Current Affairs
Issue 259, 6th June – 1st July 2025
Training news
Listed medicine labels – the TGA has recently targeted compliance of medicine labels, especially relating to mandatory label warnings. Read the full TGA compliance reports here https://www.tga.gov.au/resources/listed-medicine-compliance-reports. To enhance your knowledge and compliance of your listed medicine labels, book our course here.
Our old friend and very experienced GMP expert Quentin Blades is back on board. In particular our course Specifications has been updated and now comes with finished product templates for several common dosage forms. Read about it and book here.
View the agenda for all 40 courses and book online here.
Regulatory affairs news
Complementary Medicines and Medical Devices
New Ingredients permitted for use in listed complementary medicines.
* Citicoline – Cognizin® promoted for focus, attention, mental energy and memory.
* Methoxypropylamino cyclohexenylidene ethoxyethylcyanoacetate – an organic compound used in sunscreens.
In addition, another 23 already permitted ingredients have legislated changes (many of these are Prunus species). Source: TGA
If you are interested in submitting a new ingredient to be included in listed complementary medicines, book our course New substance applications – agenda is here.
Medical devices exempt from ban on PFAS chemicals. From 1 July 2025, restrictions under the Industrial Chemicals Environmental Management Standard (IChEMS) will prohibit the import, manufacture and use of three PFAS chemicals in Australia (more details below). However, IChEMS does not apply to chemicals used for therapeutic purposes. This means medical devices, including components in the device, primary packaging, instructions for use, and spare parts, will not be affected by the ban. Source: TGA
TGA presentation: Launch of the Australian UDI regulatory framework and Australian UDI Database. Slides of the presentation are available here.
New regulations to strengthen medical device patient safety. Include:
* Mandatory reporting of medical device-related injuries or suspected injuries will begin on 21 March 2026 for all public, private and day hospitals
* Unique Device Identification System – Manufacturers supplying medical devices in Australia must use barcodes to identify their products on all packaging and labelling
* Improved and clearer national recall processes
Source: TGA
Webinar: GMP clearance backlog: slides are available here.
Nicotine vaping products
* New standards start 1st July 2025. These include stricter requirements for ingredients, packaging, and labelling. Vapes are not recommended as the first-line treatment for smoking cessation support. First-line treatments include behavioural support and TGA-approved nicotine replacement therapy. Source: TGA
TGA statement on illegal vape sales – this press release discusses inaccurate information released on the number of vapes sold every month on the black market. Source: TGA
Poisons standard:
Comments are invited on the proposal to alter the poisons status of pyridoxine, pyridoxal and pyridoxamine (vitamin B6). The proposal is that oral preparations containing 50 mg or less of pyridoxine, pyridoxal or pyridoxamine per recommended daily dose will still be available in listed complementary medicines, but preparations containing more than 50 mg but less than 200 mg per daily dose will become available through a pharmacy only. The concern is the possibility of peripheral neuropathy. (Editor’s note: a close relation of mine recently suffered peripheral neuropathy after a medical doctor advised him to take 250 mg of pyridoxine per day as well as a B complex). More information here and make a submission here (closing date 27th July)
Recalls (now included under the heading “Market actions”), Compliance actions and Safety advisories
* TGA has accepted a court-enforceable undertaking from The Aussie Gelatin Company in relation to the alleged unlawful manufacture, supply and advertising of its product, Nutraviva Bone and Joint Formula. The product was not entered in the Australian Register of Therapeutic Goods (ARTG) and contained a prescription-only strength of Vitamin D3. The undertaking is enforceable for a period of 3 years and requires Aussie Gelatin to conduct a recall of the unregistered therapeutic goods and cease the manufacture, supply and advertisement of any Bone and Joint Formula, or derivatives, in contravention of the Act. Source: TGA
* Nourishmeorganics has been issued with an infringement notice of $18,780 for the alleged unlawful supply of a therapeutic good not entered in the Australian Register of Therapeutic Goods, Nourishmeorganics has paid the infringement notice for importing Thorne Basic Prenatal capsules from New Zealand and supplying them to customers in Australian. Source: TGA
* The TGA has commenced proceedings in the Federal Court of Australia against AG Therapeutics (trading as Atlus) and its sole director (Dr Shimal Jobanputra), Mamamia.com.au (Mamamia), News Life Media and Straight Up PR for advertising medicinal cannabis in alleged contravention of the Therapeutic Goods Act. Source: TGA
* Stryker is conducting an Urgent Recall of certain serial numbers of the HeartSine Defibrillators. A manufacturing problem related to a circuit board component may impair the device’s ability to function or cause failure. Source: TGA
* Pentavite is recalling two batches of Pentavite Multivitamin + Iron Kids Chewablesbecause the product is missing required warning statements on the label, relating to the presence of sulphites and sugars. Source: TGA
* TGA has issued a safety advisory about Nhan Sam Tuyet Lien Truy Phong Hoan capsules as testing revealed they contain undeclared substances meloxicam, coumarin and eugenol which can cause serious side effects. Source: TGA
USA news
* contributed by Neil O’Flaherty, partner at Amin Wasserman Gurnani, LLP. .
