Issue 231, November 2022
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Introduction to regulatory affairs in Australia. This one hour course would be very useful for a company outside of Australia that would like an overview of how we regulate foods, cosmetics, and complementary medicines (similar but quite different from “dietary supplements” in other countries). Course 1.01 on our website.
Sunscreens. Yes, it is coming up to sunburn season in Australia. Australia and New Zealand have the highest incidence of melanoma. This course explains what types of sunscreens are medicines (most primary sunscreens), and which are cosmetics, and the very different requirements for them. Course 1.40 on our website.
Pharmacovigilance – reminder! The deadline for completing your survey is 18th December 2022. Do our course, avoid penalties. Course 1.09.
Sports supplements. Flagged as an “import, advertising and compliance priority” by the TGA for 2022 – 2023. This is a complex area but if you do our one hour course, you will be an expert. Course 1.30.
Read more about these courses at www.regulatorytrainingdirect.com.
Complementary Medicines and Medical Devices:
Update to poisons schedule. The TGA has redrafted the Poisons Standard to “ensure it aligns with modern drafting conventions and rules for Commonwealth legislative instruments, is clearer, and is easier to understand” and to “improve readability and clarity”. The current standard October 2022 Poisons Standard is still in force, with the new standard to commence on 1 February 2023. TGA explanatory notes here. (Editor’s comment: this has always been one of the most difficult to read documents, and the new version doesn’t seem to be much of an improvement! Look at the formatting on the very first page here).
“How we regulate” – a summary page added to the revised TGA website.
Listed medicine compliance reviews – TGA Information page.
TGA’s “Import, Advertising and Supply Compliance Priorities 2022-23” – include:
- Deter and address the unlawful import, advertising and supply of unapproved therapeutic goods associated with COVID-19
- Disrupt and address the unlawful import, advertising and supply of nicotine vaping products
- Ensure compliance with the requirements of the Therapeutic Goods Act 1989 across the medicinal cannabis industry
- Disrupt and address the unlawful import, manufacture, advertising and supply of unapproved performance and image enhancing therapeutic goods, including sports supplements, with a focus on products containing schedule 4 and 8 poisons
- Deter and address the unlawful import, advertising and supply of unapproved therapeutic goods used in the beauty and cosmetic dental industry
- Address the unlawful use of restricted and prohibited representations in advertisements that have not been approved or permitted, particularly those that target especially vulnerable consumers
- Deter and address the unlawful advertising of unapproved therapeutic goods on digital platforms, including for pregnancy and prenatal goods, weight loss products and hangover cures
Pharmacovigilance – reminder! The deadline for completing your survey is 18th December 2022. Pharmacovigilance is mandatory for all sponsors of medicines including complementary medicines! There are penalties for not meeting these obligations. If you do not complete this survey you might be flagged for an inspection. Source: TGA.
Reforms to the regulation of nicotine vaping products. TGA is seeking public comment. The reforms aim to prevent children and adolescents accessing the products while supporting access to products of known composition and quality for smoking cessation with a doctor’s prescription. Potential reforms include changes to border controls, pre-market assessment, strengthening the standard for quality and safety and to clarify that these products are therapeutic goods. Consultation period ends on 16th January 2023. Source: TGA.
Compliance enforcement and actions.
Medical practitioner fined $2,664 for alleged unlawful advertising of prescription-only nicotine vaping products in a social media post. Source: TGA
Natural Franchises trading as Aus Labs Research Supplements, SARMs International trading as iSARMs, Smart Labs, and the sole director of the three companies, Christopher Ramsey, pleaded guilty in a Sydney court to over 200 offences of the Therapeutic Goods Act 1989 for the manufacture, supply and advertising of unapproved therapeutic goods including selective androgen receptor modulators (SARMs) and nootropics. One product contained cardarine, a substance banned in Australia due to being a potential carcinogen. Source: TGA
Safety alert vitamin B6 and peripheral neuropathy which can occur in low doses in some people. Source: TGA
Face and nasal masks that contain high strength magnetic clips to hold the masks in place on the face. The risk is that the
Sanjin Watermelon Frost Insufflation – product alert, instructions may be misinterpreted and lead to an overdose of boron. Source: TGA
The Federal Court has sentenced Alkaloids of Australia and its former export manager for engaging in criminal cartel conduct. Alkaloids of Australia manufactures the drug hyoscine, also known as scopolamine. They pleaded guilty to 6 charges and were fined $1,987,500. The former export manager was also convicted and was sentenced to two years and eight months’ imprisonment to be served as an intensive corrections order, including 400 hours of community service. Sources: ACCC and ABC News.
