current affairs
Issue 246, 5th April – 14th May 2024
Regulatory affairs news
Complementary Medicines and Medical Devices:
Vacancies on TGA advisory committees. TGA is looking for applications from professionals and consumers. These are part time positions with the expected number of meeting hours varying from 3 to 6 per year. 8 different committees covering various topics: biologicals, medicines, vaccines, complementary medicines, medical devices, chemicals scheduling and medicines scheduling. Learn about remuneration and how to apply here.
Medicinal cannabis quality standards. Some media reports noted questionable cannabis products being supplied. Regardless of whether cannabis oil or cannabis flower medicine comes from overseas or in Australia, it must comply with the relevant quality standard as per Therapeutic Goods Order 93 (TGO 93). Source: TGA. To read more go to the medicinal cannabis hub.
“Boundary products” – medicines, biologicals, or medical devices?. A list of common boundary and combination products – which regulatory category do they fall into? A useful guidance document, not legally binding. Go here to select either PDF or MSWord versions of two documents: “Guidance on boundary and combination products” and “Examples of boundary and combination products and their product category”.
Medicinal cannabis clinic branding at rugby league games. The Dolphins rugby league club has agreed to remove Alterneaf branding from its jerseys and on signages displayed at stadiums due to advertising compliance issues. Source: TGA.
Instructions for use of medical devices. Feedback sought on how the Instructions for Use (IFU) are provided, and whether they should be made available in more flexible formats. More information here.
Advertising and compliance education plan. TGA is educating advertisers, consumers, health professionals and the therapeutic goods industry to promote voluntary compliance with the import, advertising and supply requirements. Priorities for 2024 include unlawful advertising of vaping products; medicinal cannabis, psilocybin and MDMA; unapproved products used in the wellness and beauty industries; import of substandard and falsified therapeutic goods; import, advertising and supply of medicines and medical devices advertised as traditional or alternative treatments. Full details are outlined here.
TGA GMP Forum – 19th – 20th November in Melbourne. Details here
Interim decisions on proposed amendments to the Poisons Standard. Go here to download either MSWord or PDF version.
Product recalls:
Panadol Children 1 month 1 year – oral liquid – problems with dosing syringe on some batches. Source: TGA
Product Defect Alert:
Philips A30 and A40 series bi-level positive airway pressure (BiPAP) devices – interruptions and/or loss of therapy with the potential for unexpected shut down due to a Ventilation Inoperative Alarm. Source: TGA
Compliance action
* TGA has issued infringement notices for $37,560 to Global Medical Solutions (Radpharm Scientific) for unacceptable manufacturing practices identified during an inspection. Source: TGA
* A Victorian nurse has received infringement notices totalling $7,512 for allegedly importing unapproved prescription-only and cosmetic injectable products including botulinum toxin type A vials and pre-filled syringes containing hyaluronic acid. Source: TGA
* A Victorian individual has been fined $3,756 for alleged unlawful importation of a prescription-only peptide. Source: TGA
* The TGA has commenced proceedings in the Federal Court of Australia against Montu Group Pty Ltd, its subsidiary Alternaleaf and Mr Christopher Strauch, for alleged unlawful advertising of medicinal cannabis on websites and social media. Among the many breaches of advertising code were statements that medicinal cannabis is safe or without harm or side effects, or magical or miraculous. The company ignored warnings from the TGA. Source: TGA
* TGA officers executed a search warrant on a Sydney residence linked to an individual suspected of being involved in the manufacture and sale of compounded semaglutide. Several patients have suffered adverse events from the medication after it had been sent to them via the post. Source: TGA
Safety alerts
TGA tested a product labelled Dark Horse Capsules and found that the tablets contain the undeclared substance sildenafil. Source: TGA
Consultations
Proposals to amend the Poisons Standard including sildenafil, allyl esters, glyoxylic acid, intravenous potassium salts and sulfonamides. Submissions close 22nd May 2024. Read more.
Vaping:
* Presentation given on improvements in TGA standards for quality and safety of
unapproved vapes. View PDF of slides here.
* The senate of the Australian Federal Parliament has recommended a bill should be passed to ban the manufacture, sale and advertising of vapes. The recommendation came after two days of hearings and nearly 300 submissions from health, education, pharmaceutical and other sectors. The bill does not implement prohibition, as vapes will be available at pharmacists with a prescription. Source: The Guardian Australia.
