Glamour Lotus Super Lung Detox (Glamour Lotus Australia Pty Ltd)
Product Name
Glamour Lotus Super Lung Detox
Sponsor
ARTG
402222
Date of review outcome
Date cancellation takes effect
Date of publication
Jun-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 based on it potentially not working as expected in relation to lung detoxification
Review scope
Targeted
Information reviewed
ARTG Record
Issues related to safety
The name of this medicine implied that it could aid in lung detoxification. This claim is not permitted for listed medicines without prior evaluation or approval from the TGA. References to non-permitted claims have the potential to lead consumers to delay access to timely advice or treatment from a suitability qualified health professional when required, which may result in adverse outcomes.
However, current data indicate that use of this medicine is unlikely to pose an immediate risk to consumer health and safety.
However, current data indicate that use of this medicine is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The name of this medicine implied that it could aid in lung detoxification. However, this claim was not covered by the sponsor's certification that they held evidence to substantiate it.
Actions taken during the review
The TGA required the sponsor to correct the issues with this medicine. The sponsor did not respond or correct the issues. The TGA cancelled this medicine and withdrew permission for further supply.
Grounds for cancellation
It appears to the Secretary that the certification under paragraph 26A(2)(a) of the Act is incorrect (paragraph 30(1)(e) of the Act).
The medicine is not eligible for listing (paragraph 30(1A)(a) of the Act).
It appears to the Secretary that the presentation of the goods is unacceptable (subparagraph 30(2)(aa)(ii) of the Act).
It appears to the Secretary that the certification under paragraph 26A(2)(c) of the Act is incorrect (paragraph 30(2)(ba) of the Act).
The medicine is not eligible for listing (paragraph 30(1A)(a) of the Act).
It appears to the Secretary that the presentation of the goods is unacceptable (subparagraph 30(2)(aa)(ii) of the Act).
It appears to the Secretary that the certification under paragraph 26A(2)(c) of the Act is incorrect (paragraph 30(2)(ba) of the Act).