Investigations of advertising complaints

12 September 2017

The TGA's policy is to publish the outcomes of investigations into complaints about therapeutic goods advertising directed to consumers which have been referred to the TGA by the Complaints Resolution Panel (the Panel) for follow-up action.

The details of outcomes of complaint investigations published are where:

While the TGA does consider complaints about advertising of therapeutic goods independently to the Panel, the outcome of such complaints are not currently published.

The TGA's approach to advertising compliance

The TGA pursues any regulatory action in relation to advertising non-compliance in a risk-based manner in accordance with the Regulatory Compliance Framework (link). In the first instance, the TGA works with the advertiser using an educative approach in order to achieve advertising compliance. However, escalation of regulatory action may be considered if the advertiser is not willing to comply or the breaches of the advertising requirements are of a particularly serious nature.

About the complaint process

The Complaints Resolution Panel (the Panel)is established under the Therapeutic Goods Regulations 1990 (the Regulations) to consider complaints about consumer advertising of therapeutic goods appearing in radio, television, consumer magazines, newspapers, billboards, cinema or the internet. The Panel determines whether a complaint is justified and how the advertising breaches the therapeutic goods advertising legislative requirements. Panel complaint determinations are published in its Complaint Register.

Where the advertiser fails to acknowledge or fully act upon a complaint determination made by the Panel or breaches an undertaking, the Panel may recommend that the TGA take follow-up action in relation to the matter.

On receipt of such a recommendation, the TGA considers the complaint and all the material submitted to the Panel and provides the advertiser with a further opportunity to respond to the complaint and make submissions to the TGA.

The possible outcomes of the TGA's investigation of the advertising complaint and consideration of the Panel's recommendation are:

Orders made by the TGA are given effect under regulation 9 of the Therapeutic Goods Regulations 1990 (and are known as regulation 9 orders).

Following receipt of a regulation 9 order, an advertiser may seek reconsideration of the decision by the Minister under regulation 48 by lodging a written request within 90 days after the decision first comes to its notice.

The lodging of a request for a review of a decision does not affect the operation of the decision made under regulation 9. It remains in effect and must be complied with unless and until it is varied or set aside on review or another order affects it.

There may also be occasions where breaches of the advertising requirements lead to the TGA suspending or cancelling a product entry from the Australian Register of Therapeutic Goods.

Consumer guide to commonly noted advertising breaches

A consumer guide summarising the commonly noted advertising breaches is available on this website.

This guide is a summary only and the full details of these provisions are contained in the Therapeutic Goods Act 1989 and the Therapeutic Goods Advertising Code 2015.