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Current Affairs

Issue 260, 1st July – 4th August 2025

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Training news

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Regulatory affairs news

Complementary Medicines and Medical Devices

New Ingredients permitted for use in listed complementary medicines.

  • This new guidance document helps sponsors of listed medicines comply with changes to the permissible ingredients determination.
  • TGA’s timetable for changes to permissible ingredients. Detailed timetable of TGA from proposal, consideration, notification, commencement and finalisation. Source: TGA

Probiotics in listed complementary medicines. An update to the TGA monograph provides an exemption from the requirement in the BP/EP for the label to “include the name of any stabilisers and other excipients”. Source: TGA

Listed medicines at risk of containing safrole. Listed medicines must contain no more than 0.1% of safrole when they are for internal use, and no more than 1% when they are for topical application. This page gives the results of the TGA review of 31 medicines.

Efficacy of medicines containing Vitamin D that use indications relating to bone The TGA will be conducting compliance reviews of listed medicines with indications related to bone, particularly those containing colecalciferol (Vitamin D) without calcium to evaluate their efficacy. Updated with results of TGA reviews. Source: TGA

Listed medicine compliance reports – updated in June 2025, with the results of compliance reviews of (a) medicines containing Valerian, Lysine hydrochloride; (b) medicines making claims about Diarrhoea relief, Exercise performance and Maternal postnatal health; (c) sunscreens with non-compliant claims about Waterproof properties and Coverage claims; and (d) medicines with non-permitted health claims about Depression and Anxiety. Source: TGA

Compliance and education for listed medicines updated 4th August. Includes examples. Source: TGA

Medical device post-market reviews. Lists devices currently being reviewed: plastic syringes, ventilators, CPAP and BiPAP devices, and devices containing mercury; plus details on completed reviews. Source: TGA.

Nitrosamine impurities – update to acceptable intakes based on recent EMA updated information. The changes include recently internationally determined acceptable intake limits for numerous nitrosamine impurities in medicines. Source: TGA

What evidence do you need to have a medical device included in the Australian Register – updated July 2025

Manufacturing or supplying tampons. Tampons do not have to be included In The Australian Register but they must comply with the applicable standard “AS 2869:2022 Tampons – Menstrual” which sets out requirements for the manufacture and labelling of tampons to help minimise health risks. Source: TGA

GMP preclearance backlog – progress update. GMP clearances have been extended for 2 years. This webpage contains a link showing how you can check the progress of your GMP clearance application.

Consultation: safety concerns about cannabis. The TGA is conducting a public consultation to gather information from stakeholders on their knowledge, experiences and observations of the use of unapproved medicinal cannabis products in Australia, particularly those containing higher levels of tetrahydrocannabinol (THC).. Consultation begins 11th August. Read more here.

Accessing unapproved medicinal cannabis – information for registered health providers available here.

Personal import scheme. An update to guidance for individuals wanting to import therapeutic goods not entered in the Australian Register of Therapeutic Goods. Source: TGA

Advertising claims for wound dressings. Permissions as of 19 July 2025, published here.

Nicotine vaping products

  • List of therapeutic vaping goods, for use in smoking cessation or the management of nicotine dependence, that can be legally supplied in Australia. List updated 24 July, read more here.
  • Prescribing and dispensing of prescription only therapeutic vaping goods to patients under 18 years of age – information for medical or nurse practitioners published here.

Poisons standard: updated form to use when applying to amend the poisons standard, Read about it and access the form here.

Women’s Health Products Working Group. The group is compromised of representatives from consumer groups, health professionals, industry, academia, and senior officials from the Department of Health, Disability and Ageing. 6 topics were discussed at the 9th meeting in March. Source: TGA

Market actions and compliance activity

Including product recalls, safety advisories, alerts and corrections.

