TGA instigates legal action against Peptide Clinics Australia for advertising compounded prescription-only therapeutic goods to the general public without the necessary approvals.
The TGA has uncovered breaches of the Therapeutic Goods Advertising Code 2015 (the Code)Â and the Therapeutic Goods Act 1989 following an investigation.
The advertisements were accessible to registered customers and the public through the clinics’ website and social media and referenced serious forms of diseases and mental health conditions. Both of these require approval by the TGA and it is alleged no approvals were in place.
The TGA is also alleging the advertisements contained scientific information that was inaccurate, imbalanced and misleading, and that the advertisements contained statements, claims and implications that the advertised peptides were safe or, alternatively, could not cause harm and, therefore, encouraged inappropriate use of the medicines. If proven, the alleged actions would be in breach of the Code.
Peptide Clinics Australia have given an undertaking to the court that it will remove the relevant advertisements from its website and social media accounts pending final hearing of the matter in 2019.
At that time, the court will be asked to impose financial penalties, and to issue declarations and final orders requiring the removal of any references for which approvals or permissions are required, as well as the removal of any other information in breach of the Advertising Code.
The TGA says, “the use of the peptides and other prescription-only therapeutic goods sold by Peptide Clinics Australia could result in serious harm to consumers’ health and safety, particularly as it is alleged that the products are not used with adequate or appropriate medical supervision”.