Takeaways from the TGA’s annual advertising compliance report

The Therapeutic Goods Administration (TGA) recently released its fifth annual report on compliance with regulations that apply to the advertising of therapeutic goods for FY 2022-23 (Report).

Following our previous Insight into the TGA’s enforcement priorities for FY 2023-24, this Report is a timely reminder of the TGA’s current advertising compliance practices and priorities as well as trends to be aware of heading into the new year.

Below are the key takeaways.

Cooperation is critical

In FY 2022-23, the TGA:

• made 16,328 non-compliant advertising removal requests
• sent 256 warning letters
• issued 228 infringement notices
• dispensed 4 direction notices, and
• commenced 1 civil and 1 criminal proceeding.

The message is clear: in the event of non-compliance, engaging and cooperating with the TGA early, and rectifying allegedly non-complying conduct promptly, is likely to avoid severe enforcement action being taken.

The TGA adopts a risk-based approach to enforcement action, taking into account the following:

• the seriousness of the alleged non-compliance
• the risk of potential harm or injury
• the indirect risk of harm from reliance on misleading or inaccurate information in lieu of seeking professional health care advice and treatment, and
• the compliance history and behaviour of the responsible person or business, and across the relevant industry. The TGA places a strong emphasis on voluntary compliance and takes a particularly dim view of repeated or wilful non-compliance.

The findings in this year’s Report confirm that the TGA is less likely to escalate enforcement action where:

• the alleged non-compliance is less serious, and
• the advertiser is willing to engage and cooperate with the TGA early.

Conversely, the TGA is more likely to escalate enforcement action where:

• alleged non-compliance is in the TGA’s priority areas and industries, and
• where the TGA perceives the deterrent effect of enforcement to be high.

The TGA will keep watching

The TGA takes an active role in monitoring advertisers whose non-compliant advertising has previously been brought to the TGA’s attention. It also closely monitors advertisers who have previously been the subject of enforcement action. In particular, as part of its assurance review processes, the TGA considers a selection of closed cases to ensure that appropriate steps have been taken by a non-compliant advertiser, for example, that non-compliant advertising has been removed.

In FY 2022-23, the TGA found that the compliance rate of targeted advertisers was 77%, down from the FY 2021–22 compliance rate of 96% (likely due to increased monitoring).

Advertisers should ensure that any advertising removed following a request from the TGA stays removed.

The TGA is online

FY 2022-23 saw the TGA ramp up its online compliance activities significantly, particularly in relation to advertising on social media platforms.

The TGA specifically targeted:

• the advertising of unapproved therapeutic goods (that is, goods that are not registered on the Australian Register of Therapeutic Goods) 
• the advertising of prescription-only medicines (that cannot be advertised to the public in Australia), and
• advertising of unapproved indications (namely, Ozempic for weight loss).

During this period, steps taken by the TGA (including increased collaboration with digital platforms) resulted in the removal of 16,328 non-compliant advertisements from digital platforms. This was a 14-fold increase on the FY 2021–22 period.

We anticipate that, as advertisers increasingly look to digital mediums to reach consumers, the TGA will continue to focus its efforts on advertising posted on digital platforms.

Advertising of cannabis, performance-enhancing drugs, injectables and IV drips took priority

As in other years, the TGA focused enforcement efforts on advertising in areas of its compliance priorities for FY 2022-23, including medicinal cannabis products, unapproved performance and image enhancing products and IV drips.

The above table has been reproduced from page 11 of the Therapeutic Goods Advertising Compliance Annual Report 2022-23.

Medicinal cannabis

In Australia, advertising medicinal cannabis products to the public is prohibited.

The TGA took significant action in relation to the advertising of medicinal cannabis products throughout FY 2022-23, including the issuing of 101 infringement notices (with a combined value of $1,292,040).

The Report observes an upward trend in the promotion of medicinal cannabis:

• on third party platforms, including social media. 351 advertisements for medicinal cannabis products were removed from digital platforms, and
• in conjunction with the promotion of related health services. As a nascent industry in Australia, there remains confusion about how medicinal cannabis clinics can ensure patients are aware of the availability of services, while also complying with requirements under the therapeutic goods regulations. 25% of all enquiries received by the TGA during FY 2022-23 related to this issue.

We anticipate the TGA’s enforcement efforts will increasingly focus on this rapidly expanding industry and area of treatment. The TGA has specifically foreshadowed the commencement of civil penalty proceedings in cases of ongoing non-compliance following education about obligations in relation to the advertising of medicinal cannabis products. True to their word, earlier this week, the TGA commenced proceedings against CDA Clinics QLD Pty Ltd and its former director for alleged unlawful advertising of medicinal cannabis on its website and social media.

Unapproved performance and image-enhancing products

Unapproved performance and image enhancing products (including sports supplements) are a TGA compliance priority, including because these products often contain substances that require a prescription or are prohibited. Examples of these substances include:

• sport supplement products (e.g. pre-workouts), and
• Selective Androgen Receptor Modulators (SARMS).

In its Report, the TGA observes that, while industry compliance has generally improved, retailers continue to import and advertise products that contain these substances.

In FY 2022-23, the TGA issued 50 infringement notices (with a combined value of $399,600) in relation to non-compliant advertising of unapproved sport supplements. The Report also highlights the criminal conviction of the Director of AusLabs, Smart Labs and iSARMs relating to the manufacture, supply and advertising of illegal SARMs and nootropic products.

Therapeutic goods used in the cosmetic and beauty industry

In Australia, advertising prescription medicines to the public is prohibited.

Supply of products for use in cosmetic procedures — including Botox and fillers — requires a prescription. The TGA took a number of enforcement actions in relation to the advertising of these products in FY 2022-23, including:

• working closely with the Australian Health Practitioner Regulation Agency and social media platforms to identify and remove non-compliant advertising, and
• issuing 18 warning letters and an infringement notice.

The TGA identified a trend in the advertising of these products using acronyms, nicknames, abbreviations, and hashtags to promote the goods without direct reference to product names.

We anticipate that the TGA will continue to focus its efforts on this growing industry in the year ahead.

IV drips

The Report noted that intravenous vitamin and related therapies, or ‘IV drips’, are increasing in popularity among Australian consumers.

The TGA identifies that these products are being advertised ‘as a quick, safe and effective way of staying healthy and treating and preventing several (serious) medical conditions such as cancer, mental illness and chronic fatigue’. The potential for this kind of advertising to unlawfully promote unapproved therapeutic goods is a concern for the TGA.

In FY 2022-23, the TGA focused on industry education to promote compliance among IV drip manufacturers, advertisers and suppliers. The TGA issued 20 infringement notices (with a combined value of $159,840) in this space.