Complementary Medicines and Medical Devices:

Revised list of ingredients permitted in listed complementary medicines.

Listed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2022, which commenced on 18 January 2022. This web page includes a list of the 22 changed ingredients.    Source: TGA

 

New Compositional guideline: 2'-Fucosyllactose

An addition to the list of ingredients permitted in listed medicines Source: TGA

 

New Compositional guideline: Lacto-N-tetraose

An addition to the list of ingredients permitted in listed medicines.    Source: TGA

 

The Advertising Code and naming therapeutic goods

This is useful guidance on how to ensure the name of the product complies with the advertising code. Topics include: an ad must not claim that the goods are infallible, unfailing, magical or miraculous, must not be false or misleading, and not claim that the product is safe, or without harm or side-effects, or is effective in all cases. Links are provided to more information:

Source: TGA

 

Compliance enforcement

Commcare (St Francis Pharmacy) fined $39,960 for unlawful advertising of medicinal cannabis products which were not included on the Australian Register of Therapeutic Goods (ARTGC) and were promoted for the treatment of fibromyalgia.    Source: TGA

Rick's Hemp Oil Full Spectrum Hemp Supplement “a serious risk to health”. TGA testing found the undeclared substances cannabidiol (CBD) and the cannabinoid cannabichromene (CBC) in the oil; and high levels of the undeclared substance delta-9-tetrahydrocannabinol (THC).    Source: TGA

SA individual fined $7,992 for alleged unlawful advertising of medicinal cannabis for treatment of serious conditions, including cancer, autism, epilepsy and Alzheimer's disease.    Source: TGA

Ezy Company Pty Ltd fined $26,640 for alleged unlawful importation of COVID-19 rapid antigen tests and nicotine vaping products.    Source: TGA

 

TGA to review listed medicines requiring a pregnancy warning statement

TGA is initiating targeted compliance reviews of selected listed medicines that require warning statements related to use during pregnancy.    Source: TGA

 

Notice of final decisions to amend (or not amend) the current Poisons Standard

Various compounds including amygdalin and hydrocyanic acid, and ingredients used in hand sanitisers.    Source: TGA

 

Therapeutic Goods Advertising Consultative Committee

The TGACC comprises a range of stakeholder organisations with an interest in the advertising of therapeutic goods in Australia. Communique regarding the revised adverting code released 21st December.    Source: TGA

 

Medical devices that do not meet the Essential Principles for safety and performance

In such circumstances sponsors may request consent to import, supply or export, for a limited time, medical devices which do not meet an Essential Principle. A guide to how to complete an application for consent.    Source: TGA

 

Guidance on the regulation of listed disinfectants

How to ensure your product meets requirements and what claims can be made.    Source: TGA

ALSO

FAQ for new sponsors of disinfectants TGA

 

Regulator Performance Framework

The TGA’s Self-assessment Report July 2020 - June 2021 has been released.    Source: TGA

 

Listed medicine compliance reviews

A Released on 22nd December, a list of 13 products, indicating the outcomes of the reviews and any action taken. Some of the reviews were targeted to check compliance with quantity restrictions for safrole.    Source: TGA

 

Consultation: Potential reforms to medicinal cannabis manufacturing, labelling and packaging requirement

A further update on the proposed reforms which remain on track for commencement in March 2022.    Source: TGA

 

Notification of amendments to the Poisons Standard

Includes delegate-only decisions in relation to iron compounds.    Source: TGA

 

 

Foods:

Company pays penalties of $36,640 for misleading claim on “pure” vanilla extract

HBC Trading labelled the product as “alcohol free pure vanilla extract” and placed an image of vanilla beans and a vanilla flower on the label, despite the extract containing ingredients not derived from vanilla beans. This included flavouring in the form of vanillin derived from clove oil, as well as added colour, glycerine and xanthan gum.    Source: ACCC

 

Media story about “food fraud”

“The known unknown: Inside Australia’s $3 billion food fraud puzzle” was published in the Sydney Morning Herald. There is a particular focus on herbs, with this comment from Deakin University Professor Rebecca Lester: “In some of the mixes, none of the species that were labelled were actually in the jar”.    Source: SMH

 

FSANZ calls for public comment, and how to make a submission

Application A1232 - Food derived from drought-tolerant wheat line IND-00412-7​: To seek approval for food derived from wheat line IND-00412-7, genetically modified for drought-tolerance.

Application A1233 - 2′-FL from new GM source for infant formula: To permit 2′-fucosyllactose (2′-FL), produced by genetically modified Escherichia coli K-12, in infant formula products.

​​Application A1231 – Maltogenic alpha-amylase from GM Escherichia coli as a processing aid (enzyme):​ To approve the use of maltogenic alpha amylase, sourced from GM Escherichia coli, as a processing aid in baking, brewing and starch processing.

​​​Proposal P1052 – Primary Production and Processing Requirements for Horticulture (Berries, Leafy Vegetables and Melons): To consider primary production and processing requirements to address food safety for horticultural products.

Updated 20th January 2022.    Source: FSANZ

 

Recalls listed on NSW Health Authority

Saputo Dairy Australia Pty Ltd Butter and Spreadable Butter Blend Products

Fresh Food Enterprises IQ Bars

Tohato Caramel Corn Original Flavour 80g

Detox Tea with added Probiotics (20 Tea Bags) 30g

Godiva Chocolate Domes Milk Chocolate Coconut Crunch

Indulge Butterscotch Pear Gourmet Ice Cream 1L

House of Biskota Gluten Free Choc Almond Biscuits

Source: NSW Food Authority

 

Why is food recalled?

Explanatory notes include what to do if you need to recall a food, how to prepare for a recall, why food is recalled and types of food recalls.    Source: FSNAZ

 

FSANZ work plan

Includes Applications received and proposals prepared from 1 October 2007 onwards, as well as Applications received and proposals prepared before 1 October 2007. Updated 20th Jan 2002.    Source: FSANZ

 

Remote food safety audits to continue until 30 June 2022

COVID has restricted movements of auditors. Remote compliance audits from NSW Food Authority staff or approved Third Party Auditors, will be extended until 30 June 2022 unless otherwise advised.    Source: NSW Food Authority

 

 

Cosmetics, Personal Care and TGA Listed Sunscreens:

Recall: 'Banana Boat' Sunscreen Sprays SPF 50+ (aerosol)

Benzene was detected in 4 batches of three products supplied. Benzene is classified as a human carcinogen, a substance that could potentially cause cancer depending on the level and extent of exposure.    Source: TGA

 

Withdrawing pre-introduction reports

PIRs are once-off mandatory reports only for introductions of chemicals under the reported category. You submit them online through AICIS Business Services. You can now withdraw a PIR online in AICIS Business Services after you have submitted it.    Source: AICIS

 

Notice of completed evaluations - 14 January 2022

24 evaluations about the human health and environmental risks associated with the use of certain chemicals have just been published.    Source: AICIS

 

List of chemicals added to the inventory 5 years after issue of certificate

Three chemicals added to the inventory on 21st December.    Source: AICIS

 

Variation of inventory listing

Two variations published on 21st December.    Source: AICIS

 

Regulatory requirements and obligations that started on 10 December 2021

Includes Pre-introduction report requirement relating to nanoscale chemicals for research and development, permission to use international assessment report, record-keeping for 'designated kind of release into the environment'.    Source: AICIS

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