Noble Kava (Fiji Kava (Australia) Trading Pty Ltd)
Product Name
Noble Kava
ARTG
331440
Date of review outcome
Date of publication
Dec-22
Outcome
Medicine continues to be permitted for supply
Is it safe to continue using this medicine?
Yes, if you follow the recommended actions below
What action should consumers take?
Be aware that this medicine is not permitted by the TGA to treat, prevent or relieve symptoms of general anxiety disorder. Seek advice from a suitably qualified health professional if you have been or are intending on using this medicine for this purpose.
Review scope
Targeted (see Additional Information below)
Information reviewed
ARTG Record, Labels, Website
Issues related to safety
The website for the medicine contained claims that the medicine could treat general anxiety disorder (a mental illness). Advertisements of therapeutic goods are prohibited from referring to mental illnesses unless permission has been given by the TGA.
The website for the medicine contained claims that the medicine is safe or that its use has no side effects. These claims are not permitted as all medicines have the potential to cause adverse outcomes. Additionally, it may encourage consumers to take the medicine even if it is not safe or appropriate for them.
The medicine contains the ingredient Piper methysticum which requires the label warning statement that it 'may harm the liver'. The website for the medicine contained claims that the medicine does not cause any harm to the liver. The different health messages on the label and the website have the potential to mislead consumers, resulting in adverse health outcomes. However, the medicine was not recalled as the label for the medicine contained the correct warning statement.
The website for the medicine contained claims that the medicine is safe or that its use has no side effects. These claims are not permitted as all medicines have the potential to cause adverse outcomes. Additionally, it may encourage consumers to take the medicine even if it is not safe or appropriate for them.
The medicine contains the ingredient Piper methysticum which requires the label warning statement that it 'may harm the liver'. The website for the medicine contained claims that the medicine does not cause any harm to the liver. The different health messages on the label and the website have the potential to mislead consumers, resulting in adverse health outcomes. However, the medicine was not recalled as the label for the medicine contained the correct warning statement.
Issues related to efficacy
The website claimed that the medicine can treat general anxiety disorder, a mental illness. 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 the website. The sponsor updated the website to correct these issues.
Additional information
This medicine was targeted to check its compliance with warning statement requirements related to use during pregnancy