Issue 238, July 2023
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Training news
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REGULATORY NEWS
Complementary Medicines and Medical Devices:
Ingredients permitted in listed complementary medicines. Two new ingredients: Refined Buglossoides arvensis seed oil and Chicken sternum cartilage powder, two changed ingredient names (Change of name from Saccharomyces cervisiae polysaccharides to Saccharomyces cerevisiae polysaccharides) and violet leaf absolute, one ingredient removed: Poloxamine 1301. Permitted ingredients full list is here (6 volumes).
Pharmacovigilance. Guidance document pharmacovigilance responsibilities of sponsors of medicines outlines the mandatory reporting requirements and offers recommendations on pharmacovigilance best practice, TGA info here, click on links to access either PDF or Word version. Pharmacovigilance responsibilities of sponsors of medicines frequently asked questions here. TGA webinars with live Q&A outlining and explaining recent changes to safety issue reporting requirements – held on two different dates, details here.
Good clinical practice inspections. In this seminar the TGA will provide an overview of the GCP inspection program and insights from the first year of the program. Book on TGA website.
TGA import, advertising and supply compliance priorities for 2023 – 2024. Includes nicotine vaping products, unlawful advertising of medicinal cannabis, psilocybin and MDMA (prescription medicines cannot be advertised),unapproved and high-risk medicines and medical devices used in the wellness and beauty industries including those intended to alter the body’s performance and appearance, import of substandard and falsified therapeutic goods. Source: TGA.
Sponsor notification form for medical devices transitioning from the EU MDD to the new EU MDR, must be completed by 24th May 2024. Source: TGA summary and the form is here.
Form to notify the TGA of any lapsing or lapsed manufacturer’s conformity assessment certification for your medical device(s). TGA Summary, and TGA online form.
TGA Consultations
Proposed application audit framework for medical devices. This consultation is seeking feedback on the key elements of the proposed application audit framework: • risk factors informing non-mandatory audit selection • criteria for mandatory audits • the evidence to be provided with applications to inform audit selection • limiting the number of substantial assessment rounds • mechanisms to improve visibility of application audit timeframes • cost recovery measures for non-mandatory audits. TGA also also seeks feedback about pathways for Class III devices with US FDA 510(k) approval. Closes 4th Sep 2023. Source: TGA
Proposed new Guidelines for the Quality of Listed Probiotic Medicines. Relevant top probiotics included in listed complementary medicines, and focusses on quality control, safety efficacy and stability. Closes 10th Sep 2023. Draft is available here.
Product recalls
Mentholatum Australasia Pty Ltd is recalling two batches of Natural Instinct Kids SPF50+ Clean Sunscreen 200mL topical cream and 50mL rollerball products after receiving reports that the sunscreen fluid is splitting into layers. When ingredients are not properly mixed the product may not offer the same protection. Source: TGA.
Recall coordinators. This page provides the names and contact details for the federal government recall coordinators for medicines and medical devices, and also the details for the coordinators in each state and territory. Source: TGA And this page gives details on recall procedures to be followed when there is a potential health risk
Compliance action
Infringement notices totalling $82,500 issued to Trava Health for unlawful advertising of medicinal cannabis including claims that the products could be used to treat serious diseases. Source: TGA
Infringement notices totalling $105,600 issued to Nature’s Puff for the alleged unlawful advertising of 8 flavours of 2 disposable nicotine vaping products. Source: TGA.
Listed medicine compliance reports from July 2023: TGA cancelled Royal Mom (Sponsor Royal Care) as they efficacy could not be assessed as the sponsor did not provide the requested information that supports its use during pregnancy. Source: TGA
Botanical Adulteration Prevention Programme
Bulletin on tea tree adulteration: Tea tree oil is the essential oil obtained by distillation of the leaves of the tea tree (𝘔𝘦𝘭𝘢𝘭𝘦𝘶𝘤𝘢 𝘢𝘭𝘵𝘦𝘳𝘯𝘪𝘧𝘰𝘭𝘪𝘢 or 𝘔. 𝘭𝘪𝘯𝘢𝘳𝘪𝘪𝘧𝘰𝘭𝘪𝘢). Tea tree oil is used topically to treat minor wounds and cuts, and to relieve symptoms of the common cold. It is also a popular ingredient in personal care, home care, and cosmetic products. Adulteration of tea tree oil is fairly widespread. One of the reasons for unintentional adulteration may be that various species from the genus 𝘔𝘦𝘭𝘢𝘭𝘦𝘶𝘤𝘢, 𝘓𝘦𝘱𝘵𝘰𝘴𝘱𝘦𝘳𝘮𝘶𝘮, 𝘒𝘶𝘯𝘻𝘦𝘢, and 𝘉𝘢𝘦𝘤𝘬𝘦𝘢 are referred to as tea tree. However, most of the adulteration of tea tree oil is believed to be for financial gain. Economically motivated adulteration includes dilution with lower-cost byproducts derived from the processing of essential oils of 𝘌𝘶𝘤𝘢𝘭𝘺𝘱𝘵𝘶𝘴 species and other plants, or the addition of pure chemical compounds. Check for the link to read #BAPP’s tea tree oil adulteration bulletin: Researchgate
Aloe vera: Aloe (𝘈. 𝘷𝘦𝘳𝘢) has played an important role as medicinal plant for thousands of years. The liquids and gels (often dried into powders) obtained from the leaf of aloe are widely utilized as ingredients in dietary supplements, personal care, and cosmetic products. Furthermore, aloe leaf juice ingredients for internal consumption are popular in the food and beverage industry. Materials used to adulterate aloe inner leaf juice and juice powder include other aloe species and juice made from whole aloe vera leaf. Substitution of dried powdered aloe leaf juices with undeclared maltodextrin or sucrose has also been reported. To learn more visit website
In the press
“Can weight loss and diet drugs avoid the mistakes of the past?” Discusses past and present controversies out weight loss medicines. Source: ABC news.
