Issue 232, December 2022 – January 2023
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Complementary Medicines and Medical Devices:
Proposed amendments to the Poisons Standard. Consultation closes 3rd February. Incudes proposed changes to azelaic acid which is found in wheat, rye, and barley. Source: TGA
Listed medicine compliance reviews. TGA information pageupdated 15th December 2022. – TGA Information page
Nitrosamine impurities in medicines. TGA is working with other agencies internationally and has published a comprehensive information page on responsibilities for sponsors and manufacturers, as well as possible sources of contamination. Source: TGA
Pharmacovigilance inspection programme Jan – Dec 2021. A TGA overview of inspection deficiencies including a comparison of deficiencies identified in the previous reporting periods, to assist sponsors with improving their pharmacovigilance systems and preparing for pharmacovigilance inspections. 3 critical deficiencies, 37 major deficiencies and 15 minor deficiencies. Full details provided here.
TGA warning to social media influencers that advertising Ozempic (semaglutide) for weight loss is prohibited. Criminal penalties (up to $888,000 for individuals) and civil penalties (up to $1.11 million for individuals) can be imposed. Source: TGA
Product alert: NexGen Stemmed Option Tibial Component used in knee implants. Source: TGA
Vaping. This has become a controversial topic with concerns that products are marketed toward children and many imported products do not disclose the presence of nicotine.
NSW Health is urging parents to be aware of the dangers of vaping among young people. They state “Vapes contain dangerous ingredients which could cause irreversible damage to the health and development of young people. There is no such thing as a safe vape.” And “there are links between mental health concerns and vaping among young people.”
In the press:
Various articles including this one at Australian Broadcasting Commission which looks at the influence of “Big Tobacco”, illegal advertising and exploitation including products that contain up to 200 chemicals; another article from the Sydney Morning Herald talks about a push from convenience stores to sell the product behind the counter. Their association represents 7000 stores, and counts Philip Morris, British American Tobacco and Imperial Brands among its members. The Guardian states “The criminalisation of nicotine vaping risks “unintended consequences” including fuelling the black market, causing worse health outcomes and even potentially putting people in prison when we should be trying to keep them out, the Australian Alcohol and other Drugs Council (AADC) says”. This Sydney Morning Herald article talks about the government taking on “Big Tobacco” again. Victoria’s health promotion foundation is urging the federal government to act “swiftly” to stop Australian youths from vaping. Source: Australian Broadcasting Commission.
Glute Master – Maxx products. All batched of Shred Maxx, Shred Maxx Male, Shred Maxx Super Strength, Glow Maxx, Cli Maxx, X Maxx and GMax are being recalled. The products are not on the Australian Register of Therapeutic Goods and some contain 40 times the maximum permitted amount of Vitamin D in the recommended daily amount, which could result in toxic effects such as vomiting and diarrhoea after prolonged use. Source: TGA
ComforCleanse by Young Living Essential Oils recalled due to the packaging “missing a crucial warning for children and women who are pregnant, want to fall pregnant or are breastfeeding” for the ingredient fennel Source: news.com.au
GMP Forum. The TGA’s Sydney 2023 forum will be an in-person only event held at the International Convention Centre in Darling Harbour on 21st March. Topics include inspection deficiencies and trends, GMP for listed medicines, medicinal cannabis and more. View the programme for the forum here.
Medicinal cannabis reforms – manufacturing, labelling and packaging requirements. A one-hour online webinar to be held 1st February. More information and registration form here.
In the press
Influencers spruik hangover cures, but do they actually work? Are their claims based on limited evidence? Some products falsely claim to be “TGA approved”. Are they encouraging excessive consumption of alcohol? Source: : Sydney Morning Herald.
Patients report side effects after popular cosmetic procedure to dissolve facial fillers with unregulated ‘off-label’ drug hyaluronidase. Multiple side effects reported. Source: Australian Broadcasting Commission.
Social media influencers promoting diabetes drug Ozemopic as a weight loss treatment. This has led to a world-wide shortage of a drug needed by people suffering from diabetes. Source: The Guardian and Australian Broadcasting Commission.
Australia’s first fixed-site pill testing clinic – what ingredients are being found? Source: Australian Broadcasting Commission, and another article says says “Canberra’s pill-testing service discovers deadly substance in counterfeit oxycodon tablets”
New Zealand news
Supplied by Michell Cubitt, Smart Regulatory Solutions
The draft Therapeutic Products Bill is open for submissions. The close off date for submissions is 15th February. The Bill is intended to replace the Medicines Act 1981 and the Dietary Supplements Regulations 1985. It covers both oral products (dietary supplements) and topicals intending to make health function type claims. Source: New Zealand Parliament and New Zealand Legislation.
