Issue 236 | May 2023
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AU Complementary medicines – course 1.03. Labels – this course has been updated and is now available. Information here.
Pharmacovigilance obligations: We have an Associate Professor of Medicine available to be your pharmacovigilance “qualified person” if required. For information contact firstname.lastname@example.org
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Complementary Medicines and Medical Devices:
Ingredients permitted in listed medicines. This was updated in May, with 3 ingredients added, 11 ingredients changed, and 25 ingredients removed (mainly common names of herbal ingredients). Summary of changes here, and the new list of permitted ingredients is here.
GMP clearance processing times. The TGA has a high volume of GMP clearance extension applications resulting in delays in processing times. The TGA advises sponsors to submit extension applications at least one month prior to the expiry date of prior GMP clearance. More information here.
Medical devices and EU transition extension. As the EU has extended the transition period, the TGA is to review its strategy, and is to review the impact on reclassification reforms underway in Australia. Various classes of medical devices have different transition periods. Source: TGA
Prescribing Medicines in Pregnancy database has now been updated to include 12 new entries, and one amended entry (raltegravir). Source: TGA
In vitro diagnostic (IVD) medical devices. The transition period for the TGA to accept ISO 13485 certificates as manufacturer evidence for ended on 26 May 2023. This means the TGA can no longer accept ISO 13485 certificates to support IVD inclusion applications. Source: TGA
Plant parts. There is sometimes confusion as to the name of the part of a herb that the herbal medicine is derived from. This page lists and defines the correct terms to use in product applications and on medicine labels if the product contains plant parts as part of its herbal ingredients.
Application to amend the poisons standard. A new form is available and feedback is requested by 15th July 2023. View the new form here.
Six infringement notices totalling $15,984 have been issued to an individual in Queensland for the alleged unlawful importation of nicotine vaping products. The importer owns a tobacco store. More information here.
Five infringement notices totalling $13,320 to 3 health practitioners for the alleged unlawful importation of unregistered prescription-only medicines. The three separate cases included a Queensland-based osteopath who allegedly imported 2 strengths of unregistered injectable procaine – a prescription-only general anaesthetic, a New South Wales-based general practitioner who allegedly imported unregistered botulinum toxin type A – a prescription-only medicine often used in cosmetic procedures to smooth wrinkles on the face, and a Victoria-based dentist who allegedly imported unregistered tinidazole – an antibiotic. Source: TGA
Guidance on applying the advertising rules. Updated 12th May 2023. Divided into sections reflecting the various Parts of the Advertising Code. Numerous examples are provided for compliant and non-compliant advertising. TGA summary here and links to individual parts are below:
Parts 2 and 3 … when does the code apply to advertising and general principles including that it is accurate, balanced, not misleading, is substantiated, and encourages the safe and proper use of therapeutic goods.
Parts 4 and 5 .. mandatory statements and requirements for particular therapeutic goods including analgesics, complementary medicines (including vitamins and minerals), sunscreens and weight management.
Part 6 .. testimonials and endorsements, including disclosure of “valuable consideration” (various forms of payment)
Part 7 – samples and incentives – includes what types of products are allowed to be advertised as free samples
Part 8 .. restricted representations or claims referring to a serious form of a disease, condition, ailment or defect
Part 9 .. providing information to the general public about the price of prescription medicines and certain pharmacist-only medicines
Botanical adulterants. In his talk at the International Conference on the Science of Botanicals (ICSB) 2023, the American Botanical Council’s ABC Chief Science Officer Stefan Gafner discussed the impact of Covid-19 on the supply chain and quality of botanical ingredients. Using publicly available information from investigations into the authenticity of popular herbal dietary supplement ingredients such as echinacea, elder, and ginkgo, he presented estimated rates of adulteration before and during the pandemic.
Summarised in the link below are the findings from 28 investigations into the authenticity of commercial ginkgo extracts conducted between 2003 and 2023. While the sample sizes varied between the investigated periods, it is evident that the percentage of adulteration has been increasing progressively over time.
The abstract of the presentation is available from this link https://lnkd.in/gKvyQurz.
