Consumer gains – The regulation of sports supplement pills

Consumers of sports supplements stand to gain from increased oversight of sports supplements in medicinal dosage form through regulation of such supplements as therapeutic goods (ie medicines). The sports supplement industry has been regulated for some time now. For instance, oral sports supplements that contain certain high-risk substances, and claim to improve or maintain performance […]

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Defamation – what is required to establish ‘serious harm’?

The Federal Court of Australia recently handed down a decision in Selkirk v Hocking (No 2)[1] shedding light on the serious harm element of the cause of action for defamation. Background In November 2019, Ms Selkirk was convicted of multiple counts of dishonestly obtaining financial advantage by deception by using falsified receipts to return goods […]

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FMCG Express | September 2023 Edition

In this edition of FMCG Express we consider the practicalities of implementing UCT regime required changes, recent ACCC enforcement activity and consider what risks ‘greenwashing’ can pose for our clients. We also touch on employer obligations regarding psychosocial safety and hazards, the Retail Award and other legislative changes. Partner Breanna Davies and the Gadens team […]

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Unmasking errors – the TGA’s post-market face mask review

The Therapeutic Goods Administration (TGA) has recently had to make amends after releasing information about surgical face masks sponsored by M House Pty Ltd (M House) without authority under the Therapeutic Goods Act 1989 (Cth) (Act). The Australian Register of Therapeutic Goods (ARTG) saw a rapid rise of medical device inclusions in the wake of […]

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Digital Tools and Medical Devices used for mental health – is yours a regulated medical device?

The Therapeutic Goods Administration (TGA) recently released guidance on digital tools and medical devices for the mental health sector (Guide).[1] The Guide aims to clarify whether software-based medical devices, products, services and tools used in the mental health sector (collectively, digital mental health products) are regulated by the TGA. Prior to the Guide, information about […]

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Senate to shine spotlight on concerning greenwashing behaviour

On 29 March 2023, the Senate announced a landmark inquiry into the practice of greenwashing in Australia, with its final report due for publication by 5 December 2023. This development echoes growing concerns both in Australia and globally regarding greenwashing by businesses across a range of sectors, including the making of vague, false or misleading […]

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FMCG Express | March 2023 Edition

The latest edition of FMCG Express goes straight to the heart of legal issues affecting corporate Australia in 2023; reforms to unfair contracts legislation; changes to the Fair Work Act; privacy law amendments; and cyber and data security. Partner Breanna Davies and the Gadens team of contributors are at the forefront of the analysis of […]

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ACCC internet sweep uncovers concerning environmental and sustainability claims

The Australian Competition and Consumer Commission (ACCC) has completed its anticipated internet sweep following clear messaging last year that the regulator would crackdown on misleading environmental claims. More than half of the businesses that were subject to the ACCC’s internet sweep in October 2022 were considered to have made concerning misleading claims about their environmental […]

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Regulatory action for greenwashing is upon us

Last week, the Australian Securities and Investments Commission (ASIC) commenced civil penalty proceedings for alleged greenwashing against Mercer Superannuation (Australia) Limited (Mercer). This is in addition to ASIC having issued penalty notices to at least four companies for alleged greenwashing, since October 2022. Last year, ASIC identified investigating greenwashing and taking enforcement action where greenwashing […]

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Higher Education Research Commercialisation Intellectual Property Framework – a tool to increase collaboration and partnerships between industry and universities

Most Australians are aware of the strength and quality of our nation’s research sector, particularly in fields such as life sciences and medical research. Never has this been more evident that during the COVID-19 pandemic, when Australians could, quite rightly, be proud of the role that Australians researchers played in the global efforts to develop […]

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FMCG Express | September 2022 Edition

In the latest edition of FMCG Express, Partner Breanna Davies and the Gadens team bring you the latest developments in the consumer, retail and hospitality sectors in Australia. In this issue, our team delves into the issues surrounding positive obligations to eliminate sexual harassment in the workplace; risks and solutions when dealing with commercial contracts […]

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Advertising under the influencers and changes to the TGA Code: Are you ready for 1 July 2022?

We are in a transition period in the world of therapeutic goods advertisements (TG Advertisements). Currently, TG Advertisements must comply with either the Therapeutic Goods Advertising Code (No.2) 2018 (Cth) (Former Code) or the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 (Cth) (New Code). The transition period ends on 30 June 2022. A caveat […]

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