Naturopathica FatBlaster FatMagnet (Cat Media Pty Ltd)
Product Name
Naturopathica FatBlaster FatMagnet
Sponsor
ARTG
145959
Date of review outcome
Date cancellation takes effect
Date of publication
Mar-21
Outcome
Medicine is no longer permitted to be supplied
Is it safe to continue using this medicine?
Yes, if you follow the recommended actions below
What action should consumers take?
Consider whether the medicine is right for you given that claims for maintaining or supporting general health and wellbeing, decreasing or reducing dietary fat absorption in the digestive system and aiding elimination of dietary fat were not substantiated by the sponsor.
Review scope
Targeted
Information reviewed
ARTG Record, Evidence, Labels, Website
Issues related to safety
The safety of the medicine was not assessed as part of this review
Issues related to efficacy
The sponsor did not hold evidence to support the claim about maintaining general health and wellbeing. The sponsor did not hold sufficient evidence to support claims relevant to reducing dietary fat absorption and aiding elimination of dietary fat, which were advertised on the label and website for the medicine. The clinical trials provided had limitations including not providing enough detail about the study population to be sure it is relevant to the target population of the medicine; the dosage of the active ingredients was different to the dosage in the medicine; information about the monitoring of food intake was unclear; unexplained dropout of participants; possible conflict of interests; and the effect of the medicine ingredients on dietary fat absorption or dietary fat elimination was not assessed.The remaining evidence included review articles, animal studies, in vitro laboratory studies and an evidence-based textbook. These types of evidence are insufficient in the absence of robust scientific studies, such as clinical trials or systematic reviews, to support these claims. This is because they generally do not include sufficient detail regarding population demographics, sample size, ingredient preparation, dose and statistical analysis to allow for comparison with the medicine.The name of the medicine was considered to be misleading, as it suggests that the medicine can help with fat loss or weight reduction, yet these claims were not covered by a certification by the sponsor 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 provide additional information to address the issues. The TGA cancelled the medicine and withdrew permission for further supply.
Grounds for cancellation
It appeared to the Secretary that a statement made in, or in connection with, the application for listing of the goods was false or misleading in a material particular.As there was insufficient evidence to support the indications for the product, the certification made under s.26A(2)(ja) of the Act was incorrect. It appeared to the Secretary that the presentation of the goods was unacceptable.