Did you know that a new Therapeutic Goods Advertising Code (TGAC)1 will commence on 1 January 2022 following an 18 month consultation period? The new TGAC was only announced by the Therapeutic Goods Administration (TGA) earlier this month.
From 1 January to 30 June 2022, your business may comply with either the current TGAC2 or the new TGAC. From 1 July 2022, all advertising and marketing of therapeutic goods must comply with the new TGAC.
Testimonials and Endorsements
The Explanatory Statement accompanying the new TGAC notes that stakeholder views regarding who should / should not be permitted to make testimonials and endorsements were ‘wildly divergent’.3 The direct selling industry was hopeful that direct sellers might have been permitted under the new TGAC to make testimonials provided that their role as a direct seller was disclosed clearly in the testimonial. Unfortunately, despite concerted efforts by the direct selling industry, an amendment of this nature was not made.
Section 24 of the new TGAC concerns testimonials and endorsements (addressed in section 16 and 17 of the current TGAC). The rules concerning testimonials and endorsements remain largely the same. Paid and incentivised testimonials are prohibited.
Testimonials are unable to be made by:
- a ‘relevant person’ who is involved in the production, marketing or supply of therapeutic goods; or
- a member of the relevant person’s immediate family, unless the advertisement discloses that the person making the testimonial is an immediate family member of the relevant person.
The new TGAC defines ‘relevant person’ as ‘a person who is engaged in the marketing or supply of therapeutic goods’ and ‘includes influencers, direct sellers and other persons who have, or will receive valuable consideration for making the testimonial.
The requirements regarding endorsements have been clarified to prohibit expressly endorsements from:
- not only current health practitioners, health professionals or medical researchers from providing endorsements but also individuals formerly employed in these roles; and
- people who represent themselves as being qualified or trained to diagnose, treat or prevent disease, ailments, defects or injuries in people (which is a new addition to the new TGAC).
Other changes include:
- the simplification of mandatory statements;
- the expansion of the list of product samples which are permitted;
- the consolidation of rules regarding prohibited representations in the Therapeutic Goods Regulations 1990; and
- the clarification of various definitions in the TGAC.
The TGA intends to publish guidance material in respect of the new TGAC in early 2022 and to host explanatory webinars in the first half of the new year.
We will be monitoring the TGA’s website for developments.
We recommend that all marketing and advertising material, includes websites and social media pages, be reviewed to ensure compliance with the new TGAC by 30 June 2022 and, if your business utilises influencers, that the terms of those relationships also be reviewed.
1 Therapeutic Goods Advertising Code 2021, https://www.legislation.gov.au/Details/F2021L01661
2 Therapeutic Goods Advertising Code (No. 2) 2018, https://www.legislation.gov.au/Series/F2018L01524
3 Explanatory Statement, https://www.legislation.gov.au/Details/F2021L01661/Explanatory%20Statement/Text