current affairs
Issue 270, 1st June – 30th June 2026
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CONTENTS
Training news
Complementary medicines and medical devices
Foods
Cosmetics and sunscreens
ACCC and other 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.
Courses updated recently:
TGA evidence requirements for claims – new examples, this is an important course for all sponsors of complementary medicines, available in both “live” and pre-recorded formats. Read about it and and book here
Coming soon: a new course on pet supplements..
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
Ingredients permitted in listed medicines.
Two new ingredients:
* oxaceprol and
* Lactococcus lactis subsp. lactis;
and three ingredients have had their conditions changed:
* Xanthium sibiricum
* Xanthium strumarium and
* threanine.
Consultation: Permissible indications for listed complementary medicines. This is the list of indications (“claims”) that can be made for listed complementary medicines. Thecurrent list is here. Consultation closes 12th August. Issues include:
* Omission of the word mild from an indication referring to eczema.
* Inconsistent/incorrect requirements for indications relating to the thyroid.
* Lack of flexibility to use alternative label statements for an indication including the term antipyretic.
* Missing label statement requirement for an indication referring to neural tube defects.
* Missing label statement requirement for an indication referring to inducing sleep.
* Inconsistent/incorrect requirements for indications relating to the thyroid.
* Lack of flexibility to use alternative label statements for an indication including the term antipyretic.
* Missing label statement requirement for an indication referring to neural tube defects.
* Missing label statement requirement for an indication referring to inducing sleep.
New compositional guidelines:
* Akkermansia muciniphila strain ATCC BAA-835 permitted for use in listed medicines – published here.
* Lactococcus lactis subsp. lactis strain ATCC 19435 permitted for use in listed medicines – published here.
Consultation: increasing transparency of GMP inspection outcomes. TGA is seeking views on
* how GMP certificates and inspection outcomes should be displayed and accessed
* how to ensure published information is clear, accurate and does not disclose confidential information
* any potential benefits or impacts of publishing this information.
Consultation closes 13th July. Read more and submit your views at the consultation hub.
Advertising health services that involve therapeutic goods – how to avoid prohibited advertising. Updated 18th June.
Advertising therapeutic goods in specific circumstances, such as social media, and for specific types of products, like weight loss injections. Updated 18th June, here.
Advertising: what can and cannot be advertised to the general public, updated 18th June, read it here
Poisons Standard
* interim decisions on proposed amendments arising from two meetings of the advisory committee can be accessed via this link. includes azelaic acid, and extracts and essential oils primarily composed of methyl salicylate.
* Final decisions in relation to Bacillus paralicheniformis, dimethyl disulfide, enflicoxib sodium, spidoxamat, published 2nd June here.
Pharmacovigilance
* Pharmacovigilance inspection program – includes annual inspection program metrics reports – published 2nd June here
* Details of January 2023 to December 2024 inspections, includes critical, major and minor deficiencies. Case studies included. Published 2nd June here.
TGA annual fees and charges:
* It’s a new financial year in Australia on 1st July. The new TGA fee and charges are summarised here – contains a link to either MSWord or PDF version.
Required Advisory Statements for non-prescription medicine labels (RASML) – updated 24th June, published here.
Medicines and medical devices that have been cancelled or suspended and no longer appear in the ARTG – no updates since 28 May.
TGA compliance principles and priority focus areas for 2026 and 2027. Summary is here and more details in PDF document you can download here
Listed medicine compliance reviews – guidance explaining the post-market surveillance of listed medicines and how the TGA undertakes compliance reviews updated 22nd June. Listed medicines are included in the Australian Register of Therapeutic Goods (ARTG) without undergoing a full pre-market evaluation by the TGA. Sponsors of listed medicines must certify that their medicines meet all the requirements. Reviews can be targeted or random
Listed Medicine Compliance Reports – June 2026 update published 30th June, updated with results of compliance reviews of 13 listed medicines:
* medicines reviewed to check whether they meet stability requirements
* medicines reviewed to check evidence to support health claims about exerciseperformance
* medicines with non-permitted health claims about nicotinamide adenine dinucleotide (NAD, NAD+, NADH) or nicotinamide mononucleotide (NMN); fertility, preconception health and use by postpartum and breastfeeding women; and arthritis, osteoarthritis, irritable bowel syndrome, stomach ulcers, balancing cholesterol levels, autoimmune skin conditions, psoriasis, eczema, and rosacea.
