FatBlaster Max cancelled by TGA for alleged breaches of Therapeutic Goods legislation

TGA

On 16 May 2022, the Therapeutic Goods Administration (TGA) cancelled the listed complementary medicine FatBlaster Max (AUST L 348163) from the Australian Register of Therapeutic Goods (ARTG) for alleged breaches of the Therapeutic Goods Act 1989. Cat Media Pty Ltd is the sponsor of this medicine.

When a medicine is listed on the ARTG, the applicant must state what therapeutic uses (known as indications) that medicine is suitable for. The Act does not allow a listed medicine to be advertised for an indication that is not included in the medicine’s listing on the ARTG.

The TGA considers that the name ‘FatBlaster’, as used on the label for FatBlaster Max and on a website where Cat Media Pty Ltd advertised that medicine, would be understood by consumers to represent that the medicine causes loss of body fat and therefore weight loss.

When the medicine was listed on the ARTG, however, Cat Media Pty Ltd had not included weight loss or body fat loss in the list of indications for the medicine. Thus the TGA is unable to ensure that the medicine is effective for this advertised purpose.

The TGA concluded that the label for the medicine and related advertising promotes FatBlaster Max for a therapeutic use for which it is not listed on the ARTG, in breach of the Therapeutic Goods Act 1989. Consumers who have been using FatBlaster Max for weight loss should be aware that the medicine is not listed on the ARTG for that purpose.

Cat Media Pty Ltd has applied to the Administrative Appeals Tribunal for review of the decision to cancel the medicine. The Tribunal will decide whether to confirm, vary or set aside the decision to cancel the listing of FatBlaster Max in the coming months.

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