current affairs
Issue 243, January 2024
From 13th December 2023 to 30th January 2024
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Training news
In case you missed our announcement during the Silly Season at the end of 2023, we have added two courses to our e-learning programme. Our e-learning courses:
👩🎓 Are pre-recorded and available on demand.
👩🎓 Can be done at a time that suits you.
👩🎓 Contain modules, can be spread over sessions.
👩🎓 Include extensive resources and templates.
👩🎓 Include hints, tips, examples and case studies.
5.01. USA Dietary Supplements (e-learning). Written and presented by US Dietary Supplement law specialist and lecturer, Rend Al-Mondhiry Partner at Amin Talati Wasserman, LLP. Rend is a resident expert and a lecturer at Georgetown University Law Center RISE on the topic of dietary supplement regulation. Agenda includes ingredient requirements, labelling, quality and safety.
Read more and book this course here: https://www.regulatorytrainingdirect.com/#toggle-id-26
1.02. Evidence packages – TGA evidence requirements for claims (e-learning). This comprehensive 3.5 hour course teaches the fundamentals of regulations for claims on complementary medicines, how to find and assess evidence and how to compile an evidence package to support therapeutic and marketing claims.
Read more and book this course here: https://www.regulatorytrainingdirect.com/courses/1-02-evidence-packages/
Our course 2.10 Advertising and Social Media in Australia and New Zealand has just had a significant upgrade to take into account developments over the past 12 months with new policies around social media, influencers, testimonials, greenwashing and similar issues. View the agenda and book here: https://www.regulatorytrainingdirect.com/#toggle-id-20
1.03. Listed medicine labels course has also just been refreshed. It includes a label template and SOP to use when preparing your label copy. View the agenda and book here: https://www.regulatorytrainingdirect.com/#toggle-id-3
All our courses can be viewed here: https://www.regulatorytrainingdirect.com/#course-summary
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Note from the editor. This issue covers the period from mid December 2023 to end of January 2024. Thrilling reading!
Regulatory news
Complementary Medicines and Medical Devices:
Medicinal cannabis – updated guidance. TGA has published a new version of advertising guidance for businesses involved with medicinal cannabis. More details here.
“Create content that plays by the rules” – a guide specifically directed towards social media influencers who rely on sponsorships and collaborations but have no knowledge of their responsibilities when they are promoting therapeutic goods. There are strict rules about promoting medicines (including vitamins and minerals), medical devices and even most sunscreens online. These rules apply equally to all advertisements for these products, including advertisements in social media. Issues mentioned include Know if the product you’re promoting falls under these rules; Know if you’re giving a testimonial or an endorsement; Know how the rules apply when you’re being paid; Know where to get more information when you need it
Therapeutic Vaping Goods – transitional manufacturer notification form. Notification for manufacturing unapproved vapes for smoking cessation or management or nicotine dependence without GMP from 1 January 2024 until 1 December 2024. Form available here.
Therapeutic Vaping Goods – Sponsor Notice Form. For suppliers of vaping products, this form must be submitted prior to importing or supplying unregistered vaping goods intended for smoking cessation or management or nicotine dependence. Available here.
Vaping reforms webinar – an overview of the vaping reforms and how these will impact consumers, suppliers and health professionals was held in January. The PDF file of the presentation can be viewed here.
As of 1st January, pharmacies can no longer advertise the availability of prescription nicotine to customers. Source: TGA
Updated guidance on therapeutic vapes:
– Guidance for health practitioners, consumers, importers and other sponsors, wholesalers and manufacturers to understand the minimum safety and quality requirements that apply to unregistered products.
– Information for prescribers on changes to the regulation of vapes
– An overview of what pharmacists need to know in relation to sourcing and dispensing vapes for smoking cessation or the management of nicotine dependence
– Practical guidance to assist medical and nurse practitioners with prescribing therapeutic vapes for smoking cessation or the management of nicotine dependence.
Regulation of tampons in Australia – revised guidelines on how to meet regulatory requirements for the manufacture and supply of tampons in Australia. Tampons are exempt from the requirement to be placed on the Australian Register of Therapeutic Goods, however they must comply with the Australian Standard “AS 2869:2008 Tampons – Menstrual”. Full details here – choose either MS Word or PDF version.
A new form for sponsors of clinical trials to report Significant Safety Issues and Urgent Safety Measures to the TGA – word and PDF versions available here.
