Latest Regulatory Affairs Newsletter
A collection of regulatory news from this month.
Complementary Medicines and Medical Devices
New TGA fees now in place
TGA fees rise at the beginning of the financial year i.e. the 1st July. For nonprescription medicines go here. The application fee for a listed complementary medicine has risen by $10 is now AUD$870 and the annual charge has also increased by $10 to $1,170. For all other fees for medicines including complementary medicines and medical devices, go here and select “2021-22”
Guidance on regulation of vaping products
For health practitioners, consumers and importers. Source: TGA
Button batteries in medical devices for domestic use
Button batteries continue to be of concern due to the potential for young children to ingest them. Source: TGA
Aidacare fined $26,640 for alleged non-compliance with requests for face masks information TGA
V P & Associates fined $26,640 for alleged unlawful advertising of Liquim in relation to SARS-CoV-2 coronavirus TGA
Queensland man fined $7,992 for alleged unlawful importation of nootropic 'smart drugs'. Three infringement notices have been issued to a Queensland man for the alleged unlawful importation of a medicine containing Armodafinil, which is a prescription only medicine and popularly known as a “smart drug”. TGA. See also TGA alert on “smart drugs”.
Dentist fined $5,328 for alleged unlawful importation of injectables TGA.
Compliance reviews of listed complementary medicines
This list published in June summarises the outcomes of 15 medicines compliance reviews. Some products passed, others needed some corrective action, and some were cancelled. Source: TGA. Search by “Publication date” to see recent entries.
Laboratory test results
There is a minimum delay of 6 months between the testing and publication of results, to allow the TGA to undertake any investigations and follow-up action in response to non-complying test results. Source: TGA. Click on “Release date” for latest entries.
More news on regulation of faecal microbiota transplant products
What are FMT products, what are they used or, when does the regulation commence, what action is required, how can you source these products. Source: TGA
Counterfeit human growth hormone products
The TGA, in conjunction with Sandoz and Novartis Australia, has investigated reports of counterfeit Somatropin HGH vials in community circulation. The product is labelled as “Novartis-Bio Somatropin HGH (191 amino acid sequence rDNA origin for injection) 3.7mg per Vial (10x10IU Vials of Somatropin)”. Source: TGA
Cosmetics, Personal Care and TGA Listed Sunscreens:
Registration of a business that imports industrial chemicals
This is relevant to any business that imports cosmetics or ingredients to be used in cosmetics. This summary guide explains who must register, and which chemicals do not require categorisation and registration. Source: AICIS
List of chemicals added to the Inventory during May 2021
10 chemicals listed by name and CAS numbers. Source: AICIS
Banned or restricted chemicals
In Australia, there is no single list of banned or restricted chemicals that you can view or download. Bans and restrictions on chemicals and consumer product ingredients – including cosmetics – are regulated by each state and territory authority. This guide lists a number of sources of chemical legislation. Source: AICIS
Cosmetics and therapeutics
Products are determined to be either ‘cosmetics’ or ‘therapeutic goods’ based on three factors:
- the primary use of the product
- the ingredients in the product
- the claims made about the product
A cosmetic product is a substance designed to be used on any external part of the body – or inside the mouth – to change its odour or appearance, cleanse it, keep it in good condition or protect it. Source: AICIS
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
Australian and New Zealand honey producers in dispute over the word Manuka
The New Zealand government is throwing its support behind the Manuka Honey Appellation Society, which represents a group of New Zealand producers, for a certification mark on the word “manuka”. The Australian Manuka Honey Association is opposing the application. Manuka honey is produced from the nectar of Leptospermum scoparium, which is indigenous to both Australia and New Zealand. Source: Sydney Morning Herald
Recall of “Yummy” snacks due to presence of soy and wheat
Yummy Snack Foods has recalled their Pink Berry Bliss, Drake Brand Strawberry Yoghurt Mix, Yummy Brand Choc Orange Lounge Mix, and Drake Brand Chocolate Orange Mix (400g) with all best before dates. The recall was due to the presence of undeclared allergens, soy and wheat. Source: news.com.au.
FSANZ calls for comment: Processing aid from a new source
FSANZ is calling for comment on an application to allow an already approved processing aid to be produced from a new genetically modified (GM) source. The enzyme β-galactosidase is already approved in the Food Standards Code and has a long history of safe use. This application is looking to produce the same enzyme from a GM strain of Bacillus subtilis. Source: FSANZ
Review of the standard for Infant Formula
FSANZ is calling for comments on Proposal P1028– Infant Formula Products Consultation paper 1. To read about the background and learn how to make a submission, refer to FSANZ website. Also at this site there is information on a proposed new method of analysing for dietary fibre - the AOAC method 2017.16 (Rapid Integrated Total Dietary Fibre Method).
Failing Food Report – March 2021
Foods inspected at the border, includes risk food test results (Listeria monocytogenes, Salmonella, E. coli, aflatoxin, hydrocyanic acid, iodine) and surveillance food test results (including additives and vitamins not permitted in certain foods). Source: Dept of Agriculture, Water and Environment
Approvals and amendments to the Food Standards Code
A1193 – Irradiation as a phytosanitary measure for all fresh fruit and vegetables
A1206 – Subtilisin from GM Bacillus licheniformis as a PA (enzyme)
A1207 – Rebaudioside M as Steviol Glycoside
A1216 – Food derived from herbicide-tolerant canola line MON94100
Application A1205 – Disodium Adenosine 5’ Triphosphate as a nutritive substance in sport foods: Application to amend the Food Standards Code to permit the use of Disodium Adenosine 5’ Triphosphate (Na2ATP) as a nutritive substance in Standard 2.9.4 - Formulated Supplementary Sports Foods.
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