Follow the Botanical Adulterants Prevention Program on LinkedIn
Investigation into e-cigarettes. Queensland Government’s investigation finds ‘staggering’ levels of nicotine and toxic materials. One 5mL vape was found to have the same amount of nicotine as 6 packets of cigarettes. In all, 17 vapes were tested and found to also include arsenic, formaldehyde, zinc and other toxic metals including lead, mercury, nickel, chromium, antimony, aluminium, iron, nickel, barium, manganese, copper, strontium and vanadium. Source: Joint statement from Premier of Queensland and Minister for the Olympic Games, and the Queensland Minister for Health, Mental Health and Ambulance Services and Minister for Women
New safety warning for medicines used in arthritis and other inflammatory conditions. This mainly effects a class of medicines called Janus Kinase inhibitors. Source: TGA
Changes to pack sizes of paracetamol products. Due to the high number if people admitted to hospital with liver injury, and suicides among adolescents and young adults, the new restrictions are: – reduce the maximum size of packs available for general sale (e.g. supermarkets and convenience stores) from 20 to 16 tablets or capsules – reduce the maximum size of packs available in pharmacies without the supervision of a pharmacist (i.e. ‘Pharmacy Only’ packs) from 100 to 50 tablets or capsules – make other pack sizes of up to 100 tablets or capsules available only under the supervision of a pharmacist (‘Pharmacist Only’ medicines). Source: TGA
Fake vials of Ozxemopic/semaglutide. TGA has detected counterfeit products being imported into Australia. Laboratory testing confirmed that Global Health Pharmaceuticals and Therapeutics branded Semaglutide 5mg vial, and Peptides Lab branded Semaglutide 10mg vial, did not contain semaglutide as labelled. Another reason to only buy products that are included on the ARTG (Australian Register of Therapeutic Goods) as the internet is awash with counterfeit and adulterated products. Source: TGA
Eve Allylisopropylacetylurea (apronal) tablets. TGA warns against importing products containing apronal, a hypnotic sedative that was withdrawn from clinical use in Australia due to dangerous side effects and is banned in most countries in the world. It can go by many names including apronalide, ACE and (2-Isopropyl-4-pentenoyl) urea. Products found to contain apronal include EVE Quick for Headache, EVE Quick for Headache DX, EVE A and EVE A EX. Source: TGA
In the press
A diabetes drug is being used for ‘easy’ thinness. Is it as magical as it seems? This article discusses the pros and cons of using Ozempic/semaglutide for weight loss and the quality of products supplied online. Sydney Morning Herald.
New applications and proposals
Application A1236 – Low-THC hemp leaf, seed sprout and root as food and food ingredients
To permit the sale of low-THC hemp leaf, seed sprout and root as food and food ingredients in Australia and New Zealand.
Application A1272 – Food derived from herbicide-tolerant and insect-protected corn line DP915635
To permit the sale and use of food derived from corn line DP915635, genetically modified for herbicide-tolerance and protection from insect pests.
Application A1274 – Food derived from disease-resistant banana line QCAV-4
To permit the sale food derived from banana line QCAV-4, genetically modified for resistance against the fungal disease fusarium wilt tropical race 4.
Pregnancy warning labels. Requirements for pregnancy warning labels on alcoholic beverages were introduced on 31 July, 2020. Optional alternative requirements for pregnancy warning labels for corrugated cardboard outer packaging were also introduced on 4 May 2023. These downloadable files include items such as label elements, font type, clear space around pregnancy warning mark and label colours. Examples of labels and downloadable files can be found on this FSANZ webpage
Current calls for comment updated 26th April 2023 (from FSANZ):
Proposal P1028– Infant Formula: To revise and clarify standards relating to infant formula products comprising category definitions, composition, labelling and representation of products. To read the call for submissions report click here. Submissions on this application are due by 6pm (Canberra time) 7 July 2023.
Application A1264 – Food derived from drought-tolerant and herbicide-tolerant soybean line IND-00410-5: To seek approval for food derived from soybean line IND-00410-05, genetically modified for drought and herbicide tolerance. To read the call for submissions report click here. Submissions on this application are due by 6pm (Canberra time) 7 June 2023.
Application A1266 – Endo-1,4-beta-xylanase from GM Trichoderma reesei (gene donor: Fusarium verticillioides) as a processing aid: To permit the use of endo-1,4-beta-xylanase sourced from a genetically-modified strain of Trichoderma reesei containing the endo-1,4-beta-xylanase gene from Fusarium verticillioide as a processing aid in starch processing and the production of potable alcohol. To read the call for submissions report click here. Submissions on this application are due by 6pm (Canberra time) 10 July 2023.
Korea Connections Enoki Mushrooms 300g – due to the contamination of Listeria monocytogenes and no instructions to cook the product prior to consumption. Source: FSANZ.