Product recalls
Phytologic is recalling two batches of Henry Blooms Herb-a-lax 200-gram dried herb powder (Aust L 23408) due to live insects (Tobacco beetles, Lasioderma serricorne) being found in some bottles. Source: TGA
Sun Herbal is recalling all batches of Liu Wei Di Huang Wan (Rehmannia Six Formula) BP015 (AUST L 99121) as a precautionary measure due to the potential for the medicine to result in unacceptable amounts of lead. Source: TGA
Aerowash Eyewash and Wound Irrigation ampoules – preliminary testing indicates the presence of Ralstonia pickettii. Source: TGA
Bondi Sands Mineral Sunscreen SPF50+ Face and Body Lotion – the sunscreen fluid is splitting into layers, ingredients that prevent sunburn are not properly mixed and when applied, the products may not offer the same protection. Source: TGA
FOR-DE Group is recalling the RG554H2 Space Saver Shower Stool due to potential for the seat section to crack. Source: TGA
Legency Remedies Sodium Chloride 0.9% ampoules – preliminary testing indicates the presence of Ralstonia pickettii. Source: TGA
Medtronic Australasia implanted SynchroMed II Pump (model 8637) – may not function properly after patient has a Magnetic Resonance Imaging (MRI) procedure. Source: TGA
Hazard alert: Lima Orthopaedics is alerting patients who had anatomic shoulder arthroplasty procedures, and specifically have been implanted SMR MB L1 Liner within the SMR/SMR L1 total stemmed devices, as there may be at higher risk of requiring revision surgery. Symptoms of device failure may include any new or worsening pain or swelling; inability to bear weight; grinding; or weakness around the implanted device. Source: TGA
No smoking means no vaping. Everywhere smoking is banned, vaping is too. The ban includes areas such as shopping centres, cinemas, public transport stops and platforms, outdoor dining areas, sports grounds, playgrounds and many other spaces. The NSW government is offering signs that can be downloaded and printed to be displayed in the workplace. Order them here.
Safety alerts – adulterated products
TGA has tested a product labelled Kamasutra Herbal Jelly for him oral jelly sachets and found that the product contains the undeclared substance t adalafil, and advises not to purchase the product or continue taking it Source: TGA
TGA has tested product labelled Bullblood and found that the tablets contain the undeclared substance sildenafil. Do not purchase the product or continue to take it. Source: TGA
TGA has tested Tantra Jelly oral jelly satchels and found that the product contains the undeclared substances sildenafil and t adalafil. As per above, do not purchase or continue to take it. Source: TGA
TGA has tested Throb Herbal supplement tablets and found that the product contains the undeclared substance vardenafil. Source: TGA
TGA has tested Excite for her and found that the tablets contain the undeclared substance sildenafil. TGA
TGA has tested Commander Stamina Time tablets and found that the product contains the undeclared substance t adalafil. Source: TGA
Compliance action
TGA along with NSW Police has seized hundreds of potentially dangerous sport supplements seized from Sydney retail store. Some of the supplements are alleged to contain substances which are banned from sale and supply in Australia due to their high risk to consumer health. Source: TGA
Marvel Health (Australia) issued with infringement notice for $13,320 for an alleged failure to comply with a notice from the TGA requiring it to provide information in relation to a complementary (listed) medicine. Source: TGA
TGA executed a search warrant on a residential property in Brisbane, with assistance from the Queensland Police Service and Queensland Health, and seized various items including jars suspected to contain black salve made using the Schedule 10 prohibited substance bloodroot, capsules suspected to contain the Schedule 10 prohibited substance, amygdalin (B17 laetrile) and medicines suspected to contain the Schedule 4 prescription-only substance spancreatic enzymes and t adalafil. Source: TGA
Yossef Wahib, operator of the online store Aussie Mega Supplements, has been fined and issued with a court enforceable undertaking in relation to alleged illegal manufacture, supply and advertising of unregistered therapeutic goods containing amygdalin, which is broken down within the body into hydrogen cyanide, a highly poisonous substance which could cause death at higher doses or for people with lower bodyweight, such as children. Source: TGA
Nurses fined for allegedly importing unapproved prescription-only medicines, medical devices containing prescription-only medicines, and advertising prescription-only medicines. A Victorian-based registered nurse has been issued with 2 infringement notices totalling $6,600 for allegedly importing vials of unapproved botulinum toxin type A, which is a cosmetic injectable product often used as a wrinkle relaxer, and pre-filled syringes containing hyaluronic acid and lidocaine. A Queensland-based registered nurse has also been issued 2 infringement notices totalling $7,056 for allegedly importing vials of unapproved botulinum toxin type A, and advertising prescription-only medicines on social media websites.
