current affairs

Issue 261, 4th August – 1st September 2025

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CONTENTS

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

Training news

Regulatory Training Direct is an online training organisation with a focus on regulatory affairs and related topics.
Advertising medicines and medical devices in Australia – e-Learning pre-recorded course now available! Our existing live course has been revised and is now available to purchase online as an e-Learning module available on demand. This delivery method will suit people who prefer to do the course in their own time, or who cannot commit to a live course due to time zone differences, or work commitments. If you are outside of Australia and you have your “dietary supplements” being sold in Australia as complementary medicines, this course will be of great benefit. You can view the agenda and book our course here. Your access code expires 60 days after you purchase the course. During this access period, you can listen an unlimited number of times to truly absorb the valuable content.
The live version of the course  is still available if you prefer interaction with our trainer and to have Q & A time. Book it here. This course is conducted by Leanne McCauley, who spent more than 9 years working at the Therapeutic Goods Administration (TGA) working with the advertising code and advertising compliance. Read about Leanne’s background here.
Pharmacovigilance course has been updated to include recent TGA guides. The course is includes a full set of SOPs and forms that will enable you to set up your own pharmacovigilance system. Presented by Mary Nteris, an expert in this subject. Read the agenda and book a course here.
Testimonials – they keep coming in, view them here.
Some courses are available as live tuition, others are e-Learning (pre-recorded), and some are available in both formats.
View the agenda for all 40 courses and book online here. Read some lovely testimonials here

Regulatory affairs news

Complementary Medicines and Medical Devices

Nicotine pouches are illegal unless prescribed. There are no nicotine pouches approved in Australia by the TGA. They are prescription only medicines. They cannot be sold by retail outlets or tobacconists; cannot be advertised; and cannot be imported or sold without TGA approval or a valid written authority or prescription from an Australian health practitioner. Nicotine is highly addictive and can have many side effects including fast heart rate and high blood pressure. Source: TGA.
Vapes: information for sponsors, importers and manufacturers on what the regulatory changes mean for the importation and manufacture of therapeutic vapes. Vapes are only lawfully available for therapeutic purposes and for supply through pharmacies and pharmacy settings. Source: TGA
Digital scribes: can be regulated as medical devices, if they are intended to: diagnose, monitor, predict, provide a prognosis, treat, alleviate or compensate for a disease, injury or disability; investigate the anatomy or a physiological process; control or support conception; examine specimens derived from the human body for a medical purpose. Source: TGA
Medical devices – reporting an adverse event. Relevant to sponsors, manufacturers and healthcare facilities. Updated 26 August published here along with incident reporting forms.
Understanding regulation of software-based medical devices – revised August, published here.
Ventilator, CPAP and BiPAP devices – TGA is undertaking a post-market review of ventilator, CPAP and BiPAP devices. Risks posed by a polyester-based polyurethane (PE-PUR) foam used as soundproofing material. Source: TGA
Instructions for disinfectant testing – Guidance on testing of disinfectants and sterilants, revised August.
Medicines and medical devices that have been cancelled or suspended – list updated Auigust 2025, includes 6 products, 5 cancelled at request of the manufacturer, and one (Star Combo Living Healthy Magnesium Plus) as “The sponsor has refused or failed to comply with a condition to which the inclusion of the goods is subject”. Source: TGA
Medicinal cannabis news and updates: 21 August update
GMP guidelines – PIC/S has launched a public consultation on proposed revisions to its ‘Guide to GMP for Medicinal Products’. You can provide feedback directly to the European Commission website. Consultation closes 7th October. More information on “Update to the Manufacturing Principles for medicines, APIs & sunscreens” is on TGA website here.
GMP clearance applications. Update to the sponsor “dashboard” where you can view the progress of your application, read about this here.
Update to Manufacturing Principles for medicines, APIs and sunscreens. TGA will be adopting the PIC/S Guide to GMP – 25 August 2023, except for Annexes 4, 5 and 14 on 1 September 2025.  The changes in version 17 relate only to Annex 1. This annex has been amended and contains information and requirements related to the manufacture of sterile medicinal products. Source: TGA
