Latest Regulatory Affairs Newsletter
A collection of regulatory news from this month.
Complementary Medicines and Medical Devices:
Pharmacovigilance Obligations - important reading, scroll down for full story
Changes to permitted ingredients list
This explains how often and why changes are made to the list. “High-moderate risk changes” have been made for Andrographis paniculata and caffeine. Source: TGA
Consultation on proposed improvements to the Therapeutic Goods Advertising Code
Unlawful advertising of a complementary medicine
Global Therapeutics has paid penalties of $119,880 in response to nine infringement notices issued by the TGA. The infringement notices related to five listed complementary medicines sponsored by Global Therapeutics. The advertising of these medicines was alleged to refer to serious conditions without approval or permission of the TGA, contravene requirements of the Therapeutic Goods Advertising Code, and include therapeutic uses that were not accepted as indications for the medicines. Source: TGA
Peter Evans Chef Pty Ltd fioned $79,920 for alleged unlawful advertising
Fines were issued to the company for the alleged advertising of therapeutic goods that were not, at the time of advertising, included in the Australian Register of Therapeutic Goods. These include the 'BioCharger' device, hyperbaric oxygen therapy chambers and two oral medicines. This is in addition to two fines issued in 2020. Source: TGA
Warning about unlawful advertising of listed medicines
This warning is particularly relevant to products that were cancelled in March 2021 for not transitioning to only include permitted indications. Source: TGA
ACCC issues five infringement notices to Mosaic Brands for alleged false or misleading representations
Mosiac Brands has paid penalties totalling $630,000 advertising breaches related to hand sanitisers and face masks:
- Air Clean hand sanitiser sold on the NoniB website contained 70 per cent alcohol, when a sample tested by the ACCC was found to contain 17 per cent alcohol;
- Miaoyue hand sanitiser sold by Millers contained 75 per cent alcohol, when a sample tested by the ACCC was found to contain 58 per cent alcohol;
- Velcare-branded hand sanitiser products sold on its websites were ‘WHO-approved’, when they were not;
- KN95 Kids Safety Face Masks sold on its websites were ‘CE/FDA certified’, when they were not; and
- KN 95 Adult Face Masks were” non-refundable”, when in fact consumers have a statutory right to a refund under the consumer guarantee remedies.
Proposed amendments to the poisons schedule
TGA warns about some counterfeit products being sold online, and summarises how to legally obtain medicinal cannabis. It is illegal to advertise medicinal cannabis. Source: TGA
Recall - Hydralyte Strawberry Kiwi Effervescent Electrolyte Tablets
Care Pharmaceuticals is recalling 10 batches of Hydralyte Strawberry Kiwi Effervescent Electrolyte Tablets due to the presence of Carthamus tinctorius flower (safflower flower) as an inactive ingredient. The level of exposure of Carthamus tinctorius flower in this product poses an unacceptable risk if used in pregnancy. Source: TGA
‘Meeting Your Obligations’ workshop
The TGA is live streaming another ‘Meeting Your Obligations’ workshop on Wednesday 23 June 2021. This is a free event aimed at beginners unfamiliar with therapeutic goods regulation. Registration page is here.
Medical device regulation reforms
Some medical devices are to be re-classified to align, wherever possible, with the changes being introduced in European Union medical devices framework. Comprehensive summary on TGA site.
Guidance on regulation of exempt disinfectants, and regulation of listed disinfectants
Listed disinfectants may make more specific claims, but listed disinfectants must still meet certain regulation requirements even though they are not required to be included on the Australian Register of Therapeutic Goods. TGA sources: listed disinfectants and exempt disinfectants.
Changes to regulation of nicotine e-cigarettes
From 1 October 2021 you will no longer be able to buy or import nicotine e-cigarettes or nicotine vaping products from overseas websites without a valid doctor's prescription. Child resistant closures for nicotine vaping products will also become mandatory to reduce the risk to children of accidental ingestion. Source: TGA
Large number of N95 face masks ailing tests.
