Latest Regulatory Affairs Newsletter
A collection of regulatory news from this month.
Complementary medicines ('Dietary supplements')
TGA Suspends Overseas GMP Inspections and QMS Audits Until Further Notice
Consistent with the Australian Government's latest travel restrictions, the TGA has suspended all overseas GMP (Good Manufacturing Practice) inspections and QMS (Quality Management System) audits until further notice. Currently there is no impact on domestic inspections and audits; however, the TGA is continuing to monitor the situation and will provide updates should there be any change to this position. Source: GMP inspections suspended
Update on Proposed Clarification that Certain Sports Supplements are Therapeutic Goods
A public consultation was held in late 2019 on a proposal to clarify that certain sports supplements are therapeutic goods. After consideration of stakeholder submissions and feedback from two stakeholders, the proposal has been refined to clarify the intent of the reform and avoid unintentionally capturing food products (such as whey protein, sugar substitutes and meal replacement shakes). Source: Sports supplements
Permissible Ingredients Determination - Update to Listed Medicine Ingredients in March 2020
Listed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2020, which commenced on 2 March 2020. A total of 108 changes have been made in the updated Determination. A complete list of changed ingredients can be read here. Source: Permissible ingredients
Important Dates for 2020
31 March - Final date to make fee-free changes to expression of content on ARTG for propolis and royal jelly.
30 April - Final transition date for ingredient name harmonisation. All medicines released for supply after this date must carry the updated ingredient names.
2 May - Final transition date - all medicines containing Andrographis Paniculata must have the new warning statement.
1 September - Final transition date for all labels released for supply to comply with TGO 92.
Important Dates for 2021
2 March - Final transition date for caffeine requirements including concentration limits, dosage limits, direction for use limits, and new warning statements.
2 March - Final date to change to permitted indications to avoid cancellation by the TGA as permissible indications transition ends.
6 March - Permissible Indications Determination - Labels must be aligned with changes to indications and new warnings made in February and November 2019.
31 March - TGO 101 - Final date for compliance with TGO 101 dealing with elemental impurities and, residual solvents
Court Proceedings Commenced Against Australian Sponsor for Alleged Advertising Breaches
Proceedings in the Federal Court of Australia (Court) have commenced against Evolution Supplements Australia Pty Ltd and Mr Cumhur Keskin, the sole director and secretary of the company, for alleged breaches of the Therapeutic Goods Act 1989 (the Act). Evolution Supplements Australia and Mr Keskin are alleged to have advertised therapeutic goods not entered in the Australian Register of Therapeutic Goods (ARTG). It is also alleged that Evolution Supplements Australia and Mr Keskin continued to advertise the goods in question during 2019 despite both a warning letter and a formal direction being issued to Mr Keskin by the TGA and that this advertising is alleged to have included references to Selective Androgen Receptor Modulators (SARMs). SARMs are experimental medicines and no SARM has been fully researched or approved for human use. The use of SARMS has been linked to liver failure and increased risk of heart attack and stroke. Importing, supplying or possessing SARMs without a valid prescription, license or authority is illegal. Source: Advertising breach (Please see also SARM personal story covered in April 2019 edition of this newsletter: Tim’s Story )
Oxymed Australia Pty Ltd fined $63,000 for Alleged Advertising Breaches
The TGA has issued Oxymed Australia Pty Ltd five infringement notices, with penalties of $63,000 for alleged advertising breaches. The alleged contraventions relate to the advertising of hyperbaric oxygen therapy chambers, not included in the Australian Register of Therapeutic Goods (ARTG). Unless a specific exemption applies, therapeutic goods must be entered in the ARTG before they can be lawfully supplied or advertised in Australia. Source: Oxymed fined
India Limits Medicine Exports After Supplies Hit by Coronavirus
The coronavirus outbreak has led India to restrict the export of dozens of drugs including paracetamol, antibiotics such as tinidazole and erythromycin, the hormone progesterone, which is used in the contraceptive pill, and vitamins B12, B1 and B6. India is one of the world’s largest producers and exporters of drugs, with the US and Europe heavily reliant on the supply. Source: India's medicine restrictions
Independent Review of the Reforms to the Therapeutic Goods Advertising Framework to Commence
The independent review of the advertising reforms (the Review) has now commenced, and is being led by Ms Rosemary Sinclair AM. The Review will assess the impact of the new advertising measures as included in the Therapeutic Goods Amendment (2017 Measures No.1) Act 2018. The Review may also advise on whether further changes to the management of the regulation of therapeutic goods advertising, including complaints, are required. However, the Review will not consider the Government's decision, implemented through legislative change in 2018, to remove pre-approval for advertisements of medicines that appear in specified media from 1 July 2020. Nor will it consider the legislation other than in the context of its operational impact on the new advertising measures. Source: Independent legislative review
The Lactobacillus Taxonomy Change is Coming: Why, and How to Make the Most of it?