JSHealth Vitamins – Detox + Debloat – missing warning statements, not recommended for children under 12 years and for people pregnant or breastfeeding due to a component of Foeniculum vulgare (fennel) seeds. Source: TGA
Omnipod DASH Personal Diabetes Manager (PDM) – battery swelling, fluid leaking from the battery and in rare cases, extreme overheating which may pose a fire hazard. Source: TGA
Vicks VapoRub Xtra Strong 100g – the jar has been incorrectly labelled as Vicks Vaporub ointment 100g when it contains the Xtra Strong formula. Source: TGA
FSANZ Food Standards News November 2022 available here
Supermarkets permitted to cooperate to reduce stockpiles of plastic waste. Following the collapse of REDcycle which was run by the RED Group, the ACCC has issued interim authorisation for Coles, Woolworths and Aldi to work together to seek to develop and implement a short-term solution for the storage, transportation, processing, recycling and/or management of soft plastics. Source: ACCC
Application to permit the addition of phytosterols, phytostanols or their esters as a novel food to plant-based milk alternatives Source: FSANZ
Feedback sought on development of new FSANZ website, set to launch in first half of 2023.
FSANZ Annual Report for 2021-2022 now available here. Includes performance outcomes, management and completions of applications and proposals, review of kava standard, electrolyte drink regulations, genetically modified food and new breeding techniques, infant formula regulations, highly concentrated caffeine products, sports foods, nutrition labelling of added sugars, energy labelling of alcoholic beverages and more! There were two million visits to the FSANZ website in 2021-2022.
Moon Dog Fizzer Alcoholic Seltzer 6% Summer Berry and Grape flavours – secondary fermentation. Source: NSW Food Authority
Chocolatier Australia Plum Puddings – have been mislabelled as Christmas Caramels or Gingerbread Chocolates. NSW Food Authority
The Protein Bread Company Vegan Egg Replacer 180g, Protein Muffin Mix 340g and Protein Pancake Mix 300g – presence of an undeclared allergen (soy). NSW Food Authority
Hoyts Food Manufacturing Poppy Seeds (100g sachet packet and 240g PET jar) – potential presence of a chemical (thebaine) due to unsafe poppy seeds entering the food supply. Source: NSW Food Authority
Cosmetics, Personal Care and TGA Listed Sunscreens:
Misleading claims about health insurance rebates for teeth aligners. The ACCC has issued penalties totalling $3.5 million to SmileDirectClub Aus Pty Ltd and its US parent company SmileDirectClub LLC for falsely claiming that consumers would get reimbursements from their health insurers for their teeth aligner products. Source: ACCC
The transition from NICNAS to AICIS has led to different rules for “chemical introductions”. AICIS has just published guidelines for introductions of 10 kg or less:
- Simpler record-keeping obligations for listed introductions up to 10 kg
- New type of reported introductions: 10 kg or less
- Guidance on submitting a pre-introduction report for 10 kg or less
- To be eligible as a reported introduction – 10 kg or less in a reported year – your introduction must meet the criteria in Step 3 of ‘Guide to categorising your chemical importation or manufacture’(updated guide)
AICIS has published have published 18 draft evaluation statements on 187 industrial chemicals and is looking for comments, open until 7th December. Read more here.
Chemicals added to the Inventory 5 years after issue of assessment certificate. (chemical names not included here, refer to AICIS link here)
New risk management recommendations register. Potential risks to human health and the environment. Link here.
Variation of Inventory listing following revocation of confidential business information approval – CAS 2093197-30-7. Source: AICIS
Published by Regulatory Training Direct www.regulatorytrainingdirect.com
Providing regulatory training courses for complementary medicines, GMP, foods, cosmetics. dietary supplements.
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