The Therapeutic Goods Administration (TGA) has accepted a court-enforceable undertaking from The Aussie Gelatin Company Pty Ltd (Aussie Gelatin) in relation to the alleged unlawful manufacture, supply and advertising of therapeutic goods.
Between 1 May 2023 to 17 November 2024, Aussie Gelatin manufactured, supplied and advertised its product, Nutraviva Bone and Joint Formula, in contravention of the Therapeutic Goods Act 1989 (the Act). The product was not entered in the Australian Register of Therapeutic Goods (ARTG) and contained a prescription-only strength of Vitamin D3 (colecalciferol).
Vitamin D is regulated as a prescription-only medicine when included in preparations containing over 25 micrograms of Vitamin D per recommended daily dose.
In Australia, therapeutic goods must be entered in the ARTG before they can be lawfully manufactured, supplied, or advertised, unless a specific exemption applies. This requirement serves as a critical safeguard to ensure that therapeutic goods available to consumers are safe and high quality, and that they work as intended.
The undertaking is enforceable for a period of 3 years and requires Aussie Gelatin to:
- conduct a recall of the unregistered therapeutic goods and comply with all requirements of the recall process
- cease the manufacture, supply and advertisement of any Bone and Joint Formula, or derivatives, in contravention of the Act
- conduct a comprehensive analysis over the alleged non-compliance and submit a root cause analysis report to the TGA
- perform a risk assessment, then develop and submit a prevention strategy to the TGA to mitigate the risk of non-compliance with the Act, and
- within 12 months, deliver an annual report to the TGA detailing its compliance with the Act, outlining how it has addressed the findings of the risk assessment and implemented the prevention strategy.
Breaching any term of the undertaking may result in the Federal Court imposing further orders on the company, including financial penalties or compensation.
Businesses have a responsibility to understand their legal obligations before manufacturing, supplying, and advertising therapeutic goods. Consequences for non-compliance with relevant legislation may include infringement notices or civil or criminal proceedings.
The TGA will continue to take enforcement action when it identifies alleged unlawful import, supply, manufacture and advertising of therapeutic goods, to protect the health and safety of the community.