There are major international naming changes coming up for probiotics currently named under the Lactobacillus genus, expected to be announced during 2020. Developed with consensus by taxonomic experts, it aims to ensure a shared and stable language for identifying existing organisms and will be a historic event in the field of taxonomy leading to global impacts as well as hoped-for long-term benefits on the probiotics industry. Now and for the first time, the upcoming taxonomy change will have an unprecedented impact on probiotics – a category consumed by millions of people Worldwide and projected to reach almost 70 billion USD of market value by 2023. The two key aspects for the choice of the new classification will be to create new genera with a better homogeneity that respects the defined rules for similarity between organisms in a same genus, and most importantly, to create a stable number of genera that will accommodate future species without the need of a further reclassification. Source: Renaming probiotics (Please see also the International Scientific Association for Prebiotics and Probiotics )
Importer fined $10,000 for Importing Illegal Supplements
The owner of an online supplements business has been fined $10,000 and ordered to perform 400 hours of community service after he failed to realise products he imported from the United States contained ingredients that were illegal. Daniel Katsogiannis, 32, was charged in 2018 after the Border Force intercepted two shipments of workout supplements containing DHEA (Dehydroepiandrosterone) and DMAA (1,3-dimethylamylamine). The use of DMAA was banned in Australia by the Therapeutic Goods Administration in 2012, with the substance described as "toxic" with "dangerous side-effects". DHEA is available in supplements in the US but is classified as a steroid precursor in Australia. In an interview with authorities, Mr Katsogiannis said he didn't consider DHEA a steroid and had no idea it was illegal. DMAA was not listed as an ingredient on the product labels, so he thought he was "good to go", but the substance was found to be present in testing. Source: Georgina Mitchell, SMH DHEA import bust
How to Spot a Counterfeit Medicine
There are two types of fake medicines: products that imitate genuine medicines, and products that make false claims about their ingredients. A counterfeit medicine could have no/substandard or undeclared active ingredients. The ingredients could be illegal or dangerous, the dosage could be incorrect or there may contain contaminants from unhygienic manufacture. In countries that have strong medicines regulation, such as Australia, fake medicines are rarer, especially when bought from reputable retailers. The quickest way to spot a bogus medicine is to compare it with an authentic medicine. Medicines are manufactured with precision, so any variation in size, weight, colour, quality or embossing could indicate a forgery. If you do buy your medicines online, make sure they are listed or registered on the Australian Register of Therapeutic Goods (ARTG) Source: Counterfeit meds
Australia and New Zealand Ministerial Forum on Food Regulation Communiqué
The Australia and New Zealand Ministerial Forum on Food Regulation (the Forum) met this month via video conference to consider a range of food regulation and policy matters. The Forum comprises all Australian and New Zealand Ministers responsible for food, and the Australian Local Government Association. Matters covered included: Pregnancy warning labels on alcoholic beverages; and, Health Star Rating (HSR) System review implementation update. Source: Food regulation
Proposed Interim Import Conditions for Uncooked Prawns Imported for Human Consumption into Australia
FSANZ Releases Food Recall Statistics
Food Standards Australia and New Zealand has collected data on Australian food recalls since 1990. This data can be used to identify trends and common problems occurring in the food industry, so that steps can be taken to prevent future issues. These statistics are updated annually. Between 1 January 2010 and 31 December 2019, FSANZ coordinated 707 recalls. The average number of recalls per year for the last 10 years has risen to 71 (previously 67). For the last 10 years, most recalls have been due to undeclared allergens (283 recalls or 40% of all recalls during this period), and microbial contamination (181 recalls or 26% of all recalls during this period). Recalls due to undeclared allergens continue to increase however ‘microbial’ and ‘other’ recalls are also increasing, but at a lesser rate. Foreign matter recalls are decreasing. Source: Food recall stats
