Issue 234, March 2023
Sponsor an issue of this newsletter and promote your company to thousands of potential customers! To enquire, contact us on firstname.lastname@example.org
2.10 Advertising and Social Media in Australia and New Zealand: This course has been our most popular course to date! We have received many bookings since launching it in February and participants have reiterated the great value the content delivered to their business. This two-hour course covers multiple product categories in the natural health industry, including listed medicines (AU), dietary supplements (NZ), foods and cosmetics. Read more here
1.20 Cosmetic Regulations – Claims, Advertising, Labelling and Ingredients: we have revised our two cosmetics courses for Australian compliance and combined them into one two-our course. Details on the revised course here.
New cosmetics courses coming soon covering the complicated issues around AICIS ingredient introduction categories, which will include how to manage listed, exempted, reported and assessed ingredients.
And don’t forget we still have course 3.01. Cosmetics in New Zealand information is here
Follow us on LinkedIn: We hope you like our newsletter. If you want to receive up-to-the-minute announcements on new courses, new content and vital regulatory updates follow us on LinkedIn.
Complementary Medicines and Medical Devices:
Ozempic scam. TGA is warning consumers to be alert to scams promotingsemaglutide (Ozempic) for weight loss. It is illegal in Australia to promote this product. In many cases consumers who paid for products online failed to receive any product, while in other cases the product received was not semaglutide. Source: TGA
General guidance for listed medicines. A recently published TGA webpage provides guidance on recent changes to conditions of listing for low risk medicines (including most complementary medicines, herbal and nutritional medicines). General summary here. Refer to the legislation Therapeutic Goods (Listed Medicines—Conditions of Listing) Determination 2022 here.
Latest version of ingredients permitted in listed medicines (Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2023) is here. This webpage summarises the changes made to 25 permitted ingredients. The ingredient caprylic/capric glycerides has been removed from the list and a new ingredient Calanus finmarchicus oil has been added to the permitted ingredients list. Useful information about changes to the permissible ingredients determination can be found here.
Calanus finmarchicus oil – the compositional guideline has been finalised and is published here.
Additional countries added to GMP clearance for MRA pathway. Before an application for a new medicine manufactured overseas can be submitted to the TGA, the GMP status of the manufacturer has to be pre-cleared by the TGA through the Mutual Recognition pathway (MRA) or the Compliance Verification pathway (CV) . Only certain countries have the necessary GMP standard for their documents to be assessed by the TGA. The countries that have been added are Croatia, Estonia, Romania, Slovenia and Lithuania, all members of the EU. The GMP inspection of the manufacturer must be performed within the borders of the country. Source: TGA. Information on international agreements for GMP clearance is here. For complementary medicines, a licence of an overseas manufacturer that indicates that they comply with dietary supplement or food GMP (e.g. a NSF GMP certificate) is not acceptable.
Listed medicines for exercise performance. TGA is reviewing selected listed medicines to evaluate evidence to support indications related to exercise performance. The TGA press release includes “The Australian Institute of Sport released a position statement in 2021 to support informed decisions and safe practices around supplement use for enhancing exercise performance. The statement identified certain supplement ingredients that have insufficient scientific evidence to support their efficacy for exercise performance.” Source: TGA
Pregnancy warning statements. The TGA reviewed 20 listed medicines that contained either Azadirachta indica or Piper methysticum that require the inclusion of pregnancy warning statements on the respective labels. Summary of findings available here.
Changes to medical device essential principles for nanomaterials. Particular attention must be given to the chemical and physical properties and biocompatibility of materials used in medical devices in relation to nanomaterials. Additional details included in Clause 7.7. Source: TGA. Download the essential principles checklist in PDF or Wordhere.
How to prescribe or get access to MDMA or psilocybin from 1 July 2023. Authorised psychiatrists can prescribe products containing 3,4‑methylenedioxy‑ methamphetamine (MDMA) or psilocybin for specific mental health conditions from 1 July 2023. MDMA may be used for the treatment of post-traumatic stress disorder. Psilocybin may be used for treatment-resistant depression. How to become an authorised prescriber, how to access the products, and frequently asked questions posted here.