Recalls

  • Homart Pharmaceuticals is recalling SpringLeaf Fat Clear due to (a) label is missing warning about phenylalanine and (b) specified maximum daily dose exceeds the permitted limit for poliglusam. Source: TGA
  • Well Herb is recalling Xinyi Biyan Pills due to unacceptable amounts of lead above the permitted daily dose. Source: TGA

Compliance activity

  • TGA has seized millions of counterfeit and illegal therapeutic goods as part of INTERPOL’s Operation Pangea XVII. Psychostimulants such as modafinil and armodafinil were the most common category seized nationally, followed by nicotine pouches and erectile dysfunction medicines. Also seized were semaglutide products, such as Ozempic pens and Rybelsus tablets; cosmetic injectables, such as Botox vials; Laroscorbine polynucleotides ampoules; and ivermectin tablets. Source: TGA

Safety alerts

  • Two unrelated cases of counterfeit injectable botulinum toxin products have been stopped at the Australian border. The counterfeit products were packaged to appear as genuine, branded, Botox products, manufactured by Allergan, an AbbVie company. The lesson is to be very cautious when purchasing products on the internet. Source: TGA

Public and stakeholder consultation: additional controls for some sunscreen ingredients. TGA is recommending additional safeguards for 2 ingredients and action on the degradant benzophenone. This may lead to some sunscreens being reformulated. Press release here and more information available here and the consultation document is here. Closing date for consultation is 12 August 2025.

Advertising health services and cosmetic injections – more details in “Cosmetics and TGA listed sunscreens” section below in this newsletter.

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 30 July published here.

TGA business plan for 2025 – 2026, updated 21 July, available here.

USA news

  • contributed by Neil O’Flaherty, partner at Amin Wasserman Gurnani, LLP.
    Increased FDA Scrutiny on Wellness Products. On July 14, 2025, U.S. FDA issued a Warning Letter to WHOOP, Inc. concerning its Blood Pressure Insights (BPI) feature, which the company had positioned as a non-regulated general wellness product. FDA asserted it was an uncleared medical device that required 510(k) clearance. This action could represent a significant shift in FDA’s enforcement priorities that could affect the wellness product industry that has grown accustomed to little regulatory oversight in this sector. Link to Warning Letter

Botanical Adulterants Prevention Programme (BAPP) and other adulteration stories. contributed by Michael D. Levin, Founder, Health Business Strategies, LLC, Clackamas, OR

  • Adulteration and mis-labelling of Echinacea angustifolia, E. pallida, and E. purpurea root and herb. Intentional adulteration can include use of desert broomrape (Cistanche deserticola) which is an endangered species. Published in Nutrition Insight.
  • Essential oil adulteration, and how it is different from contamination. Adulteration is intentional whereas contamination is usually accidental. This is a very comprehensive article. Read the full story 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

  • Australia’s vitamin B6 saga: Legal firm considering claims against more brands. The law firm behind a potential class action against Blackmores in relation to a product containing Vitamin B6 is also considering investigations into other brands. Published in Nutraingredients-Asia
  • Nearly 240 adverse event reports on B6 received in first half of 2025 – TGA. Australia’s Therapeutic Goods Administration (TGA) received 239 adverse event reports for complementary medicines containing vitamin B6 between January 1 and June 30 this year. Published in Nutraingredients-Asia

Foods

The Food Standards Code Compilation was updated in June. Information page here, and the 862 page compilation in PDF format is available here.

Food Standards Work Plan has been updated. Go here to see their timetable for processing applications. And go here to see the Work Plan notes.

Advertising of some foods in South Australia. The government of South Australia has just published a mandatory policy restricting advertising of unhealthy foods and drinks on its government owned public transport assets: buses, trams, and trains. Categories of foods include sugar-sweetened and artificially sweetened drinks, confectionery, savoury snacks, sweet snacks, desserts, yoghurts and ice creams, and “unhealthy meals packaged or sold in quick service restaurants” – burgers, pizzas, processed meats, savoury pasties and much more! Read the official policy statement here

Amendments to Food Standards Code: the following amendments have been published:

Approvals

  • FSANZ invites written submissions on the assessment of the application to seek approval for 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. Information here. Submit your application through the consultation hub. Consultation closes 10 September.

Call for submissions

  • FSANZ invites written submissions on the assessment of the application to seek approval for aminopeptidase to be used as a processing aid in bakery applications. The enzyme is derived from Trichoderma reesei, genetically modified to overexpress the aminopeptidase gene from Aspergillus clavatus. Administrative assessment report is here, and Executive summary is here.
  • FSANZ invites written submissions on the assessment of the application to permit Phospholipase C from genetically modified Bacillus lichenformis as a processing aid in degumming of fats and oils. Administrative assessment report is here, and Executive summary is here.

