Issue 269, 6th May –  31 May 2026

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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.

New course: Herbal Fundamentals. This course is for people who are new to herbal medicines and need to know more about the regulatory requirements for manufacturing and inclusion in a finished product. Read the agenda and book here.

Stability requirements for listed medicines has been flagged by the TGA as a priority (see below). We have a course on stability testing that comes with an example of a stability testing protocol, and a stability testing schedule based on a finished product specification for a hypothetical product. Read the agenda and book a course here.

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

Sunscreens – see below in Cosmetics and Sunscreens section

TGA administration performance report 2024-25 – did they meet their 4 strategic objectives:

* Improve public health outcomes through best practice regulation

* Build trust by actively engaging with our stakeholders

* Promote and enforce compliance with regulatory requirements, and

* Innovate and continuously improve.

Read the 130 page report here.

Advertising therapeutic product in specific circumstances, such as social media, and for specific types of products, like weight loss injections. Includes “Find out ways to promote health services offering products that cannot be advertised to the public.”. This page has a huge amount of information (you might like to pour a cup of tea or coffee before reading it). It is divided into three sections – Types of advertising and communications (6 topics), Advertising your services with restricted products (2 topics), and Advertising specific products (10 topics).

Do you want to report an advertisement that you think is non-compliant? This pagesummarises:

* What can’t advertisers do?

* What types of ads can you report?

* What information does the TGA need from you?

* What happens after you report?

Listed medicines for exercise performance

* The TGA asked sponsors to provide evidence to support the indications for use. Their assessment focused on the relevance of the evidence to the specific medicine; and the quality of the evidence provided. 21 medicines were targeted. Evidence provided for five medicines was sufficient to support their exercise performance claims. However, insufficient evidence was provided for 16 medicines. Read about the consequences of the review here.

* TGA conducted compliance reviews of selected listed medicines containing magnesium. Similar results as per above, read about it here.

Compounded medicines – this is how a pharmacist can produce an unapproved medicine for a particular patient when they have a prescription, however this scheme has been abused in the past.
* How are they regulated – guidance here.
* Requirements for compounded medicines – new guideline here.
* Manufacturing, supplying and advertising compounded medicines lawfully – guidance document here.

* GMP information for manufacturers of compounded medicines – Including the supply of medicines by community pharmacists – important, comprehensive and detailed guideline here

* Understanding Good Manufacturing Practice (GMP) for compounded medicines – includes chapters on quality management, personnel, premises and equipment, documentation, production, quality control, contract manufacture and analysis, complaints and recalls, and self inspection. Essential reading! Published here.

Are you exporting products to Indonesia? there are new and emerging halal certification requirements under Indonesia’s Halal Product Assurance framework. Certain medicines and medical devices, including those containing or using animal‑derived materials, may be required to obtain halal certification from BPJPH. Read more here.

TGA Business Services portal. If you are new to dealing with the TGA you must learn how the business portal works, especially if you are the “organisation contact” for the product sponsor. It provides clarification on the different tasks people in your organisation  can undertake – the administrator, the drafter/submitter and the financial  contact. Read about it here.

TGA Annual charges – new fees and charges come into effect on 1 July. This documentsummarises important dates to be aware of. It also explains how you can apply for an exemption from some charges.

TGA compliance and education for listed medicines – current priorities updated 7 May, published here.

Women’s Health Products Working Group – a communique from the 12th meeting on 31st March. Four topics were presented – read the summary here.

Poisons Standard

* Final decisions to amend (or not amend) the Poisons Standard as of 25 May. A long list is published here (click to select either MSWord or PDF version). Of interest to complementary medicines: Chromium-DL-methionine (chromium organic chelates), and Mitragyna speciosa (kratom).

* Proposed amendments: including Loratadine, Fexofenadine, Pseudoephedrine and    Salicylic acid – consultation document July 2026 is here.

* Proposed amendment – psilocybine. “the current scheduling of psilocybine remains appropriate”. A comprehensive review of data available. Source: TGA

Prohibited and Restricted Representations

* Permission granted for 2 restricted representations

* Permission granted for 8 prohibited representations

These are in accordance with government health campaigns including HIV, HPV, Hepatitis C, skin cancers and mental illness. Conditions apply. Published by TGA here.

The TGA-Industry Working Group on Good Manufacturing Practice meeting summaries are published here.

TGA’s freedom of disclosure (FOI) log – last updated 20 May 2026, is here.