FSANZ calls for public comments:
Proposal P1010 – Review of Formulated Supplementary Sports Foods: To read the consultation paper please click here. Comments on this Proposal are due by 6pm (Canberra time) Thursday 9 March 2023
Proposal P1059 – Energy labelling on alcoholic beverages: To read the Call for Submissions Report please click here. Submissions on this Proposal are due by 6pm (Canberra time) Monday 27 February 2023.
FSANZ publishes its Work Plan current as of December 2022. PDF can be downloaded here.
Spinach: this was a huge national recall of contaminated spinach sold in several stores which resulted in multiple hospitalisations and side effects including hallucinations. The product was contaminated with jimsonweed, or Datura stramonium (also known as “Devil’s Trumpet”), which contains dangerous chemicals such as atropine, hyoscyamine, and scopolamine, which can cause serious adverse effects, including death. Sources: ACT Government Health
List of products affected at Coles Supermarkets published by FSANZ
FSANZ list of products containing Riviera Farms Baby Spinach sold at Costco.
NSW Health has issued a series of press releases including a list of reported symptoms some of which are severe, published here.
Sydney Morning Herald also reported that the farm had been previously accused of poor weed control.
Future Bake Plant Based & Gluten Free White Choc & Berry Cookie 75g – presence of an undeclared allergen (milk). Source: NSW Food Authority
Ikea Almondy Almond Cake with Daim 400g – potential presence of foreign matter (metal). Source: NSW Food Authority
Moon Dog Fizzer Alcoholic Seltzer 6% Summer Berry and Grape flavours – secondary fermentation – excess alcohol and carbonation may cause illness/injury if consumed. Source: NSW Food Authority
Watson Family Produce Pasture Raised Free Range Eggs 350g and 700g – potential microbial (Salmonella) contamination. Source: FSANZ
Nissin Big Cup Noodle Curry 120g – undeclared allergens (egg, milk, peanut, soy, sesame). FSANZ
Coles Finest Australian Washed Rind Cheese – microbial (E. coli) contamination. FSANZ
Catalano’s Seafood Fresca Fish Co Spicy Sriracha Tempura Prawns 375g – undeclared allergens (soy and gluten) FSANZ
The Yoghurt Shop Caramel Crumble Yoghurt 190g – microbial (E.coli) contamination FSANZ
Cosmetics, Personal Care and TGA Listed Sunscreens:
ACCC to target social influencers. ACCC has started a sweep to identify misleading testimonials and endorsements by social media influencers. It will also look at more than 100 influencers mentioned in over 150 tip-offs from consumers. Most of the tip-offs from members of the public were about influencers in beauty and lifestyle, as well as parenting and fashion, failing to disclose their affiliation with the product or company they are promoting. Source: ACCC
This has also been the subject of articles in the press – Australian Broadcasting Commission, the Sydney Morning Herald and The Guardian. The ABC quotes the chair of the ACCC as saying they would also consider the role of advertisers and the social media platforms themselves “in facilitating misconduct”.
To learn more about compliance for social media advertising book our new course Advertising and Social Media in Australia and New Zealand.
Controversial chemical Bisphenol A (BPA) removed from shop receipts, although experts say more research is needed to establish the safety of substitute chemicals. EU banned the issuing of receipts containing the chemical because of growing scientific concern over its potential to disrupt hormones and the immune system in humans. BPA has also been linked to development problems in children, to diabetes, heart disease and obesity and to adverse effects on fertility. Source: Sydney Morning Herald
What is a specific information requirement? A detailed guide updated 3rd January 2023
Specific information requirement forms. From January 2023 the ‘Submit information to meet your specific information requirement’ webforms will only be available in the AICIS Business Services portal. Source: AICIS
Data required for an assessment certificate for a chemical at the nanoscale. Additional information required.
Using a Canadian report in certificate application. AICIS only accepts reports from Environment and Climate Change Canada (ECCC) / Health Canada (HC) and you must follow the protocol to release the Canadian report. Full information here.
Guide to categorising your chemical importation and manufacture. Step-by-step guide revised 25th November 2022
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.
Variations to inventory listings after evaluation: CAS 84434-22-0 and 145-39-1 Source: AICIS
Removing an inventory listing after evaluation (click on link to see reasons):
Benzene, hexachloro- (HCB) CAS no. 118-74-1 Source: AICIS
Benzene, 1,2,3,4,5-pentachloro- (PeCB) CAS no. 608-93-5 Source: AICIS
Notice of completed evaluations published 22nd December 2022. 17 chemicals listed here.
New chemical assessments published 19th December 2022. Three are fragrance ingredients in cosmetic, personal and household products, and one is a component of laundry detergents. List is here.
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