According to the Sydney Morning Herald, one third of N95 face masks have failed testing. In the last 12 months, 48 defect alerts have been issued and 1,022 masks have had their registration cancelled. Source: smh.com.au and TGA
Faecal microbiota transplant products (“poo transplants”)
A faecal microbiota transplant product (a) comprises, contains or is derived from human stool; and (b) is for introduction into a person for a therapeutic use. Most are regulated as biologicals. What are they used for? Refer to TGA
Sponsors of all medicines including complementary medicines, are obliged to notify the TGA who they have nominated to be their pharmacovigilance contact person. Pharmacovigilance is the science and activity related to detecting, assessing, understanding and preventing adverse effects and other medicine-related problems. As a sponsor of medicines you must:
- let the TGA know who your Australian pharmacovigilance contact person is
- have procedures in place to enable you to meet your pharmacovigilance obligations
- submit any serious adverse reaction reports to the TGA
- notify the TGA of any significant safety issues you identify
- keep records pertaining to the reporting requirements and safety for your medicine
- answer any request from the TGA for additional information within the specified timeframe.
Earlier this month the TGA announced it has issued an infringement notice for $13,320 to Arthropharm Pty Ltd for allegedly failing to provide information on a contact person responsible for medicine safety. Source: TGA
Cosmetics, Personal Care and TGA Listed Sunscreens:
New chemical report as at 15th April.
This lists the new chemical public reports published for three new chemicals. Source: AICIS.
Unregistered importer fined.
The imported chemical is known to cause a range of harmful human health effects. AICIS inspectors, with the assistance of the Australian Border Force, seized and destroyed the chemical. Fines of up to AUD$13,320 can be issued for being an unregistered importer. Source: AICIS
Chemicals that are intentionally released to the environment during use
Intentional release is any industrial use that results in the direct exposure of a chemical to the environment. It could be released directly to land, air, fresh water, marine water, biota or municipal water supplies. This covers a wide range of chemical uses and types. Source: AICIS
Update on animal testing bans
On 1 July 2020, Australia banned animal testing on new cosmetic ingredients. This means that new ingredients used exclusively in cosmetics made or sold in Australia, can’t use information from animal testing to prove their safety from this date. Source: https://animalcosmetictestban.com.au/about/
Progress on microbeads
A voluntary industry phase-out of plastic microbeads found in rinse-off personal care, cosmetic, and cleaning products, has been led by Accord Australasia (Accord) through their BeadRecede campaign, and overseen by the Commonwealth Department of Agriculture, Water and the Environment and the NSW Environment Protection Authority. Consistent with the intention of protecting the marine environment, the phase-out targets rinse-off products which are reasonably capable of entering the marine environment through normal use. Source: Department of Agriculture, Water and the Environment.
AICIS compliance and enforcement
Follow these links:
Correction to chemical names
As of 22nd April, 31 substances have had their names on the Australian Inventory of Industrial Chemicals (AIIC) changed to align with the CAS names. Source: AICIS
Complementary Medicines and Medical Devices:
TGA conducting forum on GMP
Half yearly performance snapshot: July to December 2020
The TGA prepares an annual TGA Business Plan, which identifies the priority activities being undertaken over the financial year and is available on the TGA website. This Half Yearly Performance Snapshot provides statistical information for the period 1 July 2020 to 31 December 2020 in relation to the regulation of therapeutic goods, tracking of progress against some of the priorities identified for the year. This data will be incorporated into the Annual Performance Statistics Report for the 2020-21 financial year, to be published on the TGA website in the second half of 2021. Source: TGA news
Update on the poisons scheduling of psilocybin and MDMA
An independent review has been commissioned into the therapeutic value, risks and benefits to public health outcomes for these substances. Amended timing on the scheduling process for these substances will be published on the TGA website following the completion of the independent review. Source: TGA
Changes to regulation of nicotine e-cigarettes
These changes affect nicotine e-cigarettes, nicotine vaping products (also known as eJuice, vape juice, eLiquid), and novel nicotine delivery systems, such as heat-not-burn tobacco products. They do NOT affect nicotine replacement therapies, such as sprays, patches, lozenges, chews and gums, or e-cigarette products that do not contain vaporiser nicotine. From 1st October you will no longer be able to legally buy these products from overseas websites without first talking with a GP and getting a prescription. These products cannot be sold anywhere in Australia without a doctor's prescription, and the possession and use of these products without a prescription is illegal in all states and territories except South Australia. Between 2015 and 2019, e-cigarette use by young people increased by 96 per cent in Australia. There is evidence that nicotine e-cigarettes act as a 'gateway' to smoking in youth and exposure to nicotine in adolescents may have long-term consequences for brain development. Source: TGA
Advertising health services
An advertisement for a health service is not considered an advertisement for therapeutic goods, unless you refer to therapeutic goods used in the delivery of the service in the advertisement. Products mentioned in this summary guide include cosmetic injectables, medicinal cannabis, compounding pharmacies, vaccine providers, biologics, and more. Source: TGA
Decisions to amend, or not to amend, the poisons scheduling of certain substances as at 22nd April
This mentions substances that have had their poisons scheduling amended, and those that have not been changed, and discusses the reasons for the decisions. Includes amygdalin and hydrocyanic acid, bilastine, budesonide and formoterol, azoxystrobin, triticonazole, azelaic acid, 2-hydroxyethyl methacrylate (2- HEMA), magnesium hydroxide, tetrahydrofurfuryl alcohol, cannabidiol. Source: TGA
Supply and wholesaling of medicinal cannabis products (MCP)
Both sponsors of products, and other persons who are not the sponsor, are prohibited from supplying unregistered MCP by wholesale. This guide summarises the compliance obligations associated with the storage and supply of the products. Source: TGA
Regulation of medical device software
This is a TGA presentation delivered at an industry masterclass. When is software a medical device? A summary of reforms and international alignment. Source: TGA
TGA case studies
The TGA is publishing case studies to provide examples of how regulations are enforced.
