TGA testing finds unapproved peptides do not contain what their labels claim

Therapeutic Goods Administration (TGA) laboratory testing has found that tested Synedica peptide products did not contain what their labels claimed. Some tested products contained no detectable TB-500, despite being labelled as containing TB-500, while tested Synedica Retatrutide 10 mg products contained less retatrutide than stated on the label, with significant variation between samples.

This means consumers cannot rely on the product labels to know what substance they are taking or the amount they are receiving.

The products were identified when the TGA assisted the NSW Police State Crime Command with Strike Force Antree.

What TGA testing found

TGA laboratory testing identified the following issues:

KLOW is labelled as containing GHK-Cu, BPC-157, TB 500, KPV, and vitamin B12.

BARBIE KLOW is labelled as containing GHK-Cu, melanotan I, BPC-157, TB 500, KPV, and vitamin B12.

Professor Robyn Langham AM, Chief Medical Adviser, said the results further demonstrated the risks associated with using unapproved peptide products.

"These results demonstrate the very real risks of using unapproved peptide products. Not only is there a serious risk of a major allergic response, including anaphylaxis, but, when a product does not contain what the label says, consumers can simply not know what is in the substance they are injecting."

"Using products with unknown or unreliable ingredients can put you at risk of serious health issues. If you have purchased a Synedica peptide product, do not use it and speak to a health professional if you have concerns about your health."

What consumers should do

If you have a Synedica branded peptide product:

• Stop using it.
• Take any remaining product to your local pharmacy for safe disposal.
• If you have any concerns about your health after using this product, speak to your health professional.
• If you suspect you have experienced a side effect, also known as an adverse event, report it to the TGA.

Products identified

Risks of unapproved peptide products

Synedica branded peptide products have not been assessed by us for quality, safety or efficacy as required under Australian therapeutic goods legislation, and their place of manufacture has not been approved by the TGA.

Peptide products taken alone or in combination with other medicines can cause serious side effects. Most peptide products, including BPC-157, TB-500 and melanotan I, are prescription-only medicines in Australia.

Consumers should exercise extreme caution when buying medicines and medical devices online or from overseas.

Products obtained online:

• may be fake
• may contain the wrong amount of an active ingredient
• may contain undisclosed or harmful ingredients
• may not meet the same standards of quality, safety and efficacy as therapeutic goods approved for supply in Australia
• may be offered for sale despite not being approved for supply in Australia.

Consumers are urged not to use unapproved peptide products, particularly products supplied in unmarked vials, purchased online or obtained from overseas.

About retatrutide

Retatrutide is still undergoing clinical trials in humans and has not been approved by the TGA or any comparable international regulator. Any retatrutide product accessed outside a clinical trial could be counterfeit and should not be used outside a clinical trial setting.

The TGA has previously published a number of safety alerts relating to unapproved peptide products on its website, including a national warning from the Chief Medical Officer.

Action we are taking

NSW Police inquiries for Strike Force Antree remain ongoing.

The TGA has expanded its priority focus areas to include unapproved peptide products, following increased detection of unlawful importation, supply and advertising, posing potential risks to consumers.

Mr Chris Bedford, A/g Deputy Secretary of the Department of Health, Disability and Ageing and head of the TGA, said the findings reinforced the importance of the TGA's focus on unapproved peptide products.

"The growing unlawful supply and promotion of unapproved peptide products is a serious concern. These testing results reinforce why consumers should be extremely cautious about products promoted online and through social media."

"The TGA will continue to work with law enforcement and other partners to identify and disrupt unlawful activity and take regulatory action where appropriate."

The TGA continues to monitor peptide-related activity and will continue to take regulatory action in collaboration with partner organisations.

Consequences for non-compliance may include infringement notices, direction or prevention notices, or civil or criminal penalties. Penalties that can be imposed for breaches of the Act include civil penalties of up to $1.82 million per breach for individuals or $18.2 million per breach for corporations, and criminal penalties of up to 7 years imprisonment.

Report counterfeit medicines and medical devices

If you are worried about counterfeit medicines or medical devices, and want to report an issue, you can report the matter to the TGA: