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TurmeriX powder (TurmeriX Pty Ltd)
Product Name
TurmeriX powder
Sponsor
ARTG
307610
Date of review outcome
Date cancellation takes effect
Date of publication
Dec-22
Outcome
The medicine is no longer permitted to be supplied and the Batch number 22025401 has been recalled
Is it safe to continue using this medicine?
No, continued use is not recommended as its safety is not considered acceptable for a listed medicine
What action should consumers take?
Be aware that this medicine is not permitted by the TGA to treat, prevent or relieve symptoms of mental illness, gastrointestinal disorders, diseases of the brain including Alzheimer's disease, obesity, skin disorders, period pain or cancer. This medicine is not recommended for children under 12 years or pregnant or breastfeeding women. Seek advice from a suitably qualified health professional if you have been or are intending on using this medicine for these purposes. Be aware that the medicine may not work as expected in relation to these uses.
Review scope
Targeted
Information reviewed
ARTG Record, Labels, Manufacturing Documents, Website
Issues related to safety
The website for the medicine contained claims that the medicine could help with the conditions listed in 'What action should consumers take?'. These are serious forms of a disease that require diagnosis, treatment or supervision by a suitably qualified health professional. Reference to serious forms of a disease is not permitted for medicines that are available for self-selection without prior evaluation by the TGA.
The website also contained claims that other medicines, including over-the-counter painkillers and the influenza vaccine, are harmful. Implying that the medicine can be used for serious forms of a disease and negative comparisons to other medicines has the potential to lead consumers to delay access to timely medical advice or failing to use prescribed or recommended treatment, resulting in adverse outcomes.
The label for the medicine was missing the warning statement 'Use in children under 12 years is not recommended'. As such, carers of children under 12 years or children under 12 years may not be alerted to the fact that this medicine is not recommended for them prior to taking the medicine, which may adversely affect their health.
The label implied that taking the medicine during pregnancy and/or breastfeeding is considered acceptable in some circumstances. However, the medicine is not recommended to be taken by pregnant women or women who are breastfeeding.
The medicine was manufactured in a facility that does not carry an appropriate licence to manufacture therapeutic goods.
The remaining batch ([B]22025401) of the medicine was recalled and therefore it is unlikely to pose a significant risk to consumers.
The website also contained claims that other medicines, including over-the-counter painkillers and the influenza vaccine, are harmful. Implying that the medicine can be used for serious forms of a disease and negative comparisons to other medicines has the potential to lead consumers to delay access to timely medical advice or failing to use prescribed or recommended treatment, resulting in adverse outcomes.
The label for the medicine was missing the warning statement 'Use in children under 12 years is not recommended'. As such, carers of children under 12 years or children under 12 years may not be alerted to the fact that this medicine is not recommended for them prior to taking the medicine, which may adversely affect their health.
The label implied that taking the medicine during pregnancy and/or breastfeeding is considered acceptable in some circumstances. However, the medicine is not recommended to be taken by pregnant women or women who are breastfeeding.
The medicine was manufactured in a facility that does not carry an appropriate licence to manufacture therapeutic goods.
The remaining batch ([B]22025401) of the medicine was recalled and therefore it is unlikely to pose a significant risk to consumers.
Issues related to efficacy
The website for the medicine claimed that the medicine could help with the conditions listed in 'What action should consumers take?'. 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 the medicine. The sponsor updated the website to remove the unsupported indications and claims. However, the sponsor did not provide sufficient information to address all the issues. The remaining batch of the medicine was recalled and the TGA cancelled the medicine and withdrew permission for further supply.
Grounds for cancellation
The sponsor has refused or failed to comply with a condition to which the inclusion of the goods is subject (paragraph 30(2)(c) of the Act).