The cosmetic industry has been subjected to continuous shock waves over the past eighteen months, with multiple amendments to the regulatory guidelines and processes regulating the cosmetic injection and beauty industry. It comes as no surprise that clinics and practitioners alike are left scratching their heads, pondering whether their advertising strategies are compliant with the Therapeutic Goods Administration’s (‘TGA’) iron-fist policy approach to marketing regulation. In this article, we will explore the TGA’s position and how you can safeguard your practice against inadvertent scrutiny.

What’s changed for the cosmetic industry?

On 15 January 2024, a widespread communication was sent by the Therapeutic Goods Administration’s (‘TGA’) Assistant Director of Advertising and Compliance Education and Policy, Kate Kaylock, to the cosmetic injection and beauty industry at large, advising of the TGA’s imposition of new regulations for the promotion and advertisement of cosmetic services. The letter contained the following excerpt:

“It is an offence against s42DL(10) and a breach of s42DLB(7) of the Therapeutic Goods Act 1989 (‘TGA Act’) (the Act) to advertise where the advertisement refers to substances, or products containing substances, included in Schedule 3, 4 or 8 (but not in Appendix H) to the current Poisons Standard.”

The revised approach regarding the cosmetic industry and its regulatory obligations is intended to streamline advertising standards across all industry sectors, as the advertisement of cosmetic injectables was previously thought to influence consumers to use and/ or supply prescription medicines (i.e. antiwrinkle injections, dermal filler and cosmetic injections) through advertisements.

The latest amendment represents another wave in the Medical Board of Australia and the Australian Health Practitioner Regulation Agency.

What does this mean for the cosmetic industry?

Unsurprisingly, cosmetic injectors and clinics alike have been scratching their heads to strip back the so-called ‘legalese’ contained within the TGA’s letter. However, the amendments aren’t necessarily as daunting as they seem.

The basis behind the crackdown is avoiding cosmetic injectable substances (or prescription medicines) in advertising campaigns. In practice, this means that clinics need to remove advertising campaigns that refer specifically to, either directly or indirectly, prescription-only substances, including ‘Dermal Fillers’ or ‘Anti-Wrinkle Injections’.

To avoid doubt, advertising includes all forms of verbal, printed and electronic communication, including social media posts and content creation shared online. Other traps in seemingly unsuspecting advertising forms include testimonials from clients, claims concerning goods, before and after photos, hashtags within posts, or price lists. Practitioners should also ensure that they actively monitor and review content produced by others on their behalf to ensure compliance.

Please otherwise note that the TGA receives so-called ‘tips’ through a ‘whistle-blower’ regime, where suspected non-compliant advertising can be reported online by everyday consumers to alert the TGA of such conduct.

Enforcement Action

While the TGA’s revised position on advertising in the cosmetic industry may seem to be no more than a thorn in the industry’s side, the warnings should not be taken lightly. The TGA Act expressly provides that engaging in prohibited advertising practices is an offence, and several clinics already face the harsh consequences of non-compliance.

In a recent publication by the TGA on 7 March 2024, and consistent with the TGA’s approach to compliance, the first stages appear to seek voluntary compliance by engaging with and educating the industry in the first instance, to which the TGA has proposed to run industry information sessions in the coming months. However, future compliance-related actions will follow the usual enforcement action processes. However, the TGA has foreshadowed that it will respond to the nature and seriousness of the alleged non-compliance on a case-by-case basis.

Regarding future non-compliant advertising practices, you or your clinic may be the unwilling recipient of an infringement notice from the TGA, coupled with a financial penalty corresponding with the relevant breach of the TGA Act. In other cases, depending on the severity of non-compliance, the TGA can instigate court action, and clinics should remain well-appraised of this potential enforcement avenue.

We otherwise advise that the TGA publishes an open-access infringement notice public registry to keep the community appraised of the infringement notices issued to offending organisations (and not exclusively those who infringe upon cosmetic advertising regulations), which can be accessed here:

Changes to Practice

In light of the above, business owners and injectors alike have raised of many queries and concerns as to their practices’ current advertising strategies and mechanisms to employ in order to ensure clinic compliance with the new regulations.

At the preliminary level, practitioners have long since been required to rephrase their advertisements of specific medicines, such as Botox, and were otherwise required to use generic terms such as “anti-wrinkle treatments” when promoting such services. However, in light of the new position adopted by the TGA as per the above, phrasing alternatives must be employed as per the example provided by the TGA: ‘Our clinic can provide consultations on reducing the appearance of wrinkles’.

RAMSDEN LAWYERS – HOW WE CAN HELP

Understandably, navigating the expansive and rapidly evolving regulation can be tiresome and confusing. If you are unsure about whether your clinic engages in compliant advertising practice, our Litigation and Dispute Resolution Division can assist and otherwise has considerable expertise in assisting clients in addressing compliance-related concerns in a number of many industries.  We are happy to arrange an obligation-free initial consultation to assist you in navigating the relevant legislation for your circumstances.

This article’s content is intended to provide general guidance on the subject matter and must not be relied on as legal advice. You should seek specific advice about your circumstances.