Latest Regulatory Affairs Newsletter

A collection of regulatory news from this month.

Applications, approvals and amendments to the Food Standards Code

FSANZ has commended assessing applications for:

The steviol glycoside, rebaudioside I, produced by enzymatic bioconversion of stevia leaf extract. The bioconversion enzymes are derived from a genetically modified yeast strain, Pichia pastoris.    Source: FSANZ

Maltogenic alpha amylase, sourced from GM Escherichia coli, as a processing aid in baking, brewing and starch processing.   SourceFSANZ

Food derived from wheat line IND-00412-7, genetically modified for drought-tolerance.   SourceFSANZ


Calls for comment on proposed changes

Summarises issues on which FSANZ has called for comment. The deadlines are mostly in September, and include nutrient composition of infant formula products, maltogenic alpha amylase enzyme from genetically modified Bacillus lichenformis, 2’-fucosyllactose in infant formula products, substances used in sports foods, and the safety of titanium dioxide as a food additive.    Source: FSANZ


Failing Food Report – June 2021

Foods inspected at the border. Includes risk food test results and surveillance food test results.    Source: Dept Agriculture, Water and the Environment


Current food recalls

Summarises recalls to up until 10th August. Four recalls in August include Leggo’s Fresh Napoli Sauce, Conroy’s smallgoods, Jordan Rover dates and Koo canned mixed vegetable varieties.    Source: FSANZ.


Biosecurity import conditions

BICON is the Australian Government's database of more than 20,000 plants, animals, minerals and biological products. You can search the database to determine what import conditions may exist and if an import permit is required.    Source: Dept of Agriculture, Water and the Environment


26th Australian Total Diet Study published

FSANZ has released the results of the study which looked at levels of persistent organic pollutants including dioxins, dioxin-like compounds and polychlorinated biphenyls (PCBs) in food. Chief Executive Officer Mark Booth said the results are good news.    Source: FSANZ

New permitted ingredients for listed medicines

The Permissible Ingredients Determination (ingredients that may be use in listed complementary medicines) has been revised. 61 ingredients have been either added to the list, or had names, restrictions or label statements changed.    Source: TGA


Proposed changes to permitted ingredients list

Closing date for comments is Wednesday 15th September. Proposed changes address: Allergen statement for mollusc-derived ingredients - Peripheral neuropathy associated with lower dose vitamin B6 - Risk to infants from nasal use of benzalkonium chloride - Artemisinin and pregnancy risk. Click on link to view more details and respond to the consultation.    Source: TGA.


Compliance enforcement

Evolution Supplements Australia and its Director fined $12 million for advertising a range of unapproved sports products, including references to steroids, Selective Androgen Receptor Modulators (SARMs) and pre-workout products containing DMAA and other amphetamine derivatives. This is the largest penalty ever imposed by the Federal Court in relation to the Therapeutic Goods Act. The company Director failed to comply with TGA directions and attempted to conceal the unlawful advertising.    Source: TGA

Canberra dental practice issued with 20 infringement notices totalling $266,400 for importation and supply of unapproved dental implants and bone grafts.    Source: TGA

Gold Ant tablets seized and future shipments will be stopped at the border. The tablets contain the undeclared substance Sildenafil, a prescription-only medicine.    Source: TGA

He Absolute King sachets will be intercepted and destroyed by Australian Border Force as they contain undeclared Tadalafil.    Source: TGA

AB SLIM Slim-cellulose capsule tested and found to contain undisclosed sibutramine. Shipments will be destroyed at the border.    Source: TGA


Local GMP inspections

Where appropriate, these will take remotely during the COVD pandemic in place of on-site inspections.    Source: TGA.


Advertising nicotine vaping products

TGA has allowed pharmacies and pharmacy marketing to groups to promote that they are able to dispense nicotine vaping products (such as nicotine e-cigarettes, nicotine pods and liquid nicotine) on prescription.    Source: TGA


Post-market review of face masks

TGA is continuing its post-market reviews. List of cancelled products, non-compliance notices and other action are detailed.    Source: TGA


Guidance on regulation of personal protective equipment

Includes overview of regulations, manufacturing and standards, relevant to surgical masks and respirators, surgical gowns and gloves.    Source: TGA


Borderline disinfectant and related products with antiviral claims including COVID-19

This is a guide to those products that sit at the interface between consumer goods and therapeutic goods.    Source: TGA


TGA launches new information podcasts.