Failing Food Report – January 2020
These latest reports detail food that was found to fail under the Imported Food Inspection Scheme during the month of January. Among the usual pathogenic organisms detected in these imported foods are such organisms as Vibrio alginolyticus (found in Vietnamese prawns), Salmonella (found in Iranian pepper), Listeria (found in Italian cheese), and assorted toxins such as histamine (found in Filipino anchovies), aflatoxin (found in Malaysian peanut cake), hydrocyanic acid (found in Indian vegetable chips) and others. Of particular note are the number of foods ‘failing’ due to the illegal presence of added vitamins and or minerals (as found in Indonesian margarine). Source: January 2020 food fails
Application A1174 – Xylanase from GM Trichoderma reesei as a PA (Enzyme): The purpose of this Application is to permit the use of Xylanase from GM Trichoderma reesei as a Processing Aid. Source: Xylanase
Application A1182 – Glucose Oxidase from GM Trichoderma reesei as a Processing Aid (Enzyme): The purpose of this application is to approve a Glucose Oxidase enzyme preparation from Trichoderma reesei for use as a processing aid in cereal based products (baking) and egg processing. Source: Glucose oxidase
Application A1192 – Food derived from herbicide-tolerant corn line MON874: The purpose of this application is to seek approval for food derived from herbicide-tolerant corn line MON87429, genetically modified to provide resistance to dicamba, glufosinate, 2,4-D and the aryloxyphenoxypropionate group of herbicides (‘FOPs’). MON87429 is also genetically modified to provide tissue-specific resistance to glyphosate to facilitate the production of hybrid seeds. Source: GM corn
Proposal P1055 – Definitions for gene technology and new breeding techniques: This proposal looks at how the Food Standards Code applies to food derived using new breeding techniques (NBT foods). This proposal aims to amend the definitions in the Code to make them clearer and ensure they capture existing and emerging genetic technologies. Source: New breeding techniques
Singapore’s New Sugar-Sweetened Beverage Labelling Rules ‘Could Confuse Consumers’
Singapore has announced a colour-coded labelling scheme for pre-packaged sugar-sweetened beverages (SSBs) based on sugar content by volume – a move that has already drawn dissent from the local food and beverage industry. Source: (Copyright) Pearly Neo, Food Navigator-Asia Colour coded confusion
Complementary medicines ('Dietary supplements')
Many Suppliers of CMs Caught Out by New TGA Regulations
Suppliers of complementary medicines (CMs) in Australia are in danger, of having their products cancelled as important statutory deadlines draw near. The key dates for the changes affecting listed medicines (LMs) are: 1st September 2020 when labels must comply with Therapeutic Goods Order (TGO) 92; and 6th March 2021: when, in order to avoid cancellation, products must only use indications included in the list of pre-approved ‘permitted indications’. RFA Regulatory Affairs has noticed that many current suppliers of LMs have not yet transitioned to using permitted indications and are in danger of having their products cancelled. To assist with this, we are offering a three-step service to get your product in compliance. This includes:
- developing an evidence package for your product based on TGA permitted indications;
- revising your label to include only TGA permitted indications and complying with TGO 92; and,
- revising your product AUST L listing to only include permitted indications.
RFA Regulatory Affairs also provides training modules to help you become compliant in these areas, offering training on label compliance and preparation of evidence packages. For further details about this and all of our training courses, visit RFA Training Courses .