Medicinal cannabis hub. Information about access pathways for medicinal cannabis products, patient access data, information for consumers. Also how the TGA provides safe and legal access to medicinal cannabis products in appropriate circumstances. information for health professionals, clinical guidance, and information for sponsors and manufacturers about product quality, manufacturing standards and reporting requirements for supply of medicinal cannabis products. Source: TGA
Infringement notices: A list is available here, this indicates who was issued with the notice, the amount of the infringement notice and the alleged contraventions of the Therapeutic Goods Act that led to the infringement notice being issued.
Christopher Ramsey sentenced to 2 years imprisonment with personal and company fines of over $2.5 million for selling illegal SARMs (Selective Androgen Receptor Modulators) and nootropic products. This was not the first infringement issued. The companies fined were AusLabs, Smart Labs and iSARMs. Source: TGA. Press articles available here and here
JSHealth Vitamins fined $13,320 for alleged unlawful supply of a complementary medicine containing the ingredient Andrographis paniculata which did not include the mandatory warning statement warning of taste disturbance, including loss of taste and possible allergic reaction. (This is not the same infringement as the one included on our February newsletter for JSHealth). Source: TGA
More than 55,000 potentially dangerous products seized. The TGA, with the assistance of NSW Police, executed 3 search warrants connected to an individual as part of an investigation into the alleged importation, advertising and supply of unapproved medicines including potentially dangerous products containing alkyl nitrite, commonly known as ‘poppers’, and unapproved prescription medicines for erectile dysfunction. Source: TGA
Contract Manufacturing & Packaging Services, a TGA licensed manufacturer, fined $160,000 for breaching conditions of manufacturing licence in relation to testing. Source: TGA
Updated Safe Food Australia Guide. This incorporates the new Standard 3.2.2A Food safety management tools, which comes into effect in December 2023. Source: FSANZ
NSW Food Regulation 2015 primarily concerned with food safety,is scheduled for statutory repeal on 1 September 2023 – a formal process which occurs every five years that requires the NSW Government to determine whether the Regulation should lapse and, in doing so, allow self-regulation, or be remade as is, or be remade with amendments. Source: NSW Food Authority
Plain English allergen labelling requirements. New requirements commenced on 25 February 22021 and businesses were given 3 years to transition to the new requirements plus an additional 2 years for food that has been correctly labelled before 25 February 2024. Food businesses have less than 12 months to ensure all products are correctly labelled from 25 February 2024. The changes include using consistent names that are simple, plain English and in bold font, and displaying declarations in a specific format and location on food labels. Source: NSW Food Authority
NSW Food Authority inspections and audits from October 2022 to December 2022. Licensed meat businesses:compliance remains high, improving by 1% to 95% overall, compared with the same period in 2021. Licensed seafood businesses: a 2% drop in compliance, now at 95%. Licensed dairy businesses: compliance remains high at 95%. Licensed egg businesses: compliance remains high, improving by 1% to 96% overall. Licensed plant product businesses: a significant drop in compliance, down 9%. Licensed hospitals and aged care businesses: compliance remains high, improving by 1% to 98% overall. Source: NSW Food Authority
Application A1245 – Alpha-glucosidase from GM Trichoderma reesei as a processing aid in brewing. Written submissions invited on the assessment of the additional use of alpha-glucosidase from Trichoderma reesei containing the alpha-glucosidase gene from Aspergillus niger as a processing aid in brewing of beer. Submissions close 6pm (Canberra time) 25 April 2023. Source: FSANZ
Approval: A1252 – Glucoamylase from GM Aspergillus niger (gene donor: Penicillium oxalicum) as a processing aid Source: FSANZ
Approval: A1253 – Bovine lactoferrin in infant formula productsSource: FSANZ
Amendment 216 to the Food Standards Code was published on 2 March 2023 and included amendments from A1220 – Beta-amylase from GM Bacillus licheniformis as a processing aid, A1221 – Phospholipase A1 from GM Aspergillus niger as a processing aid, A1224 – Glucose oxidase from Penicillium rubens as a processing aid, and A1251 – 2ʹ-FL combined with galacto-oligosaccharides and/or inulin-type fructans in infant formula products Source: FSANZ
New applicationA1250 – Pullulanase from Bacillus subtilis as a processing aid. To permit pullulanase sourced from a genetically modified strain of Bacillus subtilis containing the pullulanase gene from Bacillus deramificans, as a processing aid in starch processing for the production of glucose syrups and other starch hydrolysates. Source: FSANZ.
