Latest Regulatory Affairs Newsletter

A collection of regulatory news from this month.

Ingredients added to the Inventory

The AICIS (previously NICNAS) is the regulator responsible for industrial chemicals and cosmetic ingredients.

Seven new industrial chemicals have been added to the Australian Inventory of Industrial Chemicals in accordance with section 83 of the Industrial Chemicals Act 2019 this month.    Source: Chemicals added

 

Accord's 'Hand Sanitiser Industry Benchmark for non-therapeutic products'

Accord has published a “Hand Sanitiser Industry Benchmark for non-therapeutic products” providing requirements for the quality of hand sanitiser ingredients, guidance on product performance (efficacy), safety, record keeping and quality assurance considerations, and guidance on packaging type, product claims and labelling.    Source: Industry benchmark

 

*** Learn more about AICIS and cosmetic regulatory changes***

We offer a 1 hour zoom training course on the new AICIS regulatory requirements for cosmetics and ingredient assessments. Contact us for more information by emailing This email address is being protected from spambots. You need JavaScript enabled to view it.

TGA Declares Certain Products Presented as Formulated Supplementary Sports Foods to be Medicines

The Therapeutic Goods (Declared Goods) Amendment (Sports Supplements) Order 2020) (‘the Sports Supplement Declared Goods Order’) has been released.     Source: Federal Register of Legislation

From 30 November certain sports supplements are regulated as therapeutic goods (medicines). In response to these changes, SME Assist has published a new decision tool to help those supplying sports supplements determine whether they have a therapeutic good.   See ‘Is my sports supplement a therapeutic good?

 

Failing Food Reports – August 2020

These latest reports detail food that was found to fail under the Imported Food Inspection Scheme during the month of August Among the usual pathogens detected in these imported foods are such organisms as

Salmonella (found in United Arab Emirates tahini), Listeria monocytogenes (found in Chinese crayfish), and assorted toxins such as histamine (found in Sri Lankan dried balaya tuna), and the illegal addition of vitamins to many foods.      Source: Food fails August 2020

FSANZ Notifications

Proposal P1051 – Code Revision (2020) – minor amendments to the Food Standards Code. Source: Proposal P1051

Application A1155 – 2'-FL and LNnT in infant formula and other products – Approved. FSANZ re-affirm the approval of the voluntary addition of 2′-O-fucosyllactose (2′-FL) alone or in combination with Lacto-N-neotetraose (LNnT), produced by microbial fermentation, in infant formula products and formulated supplementary foods for young children.    Source: Application A1155

FSANZ Calls for Submissions on Food Derived from Herbicide-Tolerant and Insect-Protected Corn Line DP23211

Submissions are due by 6pm 12 November 2020 in relation to Application A1202 to permit the sale and use of food derived from genetically modified (GM) corn line DP23211, which has tolerance to the herbicide glufosinate and is protected against corn rootworm insect pests.    Source: Application A1202

 

TGA Provides Latest Guidance on Medicine Label Requirements

This guidance is to help sponsors and manufacturers of medicines meet the Australian labelling requirements described in the new labelling Order TGO 92 (for non-prescription medicines).  The transition period for this Order ended on 31 August 2020. Non-prescription medicines (which includes all complementary medicines) that are released for supply on or after 1 September 2020 must comply with TGO 92.   Source: Medicine labels

TGA Lists Disinfectants for use against COVID-19 in the ARTG for Legal Supply in Australia

Claims that a disinfectant has an effect against any virus must be expressly permitted by the TGA before being used in consumer advertising (including on the label). In response to the COVID-19 pandemic, the TGA has permitted SARS-CoV-2 and COVID-19 virus claims. The following list is comprised of disinfectant products that have been entered into the Australian Register of Therapeutic Goods (ARTG) with specific claims against SARS-Cov-2 or COVID-19 on the product label.    Source: Covid sanitiser list    (Please see also story by consumer group CHOICE rating the efficacy of alcohol-based hand sanitisers ).

Post-Market Review of Face Masks: Overview

The Therapeutic Goods Administration (TGA) is undertaking a post-market review of face masks included in the Australian Register of Therapeutic Goods (ARTG). This page introduces the review and provides guidance for suppliers and users of face masks.    Source: Face-mask review.    (Please see also face-masks non-compliance notices ).

