current affairs

Issue 254, 31st December 2024 – 31st January 2025

Training news

Revised and expanded advertising course: Advertising medicines and medical devices. This course replaces our course 1.04. Product Advertising which focused on complementary medicines. However there is only one Therapeutic Goods Advertising Code in Australia, which covers all non-prescription medicines, including complementary medicines, as well as medical devices. Agenda is here

New courses coming soon:

Product recalls – medicines, medical devices, foods, cosmetics – how to deal with procedures involved

GMP Clearances of overseas manufacturers – when importing a medicine (including a complementary medicine) into Australia that is manufactured outside of Australia, you have to have the TGA “clear” each manufacturer involved. This can be tricky, as Australia has mutual recognition agreements with some countries, but not all. And even then, if a complementary medicine is classified as a “dietary supplement” then the manufacturer may not conform to the appropriate level of Good Manufacturing Practice. Coming soon.

Are you an advertising agency helping supplement, complementary medicine, cosmetic and food brands? Do you deal with social media influencers? It’s important you understand regulatory compliance fundamentals so you can develop effective AND legal content. We offer a 2.5 hour course that has been immensely popular and valuable for agencies. It teaches advertising and social media regulations covering the key issues and pitfalls across multiple product categories in Australia and New Zealand. Read more and book here

We now have over 30 regulatory affairs courses, covering regulations in Australia, New Zealand and the USA. You can view them here and book online here

Regulatory affairs news

Complementary Medicines and Medical Devices

Recalls procedure: reforms to recall procedure will commence early  March 2025. The new procedure will be known as the Procedure for Recalls, Product Alerts and Product Corrections (PRAC).  Updated information is here.

Melanotan. The TGA has worded about the risks associated with melanotan. It is illegal to advertise melanotan to the Australian public – and this includes promotions by “social media influencers”. Melanotan I and Melanotan II products, including injectables, oral products and nasal sprays, are promoted as safe. They are unsafe and can cause serious side effects, including skin cancers, kidney dysfunction and swelling of the brain. Source: TGA

TGA gives consent for listed medicines to contain whole live microorganisms (other than Arthrospira maxima or Arthrospira platensis) as an active ingredient, provided they comply with monographs in the USP or BP/EP. Source: TGA

GMP clearances of overseas manufacturers that are expiring on 31st December 2024 will be automatically extended until 31st December 2025 – due to overseas partners returning to pre-pandemic inspection frequencies. Source: TGA

TGA Advertising and Compliance Education Plan 2024-25 – a detailed summary of priorities and outcomes of recent regulatory action – includes:

* Unlawful supply and advertising of unapproved products used in the wellness and beauty industries

* Unlawful import and supply of substandard and falsified therapeutic goods

* Unlawful import, advertising and supply of medicines and medical devices advertised as traditional or alternative treatments

… and details of upcoming educational events. Read all about it here.

Probiotics – new quality guidelines. Clarifies specific issues regarding method of analysis for strain identity and enumeration (particularly in relation to medicines containing multiple probiotic strains). Includes quality control, safety, efficacy, and stability. Also covered: active ingredient identification, quantification and labelling, quantification methods, assay limits, microbial contamination, and ongoing stability. Source: TGA

Consultations

* Improving the TGA website: the TGA has published an online survey to gather opinion on how to improve the structure of the TGA website. General information, plus a link to the survey, can be found here.

* Two new guidance documents developed as part of the proposed new risk-based application audit framework for medical devices. Closes on 17 February. Read more here.

* Proposed amendments to the Poisons Standard. Consutation ends 17 February. More info here.

New forms for Special Access Scheme – Application and Notification have been approved. More details here.

TGA workshop – Disinfectants with no specific claims – will be conducted on 19 Feb, register here.

TGA workshop – to discuss proposed regulatory changes to exempt tampons and menstrual cups – 18 Feb, register here

Guidance on making labels comply with the labelling orders TGA 91 and TGA 92, published in December. For non-prescription medicines the guidance is available here.

Compliance action
* 20 businesses in Melbourne have been fine a total of $396,000 for unlawful supply of vapes. Each business was fined $19,800. Source: TGA

* A person has had 12 charges issued for criminal offences relating to the advertising and supply of black salve, bloodroot capsules and other unapproved therapeutic goods. It is alleged that the individual made claims about the products’ ability to treat serious health conditions, including anxiety and cancer. Black salve can cause sever skin reactions. Source: TGA

* A Sunshine Coast tobacconist has been fined $37,560 for the alleged unlawful possession of a commercial quantity of vaping goods. Source: TGA

Paracetamol tablets and capsules pack sizes. As from the 1st February it is now illegal to sell paracetamol in packs containing more than 16 tablets or capsules, and they must be supplied in blister packaging. Pharmacies are exempt from this requirement. Source: TGA

International guidelines for Good Clinical Practice – latest version was endorsed on 6 January. More details published on TGA website here.

