Latest Regulatory Affairs Newsletter
A collection of regulatory news from this month.
Cosmetics and TGA Listed Sunscreens:
Kimberley-Clark fined $200,000 for misleading country of origin statement
The website claimed the products were made in Australia. Source: ACCC
Correction of chemical names – updated to terminology. Source: AICIS
New Industrial chemicals – guide to preparing report
Guide to completing the most common type of pre-introduction report (PIR) – ‘highest indicative risk is low risk’. Source: AICIS
New Zealand guards against imported agricultural pests
New Zealand continues to be vigilant with imported foods that may damage their agricultural industry:
Bus driver fined NZ$4,500 for smuggling seeds and cigarettes
Auckland woman sentenced to intensive supervision for 12 months and 100 hours' community work for smuggling succulents and endangered cacti into New Zealand
And brown marmorated stink bugs continue to be a problem in both New Zealand and Australia. (Editor’s note: they are a pest on my two citrus shrubs and yes they do stink)
Maximum residue limits
Food Standards Australia New Zealand (FSANZ) today released its annual call for comment on proposed changes to Maximum Residue Limits (MRLs) for some agricultural and veterinary chemicals in food.
FSANZ Notifications and amendments
New applications: Application A1222 – Steviol glycosides from Yarrowia lipolytca:
Approval and notifications:
A1191 – Mono- and diglycerides of fatty acids (471) as a surface coating
A1202 – Food derived from insect-resistant and herbicide-tolerant corn line DP23211
Source: FSANZ media centre
Failing Food Reports November and December 2020
These latest reports detail food that was found to fail under the Imported Food Inspection Scheme. Once again, the usual pathogens were detected especially histamine, and the illegal addition of vitamins to foods including long grain rice from USA. Source: November and December.
Department of Agriculture announces changes to import conditions of some types of animal products
This notice mainly affects birds nests, table eggs, and goods that are imported in temperature-controlled containers below 10°C, that are imported for human consumption. These goods will undergo a more rigorous inspection. Source: Department of Agriculture, Water and the Environment
Department of Agriculture reviews biosecurity risks associated with importing dairy products
This review includes dairy products for human consumption manufactured from milk obtained from cattle, buffalo, sheep and goats. Source: Department of Agriculture, Water and the Environment
Pregnancy warnings on alcoholic beverages
Businesses have three years from 31 July 2020 to implement the requirements, FSANZ has published guidelines on design elements of the label and downloadable labels, and Q & A on Code requirements for pregnancy warning labels. Source: FSANZ
FSANZ Notifications and amendments
Call for comment on a new source for an enzyme processing aid - maltogenic alpha-amylase derived from Saccharomyces cerevisiae
Call for comment for food from genetically modified herbicide-tolerant canola
β-Galactosidase from Bacillus subtilis (Enzyme)
Alpha-amylase from GM Bacillus licheniformis as PA (Enzyme):
Beta-amylase from Bacillus licheniformis
Phospholipase A1 from Aspergillus niger
Source: FSANZ media centre
New Zealand Ministry of Primary Industry fines edible birds nest seller NZ$31,500
Birds nest are a potential source of avian pathogens. Source: NZ MPI
Complementary Medicines and Medical Devices:
Permitted Indications – Reminder – one week left! – If you don’t act NOW your products will be cancelled!
The deadline for all listed medicines to transition to only including permitted indications for their products is 5th March 2021. Any products that are non-compliant after this period will be cancelled. The very minimum you need to do is access your TGA product record, delete any free text indications, and ensure the only ones remaining are those on the list of permitted indications. Don’t forget - it is a legal requirement for sponsors of listed medicines to hold evidence to support the indications for use.
A new list of ingredients permitted in listed medicines has just been released. Source: Federal Register of Legislation.
AUST L(A) complementary medicines (Assessed listed medicines)
Parliament has passed a bill to provide clinical data protection for a period of 5 years.
Artemisia annua and Artemisia absinthium product recalls
TGA has announced that four products have been recalled due to the presence of high levels of artemisinin in Artemisia annua and Artemisia absinthium. The concern is an unacceptable risk if used during pregnancy. Source: TGA news
Illegal adulterated herbal products continue to be a problem
Products are regularly seized at the border, the latest is Resurrection Male Sexual Enhancement Capsules. Source: TGA news
New Zealand’s outdated dietary supplement regulations extended but to be replaced
A bill has passed through New Zealand parliament to allow an extension of the old Dietary Supplement Regulations, but there is widespread support for the development of more modern and relevant legislation to replace it. Source: Nutra Ingredients
The February 2021 update includes changes to boron and cannabidiol. Interim decisions are published for amygdalin and hydrocyanic acid, bilastine, psilocybin, magnesiun hydroxide, and other compounds.