Medicine Advertiser Reminder: Additional Allergen Warnings Effective 1 September 2020

The TGA is reminding advertisers that additional mandatory health warnings for medicines containing specific allergens are required in certain advertising from 1 September 2020. The allergens, including tree nuts and tree nut products, are specified in Part of 4 of Schedule 1 of the Therapeutic Goods Advertising Code (No.2) 2018 (the Code).    Source: Allergen label warnings

Oxymed Australia Director Now in Court for Unlawful Advertising and Ignoring TGA Orders

The TGA has initiated proceedings in the Federal Court of Australia in response to Oxymed Australia Pty Ltd and its sole director, Mr Malcolm Hooper, for the alleged unlawful advertising of hyperbaric oxygen-therapy chambers. The TGA alleges the advertising promoted the devices for the treatment of serious diseases and medical conditions, including coronavirus (COVID-19), cancer, post-traumatic stress disorder and autism spectrum disorders. The TGA recently issued Oxymed Australia with five infringement notices totalling $63,000 in relation to alleged unlawful advertising. Oxymed Australia did not pay the infringement notices, and the alleged unlawful advertising continued to be present on the Oxymed Australia website after the notices were issued.     Source: Oxymed director charged

Brisbane Company Director in Court for Alleged Illegal Activity Relating to Performance Enhancing Drugs

The TGA has initiated criminal court proceedings in response to alleged breaches of the Therapeutic Goods Act 1989 by Brisbane-based company HEALTHHUB247 PTY LTD and its director. The court will hear thirty-five charges in relation to the alleged manufacture, counterfeit, supply and advertising (across the company's website, eBay, Facebook and Instagram) of performance enhancing products including Selective Androgen Receptor Modulators (SARMs). Under the Act, the manufacture and supply of therapeutic goods that are likely to result in harm or injury to any person attracts a maximum penalty of 5 years imprisonment and/or a fine of $888,000 for offences occurring on or after 1 July 2020. The Act also provides for similarly significant penalties for unlawful advertising and dealing with counterfeit goods where harm or injury is likely to result.     Source: Healthhub247 charged    (Please see also: TGA page to report breaches or questionable practices ; How to spot a dodgy health product advertisement )

*** Do you need your advertisement checked? ***

Our team has decades of experience advising clients on complying with advertising requirements – for complementary medicines, foods and cosmetics. Contact us for more information about our advertising review services or for information on our training courses by calling +61 2 9660 8027 or emailing This email address is being protected from spambots. You need JavaScript enabled to view it.  

TGA and ACCC Continue Crackdown on Companies Seeking to Profit on COVID-19 ‘Therapies’

The TGA and the Australian Competition and Consumer Commission have been kept busy in recent months as they continue their prosecution of people and companies that use the Coronavirus pandemic in their product advertising:

Markson Sparks fined $26,640 for alleged unlawful advertising of a medical device in relation to COVID-19

Notice of Final Decision to Amend the Current Poisons Standard in Relation to Melatonin

Melatonin is currently approved for monotherapy for the short-term treatment of primary insomnia characterised by poor quality of sleep in patients who are aged 55 or over. The Schedule 3 entry has been modified to more closely align with the TGA approved indication (in the interests of public safety) through the inclusion of 'monotherapy' and restriction to short-term use in the entry. The decision to restrict the indication for a melatonin medicine to monotherapy was made on the basis that the available data are not adequate to support use in combination with other hypnotic agents. Additionally, it was recommended that treatment should be limited to a maximum duration of three weeks consistent with the evidence from the pivotal efficacy study, Neurim VII.     Source: Melatonin scheduling

TGA Targets Listed Medicines at Risk of Containing Safrole

Safrole is a naturally occurring constituent at low concentrations in certain spices including sassafras, cinnamon, nutmeg, mace, star anise and black pepper. Prior to 1960, safrole was used extensively as a flavouring additive. However, animal and in-vitro studies have shown its genotoxic and carcinogenic effects, on the basis of which the use of safrole as a food and flavouring additive became strictly regulated. There are 12 ingredients approved for use in listed medicines, which may contain safrole as a constituent. Listed medicines including one or more of these ingredients could therefore be at risk of containing safrole in concentrations above the permitted limits. Listed medicines must contain no more than 0.1% of safrole when it is for internal use, and no more than 1% when it is for topical application. Listed medicines may be subject to a compliance review at any time while they remain on the Australian Register of Therapeutic Goods (ARTG). The TGA intends to determine the compliance of medicines at risk of containing safrole with relevant requirements by undertaking targeted compliance reviews.     Source: Safrole risk    (Please see also educational resources at Compliance and education for listed medicines”)