On June 17, 2025, US FDA announced its Commissioner’s National Priority Voucher (CNPV) program whereby certain drug companies could participate in an Agency program that is intended to shorten drug review times from approximately 10-12 months to 1-2 months after a company’s final drug application submission. The program would be available to certain drug companies and their products which are aligned with U.S. national health priorities of:
* Addressing a health crisis in the US;
* Delivering more innovative cures for the American people;
* Addressing unmet public health needs; and
* Increasing US drug manufacturing as a national security issue.
Here is a link to US FDA’s announcement.
(Editor’s note: the word “drug” is used instead of “medicine” in the USA)
* contributed by Robert Durkin, partner at Amin Wasserman Gurnani, LLP.
Are you planning to export products to the USA?
FDA has announced expanded use of unannounced inspections at foreign manufacturing facilities that produce foods, essential medicines, and other medical products intended for American consumers and patients.
The goal of an FDA inspection at a foreign facility is to confirm that products made outside of the US, but intended for distribution in the US, are manufactured, packaged, labelled, or held according to the same regulatory GMP standards required for products that are manufactured, packaged, labelled, or held in the US. The FDA may initiate its evaluation of your GMP program by either announcing a planned, onsite inspection in advance, arriving at your facility to conduct an unannounced “surprise” inspection, or reaching out by email to inquire about the type of products you manufacture, package, label, or hold for distribution into the US. In the case of the last option, such an inquiry could be the beginning of what FDA calls a “Remote Regulatory Assessment” (RRA). FDA RRAs became common during the COVID-19 Pandemic.
Since the pandemic, FDA has continued to rely on RRAs as a tool to evaluate the regulatory compliance of non-domestic companies that manufacture, package, label, or hold FDA-regulated products intended for distribution into the US. RRAs can have the same consequences as a traditional, in-person inspection conducted by FDA. When companies are requested by FDA as part of an RRA to provide GMP-related materials, a company should respond as if an in-person inspector was making the request during an onsite GMP inspection. The repercussions of a company failing a RRA can be significant. For example, FDA could add a non-compliant company to Import Alert (IA) 54-14, “Detention without physical examination of dietary supplements from firms that have not met dietary supplement GMP.” There are similar Import Alerts for other FDA-regulated articles. Once a firm is added to an IA, its products cannot be imported into the US until it is removed. In the case of dietary supplements, FDA’s current position appears to be that removal from IA 54-14 requires an in-person inspection by FDA – something that likely would not occur in a timely manner relative to the company’s business needs.
If this concerns you or you have questions about FDA inspections or RRRs, please contact us.
Botanical Adulterants Prevention Programme (BAPP) and other adulteration stories. contributed by Michael Levin, Health Business Strategies LLC
New Dietary Ingredient Guidance from FDA – A Slippery Slope?
On June 11, 2025, FDA released guidance materials to industry regarding the submission of New Dietary Ingredient Notifications (NDINs) as required under DSHEA.A common failure of NDIN submissions, per FDA:
“The NDIN does not include sufficient identity information. An NDIN should include the following identity information:
1) A description of the manufacturing process used to make the NDI, including process controls;
2) A description of the physical properties and chemical or molecular composition and structure of the NDI; and
3) A specification sheet that describes the critical identity and safety attributes of the NDI (this includes the purity and strength of the NDI and the identities and levels of any impurities and contaminants.” (emphasis author)” Source: FDA
Opinion: Since many potential impurities and contaminants do not represent a risk to human health in doses supplied (as more fully described in USP <1086> “other impurities”) and as codified in 21 USC 342(a) “Adulteration of Foods”, the invitation to disclose “any impurities and contaminants” is a troubling request. The manufacturing process of many substances has a huge array of potential low level compounds; it is unclear (and disconcerting) to me if FDA truly wants all potential identities and levels of “any impurities and contaminants”. Since herbals grow in dirt, along with the microorganisms that create chloramphenicol, would a company filing a NDIN be at risk for not disclosing this potential contaminant?
