THE Therapeutic Goods Administration has issued a safety advisory in response to concerns about risks associated with the rise in the import, supply, compounding and advertising of unapproved peptide products.
Peptides are short chains of amino acids that can mimic or stimulate natural biological processes, including those involved in growth, metabolism and tissue repair, and are best known for their regulated use in insulin and GLP-1 RAs, such as semaglutide.
However, fuelled by social media promises of youthful skin, weight loss, muscle growth and enhanced cognitive function, people are buying unregulated products online that are not approved for human use.
Examples of unapproved peptide products include those containing BPC157, GHKCu, TB500, retatrutide and CJC1295, which are often supplied in injectable form and may carry disclaimers such as "research use only" or "not for human consumption".
"These practices raise significant regulatory and public health risks, and the TGA is actively monitoring this issue from both safety and law enforcement perspectives," the regulator stated.
In addition to unknown manufacturing standards, product labelling may be inaccurate or misleading, meaning consumers and healthcare professionals may not have reliable information about the ingredients, dosage and administration.
Reports of more serious adverse events associated with unapproved peptides include severe allergic reactions, systemic inflammatory response syndrome, and generalised hypersensitivity symptoms such as fullbody intense itching, palpitations, pain and sweating.
The TGA is urging individuals and businesses involved in prescribing, compounding, supplying or promoting peptide products to ensure they understand and comply with all of their legal obligations, including regulatory requirements and relevant professional practice standards.
"Pharmacists should understand the expectations of the Pharmacy Board of Australia set out in their professional practice standards and guidelines, as well as ensure they comply with all relevant pharmacy legislation in their jurisdiction," the TGA noted, with particular reference to regulations around compounding.
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