CONTENTS

Training news
Complementary medicines and medical devices
Foods
Cosmetics and sunscreens
ACCC and other news

Regulatory Training Direct is an online training organisation with a focus on regulatory compliance and related topics.

Medicine labelling – From 1 October 2026, a new labelling order comes into force. See story below. There is a transition period to allow sponsors time to update labels and manage existing stock. Our labelling course will be updated very soon – we will let you know on our website when it is ready!

View the agenda for all 40 courses and book online here. Some courses are available as live tuition, others are eLearning (pre-recorded), and some are available in both formats. When you purchase an eLearning course your password lasts for 60 days, so you can access the course as often as you want before the password expires

New labelling order for all types of medicines!
Therapeutic Goods Orders 91 and 92 are being replaced with:
* Therapeutic Goods (Standard for Labelling of Prescription Medicines) (TGO 115) Order 2026 – here
* Therapeutic Goods (Standard for Labelling of Non-Prescription Medicines) (TGO 116) Order 2026 – here
For complementary medicines, TGO 116 applies.
Sponsors have a 5-year transition period to comply with the new standards. During the transition period non-prescription medicines may comply with either TGO 92 or TGO 116.
* New labelling orders – information for sponsors – TGA guidance is here.
* We will have our training course for medicine label revised soon.

Therapeutic goods orders – newly published guideline here.

Andrographis
* Andrographis paniculata (Andrographis) has been removed from the list of ingredients allowed in new listed medicines from 17 September 2026 due to allergy risk. TGA’s explanation is here. It is still permitted in registered complementary medicines.
* The amendment to the Permissible Ingredients Determination is published here.
* High-moderate risk changes to permissible ingredients – Andrographis paniculata – TGA information published here.
* List of products recalled is here
* Industry response to removal of andrographis. The leading industry body for complementary medicines in Australia, Complementary Medicines Australia (CMA), has published a statement on its website questioning the TGA decision, read it here.
(Editor’s note: after having interacted with the TGA since 1980, mostly in a very positive way, I find this decision to be concerning. I agree with the opinions put forward by the CMA, in particular:
* there are many permitted ingredients that can cause anaphylactic reactions, the example given being royal jelly, and these are handled with an appropriate warning statement
* Andrographis is a not a new ingredient, it has been used for centuries and its safety profile and possible side effects are well known, as is its efficacy
* this is likely to drive consumers to buy products from the internet which would not have the sorts of warning labels that consumers are likely to find on Australian products, and which may not be manufactured to the same quality standard and may be adulterated.)

Consent relating to listed medicines that contain whole live microorganisms as an active ingredient, in particular a whole live microorganism, other than Arthrospira maximaor Arthrospira platensis. and that comply with certain conditions. Published here.

Consultations:
* Additional public consultation on the scheduling of ethylene oxide, propylene oxide and epichlorohydrin – read more here  and submit your feedback here. Consultation closes 26th October.
* Proposed amendments to the Poisons Standard – includes Vitamin A, Phenyl methyl ketone (acetophenone), and Methyl ethyl ketone oxime (MEKO)-releasing silanes. Read more here. Consultation closes 12th October. TGA is proposing to reduce the concentraion of vitamin A in topical preparations to 0.05% retinol equivalents in body lotions and 0.3% in all other topical preparations. No change to limit on internal use.
* Proposed amendments to the Poisons Standard two other consultations also close on 12th October: 4-Methylbenzylidene camphor here and nitrous oxide here.

Advertising:
* When news content may become advertising – guidance to help journalists and news organisations. Document is called Determining when news is subject to the therapeutic goods advertising rules and it is available here.
* Specialised advertising issues and topics updated 28th September here – includes Compounded medicines – Manufacturing, supplying and advertising compounded medicines lawfully here.
* Advertising rules for certain information to be prominently displayed or communicated in advertisements for therapeutic goods. Updated and published here.

Peptide products – a summary of how peptide products are regulated in Australia, the risks of buying unapproved products online and the rules for importing, supplying, manufacturing or advertising them. Read more here.

Personal imports
* The Personal Importation Scheme allows individuals to import therapeutic goods not entered in the Australian Register of Therapeutic Goods (ARTG), provided certain conditions are met. These products are typically shipped via mail or courier from overseas and must only be for use by that individual or their immediate family members, they cannot be sold or supplied to any other person. Latest guideline to the personal import scheme is here.
* New packaging rules for personal imports help authorities identify imported therapeutic goods and reduce the risk of unidentified, mislabelled or counterfeit products entering Australia. Medicines imported under the scheme should remain in their original packaging where possible. New guideline is published here.