TGA Declares Certain Products Presented as Formulated Supplementary Sports Foods to be Medicines

In Australia, a sports supplement can be legally classified as either a food or a medicine. How it is classified depends on factors including the product's ingredients, marketing claims and how it is presented (including the dosage form - pill, food bar, powder etc.). Many sports supplements are appropriately marketed as Formulated Supplementary Sports Foods in Australia. However, some contain ingredients that have stimulant or other drug-like effects, such as changes to hormone levels, or are in a medicinal dosage form (e.g. tablets, pills and capsules). These products can present a higher risk to the consumer and it is therefore inappropriate to have them available for purchase as foods. A declaration has been made providing legal clarification on which sports supplements are considered therapeutic goods in Australia.   Source: Sports supplements.

Interim Decision in Relation to CBD Supply

The TGA has recently announced its interim decision to down-schedule cannabidiol to Schedule 3 status. The ruling allows for CBD to be administered as an oral, oral-mucosal or sub-lingual preparation for therapeutic use on pharmacist’s advice – no doctor’s prescription required. Total cannabinoids must comprise at least 98% CBD with the remainder being sourced from the cannabis plant only and not elsewhere. The maximum recommended daily dose has been capped at 60 mg, which many consider to be a conservatively low-dose. The real catch is that any proposed CBD products can only be supplied to the Australian market after they have been put on the Australian Register of Therapeutic Goods (ARTG). Hopeful sponsors may have trouble finding the mandatory ‘high-level evidence’, using the maximum 60 mg daily dose, required to receive product listing on the ARTG.    Sources: CBD consultation submissions ; CBD scheduling decisions ; CMA response to CBD rescheduling  (If more cannabis research is required: NHMRC medicinal cannabis clinical trials grant opportunity )

TGA Safety Advisory - Bufexamac Runs Risk of Serious Skin Reactions

Bufexamac is an over-the-counter non-steroidal anti-inflammatory drug, which is used in combination with chlorhexidine and lidocaine (lignocaine) in first aid creams that are applied to the skin. Consumers and health professionals are advised that first aid creams containing bufexamac were removed from the Australian Register of Therapeutic Goods (ARTG) on 18 September 2020 and can no longer be sold in Australia. Bufexamac is associated with a risk of serious skin reactions (also known as allergic contact dermatitis). The TGA has also determined that there is inadequate evidence that the bufexamac ingredient in these products is effective.    Source: Bufexamac removed

TGA Safety Advisory - Manasmithra Vatika (Manasamitram Pills) Ayurvedic Medicine

Ayurvedic medicines are a type of complementary medicine (sometimes known as 'traditional medicine') originating from India. The TGA is aware that Manasmithra Vatika was supplied to practitioners and patients in NSW and Victoria and is investigating a report of the presence of dangerous levels of lead and other heavy metals in this product.    Source: Heavy metal contamination

Permitted Indications - Reminder

The deadline for all listed medicines to transition to only including permitted indications for their products is 5 March 2021. Any products that are non-compliant after this period will be cancelled. It is a legal requirement for sponsors of listed medicines to hold evidence to support the indications for use. Ask us for advice if you are uncertain of your obligations.

 

NSW Government Program to Support Domestic Manufacturing of Personal Protective Equipment (PPE)

The program includes a $5 million grants scheme to establish a reliable, domestic supply of PPE products that have been critical in the response to COVID-19 including masks, gowns, disinfectant, handwash and soap or their components. The key objective is to enable the supply of PPE for industry, private health care, NGOs, government and the community more broadly. This will allow industry to restart in a COVID-safe manner without relying on disrupted and volatile international source markets. Applications closed 12 October. This is a limited program available during this financial year only or until the funds are allocated, whichever comes first.    SourcePPE Manufacturing Grants

 

Medical Device Reforms 

The TGA is undertaking a program of reform to continue to improve the safety, performance and quality of medical devices in Australia. The TGA has published the following consultations:  Consultation 1: Proposed Enhancements to Adverse Event Reporting for Medical Devices - one for industry and one for consumers. Consultation 2: Exploring options for the introduction of an Australian Unique Device Identification [UDI] System [UDI Consultation paper 2].    Source: Consultation Hub

