current affairs
Issue 272, 4th August – 31st August 2026
CONTENTS
Training news
Complementary medicines and medical devices
Foods
Cosmetics and sunscreens
ACCC and other news
Training news
Regulatory Training Direct is an online training organisation with a focus on regulatory compliance and related topics.
Medicine labelling – The TGA has published the outcomes of its consultation on proposed changes. The new requirements are intended to commence from 1 October 2026, with a transition period to allow sponsors time to update labels and manage existing stock. For sponsors, now is a good time to understand the changes, assess their impact on current product labelling and plan for implementation. Our labelling course will be updated 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
Regulatory affairs news
Complementary Medicines and Medical Devices
Guidance providing an overview of listed medicines and assessed listed medicinespathways and legislative requirements. Updated on 13th August and available here. (Editor’s note: this is a very comprehensive document and recommended reading for all sponsors of complementary medicines)
Making NAD, NAD+, NADH or NMN representations for listed complementary medicines. NAD, NAD+, and NADH are currently not permitted ingredients. NMN is a permitted ingredient. The permitted ingredients list includes several substances that may act as precursors to NMN, NAD, NAD+, and NADH, such as nicotinamide, nicotinamide ascorbate, nicotinamide riboside chloride and nicotinic acid (amongst others). This is a guide to the types of claims you can make. Published 12th August, read it here.
Consultations:
* TGA is seeking comment on adoption of international scientific guidelines – in particular 11 guidelines which are listed here. Closes 11th September.
* 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.
* Consultation on sharing more information about medical devices. The intention is to provide more information to the public after post-market reviews or investigations of medical devices, particularly where review findings relate to the safety, quality, performance or use. Read more here and provide feedback here. Closes 2nd October. Feedback from a previous consultation on medical devices has been published here.
* Proposed changes to support automated decision making for applications to change listed medicines. The TGA is seeking feedback on proposed approaches to provide greater transparency and certainty regarding automated decision-making in relation to proposed variations (and other changes) for listed medicines. Read more here. Closes 14th September.
* Proposed changes to the Required Advisory Statements for Medicine Labels. Read more here. Closes 4th September.
* Improvements to the Therapeutic Goods Advertising Code – feedback sought on reviewing the code to make sure it is clear and easy to apply, reflects current advertising practices, and supports safe and appropriate use of therapeutic goods. Read more here. Closes 3rd September.
Advertising
* See item above under Consultations
* How to ask a question about advertising therapeutic goods via the industry portal – read more here.
* How to report a non-compliant advertisement for a medicine, medical device or any other type of therapeutic good using the portal, updated guidance here.
Nitrosamines in medicines
* Established acceptable intake limits, updated 14th August, here.
* Revised table showing updates to nitrosamine and other nitroso-structure is here
Guidelines for consumers – How to report a side effect, reaction or other problem with a therapeutic good – summarises how to report a medicine or vaccine defect, counterfeit medicines or devices, questionable practices, or advertising that breaks the rules.Updated 6th August – here.
GMP clearance dashboard – no updates since 27th July, here.
Good Clinical Practice (GCP) Inspection Program – inspections of clinical trial sites of investigational biologicals, medicines and medical devices – latest update here.
Poisons Standard
* Summary of public submissions made published 27th August, here. includes Chromium-dl-methionine (Chromium organic chelates)
TGA’s freedom of disclosure (FOI) log – last updated 26th August, is here.
Human Research Ethics Committee and TGA Clinical Trials Discussion Forum, Communique, Meeting 6, 14 July 2026, read more here.
Medicines that have been cancelled at the request of the sponsor, updated 19th August
Medicines and medical devices that have been cancelled or suspended and no longer appear in the ARTG – no updates since 6th July.