Food-medicine interface: the example given is a complaint about advertising which presented products as formulated supplementary sports foods, but included claims of a therapeutic nature, including conditions such as depression and autoimmune conditions. The company did not take sufficient action after being contacted by the TGA, so was issued infringement notices totalling $301,400 for 21 counts of advertising therapeutic goods not on the ARTG, two counts of using a prohibited representation and one count of using a restricted representation without TGA authorisation. The company paid the infringement notices.
Homeopathic melatonin: the product was not prepared according to homoeopathic principles and the amount of melatonin present was not sufficient to justify the claims. It was decided that describing these medicines as homeopathic melatonin could be misleading.
Weight loss products: the example given here is one of the “FatBlaster” products. The sponsor of the product could not provide satisfactory evidence to support the claims being made. The product was cancelled on 20 December 2019.
Restricted representations: multiple complaints were received about BioCharger, a medical device that emitted light, but was not included on the Australian Register. Claims on Facebook implied the BioCharger was capable of having an effect on COVID-19, as it was 'programmed with about a thousand different recipes, there's a couple on there for Wuhan coronavirus'. The company website contained other therapeutic claims. The company paid two infringements notices totalling $25,200. The device was being sold for $15,000.
Review of the Australia New Zealand Food Standards Code
The review commenced in July 2020. The plan is to reform the bi-national food regulation system to ensure it remains strong, robust and agile into the future. Option 1 is the status quo (proposes no legislative changes to the FSANZ Act), while Option 2 and 3 present increasingly ambitious suites of measures that could be taken to amend the FSANZ Act. You can read about this and review the consultation here, and provide your comments here. The due date for comments is 18th May.
Formulated Supplementary Sports Foods - review
A proposal has been formally prepared to review Standard 2.9.4 – Formulated supplementary sports foods. Other standard that may been involved are Standard 2.6.2 - Non-alcoholic Beverages and Brewed Soft Drinks - regulates electrolyte drinks and bases – and Standard 2.9.3 - Formulated Meal replacements and Formulated Supplementary Foods - may regulate some products used for sport. Source: FSNZ
Updated Guide to Allergen Management and Labelling
Managing the risks associated with food allergens is a major food safety challenge for food producers and suppliers. To help food businesses manage these risks the Allergen Bureau and the Australian Food and Grocery Council (AFGC) have just released an updated version of the Food Industry Guide to Allergen Management and Labelling. The update incorporates new requirements for the labelling of allergens in food arising from Proposal P1044 – Plain English Allergen Labelling. A copy of the guide is available from the Allergen Bureau and the AFGC. Source: Food Standards Newsletter
Failing food report for February 2021
This report lists food that has failed under the Imported Food Inspection Scheme during February 2021. Table 1 shows results of tests on risk foods. Five foods were rejected due to Salmonella (hulled sesame seeds), aflatoxin (two different peanut products) and histamine (two products – Maldive fish and fresh tuna). Table 2 lists other surveillance issues found with 21 different products. Five products contained vitamins not permitted in that type of food. A herbal syrup from India contained Borago officinalis (borage) which is prohibited in foods (but it is permitted in listed complementary medicines if the preparation is a fixed oil derived from the seeds). Source: Dept Agriculture.
