Latest Regulatory Affairs Newsletter

A collection of regulatory news from this month.

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

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

Changes to the inspection of some imported food

Kava products are classified as “risk food”. Commercial imports of kava will be inspected to verify compliance with food standards. Other foods that have had their status changed include ready-to-eat berries, ready-to-eat pomegranate arils, and bivalve molluscs.    Source: Dept Agriculture, water and Environment and FSANZ

 

27th Australian Total Diet Study

This looked at levels of per- and poly-fluoroalkyl substances (PFAS) in food. The results show that Australian consumers' exposure to PFAS through food is very low and poses no food safety concerns.    Source: FSANZ

 

FSANZ calls for comments, and applications received

Food made from a genetically modified wheat line IND-00412-7    Source: FSANZ

FSANZ has accepted an application to extend the use of Danisco New Zealand Ltd.'s alpha-glucosidase enzyme, previously assessed in application for use as processing aid in brewing. An opportunity to comment will be available at a later date.    Source: FSANZ

Urgent review of the food standard for kava. This review supports a Federal Government pilot program that will allow commercial importation of kava into Australia to build stronger cultural and economic ties with Pacific Island nations. FSANZ has invited submissions.    Source: FSANZ

Application to permit 2′-fucosyllactose (2′-FL), produced by genetically modified Escherichia coli K-12, in infant formula products.    Source: FSANZ

The use of a steviol glycoside mixture, Rebaudioside MD, that is produced by fermentation from a genetically modified Yarrowia lipolytica, permitted for use as an intense sweetener.    Source: FSANZ

 

NSW retail food enforcement

The annual report showing the sector continues to demonstrate strong food safety outcomes with a 97% compliance rate for the year. Reports received for the 1 July 2020 to 30 June 2021 period show 479 authorised officers conducted almost 45,000 food safety inspections of the approximately 40,000 fixed retail food.    Source: NSW Food Authority

 

Failing food reports for October 2021

Risk food test results – salmonella, hydrocyanic acid, aflatoxin, arsenic and iodine.    Source: Dept Agriculture, water and Environment

Surveillance food tests – non-permitted ingredients including vitamins and minerals.    Source: Dept Agriculture, water and Environment

Step by step guide to categorising your chemical importation and manufacture

With supporting self-guided decision tools helps you categorise your chemical introduction as listed or exempted or reported or assessed.    Source: AICIS

 

Infringement notice issued to chemical supply business

AICIS Compliance has issued a 60 penalty unit infringement notice of $13,320 to a business in Sydney which unlawfully imported industrial chemicals without being registered with AICIS.    Source: AICIS

New advertising code

New Therapeutic Goods Advertising Code commences 1 January 2022. Advertisers have until 30 June 2022 to transition to the new code. Key changes include simplifying mandatory statements, clarifying that paid or incentivised testimonials cannot be included in advertisements, expanded list of permitted product samples, various improved definitions, and prohibition of advertisements causing undue alarm, fear or distress.    Source: TGA

 

Large numbers of illegal nicotine vaping products seized in a joint TGA-ACT Health operation

Dangerous and prohibited ingredients were found in two out of every three nicotine vaping products tested after a joint operation resulting from consumer tip-offs. Six prohibited ingredients were found, including the flavouring agent diacetyl, which when inhaled can cause irreversible lung damage.    Source: TGA

 

New TGA website searching tool

Search by product name, AUST L or AUST R number, active ingredient, non-active ingredient, product sponsor. Trial version is available now at https://compliance.health.gov.au/artg/

 

Compliance enforcement

In our March 2020 newsletter we reported that the TGA had issued penalty notices to Oxymed Australia and its director Malcom Hooper totalling $63,000 for illegal advertising of hyperbaric oxygen therapy chambers as a cure for serious diseases. The penalty notices were not paid, so the matter was taken to the Federal Court of Australia, which has ordered Malcom Hooper and Oxymed Australia to pay fines totalling $3,000,000. Source: TGA

NSW individual fined $7,992 for alleged unlawful advertising of ivermectin and zinc for COVID-19. TGA

KL4 Pty Ltd (Medcure) fined $106,560 for alleged unlawful importation of Ayurvedic medicines. TGA

 

Compounded medicines and GMP

TGA has produced a draft updated guidance and is calling for comments.    Source: TGA also here

 

Warning on importation of counterfeit Ivermecitin

Laboratory testing has confirmed that Iversun-12, Covimectin-12, and Ivilife-12, labelled as containing 12 mg, contain less than what is declared on the labels. It is illegal to advertise the sale of ivermecetin and it is not permitted to be used in the treatment of COVID.    Source: TGA

 

First aid kits containing medicines and medical devices

First aid kits always contain at least one medical device, and therefore are regulated as medical devices.    Source: TGA

 

News story: “Inside the TGA”

Subtitled “Fake blood, artificial stomachs and state-of-the-art technology” this article was published in the press and is an interesting overview of the TGA’s activities, including additional testing done 7 days a week on surgical masks during the COVID pandemic. TGA staff includes 750 scientists, medical experts, engineers and pharmacists, former police officers, spies and lawyers!    Source: Sydney Morning Herald

 

Software based medical devices

A list of FAQ explains if your product comes under TGA regulations, and what your obligations are.    Source: TGA

 

Australian TGA licensed manufacturers

When can your licence be suspended or revoked? New guidance document.    Source: TGA

How can I apply to vary my manufacturing licence? A step-by-sept guide. TGA

 

Overseas manufacturers

When can an overseas manufacturer obtain GMP certification, via an application submitted by the Australian sponsor or agent (regulatory consultant). Another “step-by-step” guide. TGA

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