The Therapeutic Goods Administration (TGA) has published its annual Therapeutic Goods Advertising Compliance Report for 2020-21. The report contains details of the advertising breaches reported in the last financial year. It discusses the compliance and enforcement actions undertaken by the TGA. It also identifies the current compliance priorities which guide resourcing toward TGA monitoring and enforcement efforts.
Key take-aways from the TGA report
2,074 reports of alleged advertising breaches were reported in 2020-21.
All allegations of non-compliance received by the TGA were assessed for further action and between November 2020 and June 2021:
- 569 non-compliant online advertisements were removed
- 68 allegations were referred to another regulator for action
- 421 warnings were issued
- 127 infringement notices were issued
- 2 enforceable undertakings were negotiated
Common reasons for infringement notices
The most common reasons for the TGA to issue infringement notices were:
- promotion of unapproved therapeutic goods to consumers, being therapeutic goods which should have been entered in the Australian Register of Therapeutic Goods but were not
- unauthorised use of prohibited and restricted representations.
Permission to use a restricted or prohibited representation in consumer advertising
Permission to use a restricted or prohibited representation in consumer advertising was granted on 12 occasions in 2020-21. Prohibited and restricted representations refer to a serious form of a disease, condition, defect or ailment, and must not be used in consumer advertising without the prior permission of the Secretary of the Department of Health.
Four court proceedings for advertising breaches
There were also four court proceedings for advertising breaches commenced or ongoing in 2020-21.
Of special note, the Federal Court imposed the largest penalties ever for advertising breaches related to therapeutic goods in proceedings commenced by the TGA against Evolution Supplements Australia Pty Ltd and its sole director Mr Cumhur Keskin. The company was ordered to pay $11 million for unlawfully advertising a range of unapproved sports supplement products (including products containing steroids, SARMs, DMAA and other amphetamine derivatives). Mr Keskin was ordered to pay $1 million for failing to prevent the breaches and not complying with a direction issued by the TGA.
COVID-19 products are an ongoing priority
COVID-19 products including vaccines, treatments and disinfectants are an ongoing priority for the TGA advertising compliance unit. In 2020-21, 39 infringement notices totalling $412,056 were issued for COVID-related advertising breaches, and 189 entities were contacted or issued with warnings for alleged non-compliance.
Other compliance priorities
The other compliance priorities for the TGA are: stem cell products, medicinal cannabis, performance and image enhancers, therapeutic goods used in the cosmetic and beauty industry, hangover cures, weight loss products, mental/learning acuity products and bioresonance products.
Special measure for COVID-19 advertisements
As a specific measure directed to assist in increasing COVID-19 vaccination rates, until 31 December 2022, any person or company may publish promotional materials about COVID-19 vaccines which are consistent with public health messaging and offer rewards (except tobacco or some medicines) to fully vaccinated people. It is expected that these kinds of advertisements of this nature will however continue to be closely scrutinised by the TGA.
Advertising changes to nicotine vaping products
Nicotine vaping products, which have been subject to supply restrictions in 2020-21, have also been subject to advertising changes. When used for smoking cessation, nicotine vaping products are regulated as prescription medicines – which are usually prohibited from being advertised to the public.
However, since June 2021, pharmacies and pharmacy marketing groups are permitted to indicate if they stock, or can arrange the supply of, nicotine vaping products at their premises.
A new Therapeutic Goods Advertising Code
A new Therapeutic Goods Advertising Code is due to be released later this year, with the intention that it will be clearer and easier to interpret. The current Code is presently under review. Public consultation closed on 18 June 2021, with 67 submissions received.
You can view the full report, Therapeutic goods advertising compliance: 2020-21 Annual Report.
If you have any questions about the advertising rules for therapeutic goods, or how they apply to you, please don't hesitate to contact us.