“This is the problem with weight-loss ‘solutions’”. Well researched and similar article to above but looking at different aspects. Source: Sydney Morning Herald.
“Medicines watchdog investigating as online start-up emails about Ozempic”. A tech start up advertising products in possible breach of advertising laws, and the grey area of telehealth consultations with a doctor involved in marketing of the product. Source: Sydney Morning Herald
“Queensland scientists test vapes for polonium-210 after finding cancer-causing substances”. Scientists are testing vapes for radioactive polonium-210 – the poison Russia used to assassinate ex-KGB officer Alexander Litvinenko in 2006 – after finding they contained other cancer-causing substances. Quite concerning. Source: ABC News
“Urgent health warning has been issued to vape users by dentist”. A new side effect called “vape tongue”. Source: News.com.au
New Zealand News Supplied by Michell Cubitt, Smart Regulatory Solutions
The Therapeutic Products Bill has now been passed into law and become the Therapeutic Products Act 2023. This Act marks a significant overhaul in the regulation of natural health products including dietary supplements and comes into force by 1st September 2026. The next major step is the development of regulations and rules which provide the much sought-after details on how products will be regulated. The overall impact of legislation is yet to be determined so the content of the regulations will be closely monitored and expect there to be robust engagement in any consultation processes. Some of the key changes for natural health products are the implementation of a product authorisation process, permitted ingredients list, permitted claims list, and a new regulator to administer therapeutic products. As yet there is no detail on any of these, so it is unclear whether authorisation means light touch notification or something more involved, or how comprehensive the permitted ingredients and claims lists are. Given the magnitude of changes not just for natural health products but also medicines and medical devices, there is much work to be done before September 2026. Source: New Zealand Ministry of Health
Foods:
Application A1278 – Beta-Fructofuranosidase from GM Trichoderma reesei as a processing aid: This application seeks permission for beta-fructofuranosidase from a genetically modified strain of Trichoderma reesei to be used as a processing aid in the production of short chain fructooligosaccharides and to produce a reduction in sugars levels in treated food. FSANZ has accepted the application and assessment has commenced. Source: FSANZ
Current calls for comment
Proposal P1010, review of Standard 2.9.4 – Formulated Supplementary Sports Foods, looking particularly at nutrition and health claims. Open for comment 24 July 2023 – 4 September 2023. Source: FSANZ
Proposal P1049 – of carbohydrate and sugar claims on alcoholic beverages – proposal to clarify requirement for making nutrition content claims. FSANZ calls for comment.
A1267 – Fructanase from GM Trichoderma reesei as a processing aid to be used in manufacture of bakery products. FSANZ
A1243 Harmonisation of marine biotoxin standards for bivalve shellfish – to harmonise maximum levels to ensure food safety. FSANZ
Food Recalls
Long Paddock Driftwood Cheese -due to potential microbial (E. Coli) contamination Source: FSANZ
Six different brands of Lotte Pepero products due to the presence of an undeclared allergens (almond, sesame, tree nut, peanut). The products are all listed here.
Port Melbourne Paletas – Rocky Road Paleta – Ice-Creme due to the presence of undeclared allergens (milk and tree nut (cashew)) Source: FSANZ
Additional food news provided by Correct Food Systems
New food safety rules for New Zealand companies importing foods. The aim is to make imported food safer for consumers and help avoid expensive recalls, like those seen recently with frozen berries and tahini. Source: NZ Ministry for Primary Industries.
Cosmetics, Personal Care and TGA Listed Sunscreens:
A snapshot of all the chemicals on the Australian Inventory of Industrial Chemicals on 30 June 2023 and published on 28th July as a downloadable spreadsheet in an Excel format (.xlsx). Search or download the inventory here.
Renewing your AICIS registration. The business services portal will be open for re-registration in mid August. It’s an offence to introduce an industrial chemical when you don’t have an active registration. This website tells you how you can prepare for reregistration and how to work out your registration level. Source: AICIS
From 21 July 2023, Australian importers and exporters of decabromodiphenyl ether (decaBDE), perfluorooctanoic acid (PFOA) and its salts, and PFOA-related compounds, must receive annual authorisation from AICIS. How to apply, and what are the exceptions, explained here.
Variation to inventory listing after evaluation: benzene, 1-chloro-4-(trifluoromethyl)- (CAS No. 98-56-6). Variation to the Inventory terms of listing of the chemical is necessary to manage the risks from the introduction of this chemical. Source: AICIS
Chemicals added to the Inventory 5 years after issue of assessment certificate. Seven chemicals listed here.
ACCC news: (relevant to all product categories)
The ACCC is the Australian Competition and Consumer Commission, similar to other countries’ fair trading authorities such as the New Zealand Commerce Commission and the US FTC
The ACCC has published draft guidance to improve the integrity of environmental and sustainability claims made by businesses and protect consumers from ‘greenwashing’. A recent internet sweep found 57% of businesses were making potentially misleading environmental claims. Source: ACCC. (These issues are covered in our course on social media)
Country of origin: Costco Wholesale Australia has paid penalties totalling $33,000 after the ACCC issued it with two infringement notices for alleged false or misleading labelling of the country and place of origin on lobster products. Kirkland Signature products were labelled PREVIOUSLY FROZEN WHOLE COOKED WA LOBSTER’ and ‘Australian Lobster’. Other packages were also displayed for sale with the allegedly misleading labels. In fact, the lobsters were imported from Canada. Source: ACCC
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