current affairs
Issue 229 | September 2022
This issue is sponsored by Complementary Medicines Group. See below for exciting news.
Training news
We have introduced three new training courses.
Sunscreens – medicine or cosmetic?
• In Australia a sunscreen can be a medicine or a cosmetic.
• How to determine which category your sunscreen falls into
• The different legal requirements for each category
• Labelling and permitted claims
• Ingredients permitted for each category
Sports supplements – food or medicine?
• Overview of the food-medicine interface for Sports Products and determining when a sports product is a food or medicine.
• Background on regulatory changes to sports products
• The importance of product claims and types of claims that can be made under each pathway
• Ingredients, and the dose form of the product
• Brief overview of compliance for a food product
• Brief overview of submitting a medicine product to the Therapeutic Goods Administration
• Additional manufacturing requirements for medicines
New Zealand cosmetics
New Zealand’s regulations for cosmetics are different from Australia’s. Presented by Michelle Cubitt michelle@smartreg.nz
• Ingredients
• Labelling
• Permitted claims
• Importation and self assessment
Read more at regulatorytrainingdirect.com
Regulatory news
Complementary Medicines and Medical Devices:
New poisons standard October 2022. Explanatory statement is here. Source: TGA
Multivitamins and cognitive decline. Unexpected results from a phase 3 trial show daily multivitamin use, but not cocoa, is linked to a significantly slower rate of age-related cognitive decline. Source: Medscape, subscription required.
TGA guidance to help companies understand and comply with the requirements for advertising therapeutic goods when making announcements to comply with their continuous disclosure obligations. Contains information on activities that constitute advertising, and advertising compliance and enforcement. Source: TGA
Peripheral neuropathy and vitamin B6. Adverse event reports submitted to the TGA suggest there is a lack of awareness that vitamin B6 can cause peripheral neuropathy. The TGA has strengthened labelling requirements so products containing daily doses over 10mg of vitamin B6 must carry a warning about peripheral neuropathy. Source: TGA
Adoption of International Scientific Guidelines in Australia Consultation open, closes 10th November. TGA is conducting a public consultation seeking feedback on whether certain international scientific guidelines should be adopted. International scientific guidelines may apply to over-the-counter (OTC), complementary and some listed medicines. Source: TGA
Reference to TGA in advertising. TGA is considering regulatory options to allow advertisers, including product sponsors, to make references to the TGA in advertising (including on product labels) and is seeking feedback. Source: TGA
Compliance enforcement
JSHealth Vitamins fined $26,640 for alleged unlawful advertising including references and implied claims relating to serious health conditions including cancer and Alzheimer’s disease. Source: TGA
Three medicinal cannabis companies, MGC Pharmaceuticals ($306,360) Cannatrek($293,040) and Little Green Pharma ($372,960) fined almost $1 million for alleged unlawful advertising of prescription-only medicinal cannabis products. They were unapproved medicines (i.e. not entered on the Australian Register of Therapeutic Goods), and the unlawful advertising included unapproved references to the treatment of serious diseases or conditions, including in some cases cancer and epilepsy. Source: TGA
Best Body Industries and an executive officer fined almost $130,000 for alleged unlawful advertising of unapproved sports supplements. The products contained prescription-only medicines including levodopa, which is used in the treatment of Parkinson’s disease. Source: TGA
MDNE Enterprises and an executive officer fined – 2 infringement notices issued totalling $26,640 and the executive officer issued with 5 infringement notices totalling $13,320 for the alleged unlawful advertising of nicotine vaping products. The executive officer was warned by the TGA in relation to two websites advertising nicotine vaping products. While both websites were removed, a third website, allegedly controlled by MDNE Enterprises Pty Ltd was not removed. The alleged unlawful advertising used social media marketing including influencers to promote nicotine vaping products, including to teenagers and young adults. Source: TGA
Mosaic Brands pays $266,400 in penalties, relating to alleged false or misleading representations in promoting a face mask on its Autograph Fashion brand website. Mosaic Brands advertised a KN95 mask for sale, prominently described as “FDA AND CE APPROVED” in the product title. It is alleged that as a result Mosaic Brands falsely represented that the KN95 Mask product was approved by the Food and Drug Administration (USA) and Conformitè Europëenne (EU), when in fact it was not. On 26 August 2021, Mosaic Brands also promoted a McGloin’s-branded hot water bottle for sale on its Katies brand website, making alleged false and misleading statements that the water bottles had been “ACCC Approved”, when this was not true. Source: ACCC
Safety warning – breast implants. Report of squamous cell carcinoma and various lymphomas in scar tissue around breast implants. Source: TGA
Independent review of paracetamol overdose – TGA has published an independent expert report into death from intentional paracetamol overdose. The panel made 7 recommendations. TGA has opened consultation which is open until 14th October. Source: TGA
Safety alert: Philips recall action for CPAP, Bi-Level PAP devices and mechanical ventilators – update. Source: TGA
Environmental claims: ACCC has warned that business must be able to substantiate any environmental or sustainability claims. ACCC is actively targeting ‘greenwashing’ this year. Broad terms like ‘environmentally friendly’, ‘green’, or ‘sustainable’ have limited value and may mislead consumers, as they rarely provide enough information about what that exactly means in terms of the product or service consumers are considering purchasing. Source: ACCC
Foods:
Single use plastics ban Lightweight single-use plastic bags were banned on 1st June. From 1st November 2022 the supply of single-use plastic cutlery, stirrers, straws, plates and bowls, expanded polystyrene (EPS) food service items (including EPS clamshells, cups, plates and bowls) is also banned in NSW. Sources: NSW Food Authority and NSW Govt Social Pinpoint and NSW Environment Protection Authority
Changes to Health Star Ratings system come into effect 14th November 2022. Key changes include the permitted HSR logos – energy-only icon is no longer permitted (b) automatic Health Star Ratings – new advice for specific products (c) the Health Star Ratings calculator – total sodium and sugars will be penalised more strongly and dairy categories have been refined. Sources: NSW Food Authority and Australian Government.