Pracmed Healthcare and Roger Lewis directed to comply with instructions to cease advertising therapeutic goods for weight loss and bariatric surgery, improving cognitive function and for morbid or severe obesity as the indications have not been accepted for the products. Source: TGA
TGA has issued 18 infringement notices totalling $157,752 to Kilpatrick & Douglas and two directors, for the alleged unlawful advertising of nicotine vapes on their websites. Source: TGA
Botanical Adulterant Prevention Programme (BAPP)
US FDA press release: FDA analysis has determined that certain dietary supplements labelled as tejocote (Crataegus mexicana) root are adulterated because they were tested and found to be substituted with yellow oleander (Cascabela thevetia), a poisonous plant native to Mexico and Central America and a toxic substance of concern to public health officials. In other words, the tested products are labelled as tejocote but are actually toxic yellow oleander. Source: FDA
BAPP’s Laboratory Guidance Document reviews analytical techniques for distinguishing and identifying adulterants in commercial rape fruit seed extract product, and outlines the methods for separating and identifying the natural constituents of grapefruit seeds. Source: BAPP
Saffron is known as one of the world’s most expensive spices that is made from the stigmas of Crocus sativus flowers. Safflower or calendula petals that have the same colour are the main adulterants of saffron. Furthermore, powdered saffron is sometimes diluted with paprika or turmeric powder. Source: BAPP and NutraIngredients
Boswellia serrata oleogum resin. The first study that reveals undisclosed citric acid added to meet declared TBA contents through titration methods, revealing new fraudulence in adulterating Indian frankincense samples. Source: BAPP post on LinkedIn and Journal of Dietary Supplements.
Foods:
New applications
A1288 Thermolysin from Anoxybacillus caldiproteolyticus Rokko as a processing aid – This application seeks permission for thermolysin from Anoxybacillus caldiproteolyticus Rokko to be used as a processing aid for protein hydrolysis to process dairy foods, egg, meat and fish, protein concentrates and isolates, yeast and in brewing. View more details at these two links: A1288 Administrative Assessment (pdf 148kb) – A1288 Executive Summary (pdf 130kb)
Call for submissions
FSANZ invites written submissions on the assessment of the following application by 6pm (Canberra time) 9 February 2023: Application A1280 – Food derived from herbicide-tolerant and insect-protected corn line DAS1131: To seek approval for the sale and use of food derived from corn line DAS1131, genetically modified for herbicide-tolerance and protection from insect pests. Source: FSANZ
FSANZ invites written submissions by 6pm (Canberra time) 5th March 2024: Application A1281 Food derived from herbicide-tolerant and insect-protected corn line DP910521:This application seeks approval for the sale and use of food derived from corn line DP910521, genetically modified for herbicide-tolerance and protection from insect pests. Full details here
Maximum reside limits: variations proposed by the APVMA to harmonise MTLs with international standards – read more here
The APVMA has called for public comment on a number of amendments to Schedule 20 – view details on the Federal Register
Amendment to the Code
FSANZ has approved variations arising from
A1270 – Food derived from herbicide-tolerant and insect-protected corn line DP51291
M1021 – 2022 MRL Harmonisation Proposal
Amendment No. 225 to the Australia New Zealand Food Standards Code was published by FSANZ on 19 January (FSC 165). It included amendments resulting from the following applications:
A1243 – Harmonisation of marine biotoxin standards for bivalve shellfish
A1267 – Fructanase from GM Trichoderma reesei as a processing aid
Food Recalls
Exotic Bazaar Persian Love Cake Baking Kit 420g – due to mould growth found in the 15ml rosewater bottle. Source: NSW Food Authority
Woolworths Shortcrust Summer Berry Mince Pies – due to the potential presence of foreign matter (metal). Source: NSW Food Authority
Stuart Alexander & Co – Hershey’s Caramel Syrup – due to the presence of an undeclared allergen (milk). Source: NSW Food Authority
Sunraysia Prune Juice IL – due to unintended fermentation and the presence of alcohol. Source: NSW Food Authority
Koko Black A Jar of Stars 54% Dark 140g and A Bon Bon of Stars 54% Dark 200g – due to the presence of an undeclared allergen (milk). Source: NSW Food Authority Source: NSW Food Authority .
