Australia's TGA Cracks Down on Unregulated Peptides Amid Safety Concerns

Australia's medicines regulator has launched a crackdown on unregulated peptides, saying an increase in advertising, imports and supply of the unlawful drugs is posing a risk to consumer safety.

The Therapeutic Goods Administration (TGA) has moved to include unapproved peptides in its priority focus areas, alongside products like weight loss medications, vapes and sunscreens.

There has been an explosion in popularity of unregulated injectable peptides in Australia, driven by social media users promoting their supposed benefits for health and beauty.

The products are also often hyped as performance enhancing or marketed for weight loss or anti-aging, with social media influencers increasingly creating content instructing people how to buy and use them.

The TGA's chief Anthony Lawler said the decision reflected a "deliberate, risk-based response" to an evolving peptides market.

"As the availability of unapproved peptide products has increased, so too has evidence of potential risk to consumers," Professor Lawler said.

The move signals a "scaling up" in the TGA's response to unregulated peptides on the back of increased imports and supply, emerging safety concerns and various illegal products flooding social media pages.

The regulator warned responses to the importation, supply, manufacturing or advertising of unlawful peptides might include product seizures, infringement notices and even civil or criminal penalties where appropriate.

The Australian Medical Association's public health committee chair Michael Bonning said it was the "strongest action the TGA has taken on peptides".

"We know that when the TGA takes action, it has real results in terms of curbing behaviours and stopping people from profiteering off lies and dodgy science," Dr Bonning said.

"The influencer pathways that are being used to sell these drugs and bring them into the country illegally are hurting people — we are seeing it in reports from emergency departments."

The ABC last week reported several specialists were deeply concerned over potential cancer risks associated with an unregulated skin tanning peptide.

Examples of unapproved peptide products include Melanotan II, retatrutide, BPC157, GHK-Cu, TB500 and CJC-1295, often supplied in injectable form.

Experts have also been calling on health authorities to step up their response to the booming illegal peptide market, arguing more needed to be done to stamp out the illegal products.

Dr Bonning said the TGA had listened to those concerns.

"It's an acknowledgement that this space has grown so much so quickly and that traditional mechanisms of enforcement… are just being flouted more and more often," he said.

"[There is] value in the TGA putting itself much more in the frame to disrupt supply chains, to disrupt marketing and influencing that goes on often as well for people who are fairly vulnerable [like] teenagers, people with body image concerns."

What are peptides?

Peptides are short chains of amino acids which, when joined together, make up the proteins in our bodies.

Some — like many GLP-1s — are regulated and legal but unlawful peptides are increasingly being used by people seeking beauty, fitness or anti-aging results.

Many of the peptide products sold online have not been approved by the TGA, meaning they have not been assessed for their safety, quality or effectiveness.

The TGA issued a safety alert in April, warning illegal peptides posed a significant public health risk, saying it had been alerted to "severe allergic reactions" that had led to hospitalisation, as well as severe inflammation, full-body intense itching, palpitations, pain, insomnia, blurred vision and musculoskeletal injuries.

"Australians should be very cautious about buying unapproved peptide products online, particularly from overseas websites or through online platforms or social media. If you don't know exactly what's in the vial, where it was made or whether it's sterile, you could be putting your health at serious risk," Professor Lawler said.

The TGA, Australian Border Force (ABF) and Victorian Police recently seized peptides, performance and image enhancing drugs and illicit steroids with an estimated street value of more than $2 million.