The medicines regulator has issued a safety warning about unregulated peptide products that pose a significant public health risk.
Interaction with other medicines, infection or local tissue damage, severe allergic reaction and musculoskeletal injuries were among the potential health risks listed by the Therapeutic Goods Administration (TGA).
It also warned that healthcare professionals may not have reliable information about the ingredients, dosage or administration of unregulated products being used by patients.
Healthcare professionals are encouraged to report any problems with medicines or other products to the TGA.
Unapproved peptide products are being promoted on social media and other online platforms amid a surge in beauty and fitness trends.
Under the Therapeutic Goods Act 1989, peptide products are regulated as therapeutic goods in Australia. Several peptide-based medicines, such as insulin products for the management of diabetes, are approved by the TGA and are included on the Australian Register of Therapeutic Goods (ARTG).
However, unapproved products have not been assessed for safety and efficacy.
“We are aware that the use or supply of unapproved peptide products is being promoted on a number of online and social media platforms, with claims they have a range of health benefits including weight loss, muscle growth, anti‑ageing, and enhancing cognitive and athletic performance,” the TGA said in a statement.
“These products have not been evaluated for safety, quality or effectiveness by the TGA.
“Examples of unapproved peptide products include those containing BPC‑157, GHK‑Cu, TB‑500, retatrutide and CJC‑1295, often supplied in injectable form.”
The regulator flagged a number of safety considerations including a lack of information about production of the products, their side effects and ingredients.
Unapproved peptide products, particularly those that are injected, can carry other significant safety risks, including contamination, infection or local tissue damage.
“As the TGA has not reviewed any scientific evidence to support the safety or claimed benefits of these unapproved peptide products, their use may result in side effects, interactions with other medicines, and both immediate and long‑term health harms, with no demonstrated benefits.”
Adverse events and other concerns received by the TGA include:
- Severe allergic reactions, requiring doses of adrenaline and hospitalisation
- Systemic inflammatory response syndrome (SIRS) (severe inflammation in the body), requiring hospital management
- Generalised hypersensitivity symptoms such as full‑body intense itching, palpitations, pain and sweating
- Wide ranging body side effects, including insomnia, blurred vision, extreme tiredness, flu‑like illness, joint pain and skin sensitivity
- Musculoskeletal injuries, including plantar fasciitis and Achilles tendinitis
- Poor product quality, including unsealed packaging from an online supplier.
Requirements of medical professionals
The TGA issued a reminder to healthcare practitioners who compound, prescribe or supply unapproved peptide products that the products must comply with all regulatory requirements and relevant professional practice standards, including those set by Ahpra, the Australian Health Practitioner Regulation Agency.
A pharmacist or medical practitioner must generally meet the circumstances set out in Schedule 8 of the Therapeutic Goods Regulations 1990 to be exempt from being required to hold a manufacturing licence in relation to the manufacture, or a step in the manufacture, of peptide products in Australia.
Generally, only medicine compounded in a hospital for a specific therapeutic purpose within that setting, or one extemporaneously compounded for a particular person, are exempt from ARTG requirements.
Health practitioners can report an adverse event or safety problem here.
Or report counterfeit or unregulated products here.
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