Ingredients permitted in listed medicines – there have been updates to 53 ingredients, summarised here, and 4 new ingredients: Pediococcus pentosaceus, Urolithin A (Mitopure® ); maltodextrin (now approved for use as an active ingredient, it was previously an excipient only) and Crithmum maritimum (excipient use only).
Also, two ingredients which until now could only be used by the original applicant under the two-year exclusivity arrangement, are now available for general use: chicken sternum cartilage powder, and refined Buglossoides arvensis seed oil.

Update to guidelines on the legislative framework for listed medicines – published 30th September here. Important reading for anyone supplying complementary medicines in Australia.

Changes to regulations for testing of medicines. The new part provides for testing to be conducted by an analyst, or by another appropriate person or body. At the completion of testing, an analyst must issue a certificate which documents the testing conducted and the results of the testing. Source: TGA

Listed medicine compliance reports. See results for products containing vitamin D, valerian ingredients, and products making prohibited claims about fertility, vaginal infections, melatonin, and exercise performance. Source: TGA

Lysine hydrochloride for cold sores. A review of evidence held by sponsors promoting the use of lysine for cold sores found that in all cases the evidence was inadequate. All the sponsors removed the unsupported claims from their medicines and their advertisements. Read more here. If you are concerned you may not have acceptable evidence to support your product claims, you would find our course TGA evidence requirements for claims very helpful. This course is available live via Zoom appointment, or pre-recorded.

The Poisons Standard has been revised and the October 2025 version is available here. This explanatory statement summarises the changes made.

Paracetamol use in pregnancy. The TGA states that robust scientific evidence shows no causal link between the use of paracetamol in pregnancy and autism or ADHD, with several large and reliable studies directly contradicting these claims. Read the full statement here.

Medicines and medical devices that have been cancelled or suspended – list updated September 2025 Source: TGA

Medicinal cannabis news and updates: 21 August update

GMP clearance applications. This is an update to the TGA’s plan to reduce the backlog of clearance applications. More information on GMP clearance here.

Australia has adopted 3 international scientific guidelines:

* ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials

* Guideline on quality documentation for medicinal products when used with a medical device.

* Guideline on good pharmacovigilance practices (GVP) Module I – Pharmacovigilance systems and their quality systems.

Recalls

* Multiple sunscreens with lower SPF levels that what is claimed on label – see below in this newsletter.

* Pad-Paks used with the HeartSine samaritan Public Access Defibrillator – Stryker is recalling some batches due to bent locator pins and potential user error from improper insertion of Pad-Paks – more information here

Compliance activity

* 10 infringement notices, totalling $198,000, have been issued to Midnight Health for the alleged unlawful advertising of prescription-only weight-loss medicines. The company was operating various telehealth platforms. They also made reference to serous diseases such as stroke in their advertisements. They paid the infringement notices in September. Read more here.

* TGA and Victoria Police have seized illegal vaping goods with a street value of over $40,000, more than 24,000 nicotine pouches, over 110,000 illicit cigarettes, 40 kg of loose illicit tobacco and a quantity of cash in raids in Chapel Street Melbourne. Source: TGA

* A person has been issued 3 infringement notices totalling $11,268 for importing unapproved prescription-only medicines – modafinil and armodafinil. Source: TGA

* Dispensed has paid 6 infringement notices totalling $118,800 for unlawful advertising of medicinal cannabis. Source: TGA

* Illegal vape sales in Tasmania: a blitz on the sale of illegal vaping goods in Hobart and surrounds has resulted in seizures across 5 retail businesses for the alleged unlawful possession of commercial quantities of vaping goods and illegal tobacco. Source: TGA

* The TGA has issued a direction notice to Cholrem to cease advertising a therapeutic good not entered in the Australian Register of Therapeutic Goods (ARTG) and to cease advertising such goods for indications relating to heart disease and stroke, amongst others. Read more here.

Safety advisories

* Heavy metals found in some Ayurvedic products. After reports of lead poisoning, tests revealed problems with some products – Haidyanath Sundary Sakhi tablets – lead, arsenic, mercury; Sharmayu Som Pushpa – lead, arsenic; Unjiha Pushpadhanva Rasa – lead, arsenic, mercury; Baidyanath Rajahprawartini Bati – lead, arsenic, mercury; Acineutra tablets – lead, mercury; Flexy tablets – lead, mercury. Read the safety advisory here.

* Melatonin: More Australians are purchasing melatonin products often sold as gummies from online stores, particularly for use in children. Recent testing has shown many of these melatonin products contain significantly higher doses than the amount on their label, while others contained less or even no melatonin. This webpage names the products tested, and shows the variation from the labelled amount.

* Imported unregistered oral methylene blue (methylthioninium chloride) products are being promoted for unapproved (off-label) uses, such as cognitive enhancement, mood improvement, and anti-ageing effects. Key safety concerns are listed here.

* GLP-1 products that are being promoted online for weight-loss. The TGA alleges “The products are often marketed as ‘GLP-1 peptide’ oral drops or liquids and may be falsely labelled as approved by international regulators or advertised with misleading quality marks or claims with the aim of deliberately deceiving consumers. We are also aware of reports of advertising containing fake health professional and celebrity endorsements for these products”. Read the safety advisory here

Public and stakeholder consultation:

* Review of the safety and regulatory framework for medicinal cannabis products. Summary information here and more detailed information here. The full consultation paper can be viewed here.  Closing date is 07 October AEST (Canberra/Sydney/Melbourne time)

* Proposed amendments to the Poisons Standard, including Vitamin D, isotretinoin, mannitol, efepoetin, oxalic acid and hydroquinone. Consultation document is here – click on link for either DPF or Word version. Closing date is 17th October.

* Consumer administered injectables – is the paper copy of the Product Information (PI) document helpful for patients and carers? Read more here. Closes 7th November.

New: Therapeutic Goods (Therapeutic Vaping Goods—Sponsor Notice and Restatement Form) Approval (No. 2) 2025 – read more here.

Medical device reforms: point-of-care manufacturing of medical devices: Healthcare facilities in Australia are developing point-of-care (POC) manufacturing capabilities using methods such as 3D printing. This page summarises the ongoing review of medical device regulations.

Medical device reforms: personalised medical devices: overview of reforms.

The TGA is undertaking a post-market review of all silicone tubing used in dialysis products, including dialysate tubing products, haemodialysis units, and peritoneal dialysis units. More here.

List of TGA licensed manufacturers – instructions for searching Australian manufacturers licensed for the manufacture of medicines, blood and biologicals published here

Documents released by TGA under Freedom of Information (FOI) – log of documents released up to 12th September published here.

TGA contact details – email, phone, fax,. post, social media channels – have been updated.

Botanical Adulterants Prevention Programme (BAPP) and other adulteration stories.

* Uncovering coriander adulteration with GC-MS. Summary article published in LinkedIn here, full paper available in Applied Food Research.

* Botanical Adulterants Monitor – read it here.

For regular news on US dietary supplement and food regulation, go to AWG Regulatory Roundup.

IN THE PRESS

* “Record number of calls to poisons hotlines for children ingesting melatonin“. Australian poisons hotlines received a record almost 1,500 calls about children ingesting melatonin last year, in a dramatic spike that has prompted experts to warn it is “purely luck” no one has died. Published on abc.net.au 

* Sunscreens – see story below