CYSTITIS-CARE CRANBERRY 10g (Australian Naturalcare Products Pty Ltd)
Product Name
CYSTITIS-CARE CRANBERRY 10g
ARTG
287402
Date of review outcome
Date cancellation takes effect
Date of publication
Mar-22
Outcome
Medicine is no longer permitted to be supplied
Is it safe to continue using this medicine?
Yes
What action should consumers take?
Consider whether the medicine is right for you given that claims about reducing occurrence and symptoms of medically diagnosed cystitis, and supporting urinary tract health, were not substantiated by the sponsor. Be aware that the medicine may also not work as expected in relation to reducing the frequency or the risk of recurrence of medically diagnosed cystitis, and the frequency of urinary tract infections.
Review scope
Random
Information reviewed
ARTG Record, Evidence, Labels, Website
Issues related to safety
None
Issues related to efficacy
The sponsor did not hold sufficient evidence to support the label and website claims related to reducing occurrence and symptoms of medically diagnosed cystitis and supporting urinary tract health. The population described in the clinical evidence was not relevant to the target population of the medicine. The ingredient preparation and dosage form described in the evidence were not consistent with those for the medicine. The remaining evidence included review articles, monographs, book chapters, and guides. These types of evidence are insufficient for supporting the claims in the absence of robust scientific studies, such as clinical trials or systematic reviews. This is because they generally do not include sufficient detail regarding population demographic, sample size, ingredient preparation, dose and statistical analysis to allow for comparison with the medicine. Additionally, the website of the medicine advertised claims related to reducing the frequency or the risk of recurrence of medically diagnosed cystitis, and the frequency of urinary tract infections. 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 did not respond or correct the issues. 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). The goods do not comply with an applicable provision of the Therapeutic Goods Advertising Code (paragraph 30(2)(ea) of the Act). The presentation of the listed goods is unacceptable (paragraph 30(2)(aa) of the Act).