The TGA is implementing changes to the inclusion process for Class I non-sterile, non-measuring medical devices. These changes will include enhancements to the application for inclusion in the Australian Register of Therapeutic Goods (ARTG) form; and modification of the process by which the TGA reviews applications for inclusion in the ARTG. The changes are designed to make it easier for sponsors to provide the information the TGA needs to assess Class I applications. It will also make it easier for the TGA to assess applications and reduce the need to ask sponsors for more information to inform the decision to include a device in the ARTG.    Source: TGA

 

Medical Device Post Market Compliance Dashboard

Post-market reviews are conducted by the TGA on device applications to check product compliance with legislative requirements. If you have a product included in the Australian Register of Therapeutic Goods (ARTG), it may be selected by the TGA for post-market review at any time. Previously, you would respond to a post-market review by email.  A new Post Market Review Compliance Dashboard has been developed by the TGA to replace this existing process. You can find the dashboard and a user’s guide at the TGA website.    Source: New Compliance Dashboard

 

Therapeutic Goods Administration COVID-19 proceedings

The TGA continues to be busy with the prosecution of people and companies that unlawfully use the Coronavirus pandemic in their product advertising or to market products. TTB International was fined $13,320 for alleged unlawful importation of surgical face masks    Source: Unlawful import Sydney Tools Pty Ltd was issued with two infringement notices totalling $26,640 for the alleged unlawful importation of medical face masks in relation to COVID-19 . A pharmacist was fined $2,664 and Simply Elements was fined $13,320 for alleged unlawful importation of medical face masks and Livingstone International was fined $13,320 for alleged unlawful importation of infrared thermometers Source: Unlawful import.

 

TGA Declares Certain Products Presented as Formulated Supplementary Sports Foods to be Medicines

The Therapeutic Goods (Declared Goods) Amendment (Sports Supplements) Order 2020) (‘the Sports Supplement Declared Goods Order’) has been released.    Source: Federal Register of Legislation

From 30 November sports supplements with therapeutic claims containing higher-risk ingredients must be included in the Australian Register of Therapeutic Goods (ARTG). Sports supplements with therapeutic claims that are presented as tablets, capsules or pills as long as they do not contain higher risk ingredients, have 3 years (by 30 November 2023) to comply with the requirements.    Source: TGA

 

TGA Conviction for Unlawful Advertising of Sports Supplements

As part of the TGA's investigation targeting image and performance enhancing drugs a former owner of a Canberra-based sports supplements company has been convicted on four charges, for advertising therapeutic goods (sports supplements) not included in the Australian Register of Therapeutic Goods (ARTG), and those goods were neither exempt nor excluded from the operation of the Act.    Source:Unlawful advertising of sports supplements

 

Therapeutic Goods Advertising Compliance Annual Report 2019-20 Published

During the 2019-20 reporting period, the TGA received 2,227 complaints. This is a 52% increase on 2018-19, which is attributable in part to the increase of non-compliant adverting in relation to COVID-19. The advertising of illegal therapeutic goods and the use of references to serious forms of diseases, conditions, ailments or defects (prohibited and restricted representations) without TGA authorisation were the most common breaches of the Act. The TGA issued 155 infringement notices for alleged advertising contraventions, totalling nearly $1.6 million.    Source: TGA

 

Database of TGA Listed Medicine Compliance Reviews

The TGA has published the results of the outcomes of 36 listed medicine compliance reviews.    Source: TGA

 

TGA Provides Latest Guidance on Advertising Requirements

This guidance is to help sponsors and manufacturers of medicines meet the Australian advertising requirements. This page provides guidance on submitting an application for approval to use a restricted representation and a checklist for label compliance.    Source: TGA Advertising Code

 

*** Do you need your advertisement checked? ***

Our team has decades of experience advising clients on complying with advertising requirements – for complementary medicines, foods and cosmetics. Contact us for more information about our advertising review services or for information on our training courses by calling +61 2 9660 8027 or emailing This email address is being protected from spambots. You need JavaScript enabled to view it.