GMP clearance dashboard – updated 14th September, here.

Poisons Standard – see Consultations above.
* New version of The Poisons Standard – October 2026 – published here.
* Updated information, includes decisions to be implemented in future Poisons Standards – six decisions including Pyridoxine, pyridoxal or pyridoxamine (Vitamin B6) – published here.

Adverse reactions
* How to report an adverse event, including side effects from taking medicines and problems with medicines and medical devices guidance is here.
* For consumers – reporting adverse events – guidance is here.
* For health professionals – reporting adverse events guidance here.
* Reporting adverse reactions – reporting form updated 28th September and available here. A separate form for adverse events following immunisation is here

Supplying medicines during a shortage – updated 28th September is here

TGA’s freedom of disclosure (FOI) log – last updated 26th September, is here.

Medicines that have been cancelled at the request of the sponsor, no updates since 19th August

Compliance activity – Compliance enforcement
* Infringement notices: a list of infringement notices issued in response to breaches, updated 18th September published on this webpage

* More than $126,000 in infringement notices for unlawful importation and advertising of prescription-only medicines have been issued, by the TGA. All of the infringement notices have been paid. Source: TGA
* Federal Court proceedings have commenced against BioV8 (now in liquidation) and its former directors, Edward McGill and Nicholas Austin who are alleged to have unlawfully advertised prescription-only therapeutic goods, including peptideson on its website and social media pages for the treatment of serious diseases, conditions and disorders, including but not limited to cancer, HIV/AIDs and mental illnesses. Read more here.
* Two infringement notices totalling $39,600 have been issued to Suryam Energy for the alleged unlawful supply of vaping goods after the TGA received reports from members of the public that vaping goods were being supplied at a service station. More here
* URGENT RECALL – Mentholatum Australasia – two batches of Deep Heat Extra Strength 100 g cream – contamination with Pluralibacter gergoviae which can result in serious infections, particularly for patients with broken skin or weakened immune systems. More information here.
* Recall: Love to Dream Sleep Machine – portable rechargeable white noise machine with night light – lithium-ion battery can overheat while charging. Source: ACCC Product Safety

Recall coordinators – updated contact list is here.

Incorrect label statement re sweeteners: Vitaco is alerting customers that sucralose, an artificial sweetener, was used in 23 batches of Nutra-life and Musashi products rather than thaumatin, a natural sweetener. As a result, the product labels are missing the required “contains sucralose” declaration. In some cases, the labels incorrectly state the products contain natural sweeteners or no artificial sweeteners. No consumer acion is required. More here.

Criminal prosecutions: latest list of court actions, updated 28th September, is published here.

Medicinal cannabis and THC product list has been updated here.

Medicinal maggots
* What are medicinal maggots and their therapeutic use explained here.
* Manufacturing, supplying and advertising medicinal maggots new guidance explains how the domestic manufacture of medicinal maggots is regulated, including when a manufacturing licence is required and when exemptions may apply, published here. (your editor will not be applying for a licence to manufacture maggots at home.) 

Safety advisories and alerts
The TGA has received a report of a serious adverse effect linked to a product sold as retatrutide. The consumer experienced uncontrollable vomiting, resulting in a torn oesophagus, and required treatment in hospital. The product contained undeclared semaglutide and no retatrutide. The amount of semaglutide detected was approximately 8 times higher than the level found in semaglutide products assessed by the TGA. Read more here.

Listed medicine compliance reports updated 30th September, includes 7 listed medicines missing warning statements, not meeting stability requirements or with non-permitted health claims. Read more here.

TGA manufacturing licenses granted – 3 recent additions to licenses granted in 2026 – listed here.

Medical devices

European Union Medical Device Regulation transition web service provides notifications to providers and consumers going through low-risk changes, read more here.

Guidance on the clinical evidence requirements for medical devices, including in-vitro diagnostic medical devices, updated 11th September, click here to download as either PDF or MSWord.

Information about “Real world” evidence for medical devices: can be found here

How to show evidence your device complies with the Essential Principles. Available here.

List of approved companion diagnostics updated 9th September.

Medical devices incorporating AI or machine learning technologies on the Australian Register of Therapeutic Goods (ARTG) as of 10th September here.

Software regulation for medical devices and AI is a work in progress, read the latest here.

