The Therapeutic Goods Administration’s announcement regarding stricter regulations on advertising cosmetic injectables has sent shockwaves through the industry and ignited a robust debate.
In a statement on 7 March 2024, the Therapeutic Goods Administration (TGA) reinforced it has updated its guidance on advertising cosmetic injectables ‘to ensure advertising rules are applied consistently across all industries that deal with therapeutic goods’.
The update reiterated the contents of a letter sent by the TGA on 15 January 2024 addressed to the cosmetic injections and beauty industry group, in which the TGA announced an adjustment to the rules pertaining to advertising Schedule 4 substances.
General terms, including ‘anti-wrinkle injections’ and ‘dermal fillers’, are now banned when advertising cosmetic injectables. This is because, the letter states, these terms refer to (by drawing the audience’s mind to) prescription-only products. The TGA says alternatives to these references to support advertising of services include: ‘our clinic can provide consultations on reducing the appearance of wrinkles’.
The letter, sent by Kate Kaylock, the TGA’s Assistant Director of Advertising and Compliance Education and Policy, stated:
‘…The promotion of a health service as a means to obtain a prescription medicine is a form of advertising prescription medicines. Decisions about treatments that involve the use of prescription medicines should be made by a doctor in consultation with each individual patient. It is not legal to influence consumers about the use or supply of prescription medicines through advertising.
‘For the cosmetic industry this means that while the advertising of the service provided remains outside the jurisdiction of the Act, if such an advertisement refers to a schedule 4 substance or a product containing that substance (even in general terms such as ‘wrinkle reducing injection’) the advertisement will in almost all cases be considered an unlawful advertisement for therapeutic goods.’
Changes in effect immediately
The changes came into effect retroactively on 18 December 2023, when previously published guidance which included certain terms, such as ‘anti-wrinkle injections’ and ‘dermal fillers’, considered at the time to be acceptable, was removed from the TGA website.
In a media release published the same day (7 March 2024) as the newly published revised guidance on the TGA website, the TGA stated:
‘This material reinforces that the legislation itself regarding cosmetic injectables has not changed, and advertising the use or supply of prescription medicines, including most cosmetic injectable products (as opposed to services), has never been compliant with the therapeutic goods framework. This includes through use of testimonials, claims about the goods, before and after photos, or price lists.
‘Consistent with the TGA’s approach to compliance, we will seek high levels of voluntary compliance by engaging with and educating industry in the first instance and will run industry information sessions in the coming months.’
The guidance itself is succinct, with the main directive as follows:
‘Either directly or indirectly, you cannot make any reference in your advertisement for cosmetic injection services to prescription-only substances or to product trade names of such products. This includes acronyms, nicknames, abbreviations and hashtags, which may be taken by a consumer as a reference to a specific prescription- only medicine or substance.
This includes:
- anti-wrinkle injections
- dermal fillers
- injectable products used for improvement of the appearance of submental fat.
This does not apply to cosmetic injectables that do not contain any prescription-only substances.’
Ongoing monitoring & enforcement
One of the TGA’s Compliance Priorities for 2023-24 is to detect and disrupt unlawful advertising of unapproved and high-risk medicines and medical devices used in the wellness and beauty industries including those intended to alter the body’s performance and appearance.
The updated policy on general terms such as ‘anti-wrinkle injections’, ‘wrinkle-reducing injection’ and ‘dermal fillers’ is the latest in a sweep of reforms to the cosmetic surgery sector in Australia.
THE DEBATE SURROUNDING NEW ADVERTISING RESTRICTIONS
The TGA’s updated guidance on references to cosmetic injectables in advertising has triggered an avalanche of debate – both among industry professionals and across social media websites.
Among the main issues raised have been:
- SEMANTICS: the potential confusion involved in separating the TGA’s ban on specific further use of the terms ‘wrinkle reducing injection’, ‘anti-wrinkle injections’ or ‘dermal fillers’ from the TGA’s continued approval of, for example, the advertising reference ‘our clinic can provide consultations on reducing the appearance of wrinkles’;
- COST: the significant cost, in both dollars and management time, required to plan and implement (without previous warning or consultation) immediate compliance triggered by these unforeseen technical changes in advertising wording – thus saddling each operator with the urgent and enormous tasks of revising all signage, marketing materials, social media posts and related communications;
- PRACTITIONER CONFUSION: many practitioners remain confused about how to present treatment options without breaching what they describe as the TGA’s unnecessarily strict rules on wording, while still trying to abide by Ahpra requirements;
- PATIENT CONFUSION: the ban on words and phrases, previously common in advertising to explain how different drugs work without using brand names – such as ‘anti-wrinkle injections’ and ‘dermal fillers’ – won’t protect the public because, without
the ability to use even generic descriptors, doctors will be unable to educate patients already confused by the existing ban on specific drug names; - OPTION OBSCURITY: rather than invite industry consultation, the TGA has rushed through ‘ill- conceived rules that only make treatment options more obscure’ for the patient;
- PATIENT SAFETY: the new bans – widely portrayed as ‘a kneejerk response by the TGA’ – risk making patient safety worse, because removal of reasonable access to expert information will not force compliance, but instead push demand ‘underground’ into the hands of unscrupulous providers (online menopausal and weight loss services are highlighted as examples of this);
- EDUCATION: the solution to TGA concerns re minimally qualified practitioners seeking ‘fast bucks’ via anti-wrinkle medications is not to further curtail patient education from medical professionals qualified to inform and educate and help keep the public safe;
- INTERNET ACCESS: claims the banned words and phrases ‘induce vulnerable patients’ no longer apply in an age of instant access to a global network for information on drugs – including their names;
- OVERSEAS PROVIDERS: limiting what Australian professionals can say simply ensures patients will source their own ‘product information’ from overseas providers – who
- may not be doctors, nurses or even medically qualified; and may be describing similar, yet different, drugs not registered with the TGA;
- VESTED INTERESTS: inthe absence of educational information from medical professionals qualified to provide it, unqualified ‘influencers’ and/ or irresponsible suppliers with vested interests will step in to fill the void – potentially selling their latest version of ‘snake oil’;
- UNDERGROUND SUPPLY: attempting to make a regulated drug invisible doesn’t stop potential patients looking for and/ or using it – rather it may drive them ‘underground’ to access the drug in unsafe ways, via unsafe providers in the market purely for the money;
- ROGUE SUPPLIERS: providers not limited by Ahpra registration and obligations will step into this space to sell unproven therapies and confuse patients further;
- OVERSEAS TREATMENT: continuing to change regulations and restrict information flows about the latest cosmetic surgery products and treatments simply encourages more people to consider flying overseas for their surgery.