Caffeine Restrictions – Interim Decision and Invitation for Further Consultation
Regular readers of this newsletter will be aware that due to the recent appearance on the Australian market of highly concentrated caffeine products and one reported death, the TGA has been enacting legislation and consulting with industry, in order to restrict the way that these highly concentrated caffeine products can best be managed. In 2019, the TGA began a “first round” restriction of caffeine by making restrictions within the Permissible Ingredients Determination, which affect Listed medicines only. Among other changes, the TGA imposed a limit of 33% of caffeine in divided preparations such as tablets and capsule, and undivided preparations have been restricted to 4%, with an upcoming further restriction to 1% in 2021. Currently, there is a ‘second round’ review of restrictions for caffeine that is occurring via the Scheduling mechanisms which results in inclusion of caffeine in the Poisons Standard. Changes here affect the use of caffeine more widely and can also influence both Listed and Registered OTC medicine policy. On 6 February 2020, an interim decision and invitation for further comment was announced by the TGA. The interim Scheduling decision is open for consultation and will close on 5 March 2020. Source: Scheduling of chemicals and poisons (caffeine)
Meeting the Evidence Requirements for Marketing of Medical Devices
This guidance provided by the Therapeutic Goods Administration (TGA), assists researchers of new medical devices, including in vitro diagnostic (IVD) medical devices and software as a medical device (SaMD), to understand the evidence requirements for market authorisation. To supply a medical device in Australia, sponsors need to submit a market authorisation application to the TGA to include their medical device in the Australian Register of Therapeutic Goods (ARTG). Source: Medical device evidence (Please also see: Australian regulatory guidelines for medical devices).
Australian Company Fined for Supply and Advertising of Unapproved Dermapen Device
InSkin Cosmedics Group Pty Ltd has paid penalties of $37,800 for the supply and advertising of the Dermapen 4, a medical device that was not included on the Australian Register of Therapeutic Goods (ARTG). Australia's therapeutic goods legislation prohibits the import, export, manufacture, supply and advertising of therapeutic goods for human use that are not included in the ARTG or otherwise the subject of an exemption, approval or authority. Source: Microneedling fail
Reminder - Changes to Permissible Ingredient - Andrographis paniculata
In 2015, the TGA completed a safety review of Andrographis paniculata and anaphylactic/allergic reactions. Since then, the TGA has received a further 70 Australian reports of allergic reactions related to Andrographis paniculata and an additional 37 reports of anaphylaxis. For 11 of these cases, the sole suspected medicine contained Andrographis paniculata as the single active ingredient, with 4 of the 11 cases involving anaphylactic reactions. The TGA is aware of an additional 193 international reports which detail similar allergic-type reactions in relation to medicines containing Andrographis paniculata. Due to the risk, the following label warning statement is now required on all listed medicines containing Andrographis paniculata: 'Andrographis may cause allergic reactions in some people. If you have a severe reaction (such as anaphylaxis) stop use and seek immediate medical attention' (or words to that effect). Sponsors of existing listed medicines will need to ensure that medicines containing Andrographis paniculata that are released for supply from 2 May 2020 are compliant with the new requirements. Any new listed medicines need to comply with the new requirements immediately. Source: Allergy risk statement required
TGA Publishes Outcomes Regarding Changes to Low-Negligible Risk Permissible Ingredients
On 30 August 2019, the TGA sought comments on proposed changes to the following permissible ingredients: Boron, Withania somnifera, Vitex agnus-castus (VAC), Hydroxyisohexyl-3-cyclohexene carboxaldehyde ('HICC'), as well as a number of permissible ingredients relating to Ispaghula, Plantago, Psyllium, Cymbopogon and Malus species. All comments received for this consultation have now been considered and the proposals have now been published. These changes will commence on 2 March 2020. Source: Low risk ingredients (Please see also scheduling timetable for low-negligible risk changes for 2019-2020. Low risk ingredient schedule )
Changes to Propolis and Royal Jelly in Listed Medicine Applications – Free ARTG Entry Soon to End
