Concerns regarding the public health risks associated with unapproved peptide products

Australia’s health leaders are increasingly concerned about the growing availability, promotion and use of unapproved peptide products in Australia.

Reports received by the Therapeutic Goods Administration (TGA), along with hospitalisation data from states and territories, have identified serious adverse effects associated with the use of unapproved peptides. These include:

• liver damage
• severe allergic reactions requiring hospitalisation, and
• inflammation and other health complications requiring medical attention.

Unapproved peptide products that are not included in the Australian Register of Therapeutic Goods have not been evaluated by the TGA for safety, quality or effectiveness. These can include products containing BPC‑157, GHK‑Cu, TB‑500, retatrutide and CJC‑1295.

The TGA does not have oversight of the composition of ingredients, manufacturing standards, or the safety and efficacy of unapproved peptide products. Additionally, counterfeit products are often deliberately designed to mimic genuine medicines, making it difficult for consumers to identify unsafe or potentially harmful goods.

Important information relevant to consumer safety remains unknown, including:

• how these products are manufactured and whether they meet appropriate quality standards
• whether injectable products are sterile and produced under aseptic conditions
• how these peptides act in the human body, and
• the nature, frequency and severity of potential side effects.

Many of these products are supplied as powders or injections in poorly labelled or unmarked vials, making it difficult or impossible to verify their ingredients, or the safety of how they have been manufactured. This further presents significant risks to consumer safety, including potential contamination, dosing uncertainty, and exposure to unknown or harmful substances.

The TGA notes that increasing imports, online promotion and supply of these products are contributing to a growing public health concern. Evidence of potential harm continues to emerge as use of these unapproved products increases.

Professor Michael Kidd AO, Chief Medical Officer, said “unapproved peptide products pose a growing public health risk. Some of these products have not undergone sufficient human clinical trials and may cause significant harm. Australians should not use these products and should seek advice from their trusted healthcare professional.”

Dr Amanda Cuss, Acting Chief Medical Adviser, said that “the TGA is actively monitoring and responding to potential non-compliance under the Therapeutic Goods Act 1989, including unlawful importation, supply and advertising of therapeutic goods. Unapproved peptide products have been added as a priority focus area for the TGA compliance. Where serious non-compliance is identified, the TGA may take regulatory action in line with its regulatory compliance framework.”

Australians are strongly advised not to purchase and use unapproved peptide products, particularly those obtained online or from overseas. Consumers should seek advice from qualified healthcare professionals and use only products supplied through Australian pharmacies.

Reporting problems

If you experience an adverse event, please report it to the TGA. This helps us to monitor and respond to emerging safety concerns.

If you suspect non-compliance in relation to therapeutic goods, you can report a perceived breach or questionable practice to the TGA.

Dr Amanda Cuss
Acting Chief Medical Adviser – Health Products Regulation Group
Therapeutic Goods Administration

Professor Michael Kidd AO
Chief Medical Officer