Information reviewed
ARTG Record, Labels, Website
Issues related to safety
The label and website for this medicine contained claims related to cortisol management and control. 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 advice or treatment from a suitability qualified health professional when required, which may result in adverse outcomes.
While advertising of this nature is unacceptable, the label and website advised consumers with a known medical condition to consult a physician prior to use. As such, this medicine is unlikely to pose an immediate risk to consumer health and safety.
While advertising of this nature is unacceptable, the label and website advised consumers with a known medical condition to consult a physician prior to use. As such, this medicine is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The label and website 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 TGA required the sponsor to correct the issues with this medicine. The sponsor cancelled this medicine, withdrew it from further supply, and updated their website to correct the issues.