Call for submissions – glucoamylase from a genetically modified strain of Aspergillus niger containing the glucoamylase gene from Penicillium oxalicum, as a processing aid in baking processes, brewing processes and starch processing. Closes 10th November. Source: FSANZ
Unexpected allergens in foods – updated August 2022.Unexpected allergens can be present in some food ingredients, also a section on food fraud. A comprehensive and useful resource. Source: Allergen Bureau.
Annual food testing report 2021-2022. 3,025 samples were submitted for testing. Source:NSW Food Authority.
FSANZ Board approves six draft variations to the Australia New Zealand Food Standards Code. Includes Food derived from EPA+DHA & herbicide tolerant canola line LBFLFK, Polygalacturonase enzyme from GM Aspergillus oryzae, Pectin esterase enzyme from GM Aspergillus oryzae, Phospholipase A1 from Aspergillus oryzae, Glucoamylase from GM Aspergillus niger, and Food safety management tools. Source: FSANZ
FSANZ has approved variations arising from the following applications and proposals:
Composition and Labelling of Electrolyte Drinks, Primary Production and Processing Requirements for Horticulture (Berries, Leafy Vegetables and Melons), Serine endopeptidase enzyme from GM Trichoderma reesei, Chymosin from GM Trichoderma reesei as a processing aid (enzyme), Composition and Labelling of Electrolyte Drinks, Primary Production and Processing Requirements for Horticulture (Berries, Leafy Vegetables and Melons), Serine endopeptidase enzyme from GM Trichoderma reesei, and Chymosin from GM Trichoderma reesei as a processing aid (enzyme). Source: FSANZ
Food Recalls
Smith’s Crinkle Cut Salt & Vinegar Chips – presence of foreign matter (plastic pieces).
ALDI Sprinters Crinkle Cut Multi Pack Chips – presence of foreign matter (plastic pieces).
Genobile Saba – Premium Salami Pizza, Premium Margherita Pizza, Premium Garlic Pizza and Premium Pomodoro Pizza. Non compliant labelling. Printed USE BY is 11/10/23. Correct USE BY is 11/10/22.
Brownes Dairy Mango Yoghurt – chemical (sanitising solution) contamination.
Ballistic Beer Co. Hawaiian Haze Pale Ale 375mL, Hawaiian Haze IPA 375mL and Reef Pale Ale 375mL – secondary fermentation.
Fine Food Holdings Crispbic Wafer Bics Original Gluten Free – the product inside is for Crispbic Wafer Bics Original 100g which contain wheat and gluten
Happi Free From Oat M!lk Chocolate – undeclared allergen (milk) Source: FSANZ
From the press: (we cannot guarantee the accuracy of articles published in mainstream media)
Diet cola and artificial sweeteners: an article in news.com.au quotes research stating that total artificial sweetener intake is associated with increased risk of fatal conditions such as heart disease and stroke. Source: news.com.au
Cosmetics, Personal Care and TGA Listed Sunscreens:
Articles below come from AICIS – all articles below are in this link and additional links are included where relevant
Variations to the Inventory listing for CAS Number 1226781-96-9 and CAS Number 219607-67-7
Feedback requested on proposed Rules changes regarding introductions of chemicals at 10 kg or less in a registration year more here
Chemicals added to the Inventory 5 years after issue of assessment certificate – CAS numbers 69012-03-9, 1221495-27-7, 18777-32-7, 148360-81-0, 1613467-74-5, 1132688-18-6,
Specific information requirements – what does ‘significant’ or ‘significantly’ mean? More information on specific requirements here.
Latest snapshot of the Industrial Chemical Inventory information available here and this contains a link to download the inventory
List of new chemical assessment statements includes CA09482, CA09508, CA09526, CA09525, CA09576, CA09469
New features available in registered business search from 1 September 2022 – database is here
Chemicals added to the Inventory 5 years after issue of assessment certificate – 2020004-19-5, 25777-14-4, 35501-23-6, 845752-17-2, 68856-11-1, 68410-28-6, 96702-03-3, 68957-28-8.
AICIS has cancelled assessment certificate (CERT9258) for Benzene, 1,1′-(1,2-ethanediyl)bis[2,3,4,5,6-pentabromo- (also known as decabromodiphenylethane or DBDPE) as the Executive Director is not satisfied that the risks to the environment associated with the introduction or use of the industrial chemical can be managed.
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News from our sponsor
Personalised complementary medicine customises health care to an individual and their needs. It tailors and adapts medicines to achieve better overall health outcomes for individuals, rather than treating people with a ‘one size fits all’ approach. Complementary Medicines Group (CMG) is leading the way with Smartmed, a personalised system for your patients and customers. With CMG Smartmed, you are able to prescribe up to 8 tablets and capsules in a daily sachet for ease and compliance. The end product is a box of 30 daily sachets of your selected prescribed Listed Medicines sent directly to your patient/customer. For more information, contact CMG at 02 9091 0264 or craig@cmgrouponline.com.au
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Become a sponsor
Showcase your business! Become a current affairs sponsor today. To find out more contact us on info@regulatorytrainingdirect.com
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Published by Regulatory Training Direct www.regulatorytrainingdirect.com
Providing regulatory training courses for complementary medicines, GMP, foods, cosmetics dietary supplements.
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