New application A1269 – Cultured Quail as a Novel Food. Includes a novel process to grow meat without harming animals. Source: FSANZ
Counter Culture Eirinn Irish Cream Stout – presence of an undeclared allergen – Milksource: Food Authority NSW
Ceres Organics Organic Hulled Tahini 300g and Ceres Organics Organic Unhulled Tahini 300g – potential microbial (Salmonella) contamination – Source: NSW Health
K-mama Enoki Mushrooms (300g) – microbial (Listeria monocytogenes) contamination. Source: NSW Health
Doughstory Classic Paratha Jumbo Pack – presence of undeclared allergens (milk and egg) NSW Health
Your Mates Brewing Co Watermelon Sour Beer 375mL – secondary fermentation, excess alcohol and carbonation may cause illness/injury if consumed. Source: NSW Health
Georgia Food Crown Couque D’asse White and Crown Couque D’asse Coffee – undeclared allergens milk, egg and hazelnut Source: NSW Health
Noosa Hinterland Nakula Plant Based Probiotic Coconut Yoghurt Natural 500g – undeclared allergen (milk) Source: NSW Health
Mediterranean Delicacies – Baklava Traditional Assortment – undeclared allergen (Peanut) Source: FSANZ
Woolworths Market Value 24 Thin Beef Sausages – presence of foreign matter (Plastic)Source: FSANZ
Cosmetics, Personal Care and TGA Listed Sunscreens:
Common enquiries – relevant to importers of cosmetics. Topics included with links:
Evaluations open for comment until 19 May 2023. Comments welcome on 17 draft evaluation statements on 1,768 chemicals. Consultation open until 11:59 pm 19 May 2023. List of chemicals and online form available for comments. Source: AICIS
List of current and completed evaluations updated March 2023. Includes an extended timeframe to complete the evaluation on water-soluble zinc salts (EVA00105) Source: AICIS
Variation of Inventory listing following revocation of CBI approval – 7 March 2023 details here.
Chemicals added to the Inventory 5 years after issue of assessment certificate. 23rdMarch 2023. (chemical names not included herein, refer to AICIS link here)
ACCC news (relevant to all product categories)here)
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.
2023-2024 compliance and enforcement priorities. The key issues “cost of living pressures, the price of essential services including energy and telecommunications, the integrity of environmental and sustainability claims, ever increasing losses to scams, consumer and fair trading harms from manipulative marketing practices in the digital economy and the always high risk to markets, business rivals and consumers from anti-competitive conduct, strongly feature in our priorities.” Source: ACCC
“Greenwashing” internet sweep. “Of the 247 businesses reviewed during the sweep, 57 per cent were identified as having made concerning claims about their environmental credentials. The cosmetic, clothing and footwear and food and drink sectors were found to have the highest proportion of concerning claims among the industries targeted in the operation” and “Businesses using broad claims like ‘environmentally friendly’, ‘green’, or ‘sustainable’ are obliged to back up these claims through reliable scientific reports, transparent supply chain information, reputable third-party certification or other forms of evidence.” Business are encouraged to state how their product is environmentally friendly. Source: ACCC
To learn more about how to comply with ACCC requirements, book our course 2.10. Social Media and Advertising which you can read about here
Published by Regulatory Training Direct www.regulatorytrainingdirect.com
Providing regulatory training courses for complementary medicines, GMP, foods, cosmetics. dietary supplements.
This newsletter is sent at no charge. You are welcome to forward this to any colleagues who may find it useful. To receive this newsletter regularly click here
Become a sponsor
Showcase your business! Become a Current Affairs sponsor today. To find out more contact us on email@example.com