On 7 March 2024, the Therapeutic Goods Administration (TGA) updated their guidelines on advertising health services; specifically, the advertisement of services that involve therapeutic goods. The updated guidelines were effective immediately. This article explains the applicable changes to the cosmetic nursing sector, specifically to those who advertise cosmetic injectable treatments.
Changes to advertising cosmetic injectable treatments from March 2024
Cosmetic injectable treatments are colloquially referred to as treatments that remove wrinkles or enhance an individual's appearance.
The March 2024 changes to the TGA advertising guidelines mean that a cosmetic nursing clinic or practitioner cannot directly or indirectly advertise cosmetic injection treatments that contain the following substances:
- Schedule 4 medications (schedule 4 medications are drugs which are restricted to a prescription); or
- Schedule 8 medications (controlled drugs).
The promotion of any services containing treatments comprised of either Schedule 4 or Schedule 8 drugs is now strictly prohibited.
What do the TGA advertising changes mean for cosmetic injectable treatment clinics/clinicians?
The changes to TGA advertising guidelines mean that it is now prohibited to reference in advertising treatments:
- medication trade names;
- product names;
- acronyms; or
- nicknames,
which the public may construe as being a reference to a Schedule 4 medication or Schedule 8 medication.
For example, the following phrases are now banned in advertising cosmetic injectable treatments, as they could lead the consumer to consider undertaking treatments comprised of schedule 4 or schedule 8 medications:
- anti-wrinkle injections;
- dermal fillers; and/or
- injectables used for improvement of appearance of wrinkles or subdermal fat.
In making these changes to the advertising guidelines, the TGA aims to ensure that any individual seeking an injectable treatment which is comprised of a schedule 4 or schedule 8 medication, has proper consultation with an appropriate health care practitioner to discuss the general and specific risks of the desired treatments.
The TGA definition of advertising?
Section 3 of the Therapeutic Goods Act provides the definition of advertising as:
'in relation to therapeutic goods, includes make any statement, pictorial representation or design that is intended, whether directly or indirectly, to promote the use or supply of the goods, including where the statement, pictorial representation or design:
- is on the label of the goods; or
- is on the package in which the goods are contained; or
- is on any material included with the package in which the goods are contained.'
Part 5-1 of the Therapeutic Goods Act prescribes that advertising requirements apply in circumstances where an advertisement is one that is directed to the public at large and is one that promotes therapeutic goods.
It is imperative to note that whether the advertisement is intended to promote the supply and use of therapeutic goods (schedule 4 or schedule 8 medication) is determined on how a consumer interprets the intent of the advertisement and not the intended meaning behind an advertisement by the person promoting the treatment.
Failure to comply with TGA advertising guidelines
The TGA is responsible for ongoing monitoring of compliance in respect of the advertising guidelines it seeks to impose.
In circumstances where the TGA identifies a breach in advertising requirements, they may issue a direction notice which requires the advertiser to take immediate steps to redress the non-compliant advertisement.
In serious circumstances of non-compliance, the TGA may issue a prevention notice to the advertiser which prevents them from making false or misleading advertisements for therapeutic goods.
Sanctions and penalties for failure to comply with a TGA direction or prevention notice
Failure to comply with either a direction notice or prevention notice may result in further investigation by the TGA.
The following actions and enforcements are available to the TGA, depending on the result of an investigation:
- negotiating an enforceable undertaking;
- applying for an injunction;
- issuing an infringement notice;
- issuing a public warning notice;
- cancellation or suspension of a product from the Australian Register of Therapeutic Goods (ARTG), and/or recall of the goods;
- applying to the court for criminal prosecution or civil penalties.
Get help from a health law solicitor
If you have questions regarding the TGA advertising guidelines or you have been contacted by the TGA and notified that you are in breach of the TGA advertising guidelines, please contact our health law team to seek further assistance and specific advice.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.