* Federal Health Minister announced that in a joint operation, the Therapeutic Goods Administration (TGA) and Victoria Police, have identified and detained nearly 500,000 vapes suspected of being unlawful. Full story at health.gov.au.
National Symposium on Australian Traditional Medicine. This will be held at the NICM Research Institute, Western Sydney University, on 11th-12th November. Full details at westernsydney.edu.au
Botanical Adulterants Prevention Programme and other adulteration stories:
Cinnamon supplements and spices – which ones were found to be high in toxins. Of particular concern was the presence of lead. Published in consumerlab.com.
To access freely available botanical and technical resources from BAPP, click here
New Zealand
The new Therapeutic Products Act has been repealed by the new NZ government. Some sections of industry claimed it would be “over-regulation” but this has been disputed by many in the industry. The out-dated Dietary Supplements bill is still in place. Read more on NZ government website.
In the press:
Patients report alarming side effects after injecting replica Ozempic and Mounjaro. Discusses the side effects suffered as a result of products sold by an illegal compounding pharmacy “Total Compounding Pharmaceuticals”. The products are now being marketed internationally, including USA and UK. A serious issue! Source: Australian Broadcasting Corporation.
From USA: Amazon is prioritising 3 categories of dietary supplements with its updated sellers policy. These are weight management, sexual enhancement, and sports nutrition/body building. More details published in NutraIngredients USA.
Foods:
Food Regulation agreement. A food Ministers Meeting comprising the Australian and New Zealand ministers for food regulation was held early May. Topics discussed included regulatory consideration for cell-based human milk products, monitoring uptake of the Health Start Rating system, and “consumer insights tracker” results. Read more at food regulation.
FSANZ stakeholder forum. The theme is ‘Collaboration in Food Regulation: Working together for impact’, with experienced journalist and facilitator Geraldine Doogue. 20th June in Melbourne at the Intercontinental Rialto. Tickets are available for in-person or virtual attendance. $75. More info at Food Standards News
Review of Food Standards Australia New Zealand Act 1991 – Impact Analysis
Recalls
* Monta Group Holdings – Nissin Big Cup Noodles – due to the presence of an undeclared allergen (peanut). Source: NSW Food Authority
* Nutracon Foods Australia – Bibigo Mini Mandu Prawn Dumpling 360g, Bibigo Mandu Prawn Dumpling 350g, Cau Tre Spring Roll 500g, Cau Tre Spring Roll 480g – due to the potential presence of an undeclared allergen (Egg). Source: NSW Food Authority
* StrangeLove Beverage Company – Salted Grapefruit 540ml – due to unintended fermentation resulting in the presence of alcohol and increased carbonation, which may result in bottle breakage or popping caps. Source: NSW Food Authority
* HenKing Foods – Mr Lees Noodles Henking Coconut Chicken Laksa 65g – due to the presence of an undeclared allergen (milk) Source: NSW Food Authority
* Arrotex Pharmaceuticals – 28GO Go Bar – Triple Choc Protein 55g – presence of foreign matter (plastic) in products with best before date of 28/06/2024. Source: NSW Food Authority
* Patties Food Group – Little Meals Beef Cottage Pie 200g – due to the presence of foreign matter (rubber). Source: NSW Food Authority. Source: NSW Food Authority
* Elixinol Wellness (Byron Bay) – Mt Elephant Buttermylk Wholefood Pancake Mix – due to the presence of an undeclared allergen (milk). Source: NSW Food Authority
* Pinnacle Drinks – Oxford Arms London Dry Gin 37% – due to potential chemical contamination (styrene). Source: NSW Food Authority
* Globe Consultancy Services – Frisp Oats Peanut Butter, Blueberry Chia, Cacao, Maple Date & Chia – due to the presence of an undeclared allergen (milk). Source: NSW Food Authority
* Patties Food Group – On The Menu Entrée – 3 Cheese Macaroni – Beef Lasagne – Spaghetti & Meatballs – due to an error on the packaging, oven cooking instructions are not compatible with product tray. Source: NSW Food Authority
* Monta Group Holdings – Nissin Big Cup Noodle Curry – presence of an undeclared allergen (peanut). Source: NSW Food Authority
* Bellarine Brownie Company- Brownie Belgian Chocolate Vegan 86g – due to undeclared allergens (cashew and egg) due to an incorrect product being packed in the packaging.