Compliance activity – Compliance enforcement
* Infringement notices: a list of infringement notices issued in response to breaches, updated 20th August published on this webpage
* 10 infringement notices totalling $71,280 issued to Gezond and 3 registered pharmacists, for the alleged unlawful importation of unapproved melatonin products. Source: TGA
* Coordinated enforcement operations targeted a logistics company allegedly involved in the importation, storage and distribution of vaping goods, nicotine pouches, illicit tobacco and other unlawful products. A number of searches were conducted at various premises resulting in the seizure of approximately 245,473 unlawful vaping goods and 60,000 nicotine pouches, with a total estimated street value of over $12.3 million. Source: TGA
* 27 infringement notices, totalling $101,412, were issued to a NSW-based individual for the alleged unlawful supply of the Melanotan II products to Australian consumers. More details below under Safety advisories and alerts.
* The TGA and the NSW Police have seized more than $120,000 of illicit peptide and anabolic steroid products, including include retatrutide, CJC-1295 and the Wolverine Stack (combination of BPC-157 and TB-500), from 2 residential premises in New South Wales allegedly linked to a social media influencer. The influencer had been previously warned by the TGA. Source: TGA
* Following the interception of 400 vials of suspected Performance and Image Enhancing Drugs (PIEDs) between May and June 2026, Australian Border Force officers executed search warrants in Melbourne on 6 August where a further 44 vials of suspected PIEDs were seized. A man and a woman appeared before the Melbourne Magistrates’ Court on 6 August and were granted bail to next face court on 26 October. Source: TGA
* During an operation in Canberra, more than 1,500 illegal vaping goods, significant quantities of illicit tobacco, including more than 27,800 grams of loose tobacco and more than 156,800 cigarettes were seized. Source: TGA
* TGA has commenced proceedings in the Federal Court against Better Leaf, Better Life Aussie, and their sole director Mr Jack Weisberg for the alleged unlawful advertising of medicinal cannabis. This follows repeated warnings to the companies and multiple infringement notices issued which were not paid. Read more here.
Criminal prosecutions: latest list of court actions, updated 13th August, is published here. Four court actions so far in 2026.
Safety advisories and alerts
* imported, unapproved Carotone skin-brightening products found to contain undeclared prescription-only medicine hydroquinone at concentrations of 3.6%, 2.9% and 3.4%.. Source: TGA
* Melanotan II tanning peptide products found to be inconsistently dosed. Testing found the estimated amount across the 5 nasal spray bottles, labelled ‘Pure Tans Triple Strength 30 MG’, ranged between 22 mg and 54 mg of Melanotan II based on the labelled volume of 20 mL per bottle. Source: TGA. (See also above under Compliance activity)
Medical devices
Safety of medical devices. This article has been published by the TGA in response to media reports about the safety of defibrillator devices used in some ambulance services and healthcare facilities. Available here.
Extended transition for the European Union Medical Device Regulation. The TGA recognises this and is acting accordingly. Source: TGA
The EU MDR transition web publication service is a platform for sponsors to provide market notifications to health care providers and consumers for devices going through low-risk changes as part of the EU MDR transition. Updated 24th August, published here.
in-vitro diagnostic (IVD) self-tests for chlamydia, gonorrhoea and syphilis. Updated guidance published 25th August, here.
COVID-19 home use self-tests approved for supply in Australia – list updated 10th August, here.
Every patient getting an implantable medical device or an active implant must be provided with a patient information leaflet and implant card. Details on what must be included are published here
Post-market review of plastic syringes – 14th August update is here.
The Australian Unique Device Identification Database (AusUDID):
* Overview of UDI for Australian healthcare. Updated 27th August, published here.
* Enhancements and “fixes” as at 6th August are summarised here.
* How to add sponsor information to UDI records using the Australian UDI Sponsor Link Template updated here
* Streamlined Consent to Supply process for Unique Device Identification related Essential Principles – updated here
* How to electronically submit UDI records using GS1’s National Product Catalogue (NPC) – latest update here
Understanding selection criteria for medical device application audits – Guidance for sponsors of medical devices seeking to include a medical device (including in vitro diagnostic devices) in the Australian Register of Therapeutic Goods, revised 4th August here.