My Queen – Bourbon Petite Crackers Seaweed Salt (45g) – due to the presence of an undeclared allergen (sesame). Source: FSANZ
Coca-Cola Europacific Partners – Barista Bros Products – due to a potential packaging failure leading to a possible contamination risk. Source: FSANZ
Woolworths Cookies & Cream Classic Ice Cream Sandwiches 4 Pack (440mL) – due to presence of foreign matter (Metal). Source: FSANZ
Stuart Alexander – Hershey’s Syrup Indulgent Caramel Flavor – due to the presence of an undeclared an allergen (milk). FSANZ
Jabsons Roasted Peanut Thai Sweet Chilli, Jabsons Tandoori Kaju (Cashew) – due to the presence of an undeclared allergen (milk). Source: FSANZ
Big Shed Brewing Concern – Mango Sour Beer – due to secondary fermentation. Source: FSANZ
Efoodz – Thai Chilli Chicken Meatballs – due to the presence of an undeclared allergen (soy). Source: FSANZ
Smith’s Original and Cheese and Onion Chips – due to the potential presence of foreign matter (plastic pieces). Source: FSANZ
Fortitude Brewing Company – 6 and 24 packs of Pacer Beer – due to secondary fermentation. Source: FSANZ
Patties Foods – Leggo’s Fresh Ricotta & Vegetable Tortellini (630g) – due to contamination with foreign matter (metal). Source: FSANZ
Aldi – OceanRise Anchovy Fillets in Olive Oil (100 g) and OceanRise Anchovy Fillets in Olive Oil with Chilli (100 g) – due to elevated histamine levels. Source: FSANZ
Food recall statistics (1 January 2013 – 31 December 2022). A very interesting summary for a period of 10 years. FSANZ conducted 791 recalls in this period. They state “Most recalls are precautionary and initiated by food businesses to ensure that potentially unsafe food is removed from distribution and sale. Only a small amount of recalls are linked to a suspected or confirmed illness/injury”. Common reasons for recalls are undeclared allergens, microbial contamination and presence of foreign matter. The most commonly recalled foods were mixed and/or processed food (likely due to the wide range of foods that are categorised under this heading, including most long-life packaged food and manufactured items that contain multiple ingredients). Fruits, Vegetables and herbs were the second most recalled food category, with Dairy Products the third. Source: FSANZ. A summary of Undeclared allergen food recall statistics for this same period is available here.
Additional food news provided by Correct Food Systems
FSANZ: has deferred the proposal for the addition of “added sugar” as a line to nutrition panels until at least November.
Queensland: The Qld government has announced that starting from 1st Nov 2023 the 10c container deposit scheme will be expanded to include wine and spirit containers ranging in size from 150ml to 3 litre. Timeframes for transition to use existing packaging and for stock in trade have not been announced. The NT, WA and NSW governments have also announced that they intend to expand the scheme, but details are not yet forthcoming
Following the consultation, New Zealand Food Safety has updated the following documents:
Cosmetics, Personal Care and TGA Listed Sunscreens:
Updated guidelines for sunscreens. Published by the TGA on 9th May 2023, to align with the data requirement for all ingredients proposed to be included in the list of permitted ingredients. TGA summary information is here and the latest list of ingredients permitted in listed medicines is here.
Variation of inventory listing
The Executive Director varied the terms of the Inventory listings for the following chemicals because approval had been revoked for the proper names of the industrial chemicals to be treated as confidential business information (CBI).:
CAS number 2919696-28-7
CAS number 2919696-30-1
Chemical added to the Inventory following the issue of an assessment certificate: CAS 2126832-70-8
List of new chemical assessment statements published 30th May 2023
CA09524-Fragrance ingredient in fine fragrances, cosmetics and household products
CA09651-Fragrance ingredient in fine fragrances, cosmetics and household products
CA09589-UV filter in cosmetic (secondary sunscreen) products
CA09641-Fragrance ingredient in fine fragrances, cosmetics and household products
Additional cosmetic news provided by pH Factor:
Australian recycling label
As we work towards the 2025 National Packaging Targets, all businesses should be prepared for government intervention and taxes if these targets are not met by businesses.
For ALL packaging, there will no longer be the one recyclable logo with a digit inside.
(for images of packaging symbols click on links)
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.
Court enforceable undertaking. Universal Pharmaceuticals admitted that representations on its Wealthy Health website that a product contained squalene from sharks in Australian waters were likely misleading, in breach of the Australian Consumer Law. Between February 2021 and October 2022, Universal Pharmaceuticals published statements on the Wealthy Health website that its ‘Organic Squalene 1000mg with Vitamin E’ product is ‘sustainably sourced from sharks from the crystal-clear oceans of Australia’ and ‘obtained from the clear oceans surrounding Australia’. The ACCC was concerned that Universal Pharmaceuticals was aware since 2019 that its squalene supplier was unable to guarantee that the squalene it supplied was sourced exclusively from sharks from Australian waters. Universal Pharmaceuticals has undertaken not to make representations that its products contain squalene from sharks sourced from Australia waters unless it has evidence to support these claims. The company also agreed to publish a corrective advertisement on the relevant product page of the Wealthy Health website for 90 days and establish and implement an Australian Consumer Law Compliance program. Source: ACCC and a copy of the undertaking can be found here.
National Anti-Scam Centre. The ACCC has been allocated $58 million in funding to establish the National Anti-Scam Centre., which will enable it to receive a report of a scam from any institution (private or government) and centralise this intelligence, distribute data to those who need it most – such as banks to freeze an account, telcos to block a call, digital platforms to take down a website or account, and to analyse and act on the trends sourced from this data to disrupt scams and educate Australians. Source: ACCC
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Published by Regulatory Training Direct www.regulatorytrainingdirect.com
Providing regulatory training courses for complementary medicines, GMP, foods, cosmetics and dietary supplements.
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