Natural Slim Tea Extra Strength (Well Herb Pty Ltd)
Product Name
Natural Slim Tea Extra Strength
Sponsor
ARTG
188384
Date of review outcome
Date of publication
Sep-20
Outcome
Medicine is no longer permitted to be supplied
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 contains the herbal ingredients Senna alexandrina and Rheum officinale, which may produce a laxative effect. If you are using this medicine for weight loss or weight management, seek advice from a suitably qualified health practitioner.
Review scope
Targeted
Information reviewed
Labels, ARTG Record
Issues related to safety
The label of the medicine was missing mandatory warning statements declaring the presence of herbal ingredients Senna alexandrina and Rheum officinale which have the potential to cause a laxative effect. While this is unacceptable, the label contained information alerting consumers to the risks of prolonged use and a recommendation to seek medical advice if they experience side effects of a laxative (such as diarrhoea or nausea). The label of the medicine also contained a claim related to weight loss that did not indicate that this is needed to be balanced with physical activity. This may promote unhealthy habits for weight management, which is a public health concern. While the missing warning statements and advertising of this nature is unacceptable, it is unlikely to pose an immediate risk to consumer health and safety.
The sponsor of this medicine did not hold sufficient product distribution records. This is required as it ensures that, if a significant safety issue is found, those involved with the supply or use of the medicine can be notified or the medicine can be appropriately recalled. While the absence of this information is unacceptable, the medicine does not pose a significant risk to consumer health and safety that warrants action at this time.
The sponsor of this medicine did not hold sufficient product distribution records. This is required as it ensures that, if a significant safety issue is found, those involved with the supply or use of the medicine can be notified or the medicine can be appropriately recalled. While the absence of this information is unacceptable, the medicine does not pose a significant risk to consumer health and safety that warrants action at this time.
Issues related to efficacy
The efficacy of the medicine was not assessed as part of this review
Actions taken during the review
The sponsor cancelled the medicine and withdrew it from further supply. Nevertheless, TGA issued an educational letter to the sponsor outlining the issues with the medicine.