Amendments to Food Standards Code/Approved variations – includes:
• A1271 Cellulase from GM Aspergillus niger as a processing aid
• A1272 Food derived from herbicide-tolerant and insect-protected corn line DP915635
• A1274 Food derived from disease-resistant banana line QCAV-4
• A1278 Beta-Fructofuranosidase from GM Trichoderma reesei as a processing aid
Approvals from previous applications
A1257 – Australian native bee honey
A1280 – Food derived from herbicide-tolerant and insect-protected corn line DAS1131
In the press:
The Scary Truth About Adulterated Food You Need to Know! Types of adulteration include intentional and incidental. Includes a list of commonly adulterated foods and common adulterants. From India-based blog published in https://krishijagran.com/
Cosmetics and TGA listed sunscreens:
Update to sunscreen standard. Starting from 1 July 2024, all new sunscreen products included in the Australian Register of Therapeutic Goods (ARTG) must comply with the 2021 Sunscreen Standard. Existing aerosols and spray pump packs included in the ARTG prior to 1 July 2024 will have a 1-year transition period to comply with the new labelling requirements in the 2021 Sunscreen Standard. All existing sunscreens products (aerosol and non-aerosol) included in the ARTG prior to 1 July 2024 will have a 5-year transition period where they can comply with the testing requirements of the 2021 Sunscreen Standard or previous standard (2604:2012). After the transition period, all existing sunscreen products included in the ARTG and any new products released for supply must comply the 2021 Sunscreen Standard. Source: TGA
Changes to categorisation, reporting and record keeping are now in effect. Updated categorisation guide is here, and updated guidance on reporting and record-keeping obligations can be found here.
Open for comment until 27th May: 14 chemicals listed, along with form provided to provide feedback. Source: AICIS
List of current evaluations updated in April 2024. Includes evaluations under public consultation, evaluations in progress and recently completed evaluations. Source: AICIS
Chemicals added to the Inventory 5 years after issue of assessment certificate:
As at 24th April: 6 chemicals listed here along with their specific requirements.,
Chemicals added to the inventory following issue of assessment certificate (early listing) as at 1st May (source: AICIS):
CAS Number 1117765-92-0, 5-Cyclotetradecen-1-one, 3-methyl-, for use in cosmetic and household products
CAS Number 1373821-23-8, 4H-1,3-Benzodioxin, hexahydro-4-methyl-2-(phenylmethyl)-, for use in cosmetic and household products, air fresheners and fragrances.
Cosmetics compliance
Two infringement notices totalling $37,560 issued to a fragrance, toiletries, and cleaning products importer. They are alleged to have imported industrial chemicals from the US without holding an AICIS registration, and failed to submit an annual declaration required. Source: AICIS
ACCC and similar:
ACCC has instituted proceedings in the Federal Court against Clorox Australia Pty Ltd, the manufacturer of GLAD-branded kitchen and garbage bags, for allegedly making false or misleading representations that certain kitchen and garbage bags were partly made of recycled ‘ocean plastic’, in breach of the Australian Consumer Law. They were actually made from plastic that was collected from communities in Indonesia up to 50 kilometres from a shoreline, and not from the ocean or sea. Source: ACCC
Compliance and enforcement priorities: this page details ACCC enforcement and compliance priorities for 2024 – 2025
Office of New York attorney general, Letitia James, announced that it would be suing the world’s largest meat company, JBS, for misleading customers about its climate commitments. An example of greenwashing. Full story can be found in The Guardian.
Training news
1.06. Stability testing. In Australia, stability testing on the consumer pack is mandatory for all medicines, including complementary medicines. Our course has just been revised by the newest member of our training faculty, Andrew Lattimore. Andrew spent years as a GMP inspector for the TGA and APVMA, and he now runs his own consultancy. Read more about Andrew here. Topics include determining shelf life, test methodology, an example of a stability testing schedule, ongoing stability testing, and documentation of the stability testing process. Course can be viewed here: https://www.regulatorytrainingdirect.com/#toggle-id-6.
All our courses can be viewed here https://www.regulatorytrainingdirect.com/#course-summary. Book a course here.
Published by Regulatory Training Direct www.regulatorytrainingdirect.com
Providing regulatory training courses for complementary medicines, GMP, foods, cosmetics dietary supplements.
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