Following the reviews, 8 of these medicines have been cancelled from the Australian Register of Therapeutic Goods (ARTG) and are no longer permitted to be supplied.
Read more here
Compliance activity – Compliance enforcement
* 5 infringement notices totalling $19,800 issued to a health practitioner and an individual for the alleged unlawful importation of unapproved cosmetic injectables – pre-filled syringes containing hyaluronic acid, poly-L-lactic acid and lidocaine. The individual also allegedly imported unapproved prescription-only tranexamic acid without an exemption. Read more here.
* Three Victorians arrested following seizure of over $2 million worth of steroids and peptides. Source: TGA
* Infringement notices: a list of infringement notices issued in response to breaches, updated 17th June published on this webpage
Guidelines for psychiatrist prescribers and Human Research Ethics Committees (HRECs) on accessing MDMA (3,4-methylenedioxy-methamphetamine) and psilocybine – updated 22nd June, and published here. A checklist for prescribing psychiatrists is here
Medicinal cannabis
* What to know if you’ve been prescribed medicinal cannabis – new guideline published 2nd June here.
* Do your patients know the risks of unapproved medicinal cannabis products? New guideline 2nd June here.
Recalls
* Sanofi-Aventis is recalling Nature’s Own Glucosamine Sulfate with Chondroitin and Nature’s Own Magnesium Glycinate 1150 mg due to potential presence of a glass fragment within the bottle (not within the tablets). Source: TGA
Safety alert:
* Sexual enhancement products that claim to be “dietary supplements” or “natural formulas” – TGA testing has revealed that many unapproved products that can be bought online contain undeclared prescription-only substances sildenafil, tadalafil and dapoxetine. More details including the results of testing on 11 products available here.
* Concerns regarding the public health risks associated with unapproved peptide products. The TGA, along with hospitalisation data from states and territories, have identified serious adverse effects including liver damage, severe allergic reactions requiring hospitalisation, and inflammation and other health complications requiring medical attention. More details here.
* TGA has expanded its priority focus areas to include unapproved peptide products published 19th June here.
Vaping: Notified vape list, goods for smoking cessation or nicotine dependence that can legally be supplied, updated 11th June here.
* Permission for restricted representations – Medical Devices for Chronic Respiratory Diseases – 4 permissions, detailed here.
* Permission for restricted representations – Rapid Antigen Test and Nucleic Acid Amplification Test Kits – 2 permissions published here.
Medical devices – guidelines updated:
* Learn about the Australian Unique Device Identification (UDI) system – guidelines updated 2nd June – published here
* The Australian UDI Sponsor Link Template allows sponsors to add sponsor information to UDI records in the Australian Unique Device Identification Database (AusUDID) 23rd June update here – and Learn how to add sponsor information to UDI records using the Australian UDI Sponsor Link Template – updated 23rd June here
* The Australian UDI Data Dictionary includes a list of the fields in the database, including element names, descriptions, permitted values and other metadata, version 1.4 can be accessed here.
* Submitting UDI records using HL7 SPL – resources and technical documents for Machine to Machine (M2M) HL7 SPL users. Source: TGA
Advisory committee on medical devices – 89th meeting on 19 Feb – information here, and 90th meeting on 16 April, information here.
Current status of surgical mesh products – There are more stringent criteria for Class III medical devices than Class IIb medical devices. Updated list of devices is here.
Plastic syringes: an update on the post-market reviews the TGA is undertaking. This page contains the current status of the (numerous) devices included in the review.
Additional medical device news can be viewed in the June 2026 edition of TGA Medical Device Resources published on LinkedIn by Gary Burgess, Hill Valley Regulatory Consulting
USA
* USA medical device news supplied by Neil O’Flaherty, Amin Wasserman Gurnani.
On June 5, 2026, the U.S. Food and Drug Administration issued an updated guidance document entitled “Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements.” The updated guidance document adds five new product codes to the list of unclassified devices FDA intends to exempt from premarket notification (510(k)) requirements. The five product codes included in the update to the guidance are: LDK-Device, sensing, optical contour; MVV-Device, acupressure; MQZ-Prosthesis, nail; MIG-Strip, test isoniazid; and LXQ-Cup, eye. The total is now to 13 product codes across seven medical specialty panels. Guidance document is here.
Botanical Adulterants Prevention Programme (BAPP) and similar articles
* Bilberry (Vaccinium myrtillus) Extracts: The goal of this bulletin is to provide information and/or updates on issues of adulteration of bilberry extract. Published on Herbalgram here.