In the press:
This salt alternative could help reduce blood pressure. So why are so few people using it? Discusses potassium-enriched salt. Source: ABC News
More food news from Lisa and Gary at Correct Food Systems
EU parliament overwhelmingly adopts greenwashing directive, approval goes to council
The EU Parliament has given its final approval to a directive that will improve product labelling and ban the use of misleading environmental claims. The new rules aim to make product labelling clearer and more trustworthy by banning the use of general claims like “environmentally friendly”, “natural”, “biodegradable”, “climate neutral” or “eco” without proof. In addition, sustainability labels will be regulated, banning any label that isn’t based on an official certification or established by public authorities. Additionally, the directive will ban claims that a product has a neutral, reduced or positive impact on the environment because of emissions offsetting schemes. The new directive is meant to work together with the green claims directive, currently being discussed at committee stage in Parliament. The upcoming green claims directive will be more specific and elaborate the conditions for using environmental claims in greater detail. The directive also needs to receive final approval from the Council, after which it will be published in the Official Journal and member states will have 24 months to transpose it into national law.
INDUSTRY GROWTH PROGRAM The Australian Government’s Industry Growth Program is now open to support innovative small and medium enterprises (SMEs) undertaking commercialisation and growth projects within the National Reconstruction Fund priority areas through advisory services and opportunities for matched grant funding. Beverage manufacturers and some packaging manufacturers would qualify under “manufacturing products for use in or in connection with a primary industry” which includes the manufacture of food, beverage, timber, and fibre products. To participate in the program, applicants will be connected to an Industry Growth Program Adviser who will provide tailored advice to support your commercialisation and/or growth project. Once you have received this advice, you may also be able to apply for:
– grants of $50,000 to $250,000 to support early-stage commercialisation projects
– grants of $100,000 to $5 million for commercialisation and growth projects.
To qualify as an innovative project, applicants must demonstrate that they are commercialising a product that:
– is new, unique or significantly different to any other previous product, process or service in the market or industry where the product is intended to be sold/traded; or
– involves significant enhancements or developments of current products, processes or services that will enable the business to scale and transform.
Deadline for food businesses to transition to plain English allergen labelling is 25 February 2024. Read more about this here.
Cosmetics, Personal Care and TGA Listed Sunscreens:
Snapshot of all the chemicals on the Inventory on 2 January 2024 – available as a downloadable spreadsheet here
Updated guidance on the regulation of sunscreens in Australia. Includes the expanded slogan Slip, Slop, Slap, Seek, Slide. Find this on TGA website here. (We have a relevant one hour course called 1.40. Sunscreens– medicine or cosmetic?)
Last year AICIS consulted on some proposed changes to the list of chemicals with high hazards for categorisation and indicated they would update it. They have outlined a proposal to simplify the requirement for introducers to check if their chemical is an ester or salt of entries on the List. They are now providing details of these changes and are seeking feedback by 22nd February 2024. Details here and also here.
Variation of the terms of the Inventory listing 14th December 2023– CAS 91845-48-6, Santalum austrocaledonicum (a type of sandalwood) extract. Conditions imposed include notifying AICIS if the importation volume exceeds one tonne per annum assessed chemical; the final use concentration of the assessed chemical exceeds 0.23% in leave-on cosmetic products, 1.5% in rinse-off cosmetic products, 0.41% in fine fragrances, 5% in household products and 0.1% in hairspray; the function or use of the chemical has changed from a fragrance ingredient, or is likely to change significantly; the chemical has begun to be manufactured in Australia; and additional information has become available to the person as to an adverse effect of the chemical on human health, or the environment. Read more here.
Chemicals added to the inventory following issue of assessment certificate 4thJanuary 2024 – one chemical CAS 854737-09-0, 2H-Pyran, 3-heptyltetrahydro-, assessed as a fragrance component and in finished products – for maximum amounts and product types see here.
A list of chemicals added to the Inventory 5 years after issue of assessment certificate.
Five chemicals listed here, includes CAS numbers 1777808-07-7, 71512-90-8, 880105-45-3, 26040-51-7, 2016755-66-9.
Ten chemicals listed here, including CAS numbers 366806-19-1, 1431412-25-7, 77538-19-3, 96283-84-0, 2180951-94-2, 3008591-77-0, 638132-19-1, 73772-46-0, 73772-45-9, 501410-94-2.