* Botanical Adulterants Monitor – read it here.
For regular news on US dietary supplement and food regulation, go to AWG Regulatory Roundup.
Foods
FSANZ Board met on 4th June, this communique has been released – it contains matters for decision notified to the Food Ministers’ Meeting.
Amendments to Food Standards Code:
* Amendment No. 239 to the Food Standards Code was published by FSANZ on 18 June 2025 (FSC 179). It included amendments resulting from the following application:
A1269 – Cultured Quail as a Novel Food. More information on FSANZ site here.
Approvals
FSANZ has approved variations arising from the following proposal and application on 4 June 2025. FSANZ has notified this approval to the Food Ministers’ Meeting:
P1055 – Definitions for gene technology and new breeding techniques
A1323 – Food derived from insect-protected soybean line COR23134. Source: FSANZ
Call for submissions
* FSANZ calls for written submissions on application A1324 – 3-fucosyllactose as a nutritive substance in infant formula products: to permit the voluntary addition of 3-fucosyllactose, a human-identical milk oligosaccharide, in infant formula products. The 3-fucosyllactose is produced using genetically modified Escherichia coli K-12. Deadline is 23rd July, more information on FSANZ consultation page.
New applications
* FSANZ has Accepted the following application. Assessment has now commenced and an opportunity to comment will be publicly notified at a later date. A1333 – Food derived from purple tomato lines containing event Del/Ros1-N. This tomato has been modified to produce natural blue pigments (anthocyanins) as it ripens, resulting in both purple skin and flesh. Source: FSANZ
* FSANZ has approved updated definitions for genetically modified (GM) food in the Food Standards Code. Following an extensive review under Proposal P1055 – Definitions for gene technology and new breeding techniques, the GM definitions have been modernised to address advances in gene technologies and maintain strong food safety protections. Read FSANZ media release here.
Foodwise – Winter edition, the quarterly newsletter from the NSW Food Authority. Includes news on the 2025 Food Allergen Management Symposium, Updated Food Allergen Management Consensus Statement, New edition – Fast Choices program: nutritional information menu labelling published , Food Regulation Partnership Workshop, results of inspections between January and March of various food processing facilities, and new berry, leafy vegetable and melon standards. Newsletter published here.
Recalls
* Mexim Australia – Mughlai Paratha – due to presence of undeclared allergens (eggs)Source: NSW Food Authority
* IKEA Australia – frozen product, SLAGVERK breaded wheat-based pieces – due to presence of foreign object (black rubber pieces). Source: NSW Food Authority
* Choco Bliss – Dubai Chocolate – due to the presence of undeclared allergens (pistachio, milk, sesame seed, wheat). Source: FSANZ
* 1 litre PET bottles used with the Drinkmate OmniFizz to carbonate water and other drinks – the affected PET bottle may over-pressure and explode during use. Source: ACCC Product Safety
* IKEA 365+ VÄRDEFULL Aluminium chrome plated garlic press with a black plastic handle – Small metal pieces can detach from the press during use. Detached metal pieces can be swallowed with food and cause injuries. Injuries have occurred. Source: ACCC Product Safety
Additional food news contributed by Gary Kennedy, Correct Food Systems
* The Northern Territory Government is moving ahead with expanding its Container Deposit Scheme, adding glass wine and spirit bottles, along with ready-to-drink containers up to three litres, to the eligible container list. This means that, among others, flavoured milk 1-3L, and pure juice 1-3L would be captured in NT CDS, the first time these containers have entered a container deposit scheme nationally.
New Zealand Food safety insights, emerging risks, and current issues bulletins:
These bulletins contain news from all over the world. Latest issue: 5th June
New Zealand food recalls:
* Woori Kimchi brand Minced Raw Garlic due to a lack of required food safety controls. Source: NZ MPI
* Binggrae brand Power Cap Watermelon – due to the presence of an undeclared allergen (milk) Source: NZ MPI
* Nutrient Rescue brand Double Shot products – due to the possible presence of an undeclared allergen (mollusc).Source: NA MPI
* Sunson International – Haichijia brand Hua Jia Jiang Hu (Clam Vermicelli) due to the presence of undeclared allergens (gluten, wheat). Source: NZ MPI
* Daebok Rice Cake brand Ground Garlic and Korean Sundae due to lack of required food safety controls. Source: NZ MPI
USA food news contributed by Rend Al-Mondhiry, partner at Amin Wasserman Gurnani, LLP.