Post-market review of plastic syringes – 3rd September update is here.

How the Unique Device Identification can be used in healthcare settings to improve patient safety – updated 28th September, here.
* Also refer to overview of UDI for Australian healthcare here.
* List of UDI webinars from 2012 to 2026, is here – includes links to the webinars
* AusUDID roles and responsibilities updated 16th September

Medical Devices Consumer Working Group includes 15 member organisations and 3 independent consumer representatives. Latest update 14th September is here.

Additional medical device news can be viewed in the September 2026 edition of TGA Medical Device Resources published on LinkedIn by Gary Burgess, Hill Valley Regulatory Consulting

TGA Business Services
* Feedback from Beta release of new system is here
* TGA Business Services (TBS) is moving into the Health Business Services (HBS)portal. Know what’s changing and how to get ready, here.

TGA Business plan for 2026 – 2027 is detailed in PDF document here.

Botanical Adulterants Prevention Programme (BAPP) and similar articles supplied by Michael D. Levin of Health Business Strategies LLC

* Sambucus nigra – Analytical Methods to Authenticate Elder Berries and Berry Extracts – how to detect adulteration with undeclared low-cost anthocyanin-rich extracts and food dyes. Read more on BAPP website here.

* Rhodiola rosea adulteration with maltodextrin and salidroside, or other Rhodiola species. Read the bulletin here (you must register for free to access the paper).

* Botanical Ingredient Forensics: Detection of Attempts to Deceive Commonly Used Analytical Methods for Authenticating Herbal Dietary and Food Ingredients and Supplements. Published here.

* High levels of undisclosed excipients and diluents in botanical extracts may give buyers and consumers a misleading sense of botanical extracts’ strength and composition. Paper published here.

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

IN THE PRESS
* TGA flags future recall of cold and flu ingredient Andrographis paniculata – published at www.abc.net.au
* Healthcare workers are demanding answers after NSW’s patient safety agency banned hospitals from using eco-friendly medical supplies in favour of single-use products that end up in landfill and cost taxpayers millions of dollars each year. Published in www.smh.com.au 
* (New Zealand) “A long, long journey”: Supplement exporters ‘delighted’ with possible changes to out of date regulations. An interview with Natural Health Product Government Affairs Director Samantha Gray, listen to the podcast on Newstalkzb.co.nz 

FSANZ Board communique from 14th and 15th September meeting – matters discussed included updates on the progress of:
* Health Star Rating Sytsem
* Young chold formula review
* Principles-based Review of Food Labelling in the Digital Era
Published here

Food Standards Code Compilation was updated in August – available here.

Amendments to the Food Standards Code
Amendment No. 252 includes amendments resulting from the following applications:
* A1329 – Exclusion of Blacklip Rock oysters farmed in the Northern Territory from the ML for cadmium in molluscs. Comprehensive list of documents here
* A1339 – 2′-FL, 3-FL, LNT, 3′-SL, and 6′-SL from GM Escherichia coli BL21 for use as nutritive substances in infant formula products – consultation and assessment documents published here
* A1340 – 2′-FL from GM Escherichia coli BL21 (gene donor: Akkermansia muciniphila) for use as a nutritive substance in infant formula products – More information here.

New applications and proposals
* A1365 – Chitosan from Agaricus bisporus for use as a food additive – to permit chitosan from white button mushroom (Agaricus bisporus) in food categories that do not have permissions for additives permitted at good manufacturing practice. Source: FSANZ
* A1364 – Rhiza mycelium (Neurospora crassa) biomass as a novel food Source: FSANZ
* A1363 – Food derived from herbicide-tolerant corn line ZZM032 genetically modified to tolerate the herbicides glufosinate and glyphosate. Source: FSANZ
* A1361 – Phospholipase A1 from Fusarium commune for use as a processing aid in the production of bread and bakery products, and cereal and flour products (including noodles and pasta). Source: FSANZ
* A1360 – Mannanase from Aspergillus niger (gene donor: Evansstolkia leycettanus) for use as a processing aid in coffee processing. Source: FSANZ

Public consultations and calls for submissions/comments
* Use of steviol glycosides as a food additive in hot plate flour products – seeks to permit the addition of steviol glycosides to flour products that are cooked on hot plates (such as crumpets, pikelets and pancakes) at a level no greater than the proposed maximum permitted level (MPL) of 350 mg/kg (as steviol equivalents). Consultation closes 11 November, more information here 
* A1326 – Addition of phytosterols, phytostanols and their esters as a novel food to bread Submissions close 27th October, source: FSANZ

Novel foods determinations – September 2026 is here, a recent determination is Miracle berry powder (Synsepalum dulcificum) – freeze-dried powder produced from the pulp of the berry with skin and seeds removed – Non-traditional food, Novel food.

