The Therapeutic Goods Administration (TGA) regulates all advertisements in relation to therapeutic goods. In future articles, we will provide more detail in relation to the TGA and therapeutic goods generally. Therapeutic goods advertisements must also comply with the Australian Consumer Law (ACL), which forms part of the Competition and Consumer Act 2010 (CCA), however, this article focuses on the TGA advertising requirements – with a spotlight on sunscreen products and social media.
Hot topics in therapeutic goods advertising
The Therapeutic Goods Advertising Code 2021 (the Code) was introduced on 1 July 2022 and provides guidance on how advertisers can comply with the Therapeutic Goods Act 1989 (Cth) (the Act) and the Therapeutic Goods Regulations 1990. All therapeutic goods advertising must comply with these rules to avoid hefty penalties, and it is clear the TGA is burning to take action against non-compliance.
The TGA’s compliance priorities for 2022 and 2023 highlighted as core areas of concern:
- the unlawful use of restricted and prohibited representations in advertisements that have not been approved or permitted, particularly those that target especially vulnerable consumers; and
- the unlawful advertising of unapproved therapeutic goods on digital platforms; including for pregnancy and prenatal goods, weight loss products and hangover cure.
What is advertising?
“Advertise” is defined in the Act to include making any statement, pictorial representation or design that is intended, whether indirectly or indirectly, to promote the use or supply of the goods.
In assessing consumer advertising, it is important to consider the accuracy of the advertisement, the total presentation of the advertisement, the context in which it will appear and the likely impact on the reasonable consumer within the target audience.
General guidance
The way in which a therapeutic good may be advertised depends upon its classification and risk profile. However, some general guidance is below:
- advertisers are not permitted to suggest, in any advertisement to the public, that the TGA (or any Government body) endorses the goods. For example, words to the effect of ‘TGA approved’ are prohibited;
- advertisements about therapeutic goods must:1
- be accurate, balanced and not misleading;
- promote the safe and proper use of the goods; and
- be consistent with public health campaigns;
- testimonials about therapeutic goods are not permitted if the provider of the testimonial received, or will receive, valuable consideration in exchange for the review;2 and
- not all therapeutic goods can be advertised – some may only be advertised to health professionals, and some may not be advertised at all to children below 12.
TGA Slip, Slop, Slapping influencers’ paychecks for sponsored posts
It appears the TGA is turning up the heat on paid partnerships between therapeutic good businesses and influencers. In particular, the restrictions on sponsored advertisements involving personal testimony for an ARTG-listed product or treatment has raised concern that the Code operates as an “influencer ban” because an influencer is no longer permitted to publicly discuss their personal experience with a product as part of a paid (or gifted) exchange. The recent public discourse on paid endorsements of sunscreen has shone a light on the plight of “skintrepreneurs” and “skinfluencers” in the context of ARTG-listed therapeutic goods.
The Code applies to social media the same way it applies to in-store, TV, magazine, radio and print advertising. A post to Instagram, TikTok, or any other platform, promoting the use and/or supply of therapeutic goods is considered an advertisement for the purposes of the Act.
Go-To Skincare founder Zoe Foster-Blake raised concerns that the Code might undermine public health interests, in that the beauty industry thrives on word-of-mouth and “constraining personal opinions and testimonials – whether unpaid, paid or gifted – will create unnecessary friction for consumers who come to sunscreen reluctantly, even negatively, to begin with.”3
Scientist and influencer Hannah English agrees the Code is burning more than just a hole in her pocket – it restricts her from advocating for better products. English’s more than 66,000 Instagram followers tune in to her detailed sunscreen reviews, with the hope of encouraging her audience to practice sun-safety every day. Her content is a mixture of organic content and paid partnerships, however, the Code means she can now only post about the products without any personal comments.
On the other hand, the TGA’s rationale is that when it comes to social media, what you see is not always what you get. They aim to shade consumers from being misled about sunscreen products based on paid endorsements published by individuals with significant influence. A TGA spokesperson clarified that “influencers are not prohibited from collaborating with businesses [but] any testimonials about their own personal experience with the [product] must not be used.”4 In practical terms, this means an influencer can generally do the following, and this would be permitted under the Code:
- post a picture of the product without any testimony; or
- enlighten their followers on the properties of the product (e.g. mattifying and oil-free), but not their personal experience of it (e.g. how it feels).
Looking forward, while paid promotions may not necessarily slip away, the "skinfluencers" who seek to effect positive change in their followers’ sun safety practices may begin to dry up. In the meantime, we may see a proliferation of passive paid promotions where influencers can be pictured with tanning accelerant products which may provide little sun-protection.
How we can help
HopgoodGanim Lawyers’ Intellectual Property, Technology and Cyber Security team includes legal professionals with experience in the practical workings of the TGA.
We can assist individuals and companies involved in the manufacture, advertising and supply of therapeutic goods with matters including:
- preparing agreements with brand ambassadors;
- reviewing advertising collateral for compliance with Therapeutic Goods Act, Therapeutic Goods Advertising Code and Australian Consumer Law;
- assistance with determining whether your product is a “therapeutic good” and therefore subject to the TGA;
- liaising with regulatory consultants in Australia and overseas, to deliver comprehensive support in major international markets;
- preparation or review of contracts for research and development, manufacturing, clinical trials, resale and distribution arrangements;
- strategic licensing and commercialisation of your therapeutic good; and
- seeking patent and registered design protection for your therapeutic good, and trade mark protection for your brand.
For more information or discussion, please contact HopgoodGanim Lawyers’ Intellectual Property, Technology and Cyber Security team.
A special thanks to Vacation Clerks Siobhan Beckett and Matthew Stark for their assistance in putting this article together.
1. The Code, Part 3.
2. The Code, Part 6.
3. https://gotoskincare.com/blogs/the-go-to-guide/how-we-talk-about-sunscreen-matters
4. https://www.refinery29.com/en-au/tga-influencer-ban-promoting-paid products#:~:text=%E2%80%9CInfluencers%20are%20not%20prohibited%20from,using%20sunscreen%20as%20an%20example