Ex federal government senator directed to remove claims about COVID
David Leyonhjelm was advertising products containing ivermectin as a treatment for COVID. Source: TGA news.
Bajaria Global fined $26,640 for alleged unlawful importation of therapeutic goods containing betel nut
The products “Pan Masala” contained betel nut (the seed of the Areca palm Areca catechu) which is a prescription only medicine. The products were not included on the Australian Register of Therapeutic Goods (ARTG). TGA states “The Indian Journal of Medical and Paediatric Oncology published a review of the systemic adverse effects of betel nut. The journal article indicates betel nut is an addictive substance associated with a range of harmful health effects, including mouth and throat cancer. Consuming betel nut while pregnant may also be harmful to the unborn baby.” Source: TGA news
Haimex International fined $53,280 for alleged unlawful importation of medical devices
Products included infrared thermometers, rigid strapping tapes and iodine prep pads. None of the products were included on the ARTG. Source: TGA news
Federal court finds Evolution Supplements guilty of breaching advertising laws
We reported on the first story in our March 2020 newsletter. However, the director of Evolution Supplements, Mr Cumhur Keskin, failed to comply with previous directions about advertising of Selective Androgen Receptor Modulators (SARMs), and other products, when no SARM has been approved for human use. The use of SARMS has been linked to liver failure and increased risk of heart attack and stroke. Source: TGA news.
Complementary Medicines and Medical Devices:
Permitted Indications – Reminder – not much time left!
The deadline for all listed medicines to transition to only including permitted indications for their products is 5th March 2021. Any products that are non-compliant after this period will be cancelled by the TGA. The very minimum you need to do is access your TGA product record, delete any free text indications, and ensure the only ones remaining are those on the list of permitted indications. Don’t forget - it is a legal requirement for sponsors of listed medicines to hold evidence to support the indications for use. Ask us for advice!
Update list of indications for use permitted in Listed Medicines
An update to the list of permitted indications - Therapeutic Goods (Permissible Indications) Determination (No. 1) 2021 - was released on 21st January. A link to the updated list and a summary of changes can be found on TGA website.
ACCC takes Lorna Jane to court over 'Anti-virus Activewear' claims
ACCC has launched legal proceedings against Lorna Jane Pty Ltd due its publication on social media platforms, in its stores and on its website “Cure for the Spread of COVID-19? Lorna Jane Thinks So”, “With Lorna Jane Shield on our garments it meant that we were completely eliminating the possibility of spreading any deadly viruses”, and “LJ Shield – Protecting you with ANTI-VIRUS ACTIVEWEAR”. Source: ACCC
Post-market review of face masks
TGA has summarised the results of its post-market review of face masks including a list of face masks that have been cancelled. Source: TGA
Life Biotech Pty Ltd fined $106,560 for alleged non-compliance with requests for information and face mask samples in relation to COVID-19
The TGA has been conducting a post-market review of face masks. The TGA alleges that Life Biotech failed to provide samples to the TAG, failed to provide information and also provided partial, late and misleading responses to other requests. Source: TGA
Safety advisory – medicines containing Eucommia ulmoides
Medicines containing Eucommia ulmoides - (known as Du-Zhong or Tu-chung), may pose a risk for individuals with a latex allergy or sensitivity. Source: TGA
Product recall – Infants’ Friend
Due to the presence of a small amount of chloroform, there was a potential for children to consume an unacceptably high level of chloroform. Source: TGA
Quality and safety of medicinal cannabis products
The TGA is consulting on introducing GMP requirements for products manufactured overseas so they are equivalent to those manufactured domestically. Source: TGA
Test methods for cannabinoids
This method describes the analysis of samples derived from Cannabis species, specifically the assay of the primary compounds of regulatory interest [Tetrahydrocannabinolic Acid (THCA), Tetrahydrocannabinol (THC), Cannabidiolic Acid (CBDA) and Cannabidiol (CBD)] by UPLC coupled with UV or PDA. Source: TGA
Nicotine e-cigarettes now only available by prescription only
This aims to prevent adolescents and young adults from taking-up nicotine e-cigarettes while allowing current smokers to access these products for smoking cessation on their doctor's advice. The products will be available from a pharmacy on presentation of a medical doctor’s prescription. Source: TGA
Amendments to the SUSMP (“the Poisons Standard”)
Has just been released. The change to scheduling of boric acid will be of interest to suppliers of complementary medicines, cosmetics and oral hygiene products. Source: TGA
Pharmacovigilance obligations of medicine sponsors
Sponsors of medicines (including complementary medicines) have an obligation to collect and report adverse events. A “Frequently asked questions” page has been published on the TGA website here.