Liver Slim (Ferngrove Pharmaceuticals Australia Pty Ltd)
Product Name
Liver Slim
ARTG
374317
Date of review outcome
Date cancellation takes effect
Date of publication
Jun-2023
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?
Seek advice from a medical practitioner if you have been taking this medicine for reducing/removing fat from the liver or fatty liver disease
Review scope
Targeted
Information reviewed
ARTG Record, Labels
Issues related to safety
"The name and label for this medicine implied that it can aid in reducing/removing fat from the liver and/or assist people with fatty liver disease, which is a serious condition that requires diagnosis, treatment and/or supervision by a suitably qualified health professional. This is not permitted for medicines that are available for self-selection without prior evaluation by the TGA.
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 referred to a 'slim' liver and the label claimed that it could 'assist liver lipid deposition', 'support lipid re-deposition in the liver', 'assisting fatty acid metabolism in the liver', 'normalising liver fat deposition', and 'supports liver regeneration'. Further, the label implied that this medicine can aid in preventing and/or alleviating fatty liver disease. 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 this medicine. The sponsor did not sufficiently address the issues. The TGA cancelled this medicine and withdrew permission for further supply.
Grounds for cancellation
"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 (paragraph 30(2)(aa) 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)."
It appears to the Secretary that the presentation of the goods is unacceptable (paragraph 30(2)(aa) 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)."