New applications and proposals

  • A1332 – Cross-linked polyester resins as an adsorbent processing aid in wine. Administrative assessment report is here, and Executive summary is here.
  • P1066 – Review of young child formula. The purpose of this proposal is to revise and clarify Code provisions as they apply to young child formula (1-3 years), including regulatory definitions, composition, labelling and representation of products. Administrative assessment report is here.
  • A1334 – 2′-FL from GM Corynebacterium glutamicum (gene donor: Corynebacterium urelyticum) in infant formula products. Administrative assessment report is here, and Executive summary is here.

Novel foods determinations – last updated in June. Latest addition: Birch fibre (extracted from the Betula (birch) tree, and processed to produce a powder comprising 49% cellulose, 31% hemicellulose, and 17% lignin). This was determined to be a non-traditional food, and not a novel food. Read novel food determinations here.

Recalls

  • Innovative Nutrition Solutions – Snack Switch Plant Protein Bars – 6 different flavour varieties – due to the presence of an undeclared allergen (milk). Source: NSW Food Authority
  • Urban Eats Japanese Style Vegetable Gyoza – due to the presence of foreign matter (glass). Source: NSW Food Authority
  • Samyang – Oh Gamja and Oh Gamja BBQ – presence of an undeclared allergen(s) (Wheat, Soy, Peanut Milk, Crustacean and Mollusc) Source: FSANZ
  • Picnic Point Farm- Picnic Point Farm Orchard Fresh Raspberry Jam – presence of foreign matter (metal). Source: FSANZ
  • Gilbert Street Kitchens – The St Food Co Pesto Chicken Pasta – Incorrect USE BY DATE Source: FSANZ
  • Chetak Melbourne – Deep Sprouted Moong and Deep Sprouted Mat – Potential microbial (Salmonella) contamination. Source: FSANZ

Additional food news contributed by Gary Kennedy, Correct Food Systems

  • Updated PFAS Values Strengthen Drinking Water Guidelines. The National Health and Medical Research Council (NHMRC) has released updated health-based guideline values for per- and polyfluoroalkyl substances (PFAS) in the Australian Drinking Water Guidelines. The update reflects the latest scientific evidence and includes revised values for four key PFAS chemicals: PFOS: 8 ng/L ; PFOA: 200 ng/L; PFHxS: 30 ng/L; PFBS: 1000 ng/L.

New Zealand Food safety insights, emerging risks, and current issues bulletins:
These bulletins contain news from all over the world. Latest issues: 7th July and 17th July

New Zealand food recalls:

  • Innovative Nutrition Solutions New Zealand – specific batches of Snack Switch brand Plant Protein Bars (various flavours) – presence of an undeclared allergen (milk). NZ MPI
  • Nutrient Rescue NZ – specific batches of its Nutrient Rescue brand Double Shot – possible presence of an undeclared allergen (mollusc). NZ MPI
  • Woolworths New Zealand – Woolworths brand 18% Fat Beef Mince – may contain foreign matter (soft blue plastic). NZ MPI
  • NZ Drinks – specific batches of Hydr8 brand Spring Water 600ml x 24 – the product may contain foreign matter (blue plastic). NZ MPI

USA food news contributed by Rend Al-Mondhiry, partner at Amin Wasserman Gurnani, LLP.

  • HHS, FDA, and USDA Seek to Define “Ultra-Processed Food”. The agencies issued a joint Request for Information (RFI) on July 23, 2025, to gather data to help develop a national definition for ultra-processed foods. The agency estimates that approximately 70% of packaged foods in the U.S. may be considered “ultra-processed,” with children consuming the majority of their calories from such foods. Read more: FDA release notes.
  • On July 14, 2025, FDA granted a petition from the Gardenia Blue Interest Group allowing the use of gardenia (genipin) blue – a naturally sourced colour – in certain foods, including sports drinks, flavoured or enhanced non-carbonated water, fruit drinks and ades, ready-to-drink teas, hard candy, and soft candy. On the same day, FDA issued a statement encouraging companies to expedite their phase out of FD&C Red No. 3. Although the agency’s January 2025 final order revoking the authorization for Red No. 3 gives companies until January 15, 2027 to remove the ingredient from foods and dietary supplements, FDA is now encouraging companies to remove it “as soon as is practicably possible.” See more at Regulatory Roundup.

