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. General information is here and details about the changes can be seen here.

Recalls

* Caruso’s Natural Health – WEE LESS, BLOAT EZE and ASHWAGANDHA 7500 – due to tampering. Packs contained unknown capsules that are different in appearance. Source: TGA

* Omnipod DASH personal management system, works with a pod to dispense insulin. After the 3G network disconnection, the device is constantly trying to look for a network which depletes the battery much faster than normal operations. Source: TGA

* Accu-Chek Spirit 3.15 ml cartridge system – here is a potential for insulin leakage due to a manufacturing problem. Source: TGA

* Pacemakers: some ACCOLADE™ dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST™ cardiac resynchronization therapy pacemakers (CRT-Ps) have an increased risk of permanently entering Safety Mode which has limited functionality. 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

Consultations

Consultation on changes to 6 forms and processes, with closing dates ranging from 8th November 2024 up until 31st July 2029. See the full list here.

Traditional Chinese medicines are tested for elemental impurities. Information for consumers and medicine sponsors can be found here.

Medical research: $160 million Medical Research Support Program has been announced by NSW Health to support eligible independent institutes by funding the indirect costs of research, such as equipment and staff. Source: NSW Health

Compliance action
* A Sunshine Coast tobacconist has been fined $37,560 for the alleged unlawful possession of a commercial quantity of vaping goods, Source: TGA
* Multiple operations since October have resulted in the seizure of large amounts of illegal vapes, tobacco, cannabis, and counterfeit medicines. Source: TGA

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

Safety alerts –

* Maxman tablets contain undeclared sildenafil. TGA

* Dynamint X tablets contain undeclared tadalafil. TGA

* Goldmax Blue contain undeclared tadalafil. TGA

Labelling guidelines – some minor changes to the labelling orders, here

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

USA news –
Alkemist Labs Releases List Of “Herbs & Fungi We’re Watching” for Second Half of 2024, Naming 20 Ingredients Requiring Extra Scrutiny. Full list on LinkedIn post.

New Zealand

Repeal Bill implements a ‘lift-and-shift’ of the Dietary Supplements Regulations 1985.

The amendment also included two changes to the Regulations themselves:
•    Inserting a clause that provides that the adopted joint food standards do not apply to dietary supplements. Despite this, changes can be made in the future to the Regulations to adopt joint food standards where necessary.
•    Revoking Part 3 (Offences and penalty) of the Regulations. This means that the offences, penalties and defences under the Food Act 2014 apply to dietary supplements in the same way as for other “food” regulated under the Act.
As a practical consequence of the amendment, the Regulations will no longer expire on 1 March 2026 and will, instead, continue in force until amended or revoked. Source: NZ Ministry of Health newsletter.

In the press:

Traditional Thai medicine kratom hailed as wonder drug in US, but comes with risks. Source: ABC.net.au

Foods