At the start of each financial year, the Therapeutic Goods Administration (TGA) publishes its compliance and enforcement priorities for the next 12 months and the TGA has recently revealed what it will be focusing on in FY2023-2024.
The TGA oversees all areas of compliance around therapeutic goods and it has specified the following five key priority areas:
- Detect, deter and disrupt the unlawful import, advertising and supply of nicotine vaping products.
- Deter and disrupt unlawful advertising of medicinal cannabis, psilocybin, and MDMA.
- 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.
- Detect, deter and disrupt the unlawful import of substandard and falsified therapeutic goods online or at physical locations by specialist retailers.
- Detect, deter and resolve the unlawful import, advertising and supply of medicines and medical devices advertised as traditional or alternative treatments.
Nicotine vaping: The focus on nicotine vaping products is unsurprising given the Federal Government’s recent commitment to reform the regulatory framework for nicotine vaping products to restrict their availability. You can read more about these reforms here in our recent Insight here.
Medicinal cannabis, psilocybin, and MDMA: It should also be of no surprise that the TGA will also focused on unlawful advertising of medicinal cannabis, psilocybin, and MDMA, as these products have only very recently received approval by the TGA and the very strict rules around the supply, use, and advertising of these goods are not as widely known and understood as advertising for other long-established therapeutic products. For more information on the regulation of medicinal cannabis in Australia click here, and for more information on the regulation of psilocybin and MDMA in Australia, click here.
The wellness and beauty industries: The rapid growth in the wellness and beauty industries has also attracted the TGA’s regulatory attention. These include sports supplements and weight loss medications, IV drips, cosmetic injectables and other medications or medical devices intended to alter the body’s appearance. On top of clamping down on the unlawful advertising of unapproved and high-risk medicines and medical devices in the wellness and beauty industries the TGA will be:
- engaging with these industries regarding their regulatory obligations
- provide community education regarding the risks associated with these products
- monitor and identify higher-risk trends and products and
- continue to target advertising of unapproved products on social media.
Substandard and falsified therapeutic goods: The high risk of the import, supply and use of substandard and falsified therapeutic goods is a perennial problem that remains a high priority for the TGA. This problem has been exacerbated recently by the growth of the online therapeutic market, social media, and recent global supply chain issues.
Traditional or alternative treatments: As the TGA notes, some Australians are vulnerable to those intent on profiting from the sale of unregistered therapeutic goods marketed as traditional or alternative treatments. Consumers that have faced or who are facing a serious disease or condition with limited treatment options are obviously particularly vulnerable. The TGA is seeking to target digital platforms such as social media and to share their intelligence on these products and trends with other health and law enforcement agencies around the globe, to enhance their understanding of illegal supply chains and usage patterns.