Food Standards News September 2026, contents includes Nutrition Panel Calculator updated

New biosecurity legislation commences on 1 October. Source: Department of Agriculture, Fisheries and Forestry

Recalls 
* Astor Chocolate Wafer4 Stick – undeclared allergen (cashew) FSANZ
* Sunlife Import & Export Da Chả Giò Rế Net Spring Roll Wrapper- undeclared allergen (gluten) FSANZ

* Supercol Food and Liquid Thickener – Microbial (cronobacter) contamination. FSANZ

* Alog – Red Hat Cookia Matcha Chocolate Flavor – undeclared allergens (egg, milk and soy) FSANZ

* JC Seafood Sweet Chilli & Lime Salmon Portions – undeclared allergen (soy) FSANZ
* Greenstorm Foods t/a Austral Herbs – Certified Organic Premium Peppermint Leaf (Mentha piperita) – presence of foreign matter (metal). FSANZ
* Bottega 1995 – Brie Mon Sire – Potential microbial (Listeria monocytogenes) contamination. FSANZ
* The Wonderland Collection K Mini Baby Thermal Drink Bottles – product may not comply with the mandatory standard for toys for children up to and including 36 months of age. The button clip cover may become detached from the product during use, creating small parts. Source: ACCC Product Safety

Some people are slow learners. A Sydney bakery has been fined $84,000 and convicted of 18 offences. The inspection report included evidence of the presence of pests which had chewed into food items, with dirt, grease and mould observed on equipment in the premises, and food stored uncovered. An additional seven food labelling charges were identified for missing date marking on multiple baked products. The facility was placed under a Prohibition Order and remains closed. In 2023, the business was convicted of 23 offences and fined $75,000. Source: NSW Food Authority

Other food news can be found in The Correct News published by Correct Food Systems.The latest issue includes HACCP Precautionary Allergens Labelling Guideline; NSW Battery Incentive; Health Star Rating – under review and HSQF 10 Summary. Subscribe to the newsletter via their contact page.

New Zealand

New Zealand Ministry of Regulations – recent news summarises major regulatory reviews of product labelling and hospitality regulation, and also includes new product labelling guidance, installing solar, use of agricultural drones for routine spraying, removing outdated registration requirements for 19 so-called ‘offensive trades’, and understanding AI’s impact on regulation. Source: NZ Ministry of Regulation’s September 2026 newsletter

New Zealand Food safety insights and emerging risks, current issue is 12th September and it can be viewed here – a great summary of international news.

New Zealand food recalls 
* Mon Sire brand Brie – possible presence of Listeria monocytogenes. Source: NZ MPI
* Woolworths Multi Grain Cereal – may contain foreign matter (blue plastic) Source: NZ MPI
* Dongwon brand Fried Bean Curd – undeclared allergens (egg, milk, sesame) Source: NZ MPI
* Tip Top brand Jelly Tip 6 Pack – possible presence of Bacillus cereus Source: NZ MPI 

Primary sunscreens

Sunscreen ingredients. Includes the latest list of ingredients that have been reviewed, and the difference between mineral and chemical sunscreen ingredients and the safety of nanoparticles. TGA is proposing to reduce the quantities permitted in sunscreens: Homosalate and oxybenzone are active ingredients that can potentially be absorbed through the skin and may cause harmful effects if used in high concentrations, over large areas and over an extended amount of time. Benzophenone is not a permitted ingredient, but a substance that may potentially be formed in the manufacturing process or from incorrect storage conditions. It has possible carcinogenic risks, and its levels should be limited in products. Published by TGA here.

TGA is proposing options for additional safeguards for 4-methylbenzylidene camphor (4-MBC) More information here.

Cosmetics and personal care

Consultation on proposal to change the current poison scheduling of ethylene oxide, propylene oxide and epichlorohydrin. They are currently listed as Dangerous Poisons (Schedule 7) without any exception. There is a proposal that preparations containing less than 0.002% (20 ppm) be exempted from the Schedule 7 entries. This affects consumer goods, personal care products, and industrial hygiene products. Read more here and submit your feedback here. Consultation closes 26th October.