This is a 5 part series "Navigating Therapeutic Goods Regulations" to explain how the TGA works and includes "everything from how to supply therapeutic goods to the TGA Laboratories and remote GMP inspections".    Source: TGA


Independent review on MDMA and psilocybin

The Independent Expert Panel has been established to undertake a systematic literature review of the roles of MDMA and psilocybin for the treatment of mental health conditions.    Source: TGA


Proposed refinements to the regulation of personalised medical devices

This is a comprehensive summary of 137 responses from a variety of stakeholders to the three proposals put forward. A number of alternative approaches were put forward. Submissions that gave permission to be published can be viewed here.    Source: TGA

New biosecurity website

A new website - - details measures in place to protect Australia from harmful pests, diseases and weeds. This gathers information previously found on different state and federal websites.    Source: Dept of Agriculture, Water and the Environment.


Failing Food Report - May 2021

Foods inspected at the border. Includes risk food test results (the usual suspects were identified - Salmonella, aflatoxin, hydrocyanic acid, histamine) and surveillance food test results. This month many products were found to contain vitamins and minerals not permitted.    Source: Dept Agriculture, Water and the Environment


Imported food inspection scheme

This summarises data from imported food inspections conducted from 1 January to 31 December 2020. Includes information on compliance, analytical testing (contaminants, microbiological) and other tests. Interestingly, most non-compliance was for labels that did not comply with Australian food standards, including 38.8% of labels lacked or listed either incomplete or incorrect nutritional details; 18.4% of labels lacked or listed either incomplete or incorrect ingredient lists; 16.6% of labels were non-compliant with country of origin labelling requirements; 12.4% of labels lacked importer details.    Source: Dept of Agriculture, Water and the Environment


Imported food - virtual inspections of labels

The government is accepting expressions of interest from parties interested in engaging in virtual visual label inspections for eligible imported surveillance food. This is done in real time via Microsoft Teams. Food eligible for a virtual label and visual inspection is surveillance food. However the following surveillance foods are not eligible for virtual inspections: formulated supplementary sport foods; food subject to a holding order; food subject to analytical testing. Risk food is also not eligible for label and visual virtual inspections.    Source: Dept of Agriculture, Water and the Environment.


Approvals and amendments to the Food Standards Code and calls for comment on proposed changes

Call for comment on an application to allow an existing enzyme processing aid (maltogenic alpha-amylase, which has a long history of safe use and is already approved to be sourced from another microorganism) to be produced from a new genetically modified (GM) source - a GM strain of bacterium known as Bacillus licheniformis.    Source: Food Standards Australia New Zealand

Very Low Energy Diet (VLED) Products: Application to amend the Food Standards Code to include food suited for Very Low Energy Diets (VLEDs) in foods for special medical purpose (FSMPs)    Source: Food Standards Australia New Zealand

Gazetted amendments resulting from previous applications:
Irradiation as a phytosanitary measure for all fresh fruit and vegetables
Subtilisin from GM Bacillus licheniformis as a processing aid (enzyme) Variation
Rebaudioside M as Steviol (Glycoside) Variation
Food derived from herbicide-tolerant canola line MON94100 Variation


Formulated Supplementary Sports Foods - FSANZ is now calling for data on substances for use in sports foods.     Source: Food Standards Australia and New Zealand


Restrictions on marketing of infant formula

The ACCC has reauthorised an agreement among infant formula manufacturers and importers that prohibits them from advertising and promoting infant formula directly to the public. The ACCC states "A continued ban on infant formula advertising is likely to result in public benefits by protecting rates of breastfeeding, which has significant public health benefits".    Source: ACCC


Permitted novel foods

Some foods that have been deemed to be "novel" can be used in certain circumstances. This Standard lists permitted novel foods, and specifies conditions for their use.    Source: Federal Register of Legislation.


New Zealand - comments invited on import requirements

This is relevant to "importing personal consignments of products for human consumption and personal effects". This applies to fresh and stored plant products and personal effects (not otherwise already covered by a standard) and applies to items brought into New Zealand via passengers' luggage, and air and sea freight.    Source: New Zealand Ministry for Primary Industries.

New sunscreen standard in force

New sunscreen standard in forceThe new sunscreen standard, AS/NZS 2604:2021, specifies requirements and test methods for broad spectrum and water resistant sunscreen products. Includes labelling requirements.    Source: Standards Australia

Update to regulatory guidelines for sunscreens

This is relevant to primary sunscreens, which are regulated by the TGA. Most secondary sunscreens are cosmetics, and are excluded from the therapeutic goods regulations.    Source: TGA

Using an "agent" to help you with AICIS obligations

From 1st August, manufacturers or importers of industrial chemicals (includes cosmetics) can now use an agent to help submit a 'post-introduction declaration' for exempted introductions on your behalf.    Source:  AICIS

Hemp seed oil - change of status

An interim decision has been made to exclude hemp seed oil from Schedule 9 of the poisons schedule whe used for oral consumption and when compliant with the Food Standards Code. Schedule 9 includes "Prohibited Substances". Hemp seed oil is not yet available for use in listed complemetary medicines, but that may change if an application is submitted to the TGA to have it added to the list of permitted ingredients. Full details including restrictions that apply can be viewed in this link.    Source: TGA