The TGA has changed the listed medicine application system to allow equivalents in extracts or preparations of propolis and royal jelly to be correctly entered in the Australian Register of Therapeutic Goods (ARTG). Sponsors can now enter propolis and royal jelly preparations with equivalent starting material in a way that accurately reflects the active ingredient contained in their medicine. Sponsors of existing listed medicines should review this information before 31 March 2020 to check if they are eligible for a free correction to their ARTG entry. Source: Honey & propolis ARTG
Aussie Company Fined for Falsely Claiming to Hold Evidence for Kids Eye Care Medicine
Caruso's Natural Health Pty Ltd has paid penalties of $12,600 in response to an infringement notice issued by the Therapeutic Goods Administration (TGA). The infringement notice was issued to the company for making a false or misleading certification that it held evidence to support some of the indications for the product Caruso’s Kids Eye Care. The TGA reminds all medicine sponsors that they are required to certify/confirm that they hold evidence for all the indications and claims made about their medicine. The TGA conducts post-market compliance reviews of listed medicines, with a proportion of these selected randomly using a computer algorithm. These reviews allow the TGA to determine whether listed medicines comply with relevant regulatory requirements, including the truthfulness and accuracy of the certifications a sponsor makes at the time of listing a medicine. Caruso's Kids Eye Care was randomly selected for a compliance review which involved an assessment of the evidence held by the sponsor to support the efficacy of the medicine. Source: Caruso's false claim
Multi-Level Marketing Company Fined for Advertising Breaches
The Juice Plus Company Australia Pty Ltd has paid penalties of $37,800 after the Therapeutic Goods Administration (TGA) issued three infringement notices for alleged advertising breaches relating to vitamin products. The TGA alleged the advertisements did not comply with the therapeutic goods advertising requirements, by promoting the products for a condition that is not permitted for this medicine, and by using
health professional endorsement of the products. Direct sellers of these products should be aware that they have the same legal obligations as the company when advertising therapeutic goods and must comply with the Therapeutic Goods Advertising Code. Source: MLM court fine
“Let Medicine Be Thy Medicine, and Food Be Thy Food” – Hippocrates 460-370 BCE
Just what constitutes a medicine and what is legally categorised as a food can be a tricky point of difference at times; especially at the medicine-food interface (think ‘sports food supplements’). Generally speaking, food is for nutrition, while medicine treats or prevents disease. Whether a product is food or medicine also has important implications for how it is regulated. In Australia, medicines are regulated at a Federal level while food regulation comes under the jurisdiction of the individual states and territories. Any product that is taken orally (eaten) can be classified as food, however, a food cannot be a medicine, and a medicine cannot be a food. A product is classified as a medicine if it is represented to be a therapeutic good, likely to be taken for therapeutic use, or declared to be a therapeutic good. In Australia, we do not have a separate regulatory category for ‘dietary supplements’. All supplements are either foods or medicines, depending on the supplement's individual features. We’ve come a long way since Hippocrates wrote nearly 2,500 years ago, so please remember that foods and medicines are fundamentally different, and you wouldn't expect one to do the job of the other. Then you'll be able to enjoy food at every meal and take medicine when you need it. Source: Food V Medicine
China’s Botanical Firms in Supply Chain Battle as Global Orders Rebound for Immunity Ingredients
The COVID-19 epidemic has led to a rebound in demand for plant extracts with immune-boosting effects, but a China industry expert has warned there are difficulties in exporting the goods due to logistic supply chain problems. Source: (Copyright) Tingmin Koe, Nutraingredients-Asia Supply chain trouble
Naturally Good Expo (Sydney, Australia) 2020 Postponed Due to Coronavirus
The Naturally Good Expo will no longer take place on 1-2 June 2020, and the Business Summit will no longer take place on 29 May 2020, due to the impact COVID-19 is having on the community. The organisers are attempting to hold this Expo later in the year, in Sydney, but dates and venue are yet to be decided. Booth holders are entitled to a full refund or rollover of their bookings to the next show. Source: NGE20 postponed
ExpoWest (USA) Postponed as Community Voiced Concern About Coronavirus