Biologi prosecution – in our last newsletter in an article by Rita Sellars from pH Factor we mentioned the case of ACCC action taken against Biologi in the Federal Court for making false and misleading statements. In the judgement the company was ordered to publish eight corrective notices. These can now be viewed on https://biologi.com.au/ and include:
– From April 2017, Biologi depicted an Organic Food Chain logo on its website in circumstances where it was not certified as organic by the Organic Food Chain Company. The Court has declared that Biologi thereby made false or misleading representations that it was organically certified, when it was not, and that its products were of a particular standard, quality, value, grade or composition, or possessed particular characteristics when they did not.
– From 2018, Biologi represented on its website, Facebook and Instagram pages that its Biologi Bk Rejuvenating Eye Serum (made from Kakadu Plum) contains high levels of Vitamin C and that its Biologi Bf Hydration Body Serum (made from Finger Lime) contains Vitamin C. The Court has declared that Biologi thereby made false or misleading representations that its products contained high levels of Vitamin C, when they contained no Vitamin C, and that its products were of a certain standard, quality, value, grade or composition when they were not.
– From April 2017, Biologi represented on its website, Facebook and Instagram pages that its products contain only one ingredient, contain only pure plant, do not contain any additives and are not diluted. The Court has declared that Biologi thereby made false or misleading representations that its products contain only one ingredient, contain only pure plant, do not contain any additives and are not diluted, when that was untrue, and its products were of a certain standard, quality, value, grade or composition when they were not.
– From November 2017, Biologi represented on its website and Instagram page that it had, for the first time, developed a method to stabilise natural Vitamin C and that its products are the only skin care products in the world that contain natural Vitamin C. The Court has declared that Biologi thereby made misleading representations that it had, for the first time, developed a method to stabilise natural Vitamin C, when it had not, and that its products were the only skin care products in the world that contain natural Vitamin C, when they were not.
– From 2018, Biologi represented on its website that its Biologi Bf Hydration Serum contains the compound “Byangelicin” and that Byangelicin reduces the appearance of ageing. The Court has declared that Biologi thereby made false or misleading representations that Its products contained Byangelicin, when they did not, and that Its products were of a certain standard, quality, value, grade or composition, or had particular performance characteristics when they did not.
(Editor’s note: I was involved in research and development of Kakadu plum products for 20 years from the late 1990s. Cosmetics already existed then that contained Kakadu plum)
In the press:
“Too many products can stress out your skin. Here’s what to keep and give up” Published in Sydney Morning Herald – (you may be able to view one article for free)
More cosmetics news supplied by Rita Sellars from pH Factor.
TGA has announced further restrictions on advertising on cosmetic injectables, effective 18 December 2023. There is an article about this in Aesthetic Medical Practitioner, and this issue is mentioned in the TGA’s Import, Advertising and Supply Compliance Priorities 2023-24 report published in July 2023.
AICIS Registration
As we start 2024, the cost of living is increasing, and we are all feeling the pinch! You may be thinking of starting to make some products for yourself to save some money or even to sell to make some extra cash. Know your legal requirements under Australian Law. As a reminder to many people and a refresher to some, as a business that is making and selling products in Australia, you MUST register your business with AICIS.
What is AICIS registration?
This refers to the AICIS registration of a business that imports industrial chemicals (includes cosmetic ingredients) into Australia or locally manufactures industrial chemicals (referred to as an ‘introducer’). You register by completing an online form and paying a fee. You register your business, not your products or chemicals. You must register your business before you import or manufacture an industrial chemical in any given registration year. The registration year is 1 September – 31 August. Registration depends on whether you’re importing or manufacturing industrial chemicals (and products that contain industrial chemicals) for personal, hobby or commercial use.
You don’t need to register with AICIS if you:
– make products at home for your personal use
– buy products from overseas for your personal use
– gift your work to friends or family
– sell your work for the cost of the materials
However, you must register with AICIS if you sell products for a profit or use them to market your business — even if you are a small or start-up business. Read more here
ACCC AND RELATED NEWS:
The ACCC is providing updates on its work in scrutinising misleading online reviews and influencer endorsements. The social media influencer sweep was across seven categories – 96% of fashion influencers reviewed were making concerning posts and 73% of gaming and technology influencer posts raised concern. A separate sweep of online reviews found that 37% of businesses reviewed had engaged in concerning conduct. Source: ACCC
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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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