By Geoff Bloom, Partner and Caitlin Leonard, Law Graduate
Peptides are strings of amino acids, which are essentially the “building blocks” of proteins.[1] In recent years, they have become increasingly popular, particularly in the fitness and beauty industries, for their uses in building muscle, burning fat, recovering from injuries and slowing down aging. Some peptides are approved and listed in the Australian Therapeutic Goods Register (ARTG), such as insulin, glucagon-like peptide-1 (GLP-1) medications and various hormone related peptides, however they are classified as prescription-only medicines, found in Schedule 4 of the current Poisons Standard.[2] For example, GLP-1 medications such as semaglutide are approved to treat diabetes and manage weight (sold under brand names such as Ozempic and Mounjaro).
However, some peptides in Australia are sold with the indication that they are “for research use only” or “not for human use”. These peptides have not been approved by the TGA and are not registered in the ARTG. The TGA has issued warnings due to increasing concerns that many peptides being sold are unapproved therapeutic goods and, as such, their safety, quality and efficacy have not been assessed.
Over the past decade, the TGA has taken sustained regulatory and enforcement action in relation to peptides, with penalties being imposed on both individuals and companies for the unlawful advertising, importation and supply of these products in Australia. Enforcement outcomes have generally been more severe for companies, reflecting their broader consumer reach and the greater risk to public health arising from non‑compliant conduct. A review of the TGA’s reports and enforcement actions highlights consistent themes around unlawful advertising, misleading health claims, improper manufacture and importation, and escalating penalties for repeated or serious non‑compliance.
The most significant enforcement action occurred in 2018 and 2019 when the Secretary of the Department of Health commenced Federal Court proceedings against Peptide Clinics Pty Ltd (Peptide Clinics), for the unlawful advertising and supply of compounded prescription-only therapeutic goods, including peptides, on its website and social media platforms, accessible to the general public.
On 23 July 2019, the Federal Court ordered Peptide Clinics to pay $10 million in penalties, finding that Peptide Clinics deliberately and recklessly pursued its commercial interests at the expense of public health and its legal obligations, under the Therapeutic Goods Act 1989 (Cth) and the Therapeutic Goods Advertising Codes.[3]This case remains a benchmark for TGA enforcement concerning peptides and underscores the seriousness with which the regulator and the court views advertising and supply of unapproved peptides.
The advertising contained both restricted representations (ie, references to serious forms of diseases, such as cardiovascular disease, diseases of joint, bone, collagen, and rheumatic disease) and prohibited representations (with reference to mental illnesses, such as anxiety and depression), as specified in the Therapeutic Goods Advertising Code 2015.[4] Peptide Clinics Australia had not obtained the required TGA approval or permission for any of these representations.
The advertising was also found to be misleading, encouraging inappropriate use and implying that the peptides were safe or incapable of causing harm. Peptide Clinics sought to rely on an exemption that the telehealth consultations constituted advice given directly to the patient from a medical practitioner, however the Federal Court determined that this exemption did not apply as the advice must be given ‘in the course of treatment of that patient’ which it was not.[5] The TGA expressed particular concern that consumers may have been led to believe medical practitioners were involved in the business and acting in patients’ best interests, when in fact the business model promoted self‑selection of prescription-only products.
Following the above Federal Court finding, the TGA continued to issue infringement notices and penalties to businesses and individuals advertising peptides.
In September 2019, Redback SARMs was issued six infringement notices, totalling $15,210, for advertising prescription-only substances including Selective Androgen Receptor Modulators (SARMs) and Melanotan II, which can result in serious health consequences if used without adequate medical supervision.[6]
In June 2020, Net Pharmacy Pty Ltd was fined $214,200 across seventeen infringement notices for advertising peptides, SARMs and hormones, which are all prescription-only medicines, as well as stem cells which are classified as biologicals, none of which can be advertised to the general public.[7] The advertisements also included restricted representations, allegedly referring to cardiovascular disease.
