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Longevity

How wellness clinics bend the rules to supply unapproved peptides and anti-ageing injections

How wellness clinics bend the rules to supply unapproved peptides and anti-ageing injections

Wellness clinics are supplying peptides and anti-ageing injections that aren’t approved, meaning they haven’t been checked for safety or effectiveness.

Across Australia, “longevity” and “wellness” clinics, most of them online, sell injections that promise to slow ageing, build muscle, heal injuries and help you sleep.

This week’s ABC 4 Corners described a doctor prescribing a “stack” of them after a short questionnaire and a phone call. Many are peptides.

A peptide is a short chain of amino acids: the tiny building blocks of the proteins in our bodies. A few peptides, such as insulin , are approved medicines.

But the peptides sold at online wellness clinics, with names such as BPC-157, CJC-1295 and TB-500, aren’t approved, nor are most other “anti-ageing” injections.

None has been shown to have the claimed effects in humans, and the medicines regulator warns they carry real risks.

Some people import a supply for their own use. For some peptides, that is lawful with a valid prescription .

Others are controlled imports that also need an importation permit a patient cannot get. Without the right authority, or if the peptides are sold on, importing them is an offence .

And it doesn’t matter if the substances are labelled “research chemicals, not for human use” if, in substance, they are therapeutic goods . Australian law does not recognise any “research chemicals” exemption .

But others get these substances via online clinics that exploit a legal loophole: these injections are “unapproved” but that doesn’t mean they’re “banned”.

Before a medicine can be sold in Australia, it usually has to be listed on an official register . To get there, the Therapeutic Goods Administration (TGA), the government body that regulates medicines, must check it is safe, well made and works .

The TGA regulates according to risk , putting its limited resources where the danger is greatest.

But even a real, known risk may draw no regulatory action because it’s another regulator’s job or because acting is resource-intensive, costly and may not achieve the aim of making patients safer.

Either way, the peptides mentioned above have never passed that check. In other words, they’re “ unapproved ”.

Doctors have always been allowed to supply unapproved products in special cases, through the Special Access Scheme and other lawful access pathways .

That way, a patient with a rare cancer, for example, or a child who cannot take an approved medicine, still has options.

But some Australian clinics exploit a different exception. When a pharmacist mixes up a medicine intended for one patient, called compounding, that preparation doesn’t need to be on the register .

The rule was written for cases like a pharmacist making a liquid version of a tablet for someone who cannot swallow.

Making the same recipe in bulk and posting it interstate as injection pens is really manufacturing , which needs a licence .

But because each dose is labelled “for a particular person”, it never faces the TGA’s safety check .

Australia splits the job of regulating supply of medicines across two regulators, plus consumer law , which can act against misleading claims.

But it doesn’t regulate doctors or pharmacists. That falls to the Australian Health Practitioner Regulation Agency (Ahpra), which is responsible for a practitioner’s registration .

Ahpra can attach conditions to a practitioner’s registration, suspend them, or take steps to de-register them . But this usually only happens after someone complains , one practitioner at a time.

Ahpra has recently tightened its rules on cosmetic and online prescribing by doctors, so a script can’t be written after just completing a questionnaire. It has also tightened rules for compounding by pharmacists .

But online clinics can slip through a regulatory gap. If the compounded product is notionally exempt, the TGA may not intervene, while the acts of prescribing and compounding fall to Ahpra, which works case by case and can therefore be slow.

Yes. The TGA warns you often cannot be sure what is in the vial, whether the dose is right, or whether it is sterile.

Even when pure, these drugs can harm. A single dose of CJC-1295 raises a growth factor, IGF-1 , up to three-fold for over a week. High IGF-1 levels are a probable cause of breast cancer .

Peptides and anti-ageing injections are also very costly. A few weeks’ supply can cost more than A$1,000 .

Penalties run up to $1.65 million a breach for a person or $16.5 million for a company . But the TGA rarely goes that far.

It usually starts small , warning and educating first, then escalating if that fails.

This week, the TGA put suppliers and promoters on notice , admitting repeated warnings have not stopped the peptide trade.

À lire aussi : Influencers are promoting dangerous peptides on social media, and regulators are struggling to keep up

We probably don’t need new laws. Refinement of existing laws would do. The options include:

narrowing the compounding rule so it cannot work as a bulk manufacturing licence.

The government did this in 2024 , removing weight-loss drugs like Ozempic (by then, sold to at least 20,000 Australians by online clinics compounding copies at scale), along with gene therapies and medicinal cannabis . It could do the same for these peptides.

The patients buying these injections are not reckless. They are trying to look after their health. But they may be relying on a promise the clinical evidence cannot support.

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