 

TGA Valerian Safety Alert

Valeriana officinalis is permitted for use in listed medicines in Australia with no restrictions on dose, concentration, or type of preparation. Since 1983, the TGA has received 15 reports of liver injury in consumers taking products containing Valeriana officinalis. In ten of these cases, the products contained other ingredients that were considered likely to be responsible for the liver injury. However, in three cases, Valeriana officinalis was the only ingredient, and in two cases the other ingredients were considered to be unlikely to cause liver injury. Most cases of liver damage resolved after the use of Valeriana officinalis was discontinued. However, three cases had markers for severe liver injury, and two required hospitalisation. In response to these reports, the TGA has initiated a safety investigation.    Source: TGA Safety Alert

 

TGA Artemisia Species Safety Alert

The TGA is warning consumers and health professionals that listed medicines containing herbal ingredients from the Artemisia species should not be taken by women who are pregnant, think they may be pregnant, or intend to become pregnant. The TGA is currently further investigating this issue.    Source: TGA Safety Alert

 

Herbs containing safrole

The TGA is reviewing listed medicines that may contain safrole. Listed medicines must contain no more than 0.1% of safrole when it is for internal use, and no more than 1% when it is for topical application. The TGA has identified 12 ingredients approved for use in listed medicines, which may contain safrole as a constituent.    Source: Listed medicines at risk of containing safrole.

 

Botanical Adulterants Programme

The American Botanical Council continues it work on identifying adulteration of herbal ingredients supplied to manufacturers, this time focussing on milk thistle (Silybum marianum) fruit, with many extracts found to have negligible amounts of the important compound silymarin.    Source: Botanical Adulterants Monitor

 

Manufacturers of medicinal cannabis

Clarifications of the type of licensing required for manufacturers has been released along with technical guidance on the interpretation of the PIC/S Guide to GMP in relation to cannabis.    Source: https://www.tga.gov.au/publication/medicinal-cannabis-manufacture

 

Proposal to change the way nicotine is regulated

This is to address concerns that simple and legal access to nicotine containing e-cigarettes for smoking cessation (an “OFF RAMP” for smokers) should be permitted but there is concern about the rapid growth of youth uptake (“an “ON RAMP” for non-smokers).    Source: TGA webinar

 

 

 

FSANZ Calls for Call on a New Type of Glazing Agent for Fresh Fruit and Vegetables

Food Standards Australia New Zealand (FSANZ) is calling for comment on an Application to extend the use of an already approved additive as a glazing agent for fruit and vegetables.   Source: Glazing agent

Dept. Agriculture Announces Changes to the Inspection and Testing of some Imported Food

Food Standards Australia New Zealand provides advice on whether imported ​foods present a potential medium or high risk to public health. This advice is then used to classify food in the Imported Food Control Order and apply an appropriate inspection and testing regime through the Imported Food Inspection Scheme. This announcement is to advise importers and brokers that amendments to the Imported Food Control Order 2019 will change the way that some imported foods are inspected and tested.    Source: Food tests and inspection

Pure- and High-Caffeine Ban in Oceania Will Stay Despite New Public Review

Food Standards Australia New Zealand (FSANZ) has confirmed that the existing ban implemented on pure and highly concentrated caffeine food products will not be removed even with a new proposal underway to assess caffeine governance in the food supply.    Source: (Copyright) Pearly Neo, FoodNavigator-Asia High dose caffeine

Failing Food Reports – July 2020

These latest reports detail food that was found to fail under the Imported Food Inspection Scheme during the month of July. Among the usual pathogens detected in these imported foods are such organisms as Salmonella (found in Indian chili powder), Listeria monocytogenes  (found in Polish smoked salmon, Portuguese cheese, and Chinese cooked crawfish tails), and assorted toxins such as Hydrocyanic Acid (found in Indian tapioca chips), histamine (found in many varying dried seafoods), and the illegal addition of vitamins to many foods including Japanese cocoa powder, Italian cornflakes and Korean snack foods.      Source: Food fails July 2020  

FSANZ Notifications –

Applications A1184, A1185 – Glucoamylase from GM Aspergillus niger (enzyme).    Source: GM enzyme 1 ; GM enzyme 2 

Application A1192 – Food derived from herbicide-tolerant corn line MON87429.   Source: Glyphosate tolerance

Application A1194 – Glucoamylase from GM Trichoderma reesei as PA (enzyme).   Source: GM enzyme 4 

Application A1195 – Alpha-amylase as a processing aid (enzyme).   Source: Alcohol enzyme

Application A1196 – Food derived from nematode-protected and herbicide-tolerant soybean GMB151.   Source: Herbicide tolerance

Application A1199 – Food derived from Innate potato lines V11 & Z6.    Source: GM potato

Application A1210 - Maltogenic alpha amylase enzyme from GM Saccharomyces cerevisiae.   Source: GM enzyme 3

 

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