FatBlaster Max (Cat Media Pty Ltd)
Product Name
FatBlaster Max
Sponsor
ARTG
348163
Date of review outcome
Date cancellation takes effect
Date of publication
Jun-22
Outcome
Medicine is no longer permitted to be supplied
Is it safe to continue using this medicine?
Yes, based on the sponsor's certification
What action should consumers take?
Consider whether the medicine is right for you based on the medicine potentially not working as expected in relation to weight loss
Review scope
Targeted
Information reviewed
ARTG Record, Labels, Website
Issues related to safety
The safety of the medicine was not assessed as part of this review
Issues related to efficacy
The medicine name in conjunction with the medicine's label and website presentation, claim use of the medicine for weight loss. 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 the medicine. The sponsor did not provide information to sufficiently address the issues. The TGA cancelled the medicine and withdrew permission for further supply.
Grounds for cancellation
As it appeared to the Secretary that the medicine's label contained an indication that was not proposed to be accepted in relation to the inclusion of the medicine in the Register, the certification made under s.26A(2)(fba) of the Act was incorrect.
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.
The sponsor failed to comply with a condition of listing under s.28(5)(ab) of the Act (that the goods will not be advertised for an indication other than those accepted in the Register).
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.
The sponsor failed to comply with a condition of listing under s.28(5)(ab) of the Act (that the goods will not be advertised for an indication other than those accepted in the Register).
Additional information
Decision under review at the Administrative Appeals Tribunal