* Echinacea (Echinacea purpurea, Echinacea angustifolia, and Echinacea pallida) Laboratory Guidance Document on adulteration. Published on Herbalgram.
* HPTLC: The New Front Line of Global Botanical Surveillance – paper presented at 2026 International Conference on the Science of Botanicals
USP-NF
For regular news on US dietary supplement and food regulation, go to AWG Regulatory Roundup.
IN THE PRESS
* Warning issued over counterfeit weight-loss drugs labelled as retatrutide. Senior doctors are warning people against taking drugs being labelled as experimental weight loss medication retatrutide, after discovering multiple cases of liver damage and other serious illness. The injectable medication has not been approved by any worldwide drug regulator, including the US FDA and the TGA. Published on ABC.net.au
* Abnormal moles seen developing in patients chasing perfect suntan by using peptide melanotan-II. Skin specialists are sounding the alarm over potential cancer risks associated with unregulated peptides at the heart of a social media-driven beauty craze. Published on abc.net.au
* TGA still investigating 15 out of 16 sunscreens that Choice testing found failed to meet SPF claims. Senator Pocock told the ABC the process had left Australians in the dark about what sunscreens they should purchase. “I certainly find it confusing, I am really not that sure what to buy next time I go to buy sunscreen and that is not the situation we want Australians to be in, in one of the countries that has some of the highest skin cancer rates in the world,” he said. Published here on abc.net.au
* The “black triangle” scheme: Most Australians unaware of ‘black triangle’ medicine side effects reporting scheme: Similar to schemes on other countries, the scheme encourages people to report side effects. But is it working? Article published on abc.net.au.
* Health warning issued after powerful sedative etomidate was found in illegal vapes in Victoria, published here.
Foods
FSANZ Board held a meeting on 2nd and 3rd June, 29 April, the communique was published on 16th June and details can be found here. Three matters were notified to the Food Ministers’ Meeting.
New applications and proposals
* A1358 – Glucoamylase from Trichoderma reesei (gene donor: Aspergillus fumigatus) for use as a processing aid in the conversion of starchy substrates to fermentable carbohydrate. Source: FSANZ
* A1356 – Food derived from increased nicotianamine wheat lines containing event UM-12115T-1 Source: FSANZ
* A1353 – Plant sterols as a novel food in yoghurt, cheese and processed cheese. Source: FSANZ
* A1341 – Cell-cultured duck (Anas platyrhynchos domesticus) biomass – to make products such as foie gras and pâté – Closes 22nd July, more information here.
Eight amendments to the food code published here, arising from
A1334 – 2′-FL from GM Corynebacterium glutamicum (gene donor: Corynebacterium urealyticum) in infant formula products
P1056 – Caffeine Review
P1056 – Caffeine Review
Public consultations and calls for submissions/comments
Novel foods determinations – no updates since April
Australia has helped shape new international food labelling guidance that will support food trade during emergencies and promote a consistent approach to providing precautionary allergen information to consumers, following a session of the Codex Committee on Food Labelling held in Canada. Source: Department of Agriculture, Fisheries and Forestry
Recalls
* ASO United – Cooked Scampi Shrimp Head-On Shell-On – due to chemical contamination with a prohibited substance nitrofurazone Source: FSANZ
* Kaisi Melbourne – Wu Xian Zhai Soybean Snacks – Five Spice Flavour, Sauce Flavour and Spicy Flavour – undeclared allergen (Egg). Source: FSANZ
* 5 People Report ‘Violently Throwing Up’ and Other Norovirus Symptoms After Dining at Buffet Restaurant in New Zealand .. Source: www.stuff.co.nz
Stay up to date with Food News by subscribing to The Correct News, published by Correct Food Systems.