Failing food report for March 2021
Once again, “risk food test results” includes products with listeria, salmonella, E. coli, aflatoxins, hydrocyanic acid, and one containing the prohibited plant betel nut. “Surveillance food test results” includes foods with vitamins not permitted to be added to that type of food, and other additives exceeding maximum permitted limits. Source: Dept Agriculture
Legislation update: statement of ingredients in food on labels
Standard 1.2.4: Information requirements – statement of ingredients - amended 25th Feb 2021. Source: legislation.gov.au
Legislation update: infant formula products
Incorporates a change to the requirements for inulin-type fructans and galacto‑oligosaccharides. Source: legislation.gov.au.
Approvals and amendments to the Food Standards Code
A1204 – Beta-amylase from soybean (Glycine max) as a processing aid (enzyme)
A1191 – Mono- and diglycerides of fatty acids (INS 471) as glazing agent for fruits and vegetables
A1202 – Food derived from herbicide-tolerant and insect-protected corn line DP23211. Source: FSANZ
Call for comment on a new form of Vitamin B3 (niacin)
FSANZ is calling for comment on the use of nicotinamide riboside chloride as a form of vitamin B3 in food for special medical purposes (FSMPs). If approved, nicotinamide riboside chloride would be added to the Code for use as a form of niacin in FSMPs. Source: FSANZ
Consumer information about food regulations
Published by FSANZ, this is a helpful summary to additives, chemicals in food, food safety, genetically modified foods, labelling and nutrition. Source: FSANZ
Information on food labelling
A useful guide to food labelling regulations. Topics include how to read a label, understanding claims, food production, stay safe, and labels and the law. Source: NSW Food Authority.
Name and shame register of penalty notices
NSW Health has for some time maintained a register of penalty notices issued to food establishments, searchable by date, locality, and trading name. Source: NSW Food Authority.
Recent food recalls
Include Bondi Protein Co Vegan Protein Bar (two flavours) – undeclared allergen (peanut), Naturally Good Super Paleo Breakfast Biscuits - due to potential for an increase in moisture which may lead to microbial growth, and Byron Bay Pizza Co. BBQ Birdie frozen pizza - presence of an undeclared allergen (fish), Xiang Hai Crab Flavour Crisp Chips - undeclared allergen (egg), Coles Tasmanian Smoked Salmon – incorrect Use By Date, Taylor Rd IGA Pork Chipolatas - undeclared allergens (gluten and soy). Sources: FSANZ and NSW Food Authority.
Cosmetics, Personal Care and TGA Listed Sunscreens:
Conditions placed on sunscreens that were tested by AMA Laboratories in the USA.
Sunscreens must be tested to validate the SPF claims. In August 2019 the US FDA announced that several executives and supervising laboratory technicians of AMA Laboratories had pleaded guilty to fraudulent laboratory testing. In September 2020, the TGA contacted all sponsors of Australian sunscreens notifying them of its post-market review of sunscreens. Sponsors must provide adequate justification for ongoing supply of products that have been tested by AMA Laboratories, such as additional supportive testing data conducted by an independent testing laboratory. Source: TGA
A list of chemicals added to the Inventory 5 years after issue of assessment certificate
AICIS has released a list of chemicals added to the database from 23rd February to 10th March 2021. Source: AICIS news.
Guide to categorisation of fluorinated chemicals
This is relevant to importers of products that are fluorinated chemicals. A fluorinated chemical is a chemical that contains one or more fluorine atoms. Source: AICIS
Soap making and importing
This is a useful guide for importers and manufacturers of soaps and explains when you need to register your business details. It includes information on the processes used to make soaps, and soaps made from natural or organic ingredients. Source: AICIS
Banned or restricted chemicals
Bans and restrictions on chemicals and consumer product ingredients – including cosmetics – are regulated by each state and territory authority. This explains how different chemical are regulated, and lists over 10 different government authorities that may be involved including The Standard for the Uniform Scheduling of Medicines and Poisons, The Therapeutic Goods Administration, The Australian Pesticides and Veterinary Medicines Authority, Food Standards Australia and New Zealand, The Department of the Environment and Energy, Safe Work Australia, The National Transport Commission, Australian Border Force, The Australian Competition and Consumer Commission and Australian National Security. Source: AICIS