Detox + Debloat (JSHealth Vitamins Pty Ltd)
Product Name
Detox + Debloat
Sponsor
Date of review outcome
Date of publication
Jun-2024
Outcome
Medicine continues to be permitted for supply
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?
Be aware that the labels for batches B211091, B211111, B211161, B211231 and B211341 of this medicine are missing the warning statements 'Use in children under 12 years is not recommended', 'Do not use if pregnant or likely to become pregnant', and 'Do not use while breastfeeding'. Seek advice from a suitably qualified health practitioner if you have been taking this medicine while pregnant, trying to become pregnant or breastfeeding, or whether you have administered this medicine to children under 12 years of age. For further instructions, please go to the safety alerts page on the TGA website.
In addition, the medicine contains sulfites. Consider whether the medicine is right for you if you have allergies or sensitivities to sulfites. If you develop a reaction, discontinue use and consult a suitably qualified health practitioner.
Be aware that batches B23434, B23441, B23462, B23463 and B23485 of this medicine were also affected by the issues described above. However, those batches expired in November 2022 and consumers should not be taking expired medicines.
In addition, the medicine contains sulfites. Consider whether the medicine is right for you if you have allergies or sensitivities to sulfites. If you develop a reaction, discontinue use and consult a suitably qualified health practitioner.
Be aware that batches B23434, B23441, B23462, B23463 and B23485 of this medicine were also affected by the issues described above. However, those batches expired in November 2022 and consumers should not be taking expired medicines.
Review scope
Targeted
Information reviewed
ARTG Record, Labels, Website
Issues related to safety
The label for this medicine was missing the mandatory warning statements for the herbal ingredient Foeniculum vulgare, as set out under 'What action should consumers take?' above. These warning statements are necessary to ensure the safe use of this medicine and to alert consumers to safety risks prior to taking it.
The label for this medicine incorrectly claimed that this medicine does not contain sulfites. Sulfites are required to be declared on the labels of medicines as they may cause adverse reactions in individuals with allergies or sensitivities to such substances. Whilst the undeclared presence of trace amounts of sulfites may pose a safety risk for some consumers, current data suggest that severe adverse reactions due to trace residue of sulfites (such as anaphylaxis) are rare.
All 10 batches of the medicine (outlined in 'What action should consumers take?') affected by the issues described above were recalled and are therefore unlikely to pose a further risk to consumers.
The label for this medicine incorrectly claimed that this medicine does not contain sulfites. Sulfites are required to be declared on the labels of medicines as they may cause adverse reactions in individuals with allergies or sensitivities to such substances. Whilst the undeclared presence of trace amounts of sulfites may pose a safety risk for some consumers, current data suggest that severe adverse reactions due to trace residue of sulfites (such as anaphylaxis) are rare.
All 10 batches of the medicine (outlined in 'What action should consumers take?') affected by the issues described above were recalled and are therefore unlikely to pose a further risk to consumers.
Issues related to efficacy
The efficacy of this medicine was not assessed as part of this review
Actions taken during the review
The sponsor updated the label to correct the issues with this medicine, and the affected batches of this medicine were recalled. The TGA issued an infringement notice (https://www.tga.gov.au/news/media-releases/jshealth-vitamins-pty-ltd-fined-13320-alleged-unlawful-supply-complementary-medicine) to the sponsor for supplying batches of this medicine without the mandatory warning statements. The TGA then issued an educational letter to the sponsor outlining the issues with this medicine.