Medicines and medical devices that have been cancelled or suspended and no longer appear in the ARTG – updated 28 May, published here.

Listed medicine compliance reports – no update since 31st March.

Compliance activity – Compliance enforcement

* 27 infringement notices, totalling $101,412, were issued to a NSW-based individual for the alleged unlawful supply of Melanotan II. The infringement notices have been paid. Source: TGA

* 5.97 million units of unapproved and counterfeit pharmaceuticals worth $20.7 million were recently seized during an Interpol operation which the Australian TGA participated in. The operation led to over 260 arrests and the dismantling of more than 60 criminal groups. Read more here.

Recalls

* AA-Med is recalling two lots of Dexcom G7 sensors. These lots were identified for disposal and destruction in the USA due to incomplete sterilisation and deployment failure during testing. The devices from both lots were stolen during the disposal process and sold to third parties via unauthorised supply channels. Read more here.

Advisory Statements are required for labels for some non-prescription over-the-counter and complementary medicines. The most recent version of ‘Required Advisory Statements for Medicine Labels’ (RASML) is RASML No. 6, which came into effect on 1 July 2023, but this is a revised (18 May 2026) guideline. Read it here.

Infringement notices:

* We publish individual infringement notices every month in this newsletter. This webpageallows you to view summaries of previously issued infringement notices (updated 21 May)

Safety alert: risks of importing unapproved peptide products. TGA’s Chief Medical Advisor, said “the biggest risks with unapproved peptide products are not knowing what’s in the vial. There is no way of knowing how much of the peptide is in there, whether the contents are sterile or whether there are other contaminants or toxins in there that you risk administering to yourself. Unmarked vials, code‑only labels, or missing ingredient and dosing information are major red flags”. Source: TGA

Timeframes for supplying UDI compliant medical devices in Australia: download relevant documents here.

A streamlined Consent to Supply process for Unique Device Identification related Essential Principles is being introduced. More information here.

In-vitro diagnostic medical devices: updated guidance for preparing a technical file review, as part of your application to include an in-vitro medical device (IVD) in the Australian Register of Therapeutic Goods – this is a very comprehensive guidance, includes a list of documents that must be provided, components of the technical file, stability studies and much more. Updated 12 May and published here.

Completing an application for consent to import, supply or export medical devices that do not meet UDI-related Essential Principles. Summary provided here, this page contains links to a MS Word and PDF version of a comprehensive guide.

Medical devices – guidelines updated 11 May:

* Use of market authorisation evidence from comparable overseas regulators and assessment bodies – here

* Using assessments from comparable overseas regulators – read here.

COVID-19 self tests (home use) – new products have been approved. See the full list here.

Additional medical device news can be viewed in the May 2026 edition of TGA Medical Device Resources published on LinkedIn by Gary Burgess, Hill Valley Regulatory Consulting

Updated summary (19 May) of TGA’s leadership and business divisions including the 22 personnel responsible for each. Published here.

USA medical device news supplied by Neil O’Flaherty from Amin Wasserman Gurnani.

U.S. FDA Issues New Final Guidance for Patient-Matched Guides for Orthopedic Implants: Earlier this month, the U.S. Food and Drug Administration (FDA) issued a final guidance document entitled “Patient-Matched Guides for Orthopedic Implants.” The guidance document recommends information to include in regulatory submissions to FDA for patient-matched guides for orthopedic implants. The guidance document also recommends what guide manufacturers should consider when developing their design process for them. The guidance document is intended by FDA to clarify Agency expectations regarding for regulatory submissions for guides.  Here is a link to the FDA guidance document.

Botanical Adulterants Prevention Programme (BAPP) and similar articles

In the BAPP LinkedIn posts and other resources you will find:

* Cranberry Products – Laboratory Guidance Documents. Cranberry extracts are frequently adulterated. This article details various laboratory methods that can detect adulteration. Published in Herbalgram.

* Ginseng – documented adulterants and how to detect them. Published in Herbalgram

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

IN THE PRESS

Global Implications of India’s Ashwagandha Leaf Ban – an expert committee published an opinion in 2024 that formulators should exclude leaves due to higher concentrations of reactive withanolides. This article puts forward some interesting arguments against this decision. Article published in Nutraceuticals World

Foods

2026 FSANZ stakeholder forum – to be held at Queensland Parliament, Brisbane, on Wednesday 17 June 2026. You can attend in person or attend on-line. See the agenda and book here.

