Last week, the Therapeutic Goods Administration (TGA) published updated guidance for advertising health services that involve therapeutic goods (Guidance).
The Guidance indicates that going forward the TGA will:
- closely scrutinise any references (even implied) to prescription goods / substances in advertising for health services; and
- no longer accept the use of general terms to describe cosmetic injectables in advertising for cosmetic services.
Proceed with caution when advertising health services that involve therapeutic goods
In Australia, advertising prescription medicines to the public is prohibited.[1] It is common for the provision of health services to include the supply or use of products that require a prescription – for example, Botox and medicinal cannabis.
The Guidance makes clear that the TGA will consider:
- the promotion of health services as a way to obtain prescription-only medicines as advertising of a prescription medicine; and
- any references (direct or implied) to prescription-only medicines in advertising for health services will result in the advertisement being regulated as an advertisement for a therapeutic good (in addition to advertising of a health service). This now includes using substitute terms such as ‘plant-based medicine’, ‘wrinkle reducing injections’ and ‘weight loss injections’.
The TGA recommends that businesses advertising health services that may involve a prescription-only substance should only refer to the type of consultation that the service offers. The Guidance provides the example of ‘our clinic offers consultations related to smoking cessation’ as a claim that is compliant when advertising clinics that specialise in prescribing nicotine vaping products.
General terms no longer permitted in the advertising of cosmetic injectable services
The Guidance also reflects a significant shift in the TGA’s enforcement position on the use of indirect references to cosmetic injectable treatments.
Previously, the TGA had indicated that cosmetic injectable services could be promoted using acceptable general (non-product specific) terms including ‘anti-wrinkle injections/treatments’, ‘lip enhancement/augmentation’, ‘dermal fillers’ and ‘injections for submental fat’. While not explicitly referred to in the Guidance, in a letter issued to the cosmetic injections and beauty industry group on 15 January 2024 and its media release announcing the publication of the Guidance last week, the TGA announced that references to these general terms in circumstances where those terms draw consumers’ minds to prescription-only products will not be permitted.
To ensure advertising is consistent with the Guidance, businesses which offer cosmetic injectable services should remove any references to prescription-only substances or goods containing these substances (including indirect references) in advertising and instead only refer to type of consultation offered. The TGA provides the example of ‘our clinic can provide consultations on reducing the appearance of wrinkles’. The provision of a prescription should not be promoted as the expected outcome of the services offered.
This policy shift comes in light of a perceived increase in advertising of prescription-only medicines by referring to a class of goods.
While the TGA is at pains to stress that the legislation has not changed – this shift in its policy will be strongly felt by cosmetic injectable service providers.
Next steps
The media release indicates that the TGA will – in the first instance – seek voluntary compliance while businesses update their marketing collateral.
In the meantime, suppliers of health services that involve therapeutic goods should review marketing collateral to ensure it is consistent with the TGA’s Guidance.
As one of the TGA’s 2023-4 compliance and enforcement priorities is the detection and disruption of unlawful advertising of high-risk medicines used in the wellness and beauty industry, the cosmetics industry can expect that the TGA will take any conduct not consistent with the Guidance seriously.
Specifically, advertising therapeutic goods to the public that contain substances included in Schedule 3 (pharmacist-only medicines), Schedule 4 (prescription-only medicines) or Schedule 8 (controlled drugs) (but not in Appendix H) to the Poisons Standard is prohibited under sections 42DL and 42DLB of the Therapeutic Goods Act 1989.
