The Therapeutic Goods Administration (TGA) has issued 11 infringement notices totalling $43,560, to 6 individuals, for the alleged unlawful importation of unapproved therapeutic goods and the alleged unlawful advertising of therapeutic goods, in contravention of the Therapeutic Goods Act 1989 (the Act).
Therapeutic goods that are not entered in the Australian Register of Therapeutic Goods (ARTG), also referred to as unapproved therapeutic goods, have not been assessed by the TGA for quality, safety and efficacy and may pose a health risk.
The Personal Importation Scheme permits individuals to import certain therapeutic goods not included in the ARTG, provided all legislative conditions are met. In these cases, the individuals did not obtain the required approvals or authorities.
The importation of counterfeit products is unlawful under any circumstance.
All 6 individuals, including 3 Australian Health Practitioner Regulation Agency (Ahpra) registered health practitioners, are alleged to have imported unapproved therapeutic goods in breach of the Act.
One Victorian-based health practitioner is also alleged to have imported counterfeit cosmetic injectables, which pose serious safety risks due to unknown composition or contamination.
In addition, a NSW-based individual alleged to have unlawfully advertised botulinum toxin (botox) products on a social media platform.
In Australia, botulinum toxin type A is classified as a prescription-only medicine. Advertising prescription-only medicines directly to consumers is prohibited under the Act, as it can create inappropriate demand and undermine the relationship between patients and their treating health practitioner. The decision to use prescription-only medicines should be made between a prescribing health practitioner and their patient based on informed consent, including a discussion of possible side effects.
The TGA works in partnership with law enforcement agencies, other health regulators, and state and territory authorities to address unlawful activity relating to cosmetic injectables.
"These actions send a clear message that importing unapproved therapeutic goods or unlawfully advertising prescription-only medicines is unacceptable," said Professor Anthony Lawler, Deputy Secretary of the Department of Health, Disability and Ageing and Head of the TGA. "The TGA will continue to take strong compliance action and work closely with our regulatory and law-enforcement partners to protect Australians from unsafe or misleading products."
The TGA's response reflects its continued and ongoing enforcement activities with therapeutic goods used in cosmetic procedures - Compliance Principles 2026 and 2027.
Individuals, health practitioners and businesses must understand their legal obligations under the Act before importing or advertising therapeutic goods. Consequences for non-compliance may include infringement notices, direction or prevention notices, or civil or criminal proceedings.
If you suspect non-compliance in relation to therapeutic goods, or their advertising, you can report it to the TGA at any time.