Health Star Ratings. The proposal is to make it mandatory on labels for foods for sale in Australia and New Zealand to display a Health Star Rating symbol. Your editor attended the webinar held recently, and noted this is still in drat stage. Public consultation is open until 21 June. You can find more information here.

FSANZ Board held a meeting on 29 April, the communique is available here.

Food Minister’s’ meeting on 1 May Communique  – key outcomes were food regulation agreement (the Food Regulation Agreement is an agreement between the Australian Government, states and territories) – and caffeine review. More info at foodregulations.gov.au.

Approval – Food Ministers’ Meeting notification
FSANZ has approved variations arising from the following applications and proposal on 29 April 2026. FSANZ has notified this approval to the Food Ministers’ Meeting:

* A1304 – Endo-1,4-beta-xylanase from Bacillus licheniformis (gene donor: Chryseobacterium cucumeris) for use as a processing aid
* A1305 – Apha-amylase from Bacillus licheniformis (containing the gene for alpha-amylase from the gene variant ANZ105) as a processing aid
* A1332 – Cross-linked polyester resins as an adsorbent processing aid in wine
* M1023 – 2024 MRL Harmonisation Proposal

Food Standards Code Compilation was updated in May – available here.

New applications and proposals

* M1024 2025 MRL Harmonisation Proposal – prepared to consider varying maximum residue limits (MRLs) for residues of specific agricultural and veterinary chemicalsthat may occur in food commodities. The Administration Assessment Report is here.

* Variations to Maximum residue limits proposed by APVMA to align with international trading partners if there is no public health and safety risk. Read more here.

* Application: A1352 – Chymosin from Thermothelomyces heterothallica (gene donor: Bos taurus) for use as a processing aid in the production of cheese. Source: FSANZ

* A1326 – Addition of phytosterols, phytostanols or their esters as a novel food to bread and bread products Read more here.

Public consultations and calls for submissions/comments

* Review of young child formula – FSANZ is calling for submissions on a proposal to develop a modernised regulatory framework for young child formula, commonly referred to as toddler milk. Source: FSANZ

Commencement of assessment

* A1325 – Extension of use of steviol glycosides in hotplate flour products FSANZ

Novel foods determinations – no updates since our last newsletter

Recalls

* Food recall statistics over the past 10 years. The data presents the reasons for food recalls and the types of foods recalled, as well as detailed analysis of causes (e.g. allergens and contaminants) and corrective actions taken by food businesses. There are 2 types of food recalls – consumer and trade. A very interesting and comprehensive summary report can be found here.

* Global Seafood Distributors – Seafood Marinara Mix – due to the presence of foreign matter (mussel shell fragments with product). Source: FSANZ

* Murray River Smokehouse – Turkey Bacon – presence of an undeclared allergen (milk) Source: FSANZ

Stay up to date with Food News by subscribing to The Correct News, published by Correct Food Systems.

New Zealand news contributed by Gary Kennedy, Correct Food Systems

New Zealand Ministry for Primary Industries PI has produced translated versions of their allergen labelling and food recall educational materials. More information at NZMPI.

New Zealand Food safety insights, emerging risks, and current issues bulletins: 10 May issue can be viewed here. (As always, some interesting news from other countries)

New Zealand food recalls

* Leis brand Sorrel Leaves – the product may contain foreign matter (glass) NZ MPI

* Hellers brand Sweet Chilli Pork Tenders – may contain foreign matter (black plastic) NZMPI

* Rempah brand Rendang Sauce – may contain foreign matter (hard plastic) NZMPI

* Essenté – Crushed and Sliced Lemongrass – may contain foreign matter (hard plastic)NZMPI

* Pams – Chicken Laksa Soup – may contain foreign matter (hard plastic) NZMPI

* Naked Kitchen – Fragrant Thai Red Curry – may contain foreign matter (hard plastic)NZMPI

* FED – Thai Massaman Beef and Potato Curry with Rice – may contain foreign matter (hard plastic) NZMPI

* Too Easy Meals – Crumbed Chicken & Gravy – may contain foreign matter (clear plastic) NZMPI

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

Cosmetics and sunscreens

Consultation on improvements to the regulation of sunscreens.

* The public consultation period has closed. TGA will review all the responses and their decisions will be published on the consultation page. Source: TGA

New Zealand regulation of sunscreens: the NZ Ministry of Health has published on the regulatory impact of sunscreen regulation in NZ, read it here.