Updated (22 August) guidance to GMP for medicines, active pharmaceutical ingredients and sunscreens published here.
The TGA-Industry Working Group on Good Manufacturing Practice (TIWGG) meeting summaries are published here.
COVID-19 self-tests (home use tests) approved for supply in Australia. Source: TGA
What can and cannot be advertised to the general public. Updated August and includes: Certain therapeutic goods are prohibited from being advertised to the public; therapeutic goods that can be advertised to the public; non-promotional information about therapeutic goods. Source: TGA
List of unapproved products you can access under the Special Access Scheme Category C Revised list includes medicines, biologicals and medical devices. Revised list is here.
Testing of vitamin D3 in single active products. Vitamin D3 is sensitive to air, heat and light, which can affect its stability. The TGA Laboratories Branch conducted a quality survey of vitamin D3 products, focused on single-ingredient vitamin D3 products with high sales volumes in Australia between January and December 2023. The TGA tested 13 of the top-selling products, which were supplied by nine different sponsors. All of the vitamin D3 products tested met the relevant quality standard for active ingredient content. Details and results of samples analysed are published here.
Market actions and compliance activity
Including product recalls, safety advisories, alerts and corrections.
Recalls
* Ultra Violette Lean Screen SPF 50+ sunscreen – see story below
* Star Combo Australia is recalling four Living Healthy High Strength Gummies products due to non-compliant labelling – The presence of sucralose has not been declared; no warning statements for Curcuma longa (turmeric) and maltitol; includes the unapproved claim: “Vitamin D3 prevents osteoporosis”; includes the unapproved claim: “Prevents urinary tract infections”. Source: TGA
Compliance activity
* Elixir Compounding Pharmacy and Elixir Centre for Wellness have been issued with infringement notices totalling $59.400 for the alleged unlawful advertising of therapeutic goods, palmitoylethanolamide capsules and gamma-aminobutyric acid capsules. The advertisements included references to serious conditions such as depression and fibromyalgia. Source: TGA
* The TGA, assisted by Victoria Police, seized illicit vapes worth approximately $40,000, from a retail outlet (a “Candy” shop) in a highly prominent location in Melbourne’s CBD. Victoria Police also seized illicit tobacco and cash. Source: TGA
* Dispensed has been directed to cease the advertising of medicinal cannabis on all websites, social media accounts or other advertising platforms managed by a third party. Detailed information is here.
Safety alerts
t:slim X2 Insulin Pump: certain versions of the device have a wiring problem with the speaker. which may result in a failure, more information here.
Baby deaths associated with home-use foetal heart monitors. Following the post-market review of all home-use foetal dopplers completed in September 2024, all home-use foetal heart monitors were cancelled from the Australian Register of Therapeutic Goods (ARTG), meaning, they are no longer approved for advertising or supply in Australia. Source: TGA
Making a complaint to the TGA: updated August, including reporting adverse events (side effects), and reporting counterfeit products, suspicious or illegal activity, or making a report about non-compliant advertising. Information published here includes online form for lodging a complaint.
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)
Regulation of artificial intelligence in medical devices. Outcomes from consultation available here.
Documents released by TGA under Freedom of Information (FOI) – log of documents released up to  26 August published here.
TGA Laboratories: what do they test, how do they test, when do they use external laboratories, what do they do with their results. Updated 22 August.
TGA contact details – email, phone, fax,. post, social media channels – have been updated.
USA news
* contributed by Neil O’Flaherty, partner at Amin Wasserman Gurnani, LLP. .
FDA does not restrict the use of PFAS in medical devices. It will continue to monitor their use. Read the FDA’s statement here.
Botanical Adulterants Prevention Programme (BAPP) and other adulteration stories. contributed by Michael D. Levin, Founder, Health Business Strategies , LLC, Clackamas, 
Cinnamon: High rate of safety and fraud issues in commercially available cinnamon. Published by BAPP on LinkedIn here.
* Botanical Adulterants Monitor – read it here.
For regular news on US dietary supplement and food regulation, go to AWG Regulatory Roundup.
IN THE PRESS
TGA goes after vitamin D products for bone health. NuiraIngredients USA states that four products with Vitamin D but no calcium have been removed due to a lack of evidence.
Training course: we have a training course on this topic – TGA evidence requirements for claims. Go here to book a live course, and here to buy a pre-recorded eLearning course.