New Zealand Food safety insights, emerging risks, and current issues bulletins: 23rd June issue can be viewed here. (As always, some interesting news from other countries)
New Zealand food recalls
* Pak’n Save Rangiora made-in-store Death by Chicken (burger) and Chicken Katsu Garden Salad – the chicken may be undercooked. Source: NZ Ministry for Primary Industries
* Pak’n Save Deli made Sweet and Sour Chicken, Butter Chicken and Butter Chicken Panini meals – may contain foreign matter (glass) Source: New Zealand Ministry for Primary Industries
* New World Kitchen brand deli meals – may contain foreign matter (glass) Source: New Zealand Ministry for Primary Industries
* Foodstuffs Own Brands – Pams brand Simmer Sauces – may cause injury due to a packaging fault (damaged glass jar). Source: New Zealand Ministry for Primary Industries
* The Warehouse – Market Kitchen brand Sauce Range – may cause injury due to a packaging fault (damaged glass jar) Source: New Zealand Ministry for Primary Industries
* Culley’s Kitchen brand Classic Egg Mayonnaise and Zesty Aioli – may cause injury due to a packaging fault (damaged glass jar) Source: New Zealand Ministry for Primary Industries
* NZ Muscle and No Brand Creatine – possible presence of an undeclared allergen (milk) Source: New Zealand Ministry for Primary Industries
IN THE PRESS
* Doctors say more packaged foods should have health star ratings. Shoppers said they supported the idea of making the rating compulsory as it would increase consumers’ confidence in the system. Published on abc.net.au
* New seafood country-of-origin labelling in Australian hospitality venues. From 1st July, hospitality venues are required to label where their seafood is from. Industry groups say it will stop venues substituting imported fish or entirely different species for Australian product. Menus and boards at food outlets will need to include a letter next to each seafood item indicating whether it is from Australia (A), imported (I) or mixed (M). Published on abc.net.au
Cosmetics and sunscreens
No recent regulatory news on sunscreen regulation but expect to see some news soon.
From AICIS website: “Call for information on 9 chemicals we are evaluating: can you help? We’re seeking targeted Australian-based information on 9 chemicals. Your voluntary information will support our evaluations. This information request is under section 75 of the Industrial Chemicals Act 2019.!” – see the chemicals they are asking about here.
AICIS Rolling Action Plan – chemicals evaluation list.
The plan includes:
* subject of the evaluation – typically the chemical name (or chemical group name)
* the reason for each evaluation
* period within which the evaluation will be conducted
* the focus of the evaluation – chemical identity, and human health or the environment (or both)
* amendments to the list of our initiated evaluations.
* the reason for each evaluation
* period within which the evaluation will be conducted
* the focus of the evaluation – chemical identity, and human health or the environment (or both)
* amendments to the list of our initiated evaluations.
New guide: creating a chemical dossier. Use this guide if you are an applicant, agent or chemical data provider involved in an AICIS assessment certificate application. Source: AICIS
Recalls
Scented candles shaped like flowers in various styles – do not comply with the permanent ban on combustible candle holders. The affected candles contain wicks and dried flowers that present a fire risk. Source: ACCC Product safety
The Australian Inventory of Industrial Chemicals (relevant to cosmetics, but not to medicines or foods) is a searchable database of around 40,000 chemicals that are being manufactured or imported (introduced) into Australia for industrial use – the latest snapshot of the inventory as of 2nd June is here
Completed evaluations as of 26th June.
11 chemicals evaluated, see the list and evaluation outcomes here.
Commercial evaluation authorisations – as at 17th June: 4 chemicals listed here. Commercial evaluation authorisations allow a business to import or manufacture a chemical for commercial evaluation purposes
Variation of Inventory listing following revocation of CBI approval – none this month
Chemical added to the Inventory following issue of assessment certificate – as at 5th June: one chemical: CAS 2131091-72-8, Tetrapleura tetraptera, ext.. Source: AICIS
Chemicals added to the Inventory 5 years after issue of assessment certificate (obligations to provide information apply): as at 9th June:
* CAS 3126995-98-7
* 2742689-93-4
Source: AICIS
Retinal in Australia: Understanding the New Regulatory Landscape.
Retinal (retinaldehyde) has become one of the most sought after ingredients in modern skincare due to its ability to improve the appearance of fine lines, uneven skin tone and photoaged skin. As a Vitamin A derivative, retinal requires only one conversion within the skin to become retinoic acid, making it more potent than retinol while generally remaining well tolerated.
However, recent changes by the Australian Industrial Chemicals Introduction Scheme (AICIS) have significantly altered how retinal can be imported and supplied in Australia. Following its completed evaluation on 26 June 2026, AICIS confirmed that retinal can no longer be introduced under the Exempted or Reported introduction categories. This applies to both cosmetic raw materials and formulated cosmetic products containing retinal.
Importantly, this is not a ban on retinal. Existing stock already in Australia can continue to be sold and used. However, businesses wishing to import new retinal products must now follow a higher level regulatory assessment pathway.