Safety alerts

Montelukast is a prescription medicine used to prevent and treat chronic asthma in adults and children aged 2 years and older. It is also used to treat the symptoms of seasonal allergic rhinitis (hay fever). Extra safety information is being added to highlight the existing warnings about serious behaviour and mood-related changes. Source: TGA

Recalls – none this month

Botanical Adulterants Prevention Programme (BAPP) and other adulteration stories.
To access freely available botanical and technical resources from BAPP, click here 

USA news
The FDA has issued a number of rules and guidelines in the final few weeks before the new administration took over. To view a list, refer to Regulatory Roundup, and if you have questions you may direct them to Rend Al-Mondhiry: rend@awglaw.com

In the press:

State’s top doctor raises alarm as Sydney vapers develop opioid addiction. Withdrawals were observed in four young adult patients who were previously “opioid naive” and developed a nitazene addiction after inhaling illicit vape liquid that contained protonitazene, a synthetic opioid. Source: Sydney Morning Herald

Pharmacy chains and big tobacco have become unlikely rivals in a battle to gain market share among smokers and vapers. Source: abc.net.au 

Foods

Future of Food Safety. FSANZ proactively identifies and responds to emerging challenges and opportunities. Read more here.

Review of evidence and update the 2013 Australian Dietary Guidelines. The term of the Expert Committee commenced on 1 June 2021 and is scheduled to conclude on 6 March 2027. Source: NHMRC

Mechanically Attached Straws: as of 1 January you can no longer sell containers with attached plastic straws in New South Wales unless you have an exemption for use in places such as aged care, hospitals or prisons. The New South Wales revocation is the first to go into effect, with most other states also revoking their exemptions over the next 12 months. Source: NSW Environmental Protection Agency

New applications and proposals

A1322 – Extension of use of polyglycerol esters of interesterified ricinoleic acid in sauces and toppings FSANZ

A1321 – Acetolactate decarboxylase from GM Bacillus licheniformis as a processing aid –  in brewing processes and other cereal based beverage and beverage alcohol (distilling) processes. FSANZ

Withdrawn applications

* This application has been withdrawn by the applicant: A1312 – 2′-FL from GM Escherichia coli BL21 in infant formula products: To amend the Australia New Zealand Food Standards Code to permit a new genetically modified source of Escherichia coliBL21 for the production of 2′-Fucosyllactose (2′-FL) for use as a nutritive substance in infant formula products. FSANZ

Amendments to the food code to Schedules 3, 18 and 26: resulting from the applications:

A1260 – 2-methyloxolane as a processing aid
A1289 – Food derived from disease-resistant, low-reducing sugars and reduced browning potato line BG25
A1291 – Glucoamylase from GM Aspergillus niger (gene donor: Gloeophyllum sepiarium) as a processing aid

Read the amendments here.

Approvals

None this month

Call for submissions: 

*FSANZ is seeking submissions on Application A1307- Milk fat globule membrane as a nutritive substance in infant formula products. Closing date 6 February. FSANZ

* Application A1310 – Food derived from insect-protected soybean line MON94637. This application seeks the approval for the sale and use of food derived from soybean line MON94637, genetically modified for protection from lepidopteran insect pests. Deadline 18 February. FSANZ

Recalls 

*Lt Johnny’s and Caterina’s Pizza & Gourmet Food – Margherita and Prosciutto Pizza – due to undeclared allergen(s) (Soy, Sulphites and Cashew). Source: FSANZ

* REX IMPORTS AUSTRALIA  – Cape Herb & Spice Grinders, various weights – due to potential presence of foreign matter (plastic). Source: FSANZ

* RUN FENG TRADING MELBOURNE  – Biscuits (Milk Flavour) – due to presence of undeclared allergens (Milk and Egg). Source: FSANZ

* The Standard Market Company – Wagyu family pie; Beef, cheese & bacon pies; Butter chicken pies; Chicken & leek family pie; Chicken & leek party pies; Chicken & leek pies; Chicken & mushroom pies; Cottage family pie; Cottage party pies; Cottage pies; Pepper steak pies; Wagyu party pies; Beef and mushy pea pies; Wagyu beef pies – due to presence of an undeclared allergen(s) (egg). Source: FSANZ

* ALDI Stores – World Kitchen Energise High Protein Chicken Pesto Pasta – recall updated to include all use by dates up to and including 03-Jan-25.Refer to original pot re presence of cashew.

Additional food news contributed by Gary Kennedy from Correct Food Systems:

ISO have updated dozens of their standards, including ISO 9000 [Quality mgmt.], 14000 [Environment], 22000 [Food] and 45000 [OH&S] to introduce climate change clauses.

* 4.1 Understanding the organization and its context. The organization shall determine external and internal issues that are relevant to its purpose and that affect its ability to achieve the intended result(s) of its XXX management system.
Added: The organization shall determine whether climate change is a relevant issue.

* 4.2 Understanding the needs and expectations of interested parties. The organization shall determine: • the interested parties that are relevant to the XXX management system. • the relevant requirements of these interested parties. • which of these requirements will be addressed through the XXX management system.
Added: NOTE: Relevant interested parties can have requirements related to climate change.