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

IN THE PRESS

Australia approves MFGM for use in infant nutrition for the first time. The Food Standards Australia New Zealand (FSANZ) has approved the use of milk fat globule membrane (MFGM) as a nutritive substance in infant formula products in Australia for the first time. Published in NutraIngredients Asia.

Cosmetics and TGA listed sunscreens

“Reef safe” sunscreens – the position paper prepared for the Australian Society of Cosmetic Chemists has been updated and published. The paper was prepared by sunscreen expert John Staton. It discusses the major concern relating to the potential for damage to corals, especially on the Great Barrier Reef, and looks at action being taken on some ingredients by other governments. Ecotoxicity and biodegradability tests are listed along with the relevance of water resistance, with water resistance sunscreens formulated to pass Australian test conditions less likely to be an issue. Read the full article here.

Reef safe action in the Federal Court of Australia. Australian Competition and Consumer Commission (ACCC) – Applicant, and Edgewell Personal Care Australia Pty Ltd and another – Respondents. The respondents made representations in the course of supplying and promoting Hawaiian Tropic and Banana Boat branded sunscreen products in Australia that the Products were “reef friendly”. The ACCC alleges that those representations were false, misleading or deceptive because the Products contained ingredients which harm, or risk causing harm, to reefs. The ACCC further alleges that Edgewell had no reasonable basis for making the “reef friendly” representations, and/or the representations were not appropriately supported by scientific evidence or testing at the time they were made. Read the details of filing here.

Consultation: proposed amendments to the Poisons Standard in relation to two sunscreen ingredients – homosalate and oxybenzone – and one impurity/degradant – benzophenone. Public notice is here and make submission through the consultation hub. Consultation closes 12 August 2025.

Sunscreen exposure model – updated 1st August – Exposure to UVR is a significant risk factor and is known to cause skin cancer in humans. The Australian Sunscreen Exposure Model performs sunscreen exposure calculations that reflect the unique conditions and practices in Australia. Source: TGA

Understand the regulation of therapeutic sunscreen – an update to a guidance document. (“Therapeutic sunscreens” are often referred to as “primary sunscreens”). Published on TGA website.

Changes to simplify compliance with specific information requirements (SIRs) for listed introductions – updates now published. Includes improved Inventory chemical records and new online forms and guidance. Source: AICIS

There are no changes to AICIS fees and levies for 2025–26 (good news!). Existing registration levies and introduction value thresholds for each registration level continue unchanged for the 2025–26 registration year starting 1 September 2025. Read more in Cost Recovery Implementation Statement.

AICIS registration is now open for 2025 – 2026. You must register with AICIS before you import or manufacture industrial chemicals in Australia. This applies to businesses, sole traders or individuals manufacturing or importing industrial chemicals (or products containing industrial chemicals) for commercial purposes. Includes cosmetics. Read more here.

Advertising health services and cosmetic injections. Updated July 2025. TGA has published answers to frequently asked questions about advertising cosmetic injection services and our guidelines. Divided into the following topics:

  • General questions about referring to cosmetic injectables in advertising
  • FAQs about advertising specific products and treatments
  • Questions about specific types of advertising
  • Questions about compliance and enforcement

IMPORTANT READING for everyone in the cosmetics profession/industry. Published here.

Completed evaluations: none mentioned this month.

Variation of inventory listing: more details on specific information requirements – download the full list here.

List of new chemical assessment statements – as of 16 July: two assessment statements, here and here.

Chemicals added to the Inventory 5 years after issue of assessment certificate (obligations to provide information apply) as of 28 July – 4 chemicals added: CAS 1141331-70-5, CAS 637-92-3, CAS 162201-45-8, and CAS 254748-33-9. Source: AICIS

Chemicals added to the inventory following issue of assessment certificate as at 10 July: 2 chemicals: CAS 2411191-47-2 and CAS 1441045-54-0. Source: AICIS

Comment from the editor: I am often amused at the lengthy names given to some chemicals such as the ones above where just the CAS number is used. So I was wondering if there are any place names that are this complicated, and I found this one: Taumatawhakatangihangakoauauotamateapokaiwhenuakitanatahu. It is a place in New Zealand, and it means “The summit where Tamatea, the man with the big knees, the climber of mountains, the land-swallower who travelled about, played his nose flute to his loved one.”