Foods

The Food Standards Australia New Zealand (FSANZ) Board held a meeting on 6 August 2025 to discuss and decide on standards matters. The meeting communique is now available here
Amendments to Food Standards Code: the following amendments have been published:
* A1323 – Food derived from insect-protected soybean line COR23134. Approval report here.
* A1314 – Permitting small dogs and cats in aircraft cabins (to permit food to be served when pet cats and dogs are present in an aircraft cabin.) Read more here.
* P1049 – Carbohydrate and sugar claims on alcoholic beverages – to clarify that nutrition content claims about carbohydrate and sugar content can be made on alcoholic beverages. More here.
* P1059 – Energy labelling on alcoholic beverages – to mandate energy labelling on packaged alcoholic beverages. Information here.
Approvals
A1318 – Steviol glycosides produced by enzymatic conversion using enzymes produced by GM Escherichia coli BL21. Approval report is here and supporting documentation is here.
Commencement of assessments
* A1304 – Xylanase from GM Bacillus licheniformis as a processing aid in the production of distilled alcohol and starch and gluten fractions. Administrative assessment report here and executive summary here.
* A1305 – Alpha-amylase (protein engineered) from GM Bacillus licheniformis as a processing aid. Administrative assessment here and executive summary here.
Code revision/amendment
* P1065 Endo-1,4-beta-xylanase from GM Bacillus licheniformis (gene
donor: Chryseobacterium cucumeris) as a processing aid. Administrative assessment here
New applications and proposals
* A1332 – Cross-linked polyester resins as an adsorbent processing aid in wine. Assessment report here and Executive summary here
* A1336 – 2′-FL from GM Escherichia coli BL21 in infant formula products. Assessment report here and executive summary here.
Public consultations
A1333 – Food derived from purple tomato lines containing event Del/Ros1-N  – to permit the sale and use of food derived from tomato lines containing event Del/Ros1-N that have been genetically modified (GM) for purple fruit colour because of increased anthocyanin levels. Submissions close 10th September, more here.
Novel foods determinations – last updated in June.
Recalls
* ALDI is recalling Mamia Organic Baby Puffs (Apple Cinnamon, Blueberry, and Carrot flavours) – presence of an undeclared allergen (gluten). Source: NSW Food Authority
* Cocobella is conducting a recall of many yoghurt products – presence of an undeclared allergen (milk). Source: NSW Food Authority
* Global Foods Group is recalling a number of cheeses – Mon Ami Brie, Camembert, Le Fromager, and French Brie, and Emborg Brie and Camembert – due to potential microbial (Listeria monocytogenes) contamination. Source: NSW Food Authority
* Washed Rind Pty Ltd is recalling Bûche Belle du Bocage – due to potential microbial (Listeria monocytogenes) contamination. Source: NSW Food Authority
* ALDI is recalling Specially Selected French L’Ovale Cheese and Emporium Selection French Brie – due to potential microbial (Listeria monocytogenes) contamination. Source: NSW Food Authority
* Cadbury recalling Cadbury Dairy Milk Marvellous Creations Jelly Popping Candy Beanies – due to presence of foreign matter (plastic). Source: NSW Food Authority
* South Pacific Foods Distributors is recalling deep SPROUTED MOONG and deep SPROUTED MAT – due to due to potential microbial (Salmonella) contamination. Source. NSW Food Authority.
* Caris Grover is recalling Sunrise Trading NY Siok Uncooked Prawn Crackers – presence of an undeclared allergen (egg). Source: FSANZ
* Mondelez Australia is recalling Sharebag Marvellous Creations Jelly Popping Candy Beanies – presence of foreign matter (plastic). Source: FSANZ
Additional food news contributed by Lisa Owens, Correct Food Systems
Updated NSW Food Authority Food Safety Scheme Manual – Sept 2025. Read summary of changes to Food Legislation here.
New Zealand Food safety insights, emerging risks, and current issues bulletins:
These bulletins contain news from all over the world. Latest issue is 14th August
New Zealand food recalls:
* Speirs Foods brand salads and Woolworths brand coleslaw – presence of foreign matter (metal)
* Daily Foods is recalling Duria brand Durian Mochi – presence of an undeclared allergen (egg)
* Youhao Trading is recalling Cake Old (Traditional Cake (Nut Flavour)) – presence of undeclared allergens (gluten and peanut)
* MaxFoods Pty Ltd is recalling Norlax brand Double Smoked Salmon – labelled with the incorrect Use By date
* PNP Farms is recalling Butchery brand Pure Angus Beef Sausage – may contain foreign matter (glass)
* Goodfood Group is recalling Food Snob brand Classic French Brie, Classic French Camembert and Mon Ami brand Double Cream French Brie Petit, Mild & Creamy French Camembert Petit – possible presence of Listeria monocytogenes
* ANZ Pharma  is recalling Fruitae brand Lemon Sorbet – possible presence of an undeclared allergen (milk).
* Vimms Enterprise is recalling Deep brand Sprouted Mat, Sprouted Moong, and Surti Undhiu Mix – possible presence of Salmonella
* Lianhua International is recalling Nutty Black Rice Crisps – presence of an undeclared allergen (egg).
* Golden Mountain Enterprises is recalling Ny. Siok Shrimp Crackers – undeclared allergen (egg)
Details of all New Zealand recalls can be found here.
For regular news on US dietary supplement and food regulation, go to Regulatory Roundup.
IN THE PRESS
Australian ban on fish-shaped plastic soy sauce dispensers a world first. In South Australia, commencing 1st September, law on single-use plastic packaging will ban polyethylene containers known as shoyu-tai in Japan. Along with concern for the environment, plastic sushi fish are more damaging because they could be mistaken for food by marine life. Published in The Guardian

Cosmetics and TGA listed sunscreens

CHOICE report on sunscreens: TGA has published a follow-up statement here. ” the TGA is exploring alternative test methods that may be more reliable, including in vitro test methods.”
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Sunscreen recalls
* Ultra Violette Lean Screen SPF 50+ sunscreen: Grace & Fire is recalling all batches due to inconsistency in the SPF level of the product. Source: TGA
Updated (22 August) guidance to GMP for sunscreens published here.
Instructions for disinfectant testing – Guidance on testing of disinfectants and sterilants, revised August and published on TGA website here.
New specific guidance requirements now available. Includes updated SIR guidance including new forms, help guides and updated Inventory chemical records. Learn more here and here.
It’s time to submit your annual declaration for 2024–25. This page includes who must make an annual declaration for 2024–25 and how to submit an annual declaration.
September 2025 categorisation guidelines are out now. Includes chemicals added to the list of chemicals with high hazards for categorisation. Learn more and download the list here.
The latest inventory snapshot August 202 available for download here.
Completed evaluations: none listed
Variation of inventory listing after evaluation:
20-August: CAS No. 119344-86-4 , reasons listed