How to use RSS feeds to see TGA News items appear in your reader or inbox as soon as they are published to the website. Guidance here.
Additional medical device news can be viewed in the August 2026 edition of TGA Medical Device Resources published on LinkedIn by Gary Burgess, Hill Valley Regulatory Consulting
TGA Business services
* Getting started with the TGA – apply for access and manage your account details, here
* Business services forms – latest versions of 6 different forms can be found here
Botanical Adulterants Prevention Programme (BAPP) and similar articles supplied by Michael D. Levin of Health Business Strategies LLC
* Goldenseal (Hydrastis canadensis) Common Adulterants – a summary article here published here on LinkedIn by Kerry Hughes references work done by BAPP
* Milk thistle (Silybum marianum) another summary article here on LinkedIn from Kerry Hughes, addressing economic adulteration.
* European Elder Berry (Sambucus nigra) – BAPP is publishing laboratory guidance to provide an overview of analytical methods that can be used to assess the identity and authenticity of botanicals. Adulteration Issues of Elder Berry: read article here.
* Adulteration of grape seed (Vitis vinifera) – latest update on adulteration and detection techniques is published by BAPP here.
* CODEX Proposes 7th Definition of “Food Fraud” is “Finally Consistent, harmonized and ready for publication” (J.W. Spink). Definition: “Any deliberate practice intended to deceive others in regard to the characteristics of food to gain an unfair economic advantage.” Read more and submit your comments to CODEX here. Does This Definition Apply to Botanicals? Yes and No. If a botanical ingredient is used as a food, spice, culinary herb, or as a dietary ingredient used in dietary supplements in the US, it does fall under the purview of Codex food safety and fraud standards. However, the exact moment that same botanical substance is processed, marketed, and approved to diagnose, cure, mitigate, treat, or prevent a disease, it legally crosses the line into a drug and is exempt from Codex food guidelines. Hence, the CODEX definition of Food Fraud would arguably apply to all “dietary ingredients” in the US, including botanicals.
* Botanical Ingredient Forensics: Detection of Attempts to Deceive Commonly Used Analytical Methods for Authenticating Herbal Dietary and Food Ingredients and Supplements. Published by National Library of Medicine
Additional USA news provided by Amin Wasserman Gurnani
FDA Moves to Make GRAS Notification Mandatory. An in-depth summary has been published in the 25th August edition of AWG Regulatory Roundup
For regular news on US dietary supplement and food regulation, go to AWG Regulatory Roundup.
IN THE PRESS
Doctors fear possible contaminated counterfeit peptide batch after seventh case of acute liver damage. Published on abc.net.au
Foods
FSANZ Work Plan has been updated as at 13th August. Go here to access the Work Plan, and another link on this page takes you to the Work Plan Notes. A lot information here. The work plan is 29 pages long!
FSANZ media statement: Australia’s food standards agency has welcomed the ACCC initiating inquiries into claims raised on the recent ABC Four Corners program Duped. See story below under ACCC. Read here. This issue was detailed in our last month’s newsletter which you can access here.
Australian National Campylobacter Action Plan.
* FSANZ is requesting initial input to inform the development of an Australian National Campylobacter Action Plan. The primary purpose is to reduce domestically acquired campylobacteriosis. Read more here and forward your views. Closes 31st January 2027.
* Do you want to receive communications and requests for engagement? Read more here and here, and register your details on the form provided.
FSANZ Board communique from 5th August meeting – the following “matters for decisions”:” were notified to the Food Ministers’ meeting:
* The Board approved Application A1306 to amend the Code to permit the use of chitosan extracted from white button mushrooms (Agaricus bisporus) as a processing aid, namely, a fining and microbial stabilisation agent in wine, beer, cider and other alcoholic beverages.
