Criminal Law

In July 2025, five people presented to NSW emergency departments following unapproved peptide use. In September 2026, there were 217 presentations, and 1,180 across the period as a whole. Retatrutide was involved in 71 per cent of presentations.

The data, released by NSW Health, point to a sharp rise in the use of unapproved peptide products.

Unapproved peptides have been scrutinised for the health risks they pose to consumers. They also carry significant legal risks for consumers, suppliers, importers, manufacturers, and promoters.

Dr Samuel Cornell, a Research Fellow in Public Health at the University of Queensland, told Koffels the trend is a “new novel thing”:

“I think that the legal system is trying to understand, the health system is trying to understand, [and] the people taking it are trying to understand.”

At a scientific level, Dr Cornell explained that a peptide is simply a short chain of amino acids, the building blocks of protein. Peptides can play many roles in the body, including acting as hormones or neurotransmitters.

Although peptides occur naturally in the body, some can also be synthesised in laboratories.

Not all synthetic peptides are unapproved. Insulin and the GLP-1 medicines semaglutide and tirzepatide are approved peptide medicines in Australia. Many others, however, are unapproved and sold in what has been described as a “grey market”. Dr Cornell named several unapproved peptides he has encountered, including BPC-157, Melanotan, and retatrutide.

What are the health risks?

While there is some research on the short-term risks of unapproved peptide use, Dr Cornell said there is little, if any, long-term research on these substances.

A range of short-term complications have been recorded:

“Anaphylaxis is a concern, allergic reactions are a concern, general toxicity, like liver toxicity is a concern… you can be injecting practically anything into your body and the purity is unknown with the vast majority of these products.”

He referred to a case in Victoria in which a patient suffered a torn oesophagus after using a counterfeit retatrutide product. The patient experienced “uncontrolled vomiting” after using the product and was hospitalised.

The surge has also renewed concerns about the risks of self-injection:

“These drugs have caused a whole new population of people injecting themselves.”

Injection site infections and the reuse of needles and vials were among the risks Dr Cornell said some users may be unaware of.

What are the legal risks?

Many consumers assume peptides sit in a legal grey area. In Australia, they generally do not.

In the United States, some suppliers sell peptides labelled as “research chemicals” or “for research use only” to avoid regulation. That approach does not work in Australia, and it creates potential liability for everyone who handles these products.

Commonwealth regulation

At a federal level, unapproved peptides are regulated by the Therapeutic Goods Administration (TGA) under the Therapeutic Goods Act 1989 (Cth).

Therapeutic goods must generally be included in the Australian Register of Therapeutic Goods (ARTG) before they are imported, manufactured, supplied, exported, or advertised. Limited exceptions apply where there is a specific approval, authority, or exemption under the legislation. Goods that are not on the ARTG and not covered by an exception are referred to as “unapproved”.

Labelling a product “for research use only” or “not for human use” does not change whether it is regulated as a therapeutic good, and does not remove any obligations relating to its manufacture, advertising, import, export, or supply.

Individuals may be able to lawfully import certain unapproved peptides under the Personal Importation Scheme, provided all conditions are met. These include:

• holding a valid Australian prescription or written authority at the time of import (electronic prescriptions are not accepted);
• importing only for personal use or use by an immediate family member;
• importing no more than three months’ supply at a time; and
• importing no more than 15 months’ supply in any 12-month period.

Products that are not properly labelled cannot be assessed for lawful importation, and counterfeit medicines are prohibited outright. The Australian Border Force can seize non-compliant imports, and importing unapproved peptides without proper authorisation can be a serious Commonwealth offence.

Patients may also access unapproved products through the Special Access Scheme and the Authorised Prescriber scheme, which allow certain health practitioners to obtain unapproved goods for their patients. Access depends heavily on the patient’s circumstances. A pharmacist may compound a peptide only where permitted under the applicable regulatory framework and with a valid prescription.

Online advertising of unapproved peptide products is generally unlawful. Influencers, online sellers, and other promoters of unapproved therapeutic goods can face action by the TGA for unlawful advertising. Businesses involved in selling or promoting these products should seek commercial legal advice on their obligations.

NSW regulation

In NSW, many peptides sold online, including BPC-157, TB-500, and CJC-1295, are classified as prescribed restricted substances under the Poisons and Therapeutic Goods Act 1966 (NSW). Possessing them without a valid prescription can be an offence, and supplying them without authorisation is also an offence. Supply is defined broadly and can include offering a product for sale online.

Anti-doping

Athletes should be aware that possessing or using prohibited peptides can result in anti-doping rule violations, according to Sport Integrity Australia. Peptides such as BPC-157, which is marketed as promoting the healing and growth of tissues such as muscles and tendons, are banned by the World Anti-Doping Agency. Consequences can include suspension or bans from competition.

Responding to the surge

Despite their growing popularity, unapproved peptides carry significant health and legal risks.

Dr Cornell said that while people’s reasons for using peptides vary, his research suggests much of the trend is driven by optimisation culture. He believes the right response includes “education, messaging [and] trying to communicate these risks to people”.

It is equally important that everyone involved with unapproved peptides understands their legal obligations. The TGA states that non-compliance can lead to seizures, infringement notices, and civil and criminal penalties.

If you are an athlete facing an anti-doping matter, or have questions about possessing or supplying peptides, our sports law and criminal law teams can help. Contact us confidentially below.

This article provides general information only and does not constitute legal or medical advice. If you have concerns about a product you have used, speak to your GP or a qualified health professional.