For cosmetic brands, formulators, manufacturers and importers, these changes highlight the importance of considering regulatory compliance alongside formulation and product development. Staying informed of evolving cosmetic regulations is essential to avoid supply disruptions, reformulation costs and import delays.
However, recent changes by the Australian Industrial Chemicals Introduction Scheme (AICIS) have significantly altered how retinal can be imported and supplied in Australia. Following its completed evaluation on 26 June 2026, AICIS confirmed that retinal can no longer be introduced under the Exempted or Reported introduction categories. This applies to both cosmetic raw materials and formulated cosmetic products containing retinal.
Importantly, this is not a ban on retinal. Existing stock already in Australia can continue to be sold and used. However, businesses wishing to import new retinal products must now follow a higher level regulatory assessment pathway.
For cosmetic brands, formulators, manufacturers and importers, these changes highlight the importance of considering regulatory compliance alongside formulation and product development. Staying informed of evolving cosmetic regulations is essential to avoid supply disruptions, reformulation costs and import delays.
The Scientific Committee on Consumer Safety (SCCS) has recently published its opinion on the safety of use of Butylated Hydroxyanisole (BHA). CSAS considers:
* BHA is safe to use up to a concentration of 0.07% in leave-on or leave-on cosmetic products
* this opinion only takes into account dermal use and therefore applies to the use of BHA in dermal application products, and not in oral care products or cosmetic products that may result in inhalation of the end-user’s lungs
* however, this opinion does not cover the environmental safety of BHA.
* BHA is safe to use up to a concentration of 0.07% in leave-on or leave-on cosmetic products
* this opinion only takes into account dermal use and therefore applies to the use of BHA in dermal application products, and not in oral care products or cosmetic products that may result in inhalation of the end-user’s lungs
* however, this opinion does not cover the environmental safety of BHA.
Read more on LinkedIn post
IN THE PRESS
* Parkinson’s disease experts warn watchdog as deadline looms on paraquat decision. Dozens of the country’s top movement disorder specialists say the Australian Pesticides and Veterinary Medicines Authority (APVMA) has failed to engage with them during its review. Published on abc.net.au
ACCC and other news
ACCC
* Hismile, an Australian oral and personal care company, has paid $138,600 in penalties.
Hismile posted videos on its social media platforms, where apparently random shoppers in a public setting tried Hismile’s products and expressed their satisfaction with the results.
* HSK United Pty Ltd, which operates the websites Pain Free Aussies and Modern Aussies, (“Instant Smooth Hair Eraser Pain Free” ) has paid $79,200 in penalties after the ACCC issued it with four infringement notices for advertising products on both its websites with strikethrough pricing, where a higher price is crossed out and replaced with a lower price. However, the ACCC’s investigation found that certain products on the websites had not been sold at the higher ‘strikethrough’ price since at least 1 January 2025. Source: ACCC
* Miyagi and its CEO in court over alleged unfair contract terms and misrepresentations in health program sales. Miyagi made false and misleading representations about the rights of consumers to cancel and obtain a refund for its health and wellness programs, and about its staff members’ professional affiliations. Miyagi provided programs to thousands of consumers experiencing health conditions including diabetes, heart disease, sleep apnoea and menopause. Consumers were charged total costs of between about $1800 and $7500 for six to 18-month programs, which had to be paid in full either up front or through a payment plan. …. statements represented that Miyagi sales representatives were health or medical professionals and therefore had an approval from, or affiliation with, a professional health or medical institute or organisation. Miyagi’s sales staff did not possess any formal health or medical qualifications. Source: ACCC
* Doreen Egg has paid $39,600 in penalties after the ACCC issued two infringement notices for alleged false or misleading claims that its eggs were free-range. Source: ACCC
* “Greenwashing” – The ACCC has commenced proceeding against Grill’d – an Australian hamburger chain – for “allegedly making false or misleading representations to customers about the circumstances in which it would make donations to an environmental cause,” Grill’d said it would donate $1 from every burger sold on a Tuesday towards the planting of trees. Over 5 million burgers were purchased on a Tuesday but only 17 percent qualified for a donation. Source: ACCC
* Also the subject of an article in The Guardian. Grill’d burger chain sued by ACCC over alleged greenwashing.
* Superannuation greenwashing is rife: Will a new labelling system make it worse? Published by consumer group CHOICE.
Published by Regulatory Training Direct www.regulatorytrainingdirect.com
Providing regulatory training courses for complementary medicines, medical devices, GMP, foods, cosmetics, dietary supplements.
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