Compliance enforcement

Lorna Jane pays $5 million fine. In our January newsletter we reported "the ACCC takes Lorna Jane to court over 'Anti-virus Activewear' claims". The claims made by Lorna Jane about its LJ Shield Activewear included "Cure for the Spread of COVID-19? Lorna Jane Thinks So" and "LJ SHIELD is a groundbreaking technology that makes transferal of all pathogens to your Activewear (and let's face it, the one we're all thinking about is Covid-19) impossible by eliminating the virus on contact with the fabric". Lorna Jane also admitted that it had falsely represented it had a scientific or technological basis for making the 'anti-virus' claims about its LJ Shield Activewear, when no such basis existed. They also admitted that director and Chief Creative Officer, Ms Lorna Jane Clarkson, authorised and approved the LJ Shield Activewear promotional material, was involved in crafting the words and developing the imagery used in the marketing campaign, and personally made some of the false statements contained in a media release and an Instagram video.    Source: ACCC

Starpharma Holdings Limited fined $93,240 for alleged unlawful advertising of 'Viraleze' in relation to COVID-19. The TGA issued 7 infringement notices, the product was a nasal spray not registered in Australia and contained claims that it “..  that stops SARS-CoV-2, the virus that causes COVID-19”.    Source: TGA

Canberra person fined $2,664 for alleged unlawful advertising of a homoeopathic medicine in relation to COVID-19 -.    Source: TGA

Sydney person fined $10,656 for alleged unlawful advertising of medicinal cannabis. The product was not registered with the TGA, and was being marketed with claims for Alzheimer’s Disease, and as a treatment for “cancerous tumours”.    Source: TGA


Proprietary ingredients – streamlined process

TGA has implemented changes as a result of public consultation on the proposal to discontinue entering certain types of ingredient mixtures into the Proprietary Ingredients Table before they are selected into therapeutic goods applications. This proposal was limited to ingredient mixtures that contain an active ingredient (known as ‘Active Premixes’ and ‘Active Herbal Extracts’), and non-specific ‘Excipient mixes’, which do not provide sufficient information on the purpose of the mixture. The majority of respondents supported the proposal to stop processing new Active Premixes, Active Herbal Extracts, and non-specific ‘Excipient mixes’ into the Proprietary ingredients Table.     Source: TGA


New compositional guidelines

The TGA creates compositional guidelines for ingredients permitted in listed medicines that do not have a pharmacopoeial monograph. Recently published guidelines are:

Bacillus coagulans strain MTCC 5260     Source: TGA

Bittern     Source: TGA

Chondroitin Sulphate Sodium derived from fermentation of Escherichia coli     Source: TGA

Palmidrol     Source: TGA

2'-Fucosyllactose    Source: TGA


Nicotine vaping products and vaping devices

A new standard has been published - Guidance for Therapeutic Goods (Standard for Nicotine Vaping Products) Order 110 2021 (TGO 110). This is to help health practitioners, consumers, importers and other sponsors, wholesalers and manufacturers to understand the minimum safety and quality requirements that apply to unregistered products.    Source: TGA


Update on consultation on proposed enhancements to adverse event reporting for medical devices

A summary of industry and individual consumer responses to the survey has been published on the TGA Consultation Hub. The survey findings indicate that follow-up discussions should occur on some of the proposed options.    Source: TGA


Software – when is it a medical device and when is it not?

This guidance contains flow charts showing which products are regulated as medical devices, and which ones are not.    Source: TGA


Some medical devices to be re-classified

This is a project underway to investigate reclassifying a number of categories of medical devices so that they align, wherever possible, with the changes being introduced in European Union (EU) medical devices framework.    Source: TGA


Further refinement to medical device regulatory changes

TGA is seeking comment on substances that are made to go on the skin, or inside the body through an orifice, and are absorbed or dispersed. These products may fit the definition of a medicine as well as a medical device. Proposed refinements are to address this issue.    Source: TGA


ACCESS consortium of international health agencies

The TGA is a member of the Access consortium along with Health Canada, Health Sciences Authority of Singapore, Swissmedic and the UK's Medicines and Healthcare products Regulatory Agency (MHRA). The consortium's goal is to maximise international cooperation, reduce duplication, and increase each agency's capacity to ensure consumers have timely access to high quality, safe and effective therapeutic products.    Source: TGA


Amazon requires sellers of “dietary supplements” to comply with Australian regulations

Some of Amazon’s requirements include “All products must be intended for sale within Australia and comply with all laws and regulations of Australia…… All products must have an ARTG number (where required by Australian law)".    Source: Amazon


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