Registration is now open for importers or manufactures of industrial chemicals in Australia on or after 1 September 2026. Recent information on AICIS website here.

Recalls
* Kao Liese Prettia Bubble Hair Colour – The warning label on the product is unclear, is in the wrong position and does not comply with regulatory requirements. Source: ACCC Product Safety
* Mise en scéne Hello Bubble Foam Hair Colour – The warning label on the product is unclear, is in the wrong position and does not comply with regulatory requirements. Source: ACCC Product Safety
* Salon de Pro unscented hair colour fast dye cream – The warning label on the product is unclear, is in the wrong position and does not comply with regulatory requirements. Source: ACCC Product Safety

The Australian Inventory of Industrial Chemicals – the latest snapshot of the inventory was on 2nd June here

2026 categorisation guidelines and updated list of high hazard chemicals – summary information is here, and online guide to categorising your chemical importation and manufacture is here.

Draft evaluations open for comment – period for comment closes 26th November:
7 chemicals are listed here along with the form to provide your comments

New chemical assessment statements published as at 21st September:
11 chemicals are listed here – 7 of them are for inclusion in cosmetic and personal care or laundry products

Completed evaluations – none this month

Variation of Inventory listing after evaluation: CAS number 631-89-0 Retinol, 15-[(9Z,12Z)-9,12-octadecadienoate] Information here.

Chemical added to the Inventory following issue of assessment certificate
* as at 15th September: one chemical, CAS 119345-04-9 (Benzene, 1,1′-oxybis-, tetrapropylene derivs., sulfonated, sodium salts) for use in coating and cleaning products – more info here.
* as at 8th September: one chemical, (no CAS number shown) 1-Propene, polymer with ethene, maleated, 2-[[2-hydroxy-3-(carbopolycyclyloxy)propyl]heteromonocyclyl]ethyl imide – for lubricant and grease products, more info here.

Correction of chemical names and molecular formulas as at 2 October: it looks like over 100 chemical names have changed! See the full list here.

Industrial Chemicals Regulatory News – published regularly by AICIS. Current issue is 1st October and you can find it here. Most – not all – of the items are included above.

Additional EU cosmetics regulations news provided by Amandine Perez, AP Cosmetic Consult (click on “show translation”)
* Directive (EU) n°2024/825, which marks a new step in the fight against greenwashing, came into force on 27th September 2026: read it here
* New restrictions for a subgroup of PFAS, including for the cosmetic field, will come into force on 10th October 2026: read it here

IN THE PRESS
Wild Child Laboratories sued for ‘deceptive’ conduct over recalled sunscreens by Ultra Violette and Advanced Skin Technology. But Wild Child continues trading under another name after going into liquidation, and selling its assets to new company Heliora, set up by the Wild Child director and major shareholder and headed by the former Wild Child chief executive officer. Published at www.abc.net.au

ACCC

Free range claims for poultry egg and meat during avian influenza (bird flu) detections– the ACCC will not take enforcement action for free range representations made by poultry egg or meat producers affected by a mandatory housing order or voluntary housing recommendation for up to 90 days while an order or recommendation is in place. Source: ACCC

ARTIFICIAL INTELLIGENCE in health, life sciences and regulated manufacturing

The second in a series of articles on AI from Fiona Henderson of Argyll Law

When does AI become a medical device in Australia?

In my last article, I looked at the different approaches Australia and Europe are taking to the regulation of AI. In Australia, one of the consequences of relying on our existing regulatory framework is that you need to work out which existing laws apply to what your AI is actually doing. For medical devices, the TGA’s starting point is the intended purpose of the product.

Take an AI scribe used during a medical consultation.

If it records the conversation and prepares a summary for the doctor, it’s probably not a medical device. But suppose the developer releases an update. The scribe now analyses the consultation and suggests a diagnosis or treatment that the doctor and patient haven’t discussed.

The TGA says that change in functionality changes the intended purpose of the software. It moves the product into the medical device category and requires TGA approval before the new functionality is released.

The TGA calls this “scope creep” or “feature creep”.

It is something regulatory affairs teams need to watch carefully. AI products don’t necessarily stay the product you originally assessed. New functionality is added and existing functionality develops. The way customers use the product changes. This means you can’t answer the regulatory question once.

Each time your product iterates, you need to ask again – what is our product doing now? Does this version bring it within the TGA definition of a medical device?

Contact Fiona at info@argylllaw.com