The AICIS website has a new navigation menu – read about it here

New Guide to applying for an assessment certificate. This is for Australian and foreign businesses who must apply for an assessment certificate because their introduction is in the ‘assessed’ category, or have categorised their introduction as ‘exempted’ or ‘reported’ and choose to apply for a certificate to get a chemical added to the Australian Inventory of Industrial Chemicals (Inventory). Details here.

Preview of upcoming changes to the 2026 Categorisation Guidelines – will take effect in September 2026. Responses to feedback are here. Includes “High hazard salts and esters” – 5 added. Guidelines changes effective from September 2026 are summarised here.

Recalls – no cosmetics listed this month on the ACCC recalls page

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 is here

Variation of Inventory listing following revocation of CBI approval – none this month

Chemical added to the Inventory following issue of assessment certificate – as at 18 May 2026 – one chemical CAS 1821217-71-3 (a Phosphorous acid, triphenyl ester, polymer compound) – More here

Correction of chemical names on the Inventory – as at 13 May 2026 – approx 157 chemical names “corrected” – except for one name which was a typographical error, the rest were due to CAS updating the chemical name. The full list is here.

Variation to Inventory listing after evaluation: – none this month

List of new chemical assessment statements – none this month

Chemicals added to the Inventory 5 years after issue of assessment certificate (obligations to provide information apply): as at 27 May – one chemical, CAS no. 151789-08-1 – information here

Industrial Chemicals Regulatory News – published regularly by AICIS. 13 May edition is here. Subscribe here to receive newsletter by email.

Cosmetics Consultants Europe:

Cosmetics Consultants Europe’s (CCE) 9th Annual Open Academy – Participate online

Topic: “High Ambitions, Hard Realities: The EC’s Challenges with Cosmetic Products & Regulations”
* Dates: 22-23. June 2026 / Venue: Hyatt-Murano Venice, Italy
* 2-Day Agenda/Registration: www.ccecosmetic.org/open-academy-2026/
For more info, Contact: Steven L. Hanft, Business Communications, CCE steven.hanft@conusbat.com

Discounts to Members of RTD-Australia (recipients of this newsletter)

IN THE PRESS

Changes to ingredients permitted in the EU. On 28 April 2026, Regulation (EU) 2026/909 was published – this amends Annexes II (prohibited substances), III (restricted substances), V (authorised preservatives) and VI (authorised UV filters) of the Cosmetics Regulation with regard to the conditions of use of 12 cosmetic ingredients. Published here on LinkedIn by Amandine Perez from AP Cosmetic Consult

ACCC and other news

ACCC

*The big news this month is that  Australia’s second largest supermarket chains, Coles, was found guilty of making false or misleading representations about prices going “Down Down” . The ACCC has also commended proceedings against the largest supermarket group, Woolworths. More details here.

* A permanent ban on baby bottle self-feeding devices, due to the risk of injury or death, is now in effect. Source: ACCC

* Coles Supermarkets  and Brownes Foods Operations have each paid $39,600 in penalties after the ACCC issued each company with two infringement notices for separate alleged contraventions of the Dairy Code of Conduct. This was a complex matter! Source: ACCC

Additional news supplied by Gary Kennedy, Correct Food Systems (Gary presents our food courses)

* Packaging Reform Bill Introduced to Federal Parliament
Senator Peter Whish-Wilson introduced a Bill into the Senate, proposing a national packaging reform framework. The Extended Producer Responsibility Scheme for Packaging (No Time to Waste) Bill 2026 would establish a federally regulated extended producer responsibility scheme placing legally binding obligations on producers, importers and distributors of packaging for the end-of-life management of packaging placed onto the Australian market.
The Bill would also see Australia’s National Packaging Targets made mandatory and legally binding.
Additional proposed measures include stronger product stewardship requirements, a greater focus on packaging avoidance and reduction, mandatory eco-design standards, and minimum recycled content requirements for packaging.
The Bill is open for consultation through 15 June.

* New Zealand Introduces CRS Bill into Parliament
Last Friday, a Bill was introduced to the New Zealand Parliament that would establish a container return scheme. The Bill revives a previous proposal and would introduce a NZD 20 cent (approximately $0.16 AUD) refundable deposit on eligible beverage containers sold in New Zealand.
While the full Bill is yet to be publicly released, previous proposals included a mandatory return-to-retail model, requiring larger retailers selling eligible containers to also accept returns and provide refunds to consumers.
The current Coalition Government has previously deferred the introduction of a scheme due to cost-of-living concerns. However, it places renewed pressure on the governing National Party to make clear its position on this before voters head to the polls

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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