In June 2020, a Victorian-based pharmacist was fined $30,240 for unlawfully advertising peptides and hormones, with alleged references to serious conditions such as multiple sclerosis and infertility, therefore constituting restricted representations.[8]
During the COVID‑19 pandemic, peptide‑related claims attracted heightened enforcement scrutiny. In July 2020, SGC Products Pty Ltd received five infringement notices, totalling $63,000 for advertising Thymosin Alpha‑1 and Thymosin Beta‑4 peptides as preventative treatments for COVID‑19.[9] The TGA alleged multiple breaches, including use of prohibited representations relating to cancer, use of restricted representations relating to COVID‑19, advertising unapproved therapeutic goods not listed in the ARTG and advertising prescription‑only medicines to the public.
The matter demonstrated the TGA’s low tolerance for therapeutic claims linked to serious diseases, particularly where public health risk is elevated.
More recent regulatory action extends beyond advertising into the manufacture, supply and importation of peptides. In March 2024, the TGA executed a search warrant on a South Yarra pharmacy, seizing semaglutide, peptides and human growth hormones that were allegedly unlawfully manufactured.[10] The TGA raised serious safety and efficacy concerns and highlighted that non‑compliance may result in civil or criminal proceedings, not only pecuniary penalties.
The TGA has also targeted individuals importing unapproved peptides. In April 2024, an individual in Victoria was fined $3,756 for importing an unapproved peptide without authority.[11] A further three infringement notices, totalling $11,268, were issued to the same individual in September 2025 for importing additional prescription-only medicines without approval.
Apart from the specific examples mentioned at the start of this article, most peptides which people want to take in Australia have not been included in the ARTG. They are prescription medicines but not approved medicines. The standard way in which peptides may be lawfully accessed in Australia is if a medical practitioner or, in some cases, a nurse practitioner acting within their scope of practice, prescribes one, which is then compounded for the patient by a pharmacist.
This raises the question of whether a medical practitioner will be acting within the standards expected of that practitioner if they do prescribe peptides, given that evidence on safety and efficacy is scant. Medical regulators have tended to be hostile to medical practitioners prescribing peptides.[12]
[1] https://www.ncbi.nlm.nih.gov/books/NBK562260/#:~:text= A%20peptide%20is%20a%20short,the%20building%20block%20of%20proteins
[2] Therapeutic Goods (Poisons Standard—February 2026) Instrument 2026, Sch 4.
[3] Therapeutic Goods Act 1989 (Cth); Therapeutic Goods Advertising Code 2015 (Cth); Therapeutic Goods Advertising Code (No 2) 2018 (Cth).
[4] Therapeutic Goods Advertising Code 2015 (Cth) Appendix 6 Pts 1-2.
[5] Secretary, Department of Health v Peptide Clinics Australia Pty Ltd [2019] FCA 1107, [21]; Therapeutic Goods Act 1989 (Cth) s 42AA(4).
[6] https://www.tga.gov.au/news/media-releases/redback-sarms-pays-fine-advertising-prescription-only-substances
[7] https://www.tga.gov.au/news/media-releases/net-pharmacy-fined-214200-alleged-unlawful-advertising
[8] https://www.tga.gov.au/news/media-releases/pharmacist-fined-30240-alleged-unlawful-advertising
[9] https://www.tga.gov.au/news/media-releases/sgc-products-fined-63000-alleged-unlawful-advertising-dr-ageless-website-relation-covid-19
[10] https://www.tga.gov.au/news/media-releases/search-warrant-executed-south-yarra-pharmacy
[11] https://www.tga.gov.au/news/media-releases/victorian-fined-allegedly-importing-unapproved-peptide; https://www.tga.gov.au/news/media-releases/victorian-issued-further-infringement-notices-allegedly-importing-unapproved-therapeutic-goods
[12] See, for example, Health Care Complaints Commission v Hart – NSW Caselaw
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