Recalls – none related to cosmetics this month, read full list of other recalls here: https://www.productsafety.gov.au/recalls

IN THE PRESS

Princeton Consumer Research lab tested eight sunscreens that failed SPF claims. This article states “that in response to the findings (by CHOICE), the brands said they had their own original testing showing their SPF was compliant. The ABC can reveal that at least eight of those tests were performed by Princeton Consumer Research, which returned significantly higher SPF results than the Choice testing. A number of senior industry experts have raised concerns about PCR’s testing methodology and calculations. Mathias Rohr, one of the world’s top sunscreen testing experts, said he had never seen results like PCR’s in his entire career, while another senior sunscreen scientist told the ABC the results warranted investigation”. Published in ABC news

Cosmetics in Europe contributed by Steven Hanft, Conusbat

Cosmetics Consultants Europe’s (CCE) continuation for Cosmetic Product Safety Assessment Online Training
Module 2, ‘Toxicology ‘, Begins: Tues., 7. Oct. 2025 | 12EST 17GMT 18-19.30CET

  • Fee: €1.400-/Module (purchase all 6 modules, get 1 Free!)
  • Membership discounts offered: RTD-Australia, IBA, SCC-USA, SCS-UK, CCE, Cosmetics Europe
  • University degree in Biology, Chemistry preferential
  • Register here or enquires to Steven Hanft on this email.

NOTE: Subscribers to this newsletter receive a discount

Cosmetics Consultants Europe is an association of consultants working in cosmetics-/cosmetic ingredients, personal care & borderline industries. The majority of CCE’s members reside in the EU / UK, but also Belarus, China, Israel, Serbia, Switzerland, Ukraine & USA.

ACCC and other news

ACCC press release “Banana Boat and Hawaiian Tropic owner in Court over alleged greenwashing claims that its sunscreens were reef friendly”. Read the press release here.

Unsafe products in online marketplaces will be a major focus of the ACCC’s product safety priorities during 2025-26. Source: ACCC

The ACCC will not oppose Lactalis BSA S.A.S. (Lactalis)’s proposed acquisition of Fonterra Co-Operative Group (Fonterra)’s consumer, dairy ingredients and food service businesses. Lactalis and Fonterra both currently acquire raw milk from dairy farmers in Victoria and Tasmania, as well as processing and supplying a range of dairy products across Australia. Source: ACCC

“Ghost stores” – The ACCC is warning consumers about the operators of four websites allegedly misrepresenting themselves as local businesses, also known as ‘ghost stores’. It is alleged these four ghost store operators are harming consumers by making false representations that they are local Australian businesses, imminently closing down, and selling high-quality clothing and footwear products, when they are instead based overseas, not imminently closing down, and are drop-shipping low-quality products. In particular, everly-melbourne.com, willowandgrace-adelaide.com, sophie-claire.com and doublebayboutique.com. These businesses are not based in Melbourne, Adelaide or Double Bay, nor are they imminently closing down. Source: ACCC

Other news contributed by Gary Kennedy, Correct Food Systems

  • Grants Available: Energy Upgrades. Businesses across South Australia, New South Wales and Victoria have fresh opportunities to access government funding for energy upgrades and decarbonisation projects. South Australia: A new round of the Powering Business Grants is opening later this month, offering matched funding of up to $75,000 for small and medium businesses. New South Wales: The Heat Pump Feasibility Grant is now open, providing up to $30,000 (covering 75% of project costs) to help businesses assess whether heat pumps could replace existing fossil fuel heating systems. Victoria: A new $10 million round of the Energy Innovation Fund will open in September 2025, focused entirely on electrification in food and beverage manufacturing.
  • Australian Pet Brands to upgrade Dubbo facility after chemical leak. They will spend more than $1.3 million upgrading safety systems at its facility in central west New South Wales after a chemical spill in 2023 and contribute $75,000 to a local environmental education centre. Source: ABC News.
  • Final Transition Period Ends for REDcycle Logo Removal As of 1 July 2025, the final transition period for removing REDcycle and “Return to Store” logos from soft plastic packaging has concluded. Brands still displaying these outdated labels risk breaching Australian Consumer Law by potentially misleading consumers about recycling options. Brands facing challenges in updating their packaging are encouraged to contact APCO to develop a transition plan. However, it’s important to note that having a plan may not fully protect against potential ACCC enforcement actions. Read more at APCO.

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