After first confirming that Natural Products ExpoWest would continue as planned this month, in Anaheim, CA, the organisers of this event have now stated that it is officially postponed with the intention to announce, by mid-April, a new date. In its original decision to continue with events, announced March 1, show organisers estimated a 40-60% drop in attendance from previous years due to corporate travel restrictions and personal concerns about COVID-19, which has spread to at least 70 countries, infecting more than 90,000 people. More than 3,000 people have died. Last year Natural Products ExpoWest attracted more than 86,000 attendees from 136 countries, according to show organisers. Source: ExpoWest postponed
Training: RFA Provides Comprehensive Training in Regulatory Affairs
Government Grant Round Opens to Enhance Food Chain Traceability
The Department of Agriculture is inviting applications for grants to fund projects to enhance traceability in the food supply chain, enhancing trust in Australian-grown products and boosting the competitiveness of agricultural exporters. An initial $4 million round of Traceability Grants Program funding, opening from January 8, will be available to individuals, communities, government or private sector organisations, as well as agricultural export industries, to enhance traceability in supply chains. The program will provide opportunities for successful applicants to carry out projects that enhance product traceability and the competitiveness of Australian produce, for example by supporting assertions around organic or location-specific production. Source: Food traceability grants
Food Importers and Food Allergen Management
Importers of foods are reminded of the importance of understanding the supply chain for foods they import and any potential for allergen cross contact to inform risk management including appropriate allergen labelling. There have been several food recalls related to undeclared allergens, in Australia and internationally. Most recently, pesto and associated products were recalled because they contained an undeclared allergen (peanut). Peanut had contaminated one of the ingredients (processed cashew) used in these products. The recall included imported products and product manufactured in Australia from imported ingredients. Source: Food allergy contamination
ACCC Announces 2020 Compliance and Enforcement Priorities
The Australian Competition and Consumer Commission (ACCC) has outlined its priorities for 2020 and has stated that the growing community attention to health-related issues has led the ACCC to take a more active role in preventing deceptive conduct in the marketing of food products. “Misleading claims about health or nutritional benefits harm consumers as they often pay a higher price for products without receiving the benefits claimed,” said ACCC Chair, Rod Sims. Source: ACCC 2020 priorities
Application A1155 – 2’-FL and LNnT in infant formula and other products: The purpose of the application is to permit the voluntary use of 2’-O-fucosyllactose (2’-FL) alone or in combination with Lacto-N-neotetraose (LNnT), produced by microbial fermentation using genetically modified Escherichia coli (E.coli) strains, in infant formula products and formulated supplementary foods for young children. Source: GM E. coli in FSFYC
Application A1171 – Endo-inulinase from GM Aspergillus oryzae as a Processing aid (Enzyme): The purpose of this Application is to permit the use of Endo-Inulinase produced from a GM modified strain of Aspergillus oryzae as a Processing aid. Source: GM aspergillus 1
Application A1176 – Enzymatic production of Steviol Glycosides: The purpose of this application is to seek approval for a new specification for steviol glycosides produced by an enzymatic conversion method using enzymes derived from genetically modified strains of Escherichia coli (E. coli). Source: GM E. coli
Application A1181 – Maximum residue limits for Imazapyr in Barley Grain: The purpose of this application is to increase the maximum residue limit for imazapyr in barley grain from 0.05ppm to 0.7ppm. Source: Barley MRL
Application A1184 – Glucoamylase from GM Aspergillus niger (donor Trametes cingulata): The purpose of the application is to approve the use of glucoamylase sourced from GM Aspergillus niger containing the gene from Trametes cingulata. Source: GM aspergillus 2
Application A1185 – Alpha-amylase from GM Aspergillus niger as a processing aid (enzyme): The purpose of this application is to approve the use of Alpha-amylasee sourced from Rhizomucor pusillus in GM Aspergillus niger. Source: Aspergillus enzyme
Proposal P1050 – Pregnancy warning labels on alcoholic beverages: This proposal seeks to revise the warning statement to read: “Alcohol can cause lifelong harm to your baby” from, “Any amount of alcohol can harm your baby”, and also to revise the specific colour printing requirements of that warning text. Source: Warning statement