* FDA Seeks Input on Post-Market Assessments of Food Chemicals Method
On June 18, 2025, FDA released its proposed method for ranking chemicals in the food supply. FDA plans to use Multi-Criteria Decision Analysis (MCDA) to prioritize chemicals for post-market assessment. The criteria include both public health and other decisional criteria, and takes into account factors specific to exposure from food while also using a scoring method similar to the FDA’s Risk Ranking Model for Traceability. FDA’s criteria would include the following:
* The chemical may produce severe health effects (e.g., cancer, cardiovascular toxicity);
* Dietary exposure to the chemical has increased;
* The chemical is found in or could potentially be present in food intended for vulnerable subpopulations (e.g., infants);
* Newly available information, data, or science indicates a potentially high impact on the conclusions of the previous assessment of the chemical;
* There is high attention (e.g., Congressional and/or national news media coverage) on this chemical, multiple organizations monitoring it, and/or multiple stakeholder groups active in setting standards;
* Multiple other governmental agencies are making decisions or taking action on this chemical; and
* Not assessing this chemical could result in the public losing confidence in the safety of the U.S. food supply.
FDA encourages the public to submit comments via the docket through July 18, 2025 in response to the questions listed in Section 4 of the method description document.
* Defining UPF is a New Priority of FDA
On June 10, 2025, FDA Commissioner Dr. Marty Makary and the director of FDA’s Center for Biologics Evaluation and Research, Dr. Vinay Prasad, published an article titled “Priorities for a New FDA.” Among other topics such as harnessing AI and controlling drug prices, the article states that FDA has “begun work on defining ultra-processed foods.” The article also mentions that FDA has begun investigating talc, “which is ingested by millions of Americans every day” through pills and candy, despite the ingredient being removed from baby powder due to its potential carcinogenicity.
For regular news on US dietary supplement and food regulation, go to Regulatory Roundup.
Cosmetics and TGA listed sunscreens
CHOICE sunscreen findings. Consumer group CHOICE recently stated that of 20 sunscreens it tested, 16 failed to meet their advertised SPF rating. However some brands are disputing the results and are producing test results to back up their argument. International sunscreen expert John Staton is quoted as saying “any sunscreen with test results below its label claim should be addressed by the sunscreen company and regulator.” He also says “while variability between labs and test subjects was a genuine issue, there should not be large variations.” To put SPF into perspective, “SPF50 products block 98 per cent of UV rays whereas SPF30 items block 96.7 per cent, according to the Melanoma Institute.” This has significant regulatory compliance implications. Brands must ensure they test and have evidence of the SPF claims made on their sunscreen products. The article published on the ABC news site is available here, and the latest response from the TGA is here. ACCORD (national industry association representing manufacturers and suppliers of hygiene, personal care and specialty products, their raw material suppliers and service providers) has published a press release which you can download here. We have a course called “Sunscreens– medicine or cosmetic?” which you can read about and book here. The TGA also has guidelines on sunscreen classification available on their website. John Staton published an article on LinkedIn on 28th June Variability in SPF – Individual Factors of Humans and the ISO Test Method.
PFAS Chemicals. From 1 July 2025, restrictions under the Industrial Chemicals Environmental Management Standard (IChEMS) will prohibit the import, manufacture and use of three PFAS chemicals in Australia: PFOS (perfluorooctane sulfonate), PFOA (perfluorooctanoic acid), and PFHxS (perfluorohexane sulfonate). IChEMS does not apply to chemicals used for therapeutic purposes (see above story) Source: TGA.
AICIS Evaluation workplan for 2025-26 – the “Rolling Action Plan” has just been updated and can be viewed here. It lists evaluations in progress and evaluations completed recently. AICIS is asking anyone with hazard or exposure information on chemicals that are in the Rolling Action Plan to voluntarily share it with them here.
Completed evaluations
As at 26 June:18 chemicals listed here.
Variation of inventory listing following revocation of CBI approval
As at 26 June, two chemicals, CAS 3085993-14-9 and CAS 3085993-61-6. Obligations to provide information apply. See them here.
List of new chemical assessment statements – see Rolling Plan
Chemicals added to the Inventory 5 years after issue of assessment certificate (obligations to provide information apply) as of 18 June: 7 chemicals listed here.
Chemicals added to the inventory following issue of assessment certificate (none in June)
Recalls
* iKOU De-Stress Small Candle – the wax can catch fire due to excessive essential oil. Source: ACCC Product Safety
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
ACCC and similar
ACCC Product Safety Newsletter can be viewed here.
Topics in the issue include
* Second-hand doesn’t mean second best – consumer guarantees still apply
* Tips for selling second-hand products online
* Tips for buying second-hand products online
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