Germany: Foot-and-Mouth Disease Impacts Supply Chain
* Recent cases of foot-and-mouth disease in Germany have resulted in the Australian Government implementing new restrictions on imports from Europe, including dairy and dairy products. Germany has been removed from the list of certified FMD-free countries. While the import conditions continue to allow imports for products certified as manufactured in Germany prior to 14 November 2024, products made after that date containing bovine products will face heightened scrutiny, including case-by-case assessment, and possible biosecurity measures.
* Beyond dairy and dairy ingredients, other bovine items which may affect the beverages’ industry ingredient supply chain include laboratory goods such as certain gelatines and agars, test kits and culture media, and product samples.
* The German-Australian Chamber of Commerce has released an information leaflet on the changed import conditions

New Zealand food safety bulletins published each fortnight here. No bulletin published in January 2025.

New Zealand Food recalls since the last newsletter:

* Heritage Breads brand Ready to Bake Mighty Garlic Ciabatta – due to the presence of undeclared allergens (milk and peanut) NZ Ministry for Primary Industries
* Cape Herb & Spice brand Himalayan Pink Salt, Seasoned Salt, Salt & Pepper, and Sweet & Smoky BBQ – products may contain foreign matter (plastic) NZ Ministry for Primary Industries
* LollyShop brand Frosted Caramels – due to the presence of undeclared allergens (gluten and wheat)NZ Ministry for Primary Industries
* Mexicano brand Corn Chips Cheese due to the presence of an undeclared allergen (soy)NZ Ministry for Primary Industries
* Oxford Pies brand Steak Pie – due to the presence of undeclared allergens (egg and fish). Oxford Pies brand Smoked Fish Pie has been incorrectly packaged as Oxford Pies brand Steak Pie.- NZ Ministry for Primary Industries
* Sanitarium Health Food Company brand Up & Go Protein Energize Vanilla – due to product spoilage NZ Ministry for Primary Industries

Cosmetics and TGA listed sunscreens

Sunscreen – how much is really applied? An excellent article published by the sunscreen “guru” John Staton on LinkedIn. The first paragraph states ‘The challenge of educating consumers on the importance of applying sufficient sunscreen in use still rages. We have “dose” or “galenic” forms of sunscreens offered as Lotions, Creams, Oils, Liquids, Gels, Sticks, Balms, Aerosol Sprays, Pump Sprays, Foams, Roll-ons and Powders. Do formulators and marketers help by offering so many forms of their product, mostly market segmented on the basis of convenience? Are there forms we have not even identified? Should we have more customised usage instructions for at least some of these forms?’ This is an important read for any company supplying sunscreens. Read the full article here.

Latest snapshot of all chemicals on the inventory as at 3rd January available here

Completed evaluations as at 16th December – none in January

Chemicals added to the Inventory 5 years after issue of assessment certificate (obligations to provide information apply) – as at 28 January 2025: six chemicals added, see the list here.

Variation of Inventory listing following revocation of CBI approval – none in January

Chemicals added to the inventory following issue of assessment certificate as at 8 January 2025: one chemical, Acetonitrile, 2-(2,4,4-trimethylcyclopentylidene)- CAS 1392276-61-7 – used in air fresheners. More detail here.

Additional cosmetics news contributed by Rita Sellars of pH Factor:

* Azelaic acid: this article discusses the use and poisons scheduling of azelaic acid.

* GST on sunscreens. The Australian Taxation Office (ATO) has released Draft Goods and Services Tax Determination GSTD 2024/D2, outlining the preliminary views on when the supply of sunscreen products is GST-free.
Key Points:
GST-Free Sunscreen Products: Sunscreen preparations are GST-free when they meet specific criteria under subsection 38-47(1) of the A New Tax System (Goods and Services Tax) Act 1999.
• Purpose of the Determination: This draft determination aims to clarify the GST status of sunscreen products, replacing two product classification issues previously listed in the Pharmaceutical Health Forum’s issues register.
• Public Consultation: The draft was published on 14 August 2024, with the consultation period closing on 13 September 2024. The ATO is currently considering the feedback received and will advise on the expected completion date in due course.
Implications for Consumers and Suppliers:
Once finalized, this determination will provide clear guidance on which sunscreen products are GST-free, ensuring consistency in the application of GST to these items. Suppliers should review the final determination upon its release to ensure compliance with GST obligations. Read more here at ATO website.

From CCE:

* Cosmetic Consultants Europe is hosting a live workshop “Safety Assessments of Cosmetic Packaging” on Tuesday 25th February. NOTE: CCE has offered a 10% discount for our readers, register with the code RTD. Read more and register here:

https://www.ccecosmetic.org/safety-assessment-cosmetics-packaging/

* CCE advises that Expert Speakers are requested on the topic, ‘Sustainability and Green Chemistry in Cosmetics‘ – HPCI Media UK. It is a on hour webinar on Thursday 2th Feb at 15:00 GMT. If interested please contact Steven Hanft sg@ccecosmetic.org

ACCC and similar

Nothing in January that is relevant to the heath sector.

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Providing regulatory training courses for complementary medicines, GMP, foods, cosmetics. dietary supplements.

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