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PEE LESS (Caruso's Natural Health Pty Ltd)
Product Name
PEE LESS
Sponsor
ARTG details
- 394698
Date of review outcome
Date cancellation takes effect
Date of publication
Dec-2024
Outcome
Medicine is no longer permitted to be supplied
Is it safe to continue using this medicine?
Yes, based on the sponsor's certification. However, follow the recommended actions below.
What action should consumers take?
Consider whether this medicine is right for you given that the claims relating to increasing urine output in males and relieving urinary frequency were not substantiated by the sponsor.
Review scope
Targeted
Information reviewed
Advertising (other), ARTG Record, Evidence, Labels, Website
Issues related to safety
The website for this medicine incorrectly claimed it was free from sugar and soy. These misleading claims posed a safety risk for individuals with allergies or sensitivities to these substances. However, the claims were unlikely to pose an immediate risk to consumer health and safety as these substances were declared on the label for this medicine. Additionally, the sponsor removed the misleading claims from the website.
Issues related to efficacy
The sponsor did not hold sufficient evidence to support the claims outlined in 'What action should consumers take?' above. The limitations with the evidence included the results of the studies, study population and method of preparation of active ingredients not being relevant to this medicine. Two sources of evidence used were not of sufficient quality.
Actions taken during the review
The TGA required the sponsor to correct the issues with this medicine. The sponsor did not sufficiently address all of the issues. The TGA cancelled this medicine and withdrew permission for further supply.
Grounds for cancellation
It appears to the Secretary that the efficacy of the goods is unacceptable (paragraph 30(2)(a) of the Act).
It appears to the Secretary that the presentation of the goods in the case of listed goods is unacceptable (paragraph 30(2)(aa) of the Act).
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).
It appears to the Secretary that the presentation of the goods in the case of listed goods is unacceptable (paragraph 30(2)(aa) of the Act).
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).