Latest Regulatory Affairs Newsletter
A collection of regulatory news from this month.
Training: RFA Provides Comprehensive Training in Regulatory Affairs
COVID-19 (Coronavirus) update:
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Cosmetics and TGA Listed Sunscreens
Guidance on the New Scheme, AICIS (Starts 1 July 2020)
The government body responsible for the regulation of cosmetics in Australia has been known as the National Industrial Chemicals Notification Scheme (NICNAS). This body will change to the Australian Industrial Chemicals Introduction Scheme (AICIS) on 1 July 2020. Due to the growing impact of COVID-19, NICNAS/AICIS has decided to replace the planned stakeholder information sessions with educational videos you can watch at your own pace. These educational videos will be published in the coming weeks. Source: NICNAS / AICIS videos
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
COVID-19 (Coronavirus) News:
Hand Sanitiser Update
Hand sanitisers in Australia are regulated as ‘cosmetics’, ‘therapeutic‘ or ‘excluded’ goods via the new Therapeutic Goods (Excluded Goods-Hand Sanitisers) Determination 2020 . This means these products are excluded from Therapeutic Goods Administration regulation for the duration of the COVID-19. These excluded hand sanitisers must contain only the following ingredients:
- EITHER ethanol 80% v/v (pharmacopoeial grade or food standard grade) OR isopropyl alcohol 75% v/v (pharmacopoeial grade) in an aqueous solution;
- sterile distilled water or boiled cold water;
- glycerol 1.45% v/v (pharmacopoeial grade);
- hydrogen peroxide 0.125% v/v (pharmacopoeial grade); and
- cannot contain any other active or inactive ingredients, including colours, fragrances or emollients.
There are strict requirements for labelling of these products. Manufacturers must also test the alcohol concentrations of each batch, manufacture under sanitary conditions and maintain production record-keeping.
Product Claims in a Time of Corona Virus
If you are looking to promote your health or hygiene products in relation to the treatment of COVID-19 please check out the following links: TGA requirements for hard surface disinfectants and alcohol based hand sanitisers (i.e. claims, any additional test data required, label updates, process for change etc.); TGA Advertising requirements as detailed in the Therapeutic Goods Advertising Code, and, Australian Consumer Law provisions relevant to product claims. (Please see also: The risk of infection via surfaces and the new coronavirus )
Warning About Products Claiming to Treat or Prevent the Novel Coronavirus
The Therapeutic Goods Administration (TGA) has identified certain therapeutic goods such as complementary medicines or disinfectants being inappropriately promoted for the prevention or treatment of novel coronavirus (2019-nCoV) infections in Australia. The advertising of therapeutic goods to consumers in Australia is subject to legislative requirements administered by the TGA. The promotion of therapeutic goods to consumers for the prevention or treatment of novel coronavirus is likely to contravene the legislative requirements for a range of reasons, including unsupported claims or making a restricted representation. The TGA reminds advertisers to be very careful when considering making therapeutic claims related to novel coronavirus. Source: COVID-19 advertising (Please see also: COVID-19: China, Vietnam, Australia and Singapore caution against fraudulent health claims )
Surrogate Viruses for Use in Disinfectant Efficacy Tests to Justify Claims Against COVID-19
Sponsors and manufacturers wishing to make label claims of efficacy against COVID-19 for products that are either hard surface disinfectants or disinfectants that are medical devices, the following surrogate viruses can be used: Human coronavirus 229E, and, Murine hepatitis virus. Consideration will also be given to use of other human or animal coronaviruses. Viruses that have been suggested include Bovine coronavirus and Feline coronavirus. Source: Virus disinfectants
Australian and New Zealand Complementary Medicine Firms Seek Clarification on ‘Essential Services’ Status
The complementary medicine (dietary supplement) industry bodies in both Australia and New Zealand are seeking clarification that the sector is classed as an ‘essential service’, with both countries imposing movement restriction to curb the spread of COVID-19. Source: (Copyright): Tingmin Koe, NutraIngredients-Asia 'Essential service' status
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