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On 15 January 2024, in a letter addressed to the cosmetic injections and beauty industry group, the TGA announced an adjustment to the rules around 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.
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, said the TGA’s updated position on references (even in generalised terms) to cosmetic injectables in advertising is to “ensure the consistent application of the legislation related to the advertising of therapeutic goods across all industry sectors”.
The letter states:
“It is an offence against s42DL(10) and a breach of s42DLB(7) of the Therapeutic Goods Act 1989 (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 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 letter states these changes came into effect 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.
The TGA will publish revised guidance on the Advertising for health services webpage on the TGA website by mid to late January 2024, followed by an educational webinar in February 2024.
Ongoing monitoring and 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.
This correspondence forms a timely reminder that the TGA expects the advertising in the cosmetic injectable industry to comply with advertising requirements.
The updated policy on generalised 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. You can read a detailed overview of the new cosmetic surgery advertising regulation here.
More useful links:
- For assistance in obtaining advice regarding advertising of cosmetic services, the TGA has provided a list of industry organisations with TGA regulatory affairs consultants.
- For more information on the types of actions the TGA may take in instances of non-compliance, see the ‘Compliance and enforcement’ hub on the TGA website.
