New TGA Guidelines: Restriction on Specific Terms in Cosmetic Services Advertising

On 15 January 2024, in a letter sent by Kate Kaylock, the TGA’s Assistant Director of Advertising and Compliance Education and Policy announced an adjustment to the rules around advertising Schedule 4 substances.

The new rules now state that the use of general terms such as:

• Antiwrinkle injections
• Dermal Filler
• Cosmetic injections

are now banned from advertising these services. Instead, clinics can only use make statements such as: “Our clinic provides treatments that address wrinkles”.

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 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.”

Since these announcements we have received several concerns from practitioners regarding the impact that these restrictions will have, with the common consensus being that they will confuse clients.

A further concern is that these wording restrictions would place these treatments into the shadows as to what they offer, and how they are performed. 

• There was also concern that they may be considered counterproductive since AHPRA requires that practitioners stipulate what treatments were performed in all of their “before and after” photos.

• Our members also were confused as they perceived that AHPRA and the TGA appeared to be at odds with their messaging.  Additionally, the question presented is whether these new rules would help patients in terms of safety, or in gaining an understanding of what treatment they will be receiving.

APAN has contacted the TGA and forwarded a letter to Kate Kaylock, requesting further clarification and expressing our concerns, specifically, with how AHPRA treatment identification requirements would still apply when the new rules do not allow the specifics of the treatment to be identified.

We will keep you informed of developments. 

• Meanwhile, please note that these changes are effective immediately.
• 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.

APAN will keep you updated on any and all developments