* The Board approved Application to permit the use of the enzyme triacylglycerol lipase(EC 3.1.1.3) as a processing aid to hydrolyse lipids during the manufacture of dairy-based products and plant-based dairy analogues.
* The Board approved application to permit the enzyme dextransucrase (EC 2.4.1.5) for use as a processing aid in the production of oligosaccharides and polysaccharides to reduce sucrose content and improve texture in foods containing sucrose.
Details on all the above can be accessed here.
Food Standards Code Compilation was updated in August – available here.
Amendments to the Food Standards Code
Amendments have been made to Schedules 3, 19, 26 and 29, resulting from:
* Exclusion of Blacklip Rock oysters farmed in the Northern Territory from the ML for cadmium in molluscs
* 2′-FL, 3-FL, LNT, 3′-SL, and 6′-SL from GM Escherichia coli BL21 for use as nutritive substances in infant formula products
* 2′-FL from GM Escherichia coli BL21 (gene donor: Akkermansia muciniphila) for use as a nutritive substance in infant formula products
Read more here:
New applications and proposals
* Glucoamylase from Trichoderma reesei (gene donor: Fusarium verticillioides) for use as a processing aid. Source: FSANZ
* Mannanase from Aspergillus niger (gene donor: Evansstolkia leycettanus) for use as a processing aid. Source: FSANZ
Public consultations and calls for submissions/comments
* Application by Corteva Agriscience to permit food derived from genetically modified corn line COR121. This corn line has been genetically modified for protection against insect pests. Closes 3rd September. Source: FSANZ
* Application made by Danisco Australia to permit the use of the enzyme lysophospholipase as a processing aid in carbohydrate processing to produce glucose syrups and other starch hydrolysates. Closes 10th September. Source: FSANZ
* An application made by Chr. Hansen to permit protein-glutamine glutaminase from Bacillus licheniformis (gene donor: Chryseobacterium viscerum) for use as a processing aid for a variety of applications. Closes 17th September. Source: FSANZ
Novel foods determinations – no updates since July 2026, read the reasons for the determinations here.
Food Standards News August 2026, contents include:
* Health Star Rating proposal progresses to the next stage
* New food regulation system guidance published on GM food and novel DNA definitions
* Have your say on an annual common commencement date for food labelling changes
Read it here
Australia has helped shape a range of new and updated international food standardsat CODEX meeting – according to the Department of Agriculture, Fisheries and Forestry. Includes new guidance to make precautionary allergen warnings, such as ‘may contain’, clearer and more consistent; and food hygiene guidance on controlling Campylobacter and Salmonella in chicken meat, supporting practical, science-based approaches to managing food safety risks. Source: Department of Agriculture, Fisheries and Forestry
Recalls
* Chen Foods – Mr Chen’s Szechuan Chilli Oil – presence of an undeclared allergen (peanut) more details: FSANZ
* Walter’s Artisan Produce Pty Ltd – Walter’s Artisan Bread – Banana Loaf – presence of undeclared allergens (egg). more details: FSANZ
* Edesia Enterprises – noosa GOURMET Brioche Rolls – presence of undeclared allergens (milk and egg). more details: FSANZ
* Key-Sun Kids Honey & Eucalyptus + acerola lozenge – risk of the presence of foreign matter (metal). More details: FSANZ
* Tea infuser designed for use with Frank Green ceramic reusable cups and bottles – Risk of injury from cuts or scratches by the loose or raised section of the tea infuser. Source: ACCC
Support for growers to implement new food standards – applicable to growers and primary processors of berries, leafy vegetables and melons in NSW. Source: NSW Food Authority
Other food news forwarded by Gary Kennedy from Correct Food Systems
Nutrient Reference Values for Vitamin B6 and Sodium Under Review.
On 20 August, the National Health and Medical Research Council (NHMRC) opened their public consultation on revised recommendations for the Nutrient Reference Values (NRVs) for vitamin B6 and sodium. While the NHMRC NRVs are not regulatory in nature, they are used by FSANZ and the TGA to inform and determine permitted levels in food products, beverages and supplements. The NRVs for vitamin B6 were last reviewed in 2006, and since then, concerns have been raised over people developing a nerve condition (peripheral neuropathy) from taking too much vitamin B6 through supplements. Consultation closes 30th September. Read more: Vitamin B6 here, and sodium here. The key recommendation from the NHMRC is to therefore reduce the adult Upper Level from 50 mg/day to 14 mg/day.
* From Allergen Bureau newsletter: the Codex Alimentarius Commission has adopted new international guidelines governing the use of precautionary allergen labelling (PAL), including statements such as “may contain”. The decision aims to make allergen labelling more consistent, meaningful and scientifically justified for consumers worldwide.
However, the use of “may contain” labels has varied widely across countries and manufacturers, with little regulatory consistency. This has created uncertainty for consumers, who may either avoid products unnecessarily or lose confidence in allergen warnings altogether. The new Codex guidance establishes a harmonised, risk-based approach to precautionary allergen labelling. Under the guidelines, “may contain” statements should only be used after food manufacturers have implemented appropriate allergen management practices and conducted a scientific assessment showing that a residual risk from unintended allergen presence remains. Although Codex standards are voluntary, they are widely recognised as international benchmarks and often influence national food regulations. See the FAO website for more information. More information on the VITAL Program can be found here.
Stay up to date with Food News by subscribing to The Correct News, published by Correct Food Systems.
Other food news supplied by Clare Winkel of Integrity Compliance. Clare conducts a food fraud training course, details are here.
* Who’s Policing Our Food. This article by WA Farmers was posted on LinkedIn here. It talks about fraudulent food labelling especially with imported foods, and how unfair it is for Australian producers.
* Four people involved with the pork meat industry have been charged following a joint investigation conducted by the Queensland Crime and Corruption Commission and the New South Wales Police Force into alleged large-scale financial crime – approximately $10 million in transactions were deleted or not created and more than $30 million in cash was transported from New South Wales to Queensland. Source: QLD Crime and Corruption Commission
New Zealand
New Zealand Food safety insights, emerging risks, and current issues bulletins: 7th August issue can be viewed here 20th August issue can be viewed here – once again, interesting international news.
.New Zealand food recalls
* Vogel’s brand – various breads (six different varieties) – may contain foreign matter – small metal pieces. Source: New Zealand Ministry of Primary Industries
Additional New Zealand news supplied by Gary Kennedy
* A new guide to labelling of alcoholic drinks published by New Zealand Ministry of Primary Industries is available here.
IN THE PRESS
* Cow’s milk contributed to three toddler deaths in past two years as experts warn of impact to iron levels. “Experts say drinking too much cow’s milk contributed to the deaths of three toddlers in the past two years by causing severe iron deficiency anaemia. Blood specialist Dr Sally Campbell says babies aged one-and-under should not be given cow’s milk at all, and children aged one-to-five should be restricted to two cups per day.” Published on abc.net.au
* ‘Formaldehyde cabbage’ scandal sparks food safety concerns in China and beyond. Chinese authorities have confirmed Napa cabbages from China’s largest cabbage-producing region have tested positive for traces of the cancer-causing chemical formaldehyde. South Korea and Vietnam are major importers of Chinese cabbages. Published on ABC news site.
Cosmetics and sunscreens
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.
2026 Industrial Chemicals Categorisation Guidelines take effect today – 1st September 2026. The main changes will include updates to the list of chemicals with high hazards for categorisation. There is also an update to the Guide to categorising your chemical importation and manufacture. Read more here.
AICIS has released 2026 Industrial Chemicals Categorisation Guidelines and updated ‘Guide to categorising your chemical importation and manufacture‘ to reflect all the changes that take effect on 1 September 2026. Source: AICIS
Recalls no cosmetics or personal care this month
The Australian Inventory of Industrial Chemicals – the latest snapshot of the inventorywas on 2nd June here
Variation to Inventory listing after approval of an evaluation – as at 19th August: (Warning: very big word coming up): Amines, polyethylenepoly-, reaction products with 2-[(carbopolycyclicoxy)methyl]heteromonocycle and succinic anhydride monopolyisobutenyl derivs.
Completed evaluations none this month
Commercial evaluation authorisations – none this month
Variation of Inventory listing following revocation of CBI approval – none this month
Chemical added to the Inventory following issue of assessment certificate – as at 3rd August: CAS 2207590-23-4. Name: (thankfully it is a short name): Gnidia daphnifolia, ext.
Chemicals added to the Inventory 5 years after issue of assessment certificate (obligations to provide information apply): as at 26th August: one chemical CAS 1629579-82-2 Chemical name: 1-Propanamine, 3,3′-[oxybis(2,1-ethanediyloxy)]bis-, (2Z)-2-butenedioate (1:2)
Industrial Chemicals Regulatory News – published regularly by AICIS. Last issue was 14th August, here.
Additional EU cosmetics regulations news provided by Amandine Perez, AP Cosmetic Consult (click on “show translation”)
* Cosmetic Ingredient Labelling: new version of the European Glossary of Common Ingredient Names has come into force, LinkedIn post is here.
* Packaging news: The EU Packaging and Packaging Waste Regulation (PPWR) came into force from 12th August 2026, LinkedIn post is here.
IN THE PRESS
The federal government is suing 3M for $2 billion over PFAS contamination from products used at 28 defence bases in Australia. The claim alleges 3M withheld damning environmental and health information about components of its firefighting foam for decades. Published on abc.net.au
ACCC and other news
ACCC
* ACCC looking into Four Corners’ food claims. Some controversial claims were made recently about fraudulent food claims, particularly in relation to country of origin, where many brands of “Australian grown” tinned tomatoes were found to have come from China. This was covered in last month’s newsletter which is here.
* Product safety pledge. Fruugo has become the sixth online marketplace to sign the Australian Product Safety Pledge. It joins Amazon Australia, eBay Australia, AliExpress, Gumtree and Temu. Source: ACCC
Other news forwarded by Gary Kennedy from Correct Food Systems
* Updated EU PPWR Packaging Regulation FAQs Released. This month, the European Commission released an expanded second edition of its Frequently Asked Questions on the EU Packaging and Packaging Waste Regulation (PPWR).
Aspects of the PPWR are now in effect from 12 August this year. The PPWR applies to all Australian businesses exporting packaged products to the EU, or supplying packaging into European markets. The PPWR itself has not changed, but the updated guidance provides greater clarity on how businesses should interpret and prepare for key obligations.
The FAQs cover the responsibilities of manufacturers, importers, producers and distributors, Information is provided clarifying which requirements apply from 12 August 2026 and which remain dependent on future technical rules or later commencement dates.
* NSW Battery Incentive to Open for Business From 1 September, eligible NSW businesses will be able to access an upfront discount of 20–40 per cent on the cost of installing batteries through government-accredited suppliers. The NSW Battery for businesses incentives is available to commercial and industrial businesses installing batteries between 20 kWh and 30,000 kWh, with the discount increasing with battery size.
The NSW Government estimates that eligible businesses could receive discounts of around $37,000 for a small battery and up to $355,000 for a medium-sized battery.
The incentive can also be combined with the Australian Government’s discounted rooftop solar scheme for commercial buildings, helping businesses further reduce energy costs.
Published by Regulatory Training Direct www.regulatorytrainingdirect.com
Providing regulatory training courses for complementary medicines, medical devices, GMP